Prior Authorization Criterion Form
PRIOR AUTHORIZATION CRITERIA Effective 4/28/2026
Field Name
Field Description
Prior Authorization
Group
Oncology Drugs/Therapies
Drugs
Oncology Medications and Oncology Gene Therapies (specialty or non-
specialty) without product specific criteria when requested for an oncology
diagnosis
Covered Uses
Medically accepted indications are defined using the following sources: the
Food and Drug Administration (FDA), Micromedex, American Hospital
Formulary Service (AHFS), United States Pharmacopeia Drug Information for
the Healthcare Professional (USP DI) , and the Drug Package Insert, and/or per
the National Comprehensive Cancer Network (NCCN)
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert or NCCN guidelines
Prescriber
Restrictions
Prescribed by or in consultation with an oncologist, or specialist in type of
cancer being treated
Coverage Duration If the criteria are met, the request will be approved for up to 6 month duration.
Other Criteria
All of the following criteria must be met: • Requested use must be a labeled indication or be supported by NCCN Category 1 or 2A level of evidence. If the request is for an off-label use supported by NCCN as Category 2B recommendation then medical documentation has been provided as to why member is unable to utilize a treatment regimen with a higher level of evidence (e.g. allergic reaction, contraindication) • Documentation has been provided of the results of all required genetic testing where required per product package insert • Documentation has been provided of the results of all required laboratory values and patient specific information (e.g. weight, ALT/AST, Creatine Kinase, etc.) necessary to ensure the patient has no contraindications to therapy per product package insert • The product is being prescribed at a dose and duration that is within FDA approved/NCCN guidelines. • Request to initiate therapy with an oral, non-preferred brand drug with a therapeutically equivalent (AB-rated) generic drug currently available, will require a 30-day trial and failure or documented medical reason for not using, the generic equivalent drug • If the request is for a non-preferred reference biologic drug with either a biosimilar or interchangeable biologic drug currently available, documentation of one of the following: o The provider has verbally or in writing submitted a member specific reason why the non-preferred reference biologic is required based on the member’s condition or treatment history;
Revision/Review 7/2025 AND if the member had side effects or a reaction to the biosimilar or interchangeable biologic, the provider has completed and submitted an FDA MedWatch form to justify the member’s need to avoid these drugs. The MedWatch form must be included with the prior authorization request o The currently available biosimilar product does not have the same appropriate use (per the references outlined in “Covered Uses”) as the reference biologic drug being requested • If the request is for Danziten or nilotinib, the member has a trial and failure of or documented medical reason why Tasigna cannot be used
Form FDA 3500 – Voluntary Reporting
• If the request is for abiraterone (Zytiga) 500 mg tablet, a documented medical reason why two tablets of generic abiraterone acetate 250 mg cannot be used
Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Medications without Drug or Class Specific Criteria
Drugs
•
Medications without drug or class specific prior authorization
criteria
•
Brand drugs and reference biologics when a therapeutic
equivalent generic drug or biosimilar/interchangeable
biologic is available
The Oncology Drugs prior authorization criteria will be applied
to oncology drugs without drug or class specific criteria
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber Restrictions
N/A
Coverage Duration
If all of the conditions are met, requests will be approved for up to
12 months (depending on the diagnosis and usual treatment
duration).
Other Criteria
Initial Authorization:
All Requests:
•
The drug is requested for an appropriate use (per the
references outlined in “Covered Uses”)
•
The dose requested is appropriate for the requested use (per
the references outlined in “Covered Uses”)
•
Patient meets one of the three following criteria:
o
Documented trial and failure or intolerance of two
alternative formulary/preferred medications
appropriate for the requested use (per the references
outlined in “Covered Uses” or has a medical reason
why these drug(s) cannot be used [e.g. intolerance,
contraindication]). For medications where there is
only one preferred agent, only that agent must have
been ineffective or not tolerated.
o
No other preferred medication has a medically
accepted use for the patient’s specific diagnosis as
referenced in the medical compendia.
o
All other preferred medications are contraindicated
based on the patient’s diagnosis, other medical
conditions, or other medication therapy.
Revision/Review Date 10/2025 Brand drugs with a therapeutically equivalent (A-rated) generic drug currently available: • The provider either verbally or in writing has submitted a medical or member specific reason why the brand name drug is required based on the member’s condition or treatment history; AND if the member had side effects or a reaction to the generic drug, the provider has completed and submitted an FDA MedWatch form to justify the member’s need to avoid this drug. The MedWatch form must be included with the prior authorization request Form FDA 3500 – Voluntary Reporting Reference biologic drugs with either a biosimilar or interchangeable biologic drug currently available: • The prescriber has verbally or in writing submitted a medical or member specific reason why the reference biologic is required based on the member’s condition or treatment history; AND if the member had side effects or a reaction to two (if available) biosimilar or interchangeable biologics, the provider has completed and submitted an FDA MedWatch form to justify the member’s need to avoid these drugs. The MedWatch form must be included with the prior authorization • The currently available biosimilar product(s) does not have the same appropriate use (per the references outlined in “Covered Uses”) as the reference biologic drug being requested Form FDA 3500 – Voluntary Reporting Reauthorization: • Documentation of provider attestation that demonstrates a clinical benefit • The requested drug is for a medically accepted dose as outlined in Covered Uses Physician/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Prior Authorization Exception Criteria
Covered Uses
All medically accepted indications. Medically accepted indications are
defined using the following compendia resources: the Food and Drug
Administration (FDA) approved indication(s) (Drug Package Insert),
American Hospital Formulary Service Drug Information (AHFS-DI),
and DRUGDEX Information System. The reviewer may also reference
disease state specific standard of care guidelines.
Scope
Requests for exception to the drug’s prior authorization criteria
requirements
Coverage Duration
12 months
Criteria
•
The provider either verbally or in writing has submitted a
medical or member specific reason why prior authorization
criteria all or in part is not applicable to the member.
o
Medical and/or member specific reasons may include
but are not limited to:
Uniqueness of the member’s condition or other
physical characteristics of the member’s
condition.
Psychiatric, intellectual, physical, cultural,
and/or linguistic characteristics of the member
which may inhibit the provider from obtaining
all necessary prior authorization criteria
requirements.
Medical Director/clinical reviewer may override criteria when, in
his/her professional judgement, the requested item is medically
necessary.
Revision/Review
Date:
10/2025
Field Name Field Description Prior Authorization Group Description Safety Edit Exception Criteria Covered Uses All medically accepted indications. Medically accepted indications are defined using the following compendia resources: the Food and Drug Administration (FDA) approved indication(s) (Drug Package Insert), American Hospital Formulary Service Drug Information (AHFS-DI), and DRUGDEX Information System. The reviewer may also reference disease state specific standard of care guidelines. Scope Requests for formulary drugs and for previously approved non-formulary drugs: • Exceeding the Food and Drug Administration (FDA) or compendia max dose recommendations • Exceeding the FDA dosing or compendia administration frequency recommendations • Exceeding the FDA or compendia duration of therapy recommendations • Duplication of therapy error at Point of Service (POS) • Age Restriction error at POS • Day Supply Limit error at POS • Concurrent Use error at POS • Drug Drug Interaction error at POS Criteria Revision/Review Date: 10/2025 Exceeding the Food and Drug Administration (FDA) or compendia maximum dose, administration frequency or duration of therapy recommendations. • The member must have a documented treatment failure with the drug at the maximum dose based on patient age/weight, administration frequency, or duration of therapy per FDA or compendia. AND • The provider must submit a medical reason why the maximum dose, administration frequency or duration of therapy needs to be exceeded based on the member’s condition or treatment history. Duplication of therapy Transition from one agent to another • If a provider has outlined a plan to transition a member to a similar drug or provided a dose titration schedule, the requested drug is approved for one month*. Concurrent Therapy with two similar agents • The provider must submit a medical reason why treatment with more than one drug in the same class is required based on the member’s condition and treatment history. OR
• The provider must submit disease state specific standard of care guidelines supporting concurrent therapy.
Age Restriction
• The provider must submit a medical reason why the drug is needed for a member whose age is outside of the plan’s minimum or maximum age limit. AND • The indication and dose requested is supported by the Medical Compendia or current treatment guidelines. AND For members over the age of 10: if the request is for an orally disintegrating tablet, the member has a documented trial and failure of the solid dosage form (tablet or capsule) or a reason why the solid dosage form cannot be used. Day Supply Limit
• An additional fill exceeding the day supply limit is needed based on a dose increase or is needed to achieve a total daily dose OR • The provider must submit a medical reason why an additional fill is needed outside of the plan’s day supply limit. AND • The indication and dose requested is supported by the FDA, Medical Compendia or current treatment guidelines. Concurrent Use/Drug-Drug Interaction • The provider must submit a medical reason why treatment with both drugs is necessary for the member AND • The increased risk for side effects when taking the drugs together has been discussed with the member
Medical Director/clinical reviewer may override criteria when, in his/her professional judgement, the requested item is medically necessary.
Coverage Duration *One month approval for Duplication of therapy when transitioning from one agent to another and Day Supply Limit due to a dose increase. All Other Scenarios: 12 months
Field Name Field Description Prior Authorization Group Description Quantity Limit Exception Criteria Covered Uses All medically accepted indications. Medically accepted indications are defined using the following compendia resources: the Food and Drug Administration (FDA) approved indication(s) (Drug Package Insert), American Hospital Formulary Service Drug Information (AHFS-DI), and DRUGDEX Information System. The reviewer may also reference disease state specific standard of care guidelines. Scope Requests for formulary drugs exceeding the health plan’s published quantity limits Criteria • The provider has submitted a medical reason why the plan’s quantity limit will be inadequate based on the member’s condition and treatment history. • The provider has submitted justification for the approval of doubling (or higher) of the number of tablets/capsules per prescription for a medication that has a higher strength tablet/capsule available, stating why that higher dose tablet/capsule cannot be used (e.g. two lorazepam 0.5mg tablets to equal the dose of lorazepam 1mg, when lorazepam 1mg tablet exists) AND one of the following: o The member has a documented treatment failure with the drug prescribed at the health plan’s quantity limit AND the dose requested is supported by the Medical Compendia or current treatment guidelines. o The member requires a dose within prescribing guidelines that exceeds the plan’s quantity limit.
Medical Director/clinical reviewer may override criteria when, in his/her professional judgement, the requested item is medically necessary.
Coverage Duration
12 Months
Revision/Review
Date
10/2025
Field Name
Field Description
Prior Authorization
Group Description
Step Therapy Exception Criteria
Covered Uses
All medically accepted indications. Medically accepted indications are
defined using the following compendia resources: the Food and Drug
Administration (FDA) approved indication(s) (Drug Package Insert),
American Hospital Formulary Service Drug Information (AHFS-DI), and
DRUGDEX Information System. The reviewer may also reference disease
state specific standard of care guidelines.
Scope
Requests for drugs on the plan’s formulary with a step therapy restriction
which do not meet step therapy requirements
Criteria
Requests for drugs on the plan’s formulary with a step therapy restriction
which do not meet step therapy requirements will be considered when the
provider verbally or in writing has submitted a medical reason why:
•
Required step therapy drug(s) would be ineffective, or;
•
Required step therapy drug(s) have the potential to cause harm or
deterioration of the member’s condition, or;
•
The requested drug would be superior to the required prerequisite
trial(s) with preferred drug(s).
Medical Director/clinical reviewer may override criteria when, in
his/her professional judgement, the requested item is medically
necessary.
Coverage Duration
12 Months
Revision/Review
Date:
10/2025
Field Name
Field Description
Prior Authorization
Group Description
Off-Label Uses Criteria
Drugs
Medications with off-label uses
Covered Uses
Off-label uses: Medically accepted indications are defined using the
following sources: American Hospital Formulary Service-Drug
Information (AHFS-DI), Truven Health Analytics Micromedex
DrugDEX (DrugDEX), National Comprehensive Cancer Network
(NCCN) Drugs and Biologics Compendium, Wolters Kluwer Lexi-
Drugs, and Elsevier/Gold Standard Clinical Pharmacology and/or
positive results from two peer-reviewed published studies.
Exclusion Criteria
N/A
Required Medical
Information
See “other criteria”
Age Restrictions
N/A
Prescriber Restrictions
N/A
Coverage Duration
If the criterion is met, the request will be approved for up to a 12
month duration (depending on the diagnosis and usual treatment
duration).
Other Criteria
Authorization:
- One of the following:
a. Patient has had a documented trial and or intolerance
with up to two preferred medications used to treat the
documented diagnosis, or for medications where
there is only one preferred agent, only that agent must
have been ineffective or not tolerated.
b. No other formulary medication has a medically
accepted use for the patient’s specific diagnosis as
referenced in the medical compendia
AND - One of the following:
a. Medication is being requested for an accepted off-
label use and is listed in the standard clinical decision
support resources (as noted in Covered Uses section
above)
b. Requested use can be supported by at least two published peer reviewed clinical studies AND
Revision/Review Date
4/2025
Medication is being requested at an appropriate dose per literature
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description 5-Hydroxytryptamine-3 Serotonin Receptor Antagonists (5-HT3 RA), Substance P/Neurokinin 1 Receptor Antagonists (NK1 RA), and Combination Agents Drugs Preferred (Step 1):
5-HT3 RA: ondansetron (Zofran) oral tablet, orally disintegrating tablet (ODT), oral solution, IV solution, injection (IV/SQ) solution or granisetron (Kytril) oral tablet, IV solution
NK1 RA: aprepitant (Emend) oral capsule, fosaprepitant (Emend) IV emulsion
Preferred (Step 2):
5-HT3 RA: palonosetron (Aloxi) IV solution
Non-Preferred:
Sustol (granisetron ER) SQ injection, Sancuso (granisetron ER) transdermal patch, Zuplenz (ondansetron) oral film, dolasetron (Anzemet) oral tablet, Cinvanti (aprepitant) IV emulsion, Emend (aprepitant) oral suspension, Varubi (rolapitant) oral capsule, Akynzeo (palonosetron/netupitant) oral capsule, IV solution, Focinvez (fosaprepitant), Posfrea (palonosetron) IV solution
Any other newly marketed agent Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), and the Drug Package Insert (PPI). Exclusion Criteria None Required Medical Information See “Other Criteria” Age Restrictions None Prescriber Restrictions Prescribed by a specialist in the field to treat the patient’s respective medical condition Coverage Duration If all of the conditions are met, the request will be approved for up to 6 months or as long as recommended by the medical compendium and/or per the NCCN/ASCO standard of care guidelines. Other Criteria
• The medication is being requested for a Food and Drug Administration (FDA) approved indication or a medical condition that is supported by the medical compendium, the National Comprehensive Cancer Network (NCCN), and/or American Society of Clinical Oncology (ASCO) standard of
Revision/Review Date 10/2025 care guidelines for antiemetic therapy. • The requested dosing of the 5-HT3 RA and/or NK1 RA is within FDA approved, NCCN/ASCO or other medical compendia standard of care guidelines • Patients meeting one of the following criteria may receive the generic 5-HT3 RA palonosetron hydrochloride without prior trial and failure of ondansetron/granisetron o Adult patients receiving an antineoplastic agent with HIGH or MODERATE emetic risk per the NCCN Practice Guidelines o Pediatric patients receiving an antineoplastic agent with HIGH emetic risk per the NCCN Practice Guidelines who are unable to receive dexamethasone • For all other patients, if the medication request is for any 5-HT3 RA other than ondansetron, granisetron, or an NK1-RA other than aprepitant oral capsule or fosaprepitant IV emulsion: o The patient has a documented treatment failure after receiving an adequate trial of a preferred 5-HT3 RA and a preferred NK1 RA and/or has a documented medical reason (intolerance, hypersensitivity, contraindication, etc.) for not utilizing these medications to treat their medical condition.
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization
Group Description
Acute Migraine Treatments
Drugs
Preferred:
Ubrelvy (ubrogepant) – If the request is for migraine prevention please refer to the
Calcitonin Gene-Related Peptide (CGRP) Antagonists for Headache Prevention criteria
Non-preferred:
Reyvow (lasmiditan)
Nurtec ODT (rimegepant)
Zavzpret (zavegepant)
Symbravo (rizatriptan and meloxicam)
any newly marketed treatment for acute migraine
Covered Uses
Medically accepted indications are defined using the following sources: the Food and
Drug Administration (FDA), Micromedex, American Hospital Formulary Service
(AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
Member is 18 years of age or older
Prescriber Restrictions
Prescribed by or in consultation with a neurologist
Coverage Duration
If all of the criteria are met, the initial request will be approved for 3 months. For
continuation of therapy the request will be approved for 6 months.
Other Criteria
Initial Authorization:
•
Diagnosis of migraine headache
•
Requested dose is within FDA approved dosing guidelines
•
Documented trial and failure of (or medical justification for not using) two triptan
products
•
Attestation the patient was counseled regarding not driving or operating
machinery until at least 8 hours after taking each dose (Reyvow only)
•
If the request is for a non-preferred drug, a documentation of trial and failure or
medical reason for not using a preferred drug.
•
If the request is for a Symbravo, a documentation of trial and failure or medical
reason for not using the separate ingredients meloxicam and rizatriptan
concurrently
•
Medication will not be used in combination with another CGRP inhibitor for
either acute or preventative treatment of migraine
Criteria for Re-Authorization: • Documentation of improvement in migraine pain and symptom (s) (e.g., photophobia, nausea, phonophobia)
Nurtec ODT QL of 8 units per month.
Revision/Review Date: 1/2026 Reyvow QL of 8 units per month Ubrelvy QL of 16 units per month Zavzpret QL of 8 units per month Symbravo QL of 9 units per month
Criteria for exceeding the quantity limit (note all of the above criteria must also be met) • Documented trial and failure (or a medical justification for not using e.g. hypersensitivity, baseline bradycardia or hypotension, adverse events experienced from previous trial, etc.) with at least one drug from two categories below for at least 4 weeks EACH, at minimum effective doses: o Beta-adrenergic blockers o Topiramate or divalproex ER or DR o Amitriptyline or venlafaxine o Frovatriptan, zolmitriptan or naratriptan (for menstrual migraine prophylaxis)
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Corticotropin Drugs Preferred: Cortrophin (corticotropin) Non-Preferred: Acthar (corticotropin) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria • N/A Required Medical Information See “other criteria” Age Restrictions See “other criteria” Prescriber Restrictions See “other criteria” Coverage Duration If the criteria are met, the request will be approved for up to a 1 month duration. Other Criteria
Infantile Spasms (West Syndrome): • Patient is < 2 years of age • The medication is being prescribed by a neurologist. • Documentation of the patient’s current weight (in kg) and height/length (in cm) or body surface area (BSA)
Multiple Sclerosis: • Documentation was submitted that patient is having an acute attack, with neurologic symptoms and increased disability or impairments in vision, strength or cerebellar function, and has failed therapy with intravenous (IV) methylprednisolone, or a medical reason has been submitted why patient is unable to use IV methylprednisolone. • The medication is being prescribed by a neurologist • If the request is for a non-preferred product, trial and failure of, contraindication to, or medical reason for not using the preferred product
All Other FDA Approved Conditions and Indications:
• Documented trial and failure of an IV corticosteroid AND an
oral corticosteroid, or documented medical reason for why the
patient cannot use these therapies for treatment
• Documentation was provided that ALL other standard therapies
have been used to treat the member’s condition as described in
the medical compendium (Micromedex, AHFS, Drug Points,
and package insert) as defined in the Social Security Act and/or
Revision/Review Date 2/2026 per recognized standard of care guidelines OR there is a documented medical reason (i.e. medical intolerance, treatment failure, etc.) for why all other standard therapies could not be used to treat the member’s condition. • Prescriber is a specialist in the condition they are treating. • If the request is for a non-preferred product, trial and failure of, contraindication to, or medical reason for not using the preferred product
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization Group Description Adakveo (crizanlizumab-tmca) Drugs Adakveo (crizanlizumab-tmca) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions Member must be 16 years of age or older Prescriber Restrictions Prescriber must be a hematologist or sickle cell specialist Coverage Duration If the criteria are met, requests may be approved for 12 months. Other Criteria Revision/Review Date: 2/2026 Initial Authorization: • Member has a confirmed diagnosis of sickle cell disease • Documentation was provided that the member has had 2 or more pain crises in the last 12 months • Documentation was provided that the member has been taking hydroxyurea at the maximum tolerated dose and has been compliant within the last 6 months (or a medical reason was provided why the patient is unable to use hydroxyurea) • Documentation of the member’s current weight • Request is for an FDA-approved dose Reauthorization: • Documentation has been submitted that the member has demonstrated or maintained ONE of the following changes from baseline: o Reduction in pain crises o Increased time between crises o Decrease in days hospitalized • Documentation of the member’s current weight • Request is for an FDA-approved dose Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Adenosine Triphosphate-Citrate Lyase (ACL) inhibitors
Drugs
Nexletol (bempedoic acid)
Nexlizet (bempedoic acid and ezetimibe)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), and the Drug Package Insert (PPI).
Exclusion Criteria
None
Required Medical
Information
See “Other Criteria”
Age Restrictions
18 years or older
Prescriber Restrictions
Prescriber must be a cardiologist or specialist in the treatment of
lipid disorders
Coverage Duration
If all of the conditions are met, the initial request will be approved
with a 3-month duration and all reauthorization requests will be
approved with a 12-month duration.
Other Criteria
Initial Authorization:
All Requests
•
Member must have documentation of baseline low density
lipoprotein cholesterol (LDL-C)
•
Member has tried and failed a high-intensity statin (i.e.
atorvastatin 40-80 mg, rosuvastatin 20-40 mg) at
maximum tolerated dose for 3 months via claim history or
chart notes OR documentation has been provided that the
member is not able to tolerate a statin.
•
Documentation was provided indicating provider has
counseled member on smoking cessation and following a
“heart healthy diet”.
For Hyperlipidemia
•
One of the following:
o
Member has a diagnosis of heterozygous familial
hypercholesterolemia (FH)
o
Member has a diagnosis of primary hyperlipidemia
•
Member has tried and failed ezetimibe at a maximum
tolerated dose or documentation has been provided that the
patient is not able to tolerate ezetimibe.
Revision/Review Date 7/2025 For Cardiovascular Risk Reduction • Member has established cardiovascular disease (documented history of coronary artery disease, symptomatic peripheral arterial disease, and or cerebrovascular atherosclerotic disease) • Member does not have established cardiovascular disease but is considered high risk (one of the following): o Diabetes mellitus (type 1 or type 2) in females over 65 years of age or males over 60 years of age o A Reynolds Risk score > 30% or a SCORE Risk score > 7.5% over 10 years o A coronary artery calcium score >400 Agatston units at any time in the past. • Member has a fasting LDL-C ≥ 70 mg/dL Reauthorization: • Documentation provided that the member has obtained clinical benefit from medication (e.g. LDL-C lowering from baseline) Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Adrenal Enzyme Inhibitors for Cushing’s Syndrome
Drugs
Recorlev (levoketoconazole), Isturisa (osilodrostat)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
• Patients with a non-endogenous source of hypercortisolism, such as
exogenous source of glucocorticoids or therapeutic use of ACTH.
• Patient has a diagnosis of pituitary or adrenal carcinoma
Required Medical
Information
See “Other Criteria”
Age Restrictions
Per FDA approved package insert
Prescriber
Restrictions
Prescriber must be an endocrinologist or in consultation with an
endocrinologist
Coverage Duration
If all of the criteria are met, the initial request will be approved for 6
months. For continuation of therapy, the request will be approved for 12
months.
Other Criteria
Revision/Review
Date: 2/2026
Initial Authorization:
• Patient has a diagnosis of endogenous Cushing’s syndrome.
• Patient is not a candidate for surgery, surgery is not an option, or
prior surgery has not been curative.
• Documented baseline urinary free cortisol (UFC) test ≥ 1.3 times
ULN (within the past 30 days).
• Medication is prescribed at an FDA approved dose.
• For Isturisa, provider must also attest that baseline
electrocardiogram (ECG) has been obtained and hypokalemia and/or
hypomagnesemia has been corrected prior to initiating therapy if
present
• Member has had a documented trial and failure of one of the
following:
o ketoconazole
o Metopirone (metyrapone)
o Lysodren (mitotane)
o cabergoline
o Signifor/Signifor LAR (pasireotide)
o etomidate
• OR
• Member has a documented medical reason (e.g. contraindication,
intolerance, hypersensitivity) as to why these medications cannot be
used
Re-Authorization:
• Documentation or provider attestation of positive clinical response
(i.e. decrease in urinary free cortisol from baseline.)
• Medication is prescribed at an FDA approved dose
If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name
Field Description
Prior
Authorization
Group
Description
Adzynma
Drugs
Adzynma (ADAMTS13, recombinant-krhn)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug Package
Insert (PPI), or disease state specific standard of care guidelines.
Exclusion
Criteria
N/A
Required Medical
Information
See “other criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescriber must be a hematologist, oncologist, intensive care specialist,
or specialist in the treatment of rare genetic hematologic diseases
Coverage
Duration
On-demand therapy: If all criteria are met, the request will be approved
for 1 month.
Prophylactic therapy: If all criteria are met, the initial request will be
approved for 6 months. Reauthorization requests will be approved for 12
months.
Other Criteria
Initial Authorization • Diagnosis of congenital thrombotic thrombocytopenic purpura (cTTP) as confirmed by BOTH of the following: o Molecular genetic testing o ADAMTS13 activity <10% • Prescriber attestation that member has not been diagnosed with any other TTP-like disorder (i.e., microangiopathic hemolytic anemia, immune-mediated thrombotic thrombocytopenic purpura [iTTP]) • If request is for prophylactic therapy, member must also have a history of at least one documented TTP event • Member’s weight • Request is for an FDA-approved dose
Reauthorization • Documentation of positive clinical response to therapy (i.e., improvement in acute and subacute TTP events, platelet counts, microangiopathic hemolytic anemia episodes, or clinical symptoms) • Member’s weight • Request is for an FDA-approved dose
Revision/Review Date: 4/2025 Medical Director/clinical reviewer may override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization Group Description Agents for Atopic Dermatitis Drugs **Medications will be limited to 400 grams per year, Eucrisa is limited to 300 grams per year.
Preferred
pimecrolimus cream
tacrolimus ointment
Dupixent (dupilumab)
Eucrisa (crisaborole)
Zoryve (roflumilast) cream
Non-Preferred Elidel (pimecrolimus) Adbry (tralokinumab) Opzelura (ruxolitinib) Rinvoq (upadacitinib) Cibinqo (abrocitinib) Ebglyss (lebrikizumab-lbkz) Vtama (tapinarof) Nemluvio (nemolizumab-ilto)
Note: Adbry, Eucrisa, and Dupixent will pay at point of sale for members who filled a topical corticosteroid or a topical calcineurin inhibitor in the past 180 days Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria Tacrolimus ointment, pimecrolimus cream (Elidel), and Opzelura (ruxolitinib): Immunocompromised members Required Medical Information See “other criteria” Age Restrictions Per package insert Prescriber Restrictions Prescriber must be a dermatologist, pediatrician, immunologist, or allergist or in consultation with a dermatologist, pediatrician, immunologist, or allergist Coverage Duration For Opzelura, Zoryve, and Vtama: If the criteria are met, the request will be approved for up to 8 weeks and reauthorization requests will be approved for up to 6 months. For all others: If the criteria are met, the request will be approved for 12 months with a maximum quantity limit of 400 grams per year.
Other Criteria
Revision/Review Date: 4/2026 Initial Authorization • For non-preferred medications, a trial and failure of 2 preferred agents is required in addition to the criteria below
For pimecrolimus cream (Elidel):
•
Diagnosis of mild to moderate atopic dermatitis in patients who
have failed to respond adequately or are intolerant to a
formulary topical medium to high potency corticosteroid
•
If the request is for Elidel, member has a documented treatment
failure with pimecrolimus OR has a documented medical reason
(intolerance, hypersensitivity, contraindication, etc.) why
pimecrolimus cannot be used
For tacrolimus ointment:
•
Diagnosis of moderate to severe atopic dermatitis in patients who
have failed to respond adequately or are intolerant to a
formulary topical medium to high potency corticosteroid
For Eucrisa:
•
Diagnosis of mild to moderate atopic dermatitis
•
Trial and failure of a formulary medium to high potency topical
corticosteroid or topical immunosuppressant
For Opzelura, Vtama, or Zoryve:
•
Diagnosis of mild to moderate AD
•
Trial and failure of one formulary medium to high potency topical
corticosteroid
•
Trial and failure of topical tacrolimus or pimecrolimus (for members less
than 2 years of age requesting Eucrisa, trial of topical tacrolimus of
pimecrolimus is not required)
A MAXIMUM of ONE 60 g TUBE of OPZELURA MAY BE APPROVED PER WEEK
For Adbry or Dupixent:
•
Trial and failure, or contraindication/intolerance to ALL of the
following:
o One formulary medium to high potency topical corticosteroid
o Topical tacrolimus or pimecrolimus
•
For members less than 2 years of age requesting Dupixent, trial of
topical tacrolimus or pimecrolimus is not required.
For Nemluvio:
•
Diagnosis of moderate to severe AD
•
Trial and failure of, or contraindication to, ONE of the following:
o Eucrisa
o Opzelura
o Vtama
o Zoryve
For Ebglyss:
•
Diagnosis of moderate to severe AD
•
Trial and failure of, or contraindication to, ONE of the following:
o Adbry o Dupixent o Nemluvio
For Rinvoq or Cibinqo: • Diagnosis of refractory, moderate to severe, AD • Trial and failure of, intolerance to, or contraindication to another systemic drug product for AD
Reauthorization: • Prescriber attests that the member has experienced improvement in symptoms (e.g. significant clearing of the skin, reduction in itching) Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Amtagvi (lifileucel)
Drugs
Amtagvi (lifileucel)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
• Uncontrolled brain metastases
• Melanoma of uveal or ocular origin
• Systemic steroid therapy for any reason
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescriber must be an oncologist
Coverage Duration If all of the criteria are met, the initial request will be approved for a
one-time treatment.
Other Criteria
Revision/Review Date: 4/2025
Initial Authorization: • Diagnosis of unresectable or metastatic melanoma (Stage IIIc or Stage IV) • Member must have progressed through at least one prior systemic therapy including a PD-1/PD-L1 blocking antibody and, if BRAF V600 mutation–positive, a BRAF inhibitor or BRAF inhibitor in combination with a MEK inhibitor • Member must have at least one rejectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 • Medication is prescribed at an FDA approved dose The safety and effectiveness of repeat administration of Amtagvi has not been evaluated and will not be approved.
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Sublingual Allergenic Extracts Drugs Grastek (timothy grass pollen allergen extract) Odactra (house dust mite allergen extract) Oralair (sweet vernal/orchard/rye/timothy/Kentucky blue grass mixed pollen allergenic extract) Ragwitek (Short ragweed pollen allergenic extract) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions According to Package Insert Prescriber Restrictions Prescriber is an allergist or immunologist Coverage Duration If all of the conditions are met, the request will be approved for a 12 month duration. Other Criteria Initial authorization: For all requests: • Requested allergenic extract is being used to treat allergic rhinitis with or without conjunctivitis • Member has had a document trial and failure of, or intolerance to, an intranasal corticosteroid (e.g. fluticasone) used in combination with at least one of the following: o Oral antihistamine (e.g. cetirizine) o Intranasal antihistamine (e.g. azelastine) o Oral leukotriene receptor antagonist (montelukast) • Patient has been prescribed (as demonstrated by pharmacy claims or documentation) injectable epinephrine Grastek: • Diagnosis has been confirmed by positive skin or in vitro testing to Timothy Grass, or cross reactive, pollen Odactra: • Diagnosis has been confirmed by either positive skin test to house dust mite allergen extract OR positive in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssiunus
Revision/Review Date 10/2025 Oralair: • Diagnosis has been confirmed by positive skin, or in vitro, testing to Sweet Vernal, Orchard, Rye, Timothy, Kentucky Blue Grass, or cross reactive, pollen Ragwitek: • Diagnosis has been confirmed by positive skin, or in vitro, testing to Short Ragweed pollen Reauthorization: For all requests: • Member has experienced a reduction in symptoms associated with allergic rhinitis Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Agents for Graft versus Host Disease Drugs Rezurock (belumosudil), Imbruvica (ibrutinib), Jakafi (ruxolitinib phosphate), Orencia (abatacept), Ryoncil (remestemcel-L-rknd) Niktimvo (axatilimab-csfr) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, the Drug Package Insert, and/or per the standard of care guidelines Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions According to package insert
Prescriber Restrictions Prescriber must be a hematologist, oncologist, or other specialist in the treatment of hematopoietic cell transplants Coverage Duration Jakafi, Niktimvo, Rezurock, and Imbruvica: If all of the conditions are met, the request will be approved for up to a 3 month duration for initial requests and up to a 6 month duration for renewal requests.
Orencia: If all of the conditions are met, the request will be approved for 1 month duration (4 total infusions)
Ryoncil: If all of the criteria are met, the initial request will be approved for a 2 month duration (12 infusions total). If all of the criteria are met, the reauthorization request will be approved for a 1 month duration (8 total infusions). Other Criteria
For oncological indications, please refer to the “Oncology Agents” policy
Initial Authorization: • Imbruvica o Member has a diagnosis of chronic graft versus host disease o Member has tried and failed or cannot use a systemic corticosteroid or documentation is provided as to why a systemic corticosteroid cannot be used o The drug is prescribed at an FDA-approved dose • Jakafi o Member has a diagnosis of acute graft versus host disease or a diagnosis of chronic graft versus host disease o Member has tried and failed or cannot use a systemic corticosteroid or documentation is provided as to why a systemic corticosteroid cannot be used o The drug is prescribed at an FDA-approved dose • Rezurock or Niktimvo o Member has a diagnosis of chronic graft versus-host disease
Revision/Review Date: 4/2025 o Member has tried and failed at least two lines of systemic immunosuppressive therapy (e.g. corticosteroids, calcineurin inhibitors, mycophenolate mofetil, ibrutinib, ruxolitinib), one of which must be a systemic corticosteroid, or documentation is provided as to why a systemic corticosteroid cannot be used o The drug is prescribed at an FDA-approved dose • Orencia o Orencia is being requested for prophylaxis against acute graft versus host disease o Member will be undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele- mismatched unrelated donor o Member will be receiving Orencia in combination with a calcineurin inhibitor (e.g., tacrolimus, cyclosporine) and methotrexate o Member will be receiving antiviral prophylactic treatment for Epstein-Barr virus reactivation and will continue for 6 months following HSCT o Attestation provider has considered prophylactic antivirals for cytomegalovirus (CMV) infection/reactivation during treatment and for 6 months following HSCT o The drug is prescribed at an FDA-approved dose
• Ryoncil
o Member has a diagnosis of acute graft versus host disease
o Member has tried and failed or cannot use a systemic
corticosteroid or documentation is provided as to why a
systemic corticosteroid cannot be used
o Member’s weight
o Medication is prescribed at an FDA approved dose
Re-Authorization:
• Documentation is provided that the member has achieved a clinical
benefit from medication (e.g. symptom improvement, reduction in
corticosteroid dose)
• For Ryoncil requests: documentation is provided that member has
a recurrence of GvHD after achieving a complete response with
initial therapy of Ryoncil
• The drug is prescribed at an FDA-approved dose
If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name
Field Description
Prior Authorization
Group Description
Agents for Primary Biliary Cholangitis
Drugs
Iqirvo (elafibranor), Livdelzi (seladelpar)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug
Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “other criteria”
Age Restriction
Member must be 18 years of age or older
Prescriber
Restrictions
Prescribed by or in consultation with a hepatologist or gastroenterologist
Coverage Duration
If the criteria are met, the request will be approved for a 3 month duration for initial authorization and for up to a 12 month duration for reauthorization. Other Criteria
Initial Authorization:
• Diagnosis of primary biliary cholangitis (PBC) confirmed by at
least two of the following tests:
a) Positive antimitochondrial antibody test, or presence of
other PBC-specific autoantibodies, including sp100 or
gp210, if antimitochondrial antibody test is negative
b) Elevated serum alkaline phosphatase (ALP) level
c) Histologic evidence of primary biliary cholangitis from a
liver biopsy
• Drug is being requested in addition to ursodeoxycholic acid
(UDCA) due to patient having an inadequate response to UDCA
monotherapy for at least 1 year, OR member has a documented
medical reason (e.g., contraindication, intolerance,
hypersensitivity) why UDCA cannot be used and is taking the
requested drug as monotherapy
• Prescriber attests the patient does not have complete biliary
obstruction, decompensated cirrhosis (e.g., Child-Pugh Class B or
C)
•
• Submission of the following test results within 30 days of request:
a) Serum ALP
b) Total bilirubin
Reauthorization: • Provider attests that the patient has not developed complete biliary obstruction, decompensated cirrhosis (e.g., Child-Pugh Class B or
Revision/Review
Date 10/2025
C)
•
• Submission of lab tests confirming each of the following:
○ A decrease in ALP of ≥ 15% from baseline
○ ALP is less than 1.67 times the upper limit normal (ULN);
defined as 118 U/L for females and 124 U/L for males
○ Total bilirubin ≤ ULN defined as 1.1 mg/dL for females
and 1.5 mg/dL for males
○
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Alpha-1 Proteinase Inhibitors (Human)
Drugs
Preferred:
Prolastin-C
Non-Preferred:
Aralast NP
Glassia
Zemaira
Or any other newly marketed agent
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional (USP
DI), the Drug Package Insert (PPI), or disease state specific standard of
care guidelines.
Exclusion Criteria
None
Required Medical
Information
None
Age Restrictions
18 years of age or older
Prescriber
Restrictions
Prescribed by or in consultation with a pulmonologist or specialist in
the treatment of AAT
Coverage Duration
The request will be approved for up to a 12 month duration.
Other Criteria
Initial Authorization:
•
Documented diagnosis of a congenital deficiency of alpha-1
antitrypsin (AAT) (serum AAT level < 11 micromol/L
[approximately 57 mg/dL using nephelometry or 80mg/dl by
radial immunodiffusion]).
•
Documentation was submitted indicating the member has
undergone genetic testing for AAT deficiency and is classified as
phenotype PiZZ, PiSZ, PiZ(null) or Pi(null)(null) [NOTE:
phenotypes PiMZ or PiMS are not candidates for treatment with
Alpha1-Proteinase Inhibitors]
•
Documentation was submitted (member’s pulmonary function test
results) indicating airflow obstruction by spirometry (forced
expiratory volume in 1 second [FEV1] ≤ 65% of predicted), or
provider has documented additional medical information
demonstrating medical necessity
•
Documentation was submitted indicating member is a non-smoker
or an ex-smoker (eg. smoking cessation treatment)
•
Documentation of the member’s current weight
•
The Alpha-1 Proteinase Inhibitor (human) is being prescribed at
an FDA approved dosage
•
If the medication request is for an Alpha1-Proteinase Inhibitor
(human) product other than Prolastin-C, the patient has a
Revision/Review Date 2/2026 documented medical reason (intolerance, hypersensitivity, contraindication, treatment failure, etc.) for not using Prolastin-C to treat their medical condition Reauthorization: • Documentation of the member’s current weight • Documentation was submitted indicating member is a non-smoker or an ex-smoker (e.g. smoking cessation treatment) • Documentation was submitted indicating the member has clinically benefited from therapy (i.e. stable lung function, improved PFTs, alpha-1 antitrypsin serum level maintained above 11 micromol/L [approximately 57 mg/dL using or 80 mg/dL by radial immunodiffusion], improved quality of life) • The Alpha-1 Proteinase Inhibitor (human) is being prescribed at an FDA approved dosage Clinical reviewer/Medical Director must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Amifampridine Drugs Firdapse (amifampridine) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions Patients must be 6 years age or older Prescriber Restrictions Prescribed by or in consultation with a neurologist or a neuromuscular specialist Coverage Duration If all of the criteria are met, the initial request will be approved for 6 months. For continuation of therapy the request will be approved for 6 months. Other Criteria Revision/Review Date 2/2026 Initial Authorization: • Diagnosis of Lambert-Eaton myasthenic syndrome (LEMS) based on at least one electrodiagnostic study (i.e., repetitive nerve stimulation, nerve conduction studies, electromyography) OR anti-P/Q-type voltage-gated calcium channel antibody testing • Member has been screened for small cell lung cancer (SCLC) and/or other malignancies • Member does not have a history of seizures • Medication is being prescribed at an FDA approved dose or is supported by compendia or standard of care guidelines Re-authorization: • Medication is prescribed at an FDA-approved dose or is supported by compendia or standard of care guidelines • Documentation provided that prescriber has evaluated the member and recommends continuation of therapy Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization Group Androgenic Agents Drug(s) If the request is for gender dysphoria, please use the Non-Preferred/Prior Authorization Required Medications criteria
Preferred products:
•
testosterone 1.62% pump (generic Androgel)
•
testosterone cypionate intramuscular oil
•
Depo-Testosterone intramuscular oil (testosterone cypionate)
•
testosterone enanthate 200 mg/ml intramuscular oil
Non-preferred products:
•
testosterone 1% packet
•
testosterone (Vogelxo) 50 mg/5 g packet
•
testosterone (Androgel) 1.62% packet
•
testosterone 1% pump (generic Vogelxo)
•
testosterone 10 mg gel pump
•
testosterone 30 mg/1.5 ml pump testosterone (Testim) 1% gel
•
Androderm patch
•
Natesto nasal
•
methyltestosterone (Methitest) 10 mg capsule
•
Aveed 750 mg/3 ml (250 mg/ml) intramuscular solution
•
Testopel 75 mg implant pellet
•
Jatenzo capsule
•
Xyosted subcutaneous solution
•
Tlando
•
Azmiro 200mg/mL prefilled syringe
•
Undecatrex capsule
•
Any newly marketed testosterone product
Covered Uses
Medically accepted indications are defined using the following sources: the Food and
Drug Administration (FDA), Micromedex, American Hospital Formulary Service
(AHFS), United States Pharmacopeia Drug Information for the Healthcare
Professional (USP DI) and the Drug Package Insert).
Exclusion Criteria
Men with carcinoma of the breast or known or suspected prostate cancer.
Pregnant or breastfeeding women.
Required Medical
Information
See “Other Criteria”
Age Restrictions
None
Prescriber Restrictions
None
Coverage Duration
If all of the conditions are met, the initial request will be approved for 3 months; renewal
requests will be approved for 12 months.
Other Criteria
Revision/Review Date: Criteria for Initial Authorization:
- Diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired)
- Documented low testosterone level (s) below 300ng/dl (copy of laboratory result required)
- Documented adequate trial and failure or intolerance with a preferred agent. Criteria for Re-Authorization:
- Diagnosis of primary hypogonadism (congenital or acquired)
10/2025
or hypogonadotropic hypogonadism (congenital or acquired).
- Documentation that the member is benefiting from use of the medication. Medical Director/Clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization
Group Description
Injectable Anticoagulants
Drugs
Preferred
•
enoxaparin (Lovenox)
Non-preferred
•
fondaparinux (Arixtra)
•
Fragmin (dalteparin)
•
Any newly marketed injectable anticoagulant
Covered Uses
Medically accepted indications are defined using the following sources: the Food
and Drug Administration (FDA), Micromedex, American Hospital Formulary
Service (AHFS), United States Pharmacopeia Drug Information for the
Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state
specific standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
Member’s current weight
Age Restrictions
N/A
Prescriber Restrictions
N/A
Coverage Duration
If the conditions are met, the request will be approved for an appropriate duration
according to the following:
•
For the use in venous thromboembolism (VTE): up to a 30-day duration
(unless greater duration of therapy is requested and medically necessary then
will be approved for up to a 6 month duration)
•
For use in pregnant members: up to 6 weeks past the expected due date
•
For use in members with cancer: 6 months
Other Criteria
Criteria for approval for use in VTE:
•
The medication is being prescribed for the prevention and/or treatment of
VTE
•
The medication is being prescribed at a dose that is within FDA-approved
guidelines and/or is supported by the medical compendia
•
The prescriber must provide a medical reason why the member cannot be
treated with a formulary oral anticoagulant
•
If the request is for a non-preferred agent, documentation was provided as to
why the member is not able to use the preferred agent.
Criteria for approval for use in a pregnant member:
•
The medication is being prescribed for the prevention or treatment of VTE
during pregnancy.
•
Documentation of the expected due date.
•
The medication is being prescribed by an obstetrician or a hematologist
•
The medication is being prescribed at a dose that is within FDA-approved
guidelines and/or is supported by the medical compendia
•
If the request is for a non-preferred agent, documentation was provided as to
why the member is not able to use the preferred agent.
Criteria for approval for use in member with cancer:
Revision/Review Date: 10/2025 • The medication is being prescribed for the prevention or treatment of VTE for a member with cancer. • The medication is being prescribed by, or in consultation with, an oncologist/hematologist • The prescriber must provide a medical reason why the member cannot be treated with a formulary oral anticoagulant • The medication is being prescribed at a dose that is within FDA-approved guidelines and/or is supported by the medical compendia as defined by the Social Security Act and/or per the National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), or American Society of Hematology (ASH) standard of care guidelines. • If the request is for a non-preferred agent, documentation was provided as to why the member is not able to use the preferred agent. Reauthorization criteria for approval for use in member with cancer: • The medication is being prescribed for the prevention and/or treatment of VTE for a member with cancer. • The prescriber must provide a valid medical reason as to why the member needs to continue treatment and cannot be treated with a preferred oral anticoagulant. • The medication is being prescribed by or in consultation with an oncologist/hematologist • The medication is being prescribed at a dose that is within FDA-approved guidelines or is supported by the medical compendia as defined by the Social Security Act and/or per NCCN, ASCO, or ASH standard of care guidelines. Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Anti-CD19 CAR-T Immunotherapies
Drugs
Kymriah (tisagenlecleucel), Yescarta (axicabtagene ciloleucel), Tecartus
(brexucabtagene autoleucel), Breyanzi (lisocabtagene maraleucel), Aucatzyl
(obecabtagene autoleucel)
Covered Uses
Medically accepted indications are defined using the following sources: the
Food and Drug Administration (FDA), Micromedex, American Hospital
Formulary Service (AHFS), United States Pharmacopeia Drug Information for
the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or
disease state specific standard of care guidelines.
Exclusion Criteria
Patients with primary central nervous system lymphoma
Required Medical
Information
See “Other Criteria”
Age Restrictions
See “Other Criteria”
Prescriber
Restrictions
Prescriber must be an oncologist, hematologist or other appropriate specialist .
Coverage Duration
If all the criteria are met, the initial request will be approved for a single
treatment regimen per lifetime.
•
Kymriah, Yescarta, Tecartus, Breyanzi :a one-time infusion
•
Aucatzyl: a split-dose infusion administered on day 1 and day 10 (± 2
days)
Other Criteria
Initial authorization:
•
Patient must not have received prior anti-CD19 CAR-T therapy.
•
Patient will be screened for HBV, HCV, and HIV in accordance with
clinical guidelines.
•
Patient does not have an active infection or inflammatory disorder.
•
Patient will not receive live virus vaccines for at least 6 weeks prior to
the start of lymphodepleting chemotherapy and until immune recovery
following treatment.
•
Use is supported by a labeled indication or NCCN guidelines
Leukemia
B-cell precursor Acute Lymphoblastic Leukemia (ALL):
•
If the request is for Kymriah
o Patient is 25 years of age or younger
o ALL that is refractory or in second or later relapse
•
If the request is for Tecartus or Aucatzyl
o Patient is 18 years of age or older
o ALL that is relapsed or refractory
Chronic Lymphocytic Leukemia (CLL): • If the request is for Breyanzi o Patient is 18 years of age or older o Patient has relapsed/refractory disease defined as failure of two or more lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor AND a B-cell lymphoma 2 (BCL-2) inhibitor Non-Hodgkin’s Lymphoma (NHL) Follicular Lymphoma (FL): • If the request is for Breyanzi, Kymriah, or Yescarta: o Patient is 18 years of age or older o Patient has relapsed/refractory disease defined as failure of two or more lines of systemic therapy
Large B-cell Lymphoma (LBCL), Diffuse Large B-cell Lymphoma
(DLBCL) not otherwise specified, primary mediastinal large B-cell
lymphoma, high grade B-cell lymphoma, follicular lymphoma grade 3B,
and DLBCL arising from follicular lymphoma or indolent lymphoma:
•
If the request is for Breyanzi, Kymriah, or Yescarta
o Patient is 18 years of age or older
o For Breyanzi ONE of the following:
Patient is refractory to first-line
chemoimmunotherapy or relapsed within 12 months
of first-line chemoimmunotherapy
Patient is refractory to first-line
chemoimmunotherapy or relapsed after first-line
chemoimmunotherapy and is not eligible for
hematopoietic stem cell transplantation (HSCT) due
to comorbidities or age
Patient has relapsed or refractory disease after two or
more lines of systemic therapy
o For Kymriah: Patient has relapsed/refractory disease defined
as failure of two or more lines of systemic therapy
o For Yescarta ONE of the following:
Patient is refractory to first-line
chemoimmunotherapy or relapses within 12 months
of first-line chemoimmunotherapy or
Patient has failed two or more lines of systemic
therapy
Revision/Review Date: 4/2025 Mantle Cell Lymphoma (MCL): • Patient is 18 years of age or older • If the request is for Tecartus: o Patient has relapsed/refractory disease defined as failure of BOTH the following: Chemoimmunotherapy such as an anti-CD20 monoclonal antibody (e.g. Rituxan) + any chemotherapeutic agent Bruton Tyrosine Kinase (BTK) Inhibitor (e.g. Calquence, Imbruvica, Brukinsa) • If the request is for Breynazi: o Patient has relapsed or refractory disease who have received at least 2 prior lines of systemic therapy, including a BTK inhibitor
Small Lymphocytic Lymphoma (SLL):
•
If the request is for Breyanzi
o Patient is 18 years of age or older
o Patient has received at least 2 prior lines of therapy including,
a Bruton tyrosine kinase (BTK) inhibitor and a B-cell
lymphoma 2 (BCL-2) inhibitor
Re-authorization:
•
Treatment exceeding 1 single treatment regimen per lifetime will not
be authorized.
o Kymriah, Yescarta, Tecartus, Breyanzi :a one-time infusion
o Aucatzyl: a split-dose infusion administered on day 1 and day
10 (± 2 days)
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization Group Description Anti-Depressants for the Pediatric Patient Drugs bupropion (Aplenzin, Wellbutrin, Forfivo), citalopram, desvenlafaxine, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, escitalopram, venlafaxine, duloxetine, trazodone, tranylcypromine, amitriptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, phenelzine, protriptyline, trimipramine, maprotiline, Fetzima (levomilnacipran), Marplan (isocarboxazid), Trintellix (vortioxetine), vilazodone (Viibryd), Emsam (selegiline), or any newly- approved anti-depressant Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), and the Drug Package Insert (PPI). Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions Delaware Medical Assistance Program requires prior authorization for members 5 years of age and younger Prescriber Restrictions Prescriber must be a psychiatrist or a medical provider certified in pediatric mental/behavioral health Coverage Duration If the criteria are met, the request will be approved for 12 months. Other Criteria Revision/Review Date: 4/2025 Initial Authorization: • Requested dose is appropriate for age and indication per compendia Re-Authorization: • Documentation that the member has experienced a benefit from the medication or discontinuation would be detrimental Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization
Group Description
Anti-FGF23 Monoclonal Antibodies
Drugs
Crysvita (burosumab) SQ solution, or any other newly marketed agent
Covered Uses
Medically accepted indications are defined using the following sources:
The Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug
Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
See Other Criteria
Required Medical
Information
See Other Criteria
Age Restrictions
X-linked hypophosphatemia (XLH): 6 months of age or older
Tumor-induced osteomalacia (TIO): 2 years of age and older
Prescriber
Restrictions
Prescribed by, or in consultation with, an endocrinologist, nephrologist,
molecular geneticist, or other specialist experienced in the treatment of
metabolic bone disorders
Coverage Duration
If all of the criteria are met, the initial request will be approved for 6
months and reauthorization requests will be approved for 12 months.
Other Criteria
Initial Authorization:
For X-linked hypophosphatemia (XLH):
•
Diagnosis of XLH
•
Dosing is appropriate as per labeling or is supported by
compendia or standard of care guidelines
•
Labs, as follows:
o
Serum phosphorus below normal for patient age
o
eGFR > 30 mL/min/1.73 m2 or CrCl ≥ 30 mL/min
•
Patient will not use concurrent oral phosphate and/or active
vitamin D analogs (e.g. calcitriol, paricalcitol, doxercalciferol,
calcifediol)
•
Additionally, for adults:
o
Clinical signs and symptoms of XLH (e.g. bone/joint
pain, fractures, osteomalacia, osteoarthritis,
ensethopathies, spinal stenosis impaired mobility,
presence or history of lower limb deformities, etc.)
o
Trial and failure of, or contraindication to, combination
therapy with oral phosphate and active vitamin D
(calcitriol) for a minimum of 8 weeks
For tumor-induced osteomalacia (TIO):
•
Diagnosis of FGF23-related hypophosphatemia in TIO
•
Dosing is appropriate as per labeling or is supported by
compendia or standard of care guidelines
Revision/Review Date: 7/2025 • The tumor(s) is/are not amenable to surgical excision or cannot be located • Labs, as follows: o Serum phosphorus below normal for patient age o eGFR > 30 mL/min/1.73 m2 or CrCl ≥ 30 mL/min • Patient will not use concurrent oral phosphate and/or active vitamin D analogs (e.g. calcitriol, paricalcitol, doxercalciferol, calcifediol) Re-authorization: For XLH or TIO: • Documented effectiveness as evidenced by at least one of the following: o Serum phosphorus within normal limits for patient age o Clinical improvement (e.g. improved rickets, improved bone histomorphometry, increased growth velocity, increased mobility, decrease in bone fractures, improved fracture healing, reduction in bone-related pain) • 25-hydroxyvitamin D level and, if abnormally low, documented supplementation with cholecalciferol or ergocalciferol • Patient is not concurrently using oral phosphate and/or active vitamin D analogs (e.g. calcitriol, paricalcitol, doxercalciferol, calcifediol) • Dosing continues to be appropriate as per labeling or is supported by compendia or standard of care guidelines Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Antifibrotic Respiratory Tract Agents
Drugs:
Ofev (nintedanib esylate)
pirfenidone (Esbriet)
Jascayd (nerandomilast)
Covered Uses: Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), the Drug Package Insert (PPI), or disease state specific standard of care guidelines.
INITIAL CRITERIA:
For all requests:
Patient is 18 years of age or older
Prescriber is a pulmonologist or lung transplant specialist
Provider attests that they have reviewed the patient’s other medications, and have addressed all potential drug
interactions
Documentation has been provided that the patient does not smoke (Ofev and pirfenidone only)
If the request is for Idiopathic Pulmonary Fibrosis (IPF): Confirmed diagnosis of IPF Pulmonary function test indicate patient has Forced Vital Capacity (%FVC) ≥ 45% within 30 days of request For Ofev and Jascayd, patient must also have a trial and failure, intolerance, or contraindication to pirfenidone
If the request is for Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) (Ofev only): Confirmed diagnosis of SSc-ILD FVC ≥ 40% within 30 days of request Trial and failure of mycophenolate mofetil (MMF), cyclophosphamide or azathioprine. If the request is for Chronic Fibrosing Intersitial Lung Diseases (ILDs) with a progressive phenotype (Ofev only): Diagnosis of chronic fibrosing ILD (such as connective tissue disease [CTD]-associated ILD, chronic fibrosing hypersensitivity pneumonitis [HP], idiopathic non-specific interstitial pneumonia [iNSIP], unclassifiable idiopathic interstitial pneumonia [IIP]) of a progressive phenotype Recent (12 month) history of treatment with at least one medication to treat ILD (e.g., corticosteroid, azathioprine, MMF, n-acetylcysteine (NAC), rituximab, cyclophosphamide, cyclosporine, or tacrolimus). FVC ≥ 45% predicted within 30 days of request
If all of the above conditions are met, the request will be approved for a 6 month duration; if all of the above criteria are
not met, the request is referred to a Medical/clinical reviewer for medical necessity review.
REAUTHORIZATION CRITERIA:
Prescriber is a pulmonologist or lung transplant specialist
Documentation submitted indicates that the member has obtained clinical benefit from the medication
Documentation has been provided that the patient does not smoke (Ofev and pirfenidone only)
If all of the above conditions are met, the request will be approved for a 6 month duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review.
NOTE: Medical Director/Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Revision/Review Date: 2/2026
Prior Authorization Group Description Antipsychotics for Members Under 18 Years of Age Drugs All antipsychotics when prescribed for a member under 18 years of age Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria Use of more than one antipsychotic at a time is prohibited, unless cross titration is needed for up to 60 days Required Medical Information See “other criteria” Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, a psychiatrist, pediatric neuropsychologist, developmental-behavioral pediatrician, or other specialist in the field of the member’s diagnosed condition Coverage Duration If the criteria are met, requests may be approved as follows: • Members who started the antipsychotic during a recent hospitalization will receive a 6-month approval as continuity of care • Members who are new to the plan and are stable on the antipsychotic will receive a 6- month approval as continuity of care • All other requests meeting the criteria below may be approved for 12 months
Other Criteria Revision/Review Date: 2/2026 Criteria for Initial Approval: • Members who started the antipsychotic during a recent hospitalization or who are new to the plan and are stable on the antipsychotic may receive approval as continuity of care without meeting the criteria below • Antipsychotic is prescribed within FDA approved indications and dosing, recognized treatment guidelines, or recognized compendia • Provider has indicated that baseline monitoring of tardive dyskinesia using the Abnormal Involuntary Movement Scale (AIMS) or Dyskinesia Identification System Condensed User Scale (DISCUS) has been completed • Lab documentation provided (within 30 days of request) including the following information: o Weight o Body mass index (BMI) or waist circumference o Blood pressure o Fasting glucose or HbA1c o Fasting lipid panel • If lab documentation cannot be provided within 30 days, a one-time 30-day approval will be granted. • Additional criteria for requests for major depressive disorder or obsessive compulsive disorder: o Member continues to have residual symptoms despite use of evidence-based non- pharmacologic therapies such as behavioral, cognitive, and family based therapies (for new antipsychotic starts only) o Member had an inadequate response, intolerable side effects or contraindication to at least TWO different antidepressant regimens at an adequate dose and duration (at least 4 weeks); o If the request is for augmentation, the member is also receiving an SSRI or SNRI • Additional criteria for requests for aggression associated with autism spectrum disorders, tic disorders, disruptive behavior disorders, conduct disorders, or intellectual disabilities: o Chart notes documenting evidence of a comprehensive clinical evaluation of conditions have been submitted including: Treatment plan that comprehensively addresses all behaviors and conditions Provider has indicated that the member’s comorbid conditions are being treated. Documentation that aggressive behaviors continue and are not responding to non-pharmacologic therapies (e.g. behavioral, cognitive, and family based therapies) • If the request is for a non-formulary agent the above criteria must be met AND at least one preferred formulary antipsychotic for the indication has previously failed or all preferred formulary antipsychotics are contraindicated • If the request is for Opipza, a trial and failure of TWO preferred products, one of which must be aripiprazole solution, or a medical reason for not using the TWO preferred products Criteria for Reauthorization: • Prescriber indicates that there has been improvement in target symptoms as a result of antipsychotic therapy
•
Documentation of a treatment plan that contains either plan for discontinuation or
rationale for continued use
•
Prescriber indicates that monitoring tardive dyskinesia using the Abnormal
Involuntary Movement Scale (AIMS) or Dyskinesia Identification System
Condensed User Scale (DISCUS) is being conducted
•
Lab documentation provided (within 30 days of request) including the following
information:
o Weight
o Body mass index (BMI) or waist circumference
o Blood pressure
o Fasting glucose or HbA1c
o Fasting lipid panel
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Antisense Oligonucleotides for Duchenne Muscular Dystrophy Drugs Exondys 51 (eteplirsen), Vyondys 53 (golodirsen), Viltepso (viltolarsen), Amondys 45 (casimersen) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria Concomitant use with another antisense oligonucleotide Required Medical Information See “Other Criteria” Age Restrictions Age ≤ 20 years Prescriber Restrictions Prescribed by neurologist or provider who specializes in the treatment of DMD Coverage Duration If all of the criteria are met, the initial request will be approved for 6 months and reauthorization requests will be approved for 12 months. Other Criteria Initial Authorization: • Member has a diagnosis of Duchenne muscular dystrophy (DMD) and lab test was submitted confirming the mutation of dystrophin gene amenable to ONE of the following: o Exon 51 skipping for Exondys 51 o Exon 53 skipping for Vyondys 53 or Viltepso o Exon 45 skipping for Amondys 45 • Member is ambulatory • Baseline dystrophin levels AND results of motor function tests are provided [e.g. 6-Minute Walk Test (6MWT), Time to Stand Test (TTSTAND), Time to Run/Walk Test (TTRW), North Star Ambulatory Assessment (NSAA), Time to Climb 4 Steps Test (TTCLIMB)] • Member has stable pulmonary and cardiac function • ONE of the following applies: o Member has been on a stable dose of corticosteroids for at least 3 months for Viltepso o Member has been on a stable dose of corticosteroids for at least 6 months for Vyondys 53, Exondys 51, or Amondys 45 • Attestation of renal function monitoring is provided with request • The request is for an FDA approved dose Reauthorization
Revision/Review Date 4/2025 • Documentation is provided that the member had an increase in dystrophin levels from baseline • Documentation is provided that the member had the expected clinical response (e.g. provider statement that the therapy has reduced the rate of further decline in function as demonstrated by 6MWT, TTSTAND, TTRW, NSAA, or TTCLIMB) • Member is ambulatory • Attestation of renal function monitoring is provided with request • The request is for an FDA approved dose Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Anzupgo (delgocitinib)
Drugs
Anzupgo
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
Current use of Opzelura (ruxolitinib), systemic JAK inhibitors, or potent
immunosuppressants
Required Medical
Information
See “Other Criteria”
Age Restrictions
Per FDA-approved labeling
Prescriber
Restrictions
None
Coverage Duration
If all of the criteria are met, the initial request will be approved for 6
months. For continuation of therapy, the request will be approved for 12
months.
Other Criteria
Date: 10/2025
Initial Authorization:
• Medication is prescribed at an FDA approved dose
• Diagnosis of moderate to severe chronic hand eczema (CHE)
• Documentation of hand eczema persisting for >3 months or
recurring ≥2 times within 12-month time frame
• Trial and failure, or contraindication to, >2 formulary
moderate/high-potency topical corticosteroids
Re-Authorization:
• Documentation or provider attestation of positive clinical response
(i.e. significant clearing of the skin, reduction in itching)
• Medication is prescribed at an FDA approved dose
If all of the above criteria are not met, the request is referred to a
Medical Director/Clinical Reviewer for medical necessity review.
Prior Authorization Group Description Medications for Use in ADHD Treatment for Members 21 and Older Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions Preferred drugs will pay for members 20 and younger; PA required for members 21 and older Prescriber Restrictions N/A Coverage Duration If the criteria are met, the request will be approved for 12 months. Other Criteria Revision/Review Date: 4/2025 Criteria for Authorization: • Prescriber attests that the Diagnostic and Statistical Manual of Mental Disorders V (DSM-5) criteria for diagnosis of ADHD in adults has been met • Appropriate dose of medication based on age and indication. • Behavioral modification techniques have been tried prior to medication being prescribed. • The patient is not concurrently taking a benzodiazepine with the exception of medication required for a seizure diagnosis. If a benzodiazepine is required, appropriate documentation has been provided by the prescriber indicating justification. • The patient is not on a long-acting and a short-acting version of the same chemical agent simultaneously. If both a long-acting and a short- acting version of the same chemical agent are required simultaneously, appropriate documentation has been provided by the prescriber indicating justification. • If the request is for a non-preferred medication, documented trial and failure or intolerance with two preferred medications used to treat the documented diagnosis. • For medications where there is only one preferred agent, one of the following is true: o Only that agent must have been ineffective or not tolerated o No other preferred medication has a medically accepted use for the patient’s specific diagnosis as referenced in the medical compendia o All other preferred medications are contraindicated based on the patient’s diagnosis, other medical conditions, or other medication therapy Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization Group Description Atovaquone Suspension Drugs Atovaquone (Mepron) suspension Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration If the criteria are met, the request will be approved for up to a 6 month duration. Other Criteria Revision/Review Date: 4/2025 Treatment/Prevention of Pneumocystis jirovecii pneumonia • Diagnosis of mild to moderate Pneumocystis jirovecii pneumonia (PCP) or diagnosis with the need to prevent PCP infection. • Documented trial and failure with therapeutic doses or intolerance to trimethoprim- sulfamethoxazole (TMP-SMX) • Documented trial and failure with therapeutic doses or intolerance to dapsone. Treatment/Prevention of Toxoplasma gondii encephalitis in patients with HIV: • Diagnosis of Toxoplasma gondii encephalitis or documentation of supporting diagnosis for prophylaxis • Documented trial and failure with therapeutic doses or intolerance to trimethoprim- sulfamethoxazole (TMP-SMX). Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
B-Cell Maturation Antigen (BCMA) Directed Chimeric Antigen
Receptor (CAR) T-Cell Therapy
Drugs
Abecma (idecabtagene vicleucel), Carvykti (ciltacabtagene autoleucel)
Covered Uses
Medically accepted indications are defined using the following sources: the
Food and Drug Administration (FDA), Micromedex, American Hospital
Formulary Service (AHFS), United States Pharmacopeia Drug Information
for the Healthcare Professional (USP DI), and the Drug Package Insert (PPI).
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
Member must be 18 years or older
Prescriber
Restrictions
Prescriber must be a hematologist, an oncologist, or other appropriate
specialist
Coverage Duration
If all the criteria are met, the initial request will be approved for a one – time
infusion per lifetime.
Other Criteria
Revision/Review Date: 7/2025 Initial Authorization • Member has a diagnosis of relapsed or refractory multiple myeloma (RRMM) • For Abecma, member must have also received at least 2 prior lines of therapy including: o An immunomodulatory agent (e.g. lenalidomide, pomalidomide, thalidomide) o A proteasome inhibitor (e.g. bortezomib, carfilzomib, ixazomib) o An anti-CD38 monoclonal antibody (e.g. daratumumab, isatuximab) • For Carvykti, member must also be refractory to lenalidomide AND have received at least 1 prior line of therapy including: o An immunomodulatory agent (e.g. lenalidomide, pomalidomide, thalidomide) o A proteasome inhibitor (e.g. bortezomib, carfilzomib, ixazomib) • Member does not have an active infection or inflammatory disorder • Member will be screened for cytomegalovirus (CMV), hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines • Member will not receive live virus vaccines for at least 6 weeks prior to the start of lymphodepleting chemotherapy and until immune recovery following treatment • Member has not previously received a BCMA CAR-T therapy
Re-authorization: • Treatment exceeding 1 dose per lifetime will not be authorized.
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Benlysta (belimumab)
Drugs
Benlysta (belimumab)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, the Drug
Package Insert, and/or per the standard of care guidelines
Exclusion Criteria
Severe active central nervous system lupus
Required Medical
Information
See “other criteria”
Age Restrictions
Must be at least 5 years of age
Prescriber
Restrictions
Prescribed by or in consultation with a rheumatologist or nephrologist
Coverage Duration
If all the criteria are met initial authorization requests may be approved
for up to 6 months. Reauthorization requests may be approved for up to
12 months.
Other Criteria
Initial Authorization:
•
Active systemic lupus erythematosus (SLE)
o
Provider attestation that the patient is positive for
autoantibodies (or antinuclear antibodies or anti–double‐
stranded DNA [anti‐dsDNA] antibodies)
o
The member has tried and failed both of the following (or
contraindication/inability to use these medications):
Hydroxychloroquine
One other immunosuppressant [e.g., methotrexate,
azathioprine, calcineurin inhibitors or
mycophenolate]
•
Active lupus nephritis
o
Provider attestation of diagnosis confirmed by kidney biopsy
o
The member has tried and failed, or has a medical reason for
not using, both of the following
Cyclophosphamide or tacrolimus
Mycophenolate
•
Provider states the member will not be receiving concomitant
therapy with the following:
o
B-cell targeted therapy including (but not limited to)
rituximab
o
Interferon receptor antagonist, type 1 including (but not
limited to) Saphnelo (anifrolumab)
•
Dosing is appropriate per labeling
Criteria for Reauthorization:
•
Documentation or provider attestation of positive clinical
response as indicated by one of the following:
o
Fewer flares that required steroid treatment
Revision/Review Date: 2/2026 o Lower average daily oral prednisone dose o Improved daily function either as measured through a validated functional scale or through improved daily performance documented at clinic visits o Sustained improvement in laboratory measures of lupus activity • Dosing is appropriate per labeling Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization
Group Description
Benzodiazepines
Drugs
Preferred:
chlordiazepoxide
clobazam
clorazepate
clonazepam tablet
diazepam rectal, tablet, oral solution
lorazepam tablet
temazepam 15 mg, 30 mg
Nayzilam (midazolam) nasal spray
Valtoco (diazepam) nasal spray
Non-preferred (PA required):
alprazolam
clonazepam ODT
diazepam intensol
estazolam
flurazepam
lorazepam intensol
midazolam
oxazepam
quazepam
temazepam 7.5 mg, 22.5 mg
triazolam
Sympazan (clobazam) oral film
Loreev XR
Benzodiazepines are limited to an initial 14-day supply for benzodiazepine-naïve
members (defined as members without a claim for a benzodiazepine within the last 90
days).
Preferred benzodiazepines indicated only for seizure disorder are not limited to an
initial supply of 14 days
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug Package
Insert (PPI), or disease state specific standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “other criteria”
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage Duration Initial authorization:
- Exempt conditions (palliative, hospice, other end-of-life care, seizure disorder): 12 months
- Preferred drugs requested above 14 day initial fill limits: 12 months, 30 day supply per fill
- Non-preferred drugs requested for up to 14 days of therapy: 1 time approval for up to 14 day supply
- Non-preferred drugs requested above 14 days of therapy: 12 months, 30 day supply
per fill
Re-authorization: 12 months, 30 day supply per fill
Other Criteria
Initial Authorization
If the member is using benzodiazepines for the treatment of hospice, palliative, or end of
life care (e.g. anxiety related to dyspnea) the following criteria apply:
• The requested dose is within compendia guidelines If the member is using benzodiazepines for the treatment of seizure disorder, the following criteria apply:
• The requested dose is within compendia guidelines • Prescriber must attest to review of the State Prescription Monitoring Program prior to prescribing • Documentation of trial and failure or inability to use TWO preferred benzodiazepines If the request is for Loreev XR, the member is established on stable, evenly divided, three times daily dosing with lorazepam tablets If the request is for a NON-PREFERRED product for a treatment-experienced member AND/OR for 14 days or less:
• The requested dose is within compendia guidelines • Prescriber must attest to review of the State Prescription Monitoring Program prior to prescribing • Documentation of trial and failure or inability to use TWO preferred benzodiazepines Criteria for requests over the 14-day initial fill limit for benzodiazepine-naïve members, the following criteria apply: • The requested dose is within compendia guidelines • If the request is for a non-preferred product, documentation of trial and failure or inability to use at least TWO preferred benzodiazepines is required • The member is NOT currently taking an opioid. If the member will be taking an opioid, the provider has counseled the member on the risks of concurrent benzodiazepine/opioid use.
• If the member will be concurrently taking another benzodiazepine, muscle relaxant, or sedative hypnotic drug (e.g. zolpidem, zaleplon), the prescriber attests to counseling the patient on risks of concurrent use • Prescriber must attest to review of the State Prescription Monitoring Program prior to prescribing • For Insomnia: the member must have a documented intolerance or poor response to ALL of the following: o A non-benzodiazepine drug therapy for insomnia for at least 4 weeks (e.g. zolpidem, zaleplon), sedating antidepressant (e.g. trazodone, mirtazapine, amitriptyline, doxepin), sedating antipsychotic (e.g. quetiapine, olanzapine), or sedating anticonvulsant (e.g. gabapentin, tiagabine). OTC sleep aids or supplements will not be considered as pre- requisite therapy. o Non-pharmacologic therapy (e.g. stimulus control, relaxation training, cognitive behavioral therapy) o Sleep hygiene measures • For Anxiety or Panic Disorder: the member must have a documented intolerance or poor response to at least TWO of the following: o Psychotherapy (e.g. cognitive behavioral therapy, applied relaxation) o Antidepressant medications (e.g. SSRIs, SNRIs, tricyclic antidepressants) o Other serotonergic agents (buspirone, trazodone) o Other alternative agents: hydroxyzine, bupropion, olanzapine, risperidone, quetiapine, or pregabalin (Lyrica) • For Restless Legs Syndrome: ALL of the following apply: o Prescriber attests that iron deficiency has been ruled out or if member is iron deficient, they have been adherent to iron + vitamin C regimen for at least 3 months o Member has implemented good sleep hygiene practices o Member has tried TWO of the following pharmacologic treatments: pramipexole , ropinirole, gabapentin, Horizant (gabapentin enacarbil), Neupro (rotigotine), cabergoline, or pregabalin (Lyrica) • For Chronic Muscle Spasms/Spasticity: If the request is for a duration of > 14 days for the diagnosis of chronic muscle spasms or spasticity, the member must have a documented intolerance or poor response to at least TWO of the following: tizanidine, baclofen, riluzole, dantrolene, cyclobenzaprine, carisoprodol, methocarbamol, orphenadrine, or chlorzoxazone.
Revision/Review Date: 4/2025 Criteria for Reauthorization: • The requested dose is within compendia guidelines • The member is NOT currently taking an opioid. If the member will be taking an opioid, the provider has counseled the member on the risks of concurrent benzodiazepine/opioid use. • If the member will be concurrently taking another benzodiazepine, muscle relaxant, or sedative hypnotic drug (e.g. zolpidem, zaleplon), the prescriber attests to counseling the patient on risks of concurrent use • Prescriber must attest to review of the State Prescription Monitoring Program prior to prescribing • Documentation of one of the following: o A benzodiazepine tapering/ discontinuation plan is in place o A benzodiazepine is the only adequate treatment for the member’s disease state Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Blincyto Drugs Blincyto (blinatumomab) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restriction N/A Prescriber Restrictions Prescribed by or in consultation with an oncologist/hematologist Coverage Duration The request will be approved for up to a 12 month duration. Other Criteria
Revision/Review Date 4/2025 Initial Authorization: • Patient has a diagnosis of one of the following forms of Acute Lymphoblastic Leukemia (ALL): a) Relapsed CD19-positive B-cell precursor ALL b) Refractory CD19-positive B-cell precursor ALL c) CD19-positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% d) CD19-positive Philadelphia chromosome-negative B-cell precursor ALL in the consolidation phase of multiphase chemotherapy • Provider attests to monitor patient for Cytokine Release Syndrome (CRS) and neurological toxicities
Reauthorization: • Provider attests to treatment response or stabilization of disease • Prescriber attests to monitor patient for Cytokine Release Syndrome (CRS) and neurological toxicities
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Botulinum Toxins A&B Drugs Preferred Agents for FDA approved indications: IncobotulinumtoxinA (Xeomin) AbobotulinumtoxinA (Dysport) Non-preferred Agents: OnabotulinumtoxinA (Botox) RimabotulinumtoxinB (Myobloc) DaxibotulinumtoxinA (Daxxify) Or any newly marketed agent Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions According to package insert Prescriber Restrictions None Coverage Duration If all of the conditions are met, the request will be approved for 12 month duration. Other Criteria The use of these medications for cosmetic purposes is NOT a covered benefit under the Medical Assistance program For Initial Approval: • The drug is being used for a medically accepted indication and dose as outlined in Covered Uses • The member has tried and failed standard first line therapy for their disease state and/or has a documented medical reason (intolerance, hypersensitivity, contraindication, etc.) for not using first line therapy • If the diagnosis is Chronic Migraines (≥15 days per month with headache lasting 4 hours a day or longer), the member has tried and failed, or has a medical reason for not using one drug from two of the following categories for at least 4 weeks each at a minimum effective dose: o Beta blockers (e.g. propranolol, timolol, etc.) o Amitriptyline or venlafaxine o Topiramate, divalproex ER or DR, or valproic acid
Revision/Review Date 10/2025 • If the diagnosis is Overactive Bladder, the member has tried and failed 2 formulary drugs (e.g. oxybutynin) • If the diagnosis is Hyperhidrosis, the member has tried and failed a prescription strength antiperspirant (e.g. 20% aluminum chloride hexahydrate) • If the diagnosis is Chronic Sialorrhea, o Documentation is provided that the member has had sialorrhea lasting at least 3 months o The member has tried and failed, or has a medical reason for not using, an anticholinergic medication (e.g. glycopyrrolate, hyoscyamine, benztropine) • If the request is for a non-preferred agent, the member tried and failed a preferred agent if appropriate for the requested indication For Reauthorization: • Documentation of provider attestation that demonstrates a clinical benefit • The requested drug is for a medically accepted dose as outlined in Covered Uses Physician/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Brineura (cerliponase alfa)
Drugs
Brineura (cerliponase alfa)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional (USP
DI), and the Drug Package Insert, and/or per the National
Comprehensive Cancer Network (NCCN)
Exclusion Criteria
N/A
Required Medical
Information
See “other criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescriber must be a neurologist
Coverage Duration
If the criteria are met, the request will be approved for 12 months.
Other Criteria
Revision/Review
Date: 7/2025
Initial Authorization:
• Documentation of confirmed diagnosis of neuronal ceroid
lipofuscinosis type 2 (CLN2) with one of the following:
o Lab results demonstrating deficient TPP1 enzyme
activity
o Identification of causative mutations in the TPP1/CLN2
gene
• Documentation of baseline CLN2 Clinical Rating Scale motor
+language score. Baseline CLN2 score must be > 0.
• Medication is prescribed at an FDA approved dose
Re-authorization:
• Documentation of CLN2 Clinical Rating Scale motor +language
score has remained > 0
• Medication is prescribed at an FDA approved dose
Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Brinsupri (brensocatib)
Drugs
Brinsupri (brensocatib)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescribed by or in consultation with a pulmonologist
Coverage Duration
If all the criteria are met, the initial and reauthorization request will be
approved for 12 months
Other Criteria
Revision/Review
Date: 10/2025
Initial Authorization:
• Diagnosis of bronchiectasis confirmed by chest CT scan
• Documentation patient does not have Cystic Fibrosis
• At least 2 exacerbations in the past 12 months requiring an antibiotic
prescription, urgent care or emergency room visit, or hospitalization
• Medication is prescribed at an FDA approved dose
Re-Authorization:
• Documentation or provider attestation of positive clinical response
(i.e. decrease in cough, sputum production, exacerbations, etc.)
• Medication is prescribed at an FDA approved dose
If all of the above criteria are not met, the request is referred to a
Medical Director/Clinical Reviewer for medical necessity review.
Prior Authorization
Group Description
Budesonide (Pulmicort Respules)
Drugs
Preferred:
budesonide inhalation suspension 0.25 mg/2 ml, 0.5 mg/2 ml
Non-Preferred:
budesonide inhalation suspension 1 mg/2 ml
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug Package
Insert (PPI), or disease state specific standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “other criteria”
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage Duration
If the conditions are met, the request will be approved for 12 months.
Other Criteria
Revision/Review
Date: 7/2025
•
Claims for patients of ages 0 to 6 years will process at the point of
sale without prior authorization required if dosed within appropriate
dosing guidelines as follows:
o
0.25mg/2mL once or twice daily
o
0.5mg/2mL once daily or twice daily
•
For a diagnosis of asthma in patients 7 years of age or older, the
provider must submit documentation as to why the member cannot
use an inhaled corticosteroid via inhaler.
Medical Director/clinical reviewer must override criteria when, in
his/her professional judgement, the requested item is medically
necessary.
Field Name Field Description Prior Authorization Group Description Camzyos Drugs Camzyos (mavacamten) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions ≥ 18 years Prescriber Restrictions Prescribed by or in consultation with a cardiologist Coverage Duration If all of the criteria are met, the initial request will be approved for 6 months. For continuation of therapy, the request will be approved for 12 months. Other Criteria
Revision/Review
Date: 7/2025
Initial Authorization:
• Diagnosis of symptomatic New York Heart Association (NYHA) class II or
III obstructive hypertrophic cardiomyopathy (oHCM)
• Patient has a left ventricular ejection fraction (LVEF) ≥55%
• Patient has a peak left ventricular outflow tract (LVOT) gradient ≥ 50 mmHg
at rest or with provocation
• Trial and failure or contraindication to ALL of the following:
o Beta blockers (i.e. metoprolol, propranolol, atenolol)
o Non-dihydropyridine calcium channel blockers (i.e. verapamil,
diltiazem)
• Prescriber attests that patient is not diagnosed with a disorder that causes
cardiac hypertrophy that mimics oHCM (i.e., Fabry disease, amyloidosis, or
Noonan syndrome with LV hypertrophy)
• Prescriber attests that patient is not using moderate to strong CYP2C19
inducers, strong CYP2C19 inhibitors or CYP3A4 inducers
• Medication is prescribed at an FDA approved dose
Re-Authorization:
• Documentation of clinical benefit as evidenced by an improvement in oHCM
symptoms (i.e., improvement in shortness of breath, LVOT, peak oxygen
consumption, etc.) from baseline OR improvement or no worsening of
NYHA functional class from baseline
• Patient has a left ventricular ejection fraction (LVEF) ≥50%
• Medication is prescribed at an FDA approved dose
If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Prior Authorization
Group Description
Carisoprodol
Drugs
carisoprodol (Soma)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug
Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
Member 16 years of age or older
Prescriber
Restrictions
N/A
Coverage Duration
If the criteria are met, the request will be approved for a single fill for a
maximum of 84 tablets for a 90 day supply.
Other Criteria
Revision/Review
Date: 2/2026
Initial Authorization:
•
Member has had a trial and failure, or intolerance to,
cyclobenzaprine, tizanidine, baclofen or a nonsteroidal anti-
inflammatory drug (NSAID) in the last 90 days; AND
•
If the member has previously received a carisoprodol containing drug
within the past 90 days, then the provider attests the member has been
screened for, and demonstrates no signs of, carisoprodol abuse
Re-Authorization:
•
Documentation has been provided that states the member has been
screened for, and demonstrates no signs of, carisoprodol abuse
Medical Director/clinical reviewer must override criteria when, in
his/her professional judgement, the requested item is medically
necessary.
Prior Authorization
Group Description
Calcitonin Gene-Related Peptide (CGRP) Antagonists for Headache
Prevention
Drugs
Preferred:
Aimovig (erenumab)
Ajovy (fremanezumab)
Emgality (galcanezumab) 120 mg/mL pen/syringe
Qulipta (atogepant)
Non-Preferred:
Vyepti (eptinezumab)
Nurtec ODT (rimegepant) – if the request is for acute treatment of migraine,
please refer to the Acute Migraine Treatments criteria
Emgality (galcanezumab) 100mg syringe
any newly marketed drug in the class
Covered Uses
Medically accepted indications are defined using the following sources: the
Food and Drug Administration (FDA), Micromedex, American Hospital
Formulary Service (AHFS), United States Pharmacopeia Drug Information for
the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease
state specific standard of care guidelines.
Exclusion Criteria
Request for indication of chronic cluster headaches
Required Medical
Information
See “other criteria”
Age Restrictions
According to package insert
Prescriber Restrictions
Prescribed by or in consultation with a neurologist
Coverage Duration
If the criteria are met, the request will be approved for 6 months. If the
provider states that the requested medication is for a chronic or long-term
condition for which the medication may be necessary for the life of the
patient, the request will be approved for 12 months.
Other Criteria
Criteria for Initial Authorization:
Cluster Headache:
• Request for Emgality (galcanezumab) for diagnosis of episodic cluster
headache
If the request is for any other CGRP, do not approve; not indicated
Requested dose is within FDA approved dosing guidelines
AND
• Documented trial and failure (or a medical justification for not using) with
verapamil for at least 4 weeks, at minimum effective doses
• If the request is for Emgality 100mg syringe, a trial and failure of,
contraindication to, or medical reason for not using Emgality 120mg/mL pen
or syringe
Migraine Headache Prophylaxis:
Revision/Review Date: 1/2026 • Diagnosis of episodic migraine as evidenced by number of headache days per month (4 to 14 migraine days per month) or chronic migraine (≥ 15 headache days per month with ≥ 8 migraine days per month) despite use of abortive therapy (e.g. triptan or NSAIDs) • Requested dose is within FDA approved dosing guidelines • Documentation of the number of headache days per month • Documentation of members Migraine Disability Assessment (MIDAS), Migraine Physical Function Impact diary (MFPDI), or Headache Impact Test (HIT-6) score • Physician attests to trial and failure (or a medical justification for not using e.g. hypersensitivity, baseline bradycardia or hypotension, adverse events experienced from previous trial, etc.) with at least one drug from TWO categories below for at least 4 weeks EACH, at minimum effective doses:
- Beta-adrenergic blockers
- Topiramate or divalproex ER or DR
- Amitriptyline or venlafaxine
Frovatriptan, zolmitriptan or naratriptan (for menstrual migraine prophylaxis) • Medication will not be used in combination with another CGRP inhibitor for either acute or preventative treatment of migraine • If the request is for a non-preferred CGRP antagonist, the patient has a documented medical reason (intolerance, hypersensitivity, contraindication, treatment failure etc) for not using TWO preferred CGRP antagonists for migraine prophylaxis.
• If the request is for Emgality 100mg syringe, a trial and failure of, contraindication to, or medical reason for not using Emgality 120mg/mL pen or syringe • If the request is for Qulipta, a trial and failure of, contraindication to, or medical reason for not using an injectable CGRP receptor antagonist is required • If the request is for Nurtec ODT, a trial and failure of, contraindication to, or medical reason for not using Qulipta is requiredCriteria for Re-Authorization:
Episodic Cluster Headache: • Reduction in the frequency of headaches (clinical benefit)
Migraine: • For migraine: documented clinical benefit as evidenced by one of the following:
o Reduction of ≥50% in the number of headache days per month relative to pre-treatment baseline (clinical benefit) o Improvement in member’s Migraine Disability Assessment (MIDAS), Migraine Physical Function Impact diary (MFPDI), or Headache Impact Test (HIT-6) score • Provider should note on the prior authorization request the number of headache days per month • Medication will not be used in combination with another CGRP inhibitor for either acute or preventative treatment of migraine
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization Group Description Chelating Agents Drugs Preferred/Formulary: deferasirox (Jadenu) tablet, granules Chemet (succimer) capsule
Non-Preferred/Non-Formulary: deferasirox (Exjade) tablet for oral suspension Chemet (succimer) capsule deferiprone (Ferriprox) solution deferoxamine mesylate (Desferal) vial penicillamine (Cuprimine, Depen, D-penamine) capsule, tablet Radiogardase (Prussian blue) capsule trientine (Spyrine) capsule Galzin (Zinc acetate) capsule pentetate calcium trisodium ampule pentetate zinc trisdoium ampule Calcium Disodium Versenate (edetate calcium disodium) ampule Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration If the above conditions are met, the request will be for 6 months.
Other Criteria
Requests for deferasirox (Exjade, Jadenu) only:
Criteria for Approval for Chronic iron overload due to blood transfusions
For Pediatric Population:
•
Patient must be > 2 years old and < 21 years old
•
Diagnosis of chronic iron overload due to blood transfusions
•
Patient receiving blood transfusions on a regular basis/participating in blood
transfusion program
•
Serum ferritin concentration is consistently > 1000 mcg/L. If the serum ferritin
levels fall consistently below 500 mcg/L, deferasirox must be discontinued
•
If the request is for any product other than deferasirox tablets the member has
had a documented trial and failure of deferasirox tablets or medical reason
why deferasirox tablets cannot be used
•
If the request is for deferasirox oral granules in packet, the member is 10 years
of age or younger, or has a medical reason why deferasirox tablets cannot be
used
•
The medication requested is being prescribed at an FDA-approved dose
For Adult Population:
•
Patient must be > 21 years old
•
Diagnosis of chronic iron overload due to blood transfusions
•
Patient receiving blood transfusions on a regular basis/participating in blood
transfusion program
•
Serum ferritin concentration is consistently > 1000 mcg/L. If the serum ferritin
levels fall consistently below 500 mcg/L, deferasirox must be discontinued
•
Documentation that patient is unable to use deferoxamine (Desferal)
parenterally
•
If the request is for any product other than deferasirox tablets the member has
had a documented trial and failure of deferasirox tablets or medical reason
why deferasirox tablets cannot be used
•
If the request is for deferasirox oral granules in packet, the member has a
medical reason why deferasirox tablets cannot be used
•
The medication requested is being prescribed at an FDA-approved dose
Chronic iron overload in non-transfusion dependent thalassemia
syndromes:
•
Patient must be ≥ 10 years old
•
Diagnosis of thalassemia syndrome
•
Liver iron content (LIC) by liver biopsy of ≥ 5 mg Fe/g dry weight
•
If the request is for any product other than deferasirox tablets the member has
had a documented trial and failure of deferasirox tablets or medical reason
why deferasirox tablets cannot be used
•
If the request is for deferasirox oral granules in packet, the member is 10 years
old, or has a medical reason why deferasirox tablets cannot be used
•
The medication requested is being prescribed at an FDA-approved dose
Requests for Ferriprox (deferiprone) only:
Revision/Review Date: 1/2026
Transfusion iron overload due to thalassemia syndrome, sickle cell disease, or
other anemias
•
Patient must be ≥ 3 years old for oral solution OR > 8 years old for tablets
•
Diagnosis of thalassemia syndrome, sickle cell disease, or other anemia
•
Patient receiving blood transfusions on a regular basis/participating in blood
transfusion program
•
Serum ferritin concentration is consistently > 1000 mcg/L. If the serum ferritin
levels fall consistently below 500 mcg/L, Ferriprox must be discontinued
•
Documented trial and failure of deferasirox tablets or medical reason why
deferasirox tablets cannot be used
•
If the request is for Ferriprox Twice a Day there is a documented medical
reason why deferiprone 500 mg tablet and deferiprone 1,000 mg tablet cannot
be used
•
Documented patient is unable to use deferoxamine (Desferal) parenterally
•
The medication requested is being prescribed at an FDA approved dose
Requests for Wilson’s Disease:
Cuvrior (trientene tetrahydrochloride) only:
• Laboratory confirmed diagnosis of Wilson’s disease supported by
appropriate diagnostic testing (e.g., slit lamp examination, 24-urinary
copper excretion, serum ceruloplasmin, serum copper concentration,
liver biopsy, genetic testing, brain imaging, etc.)
• Patient is de-coppered
• Patient is tolerant to penicillamine and will discontinue penicillamine
before starting therapy with Cuvrior
• The medication requested is being prescribed at an FDA approved dose
Trientene (Syprine) only:
• Laboratory confirmed diagnosis of Wilson’s disease supported by
appropriate diagnostic testing (e.g., slit lamp examination, 24-urinary
copper excretion, serum ceruloplasmin, serum copper concentration,
liver biopsy, genetic testing, brain imaging, etc.)
• Documented trial and failure, intolerance, or contraindication to
penicillamine
• The medication requested is being prescribed at an FDA approved dose
Requests for all other drugs and indications:
•
The drug is requested for an appropriate use (per the references outlined in
“Covered Uses”) AND
•
The dose requested is appropriate for the requested use (per the references
outlined in “Covered Uses”)
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization
Group Description
Cholbam
Drugs
Cholbam (cholic acid)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug
Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “other criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
MD is a gastroenterologist OR hepatologist
Coverage Duration
If all of the conditions are met, the request will be approved for a 3
month duration for the first year of therapy, and then for a 6 month
duration after one year of treatment.
Other Criteria
Initial authorization:
•
Patient has a confirmed diagnosis of:
Bile acid synthesis disorder due to single enzyme defect
(SEDs)
OR
Peroxisomal disorders (PDs) including Zellweger
spectrum disorders in patients that exhibit
manifestations of liver disease, steatorrhea or
complications from decreased fat soluble vitamin
absorption
•
Current labs (within 30 days of request) have been submitted
for the following:
ALT/AST
GGT (serum gamma glutamyltransferase)
ALP (Alkaline phosphatase)
Bilirubin
INR
Re-authorization:
•
Documentation has been submitted indicating clinical benefit/
liver function has improved since beginning treatment
•
For reauthorization after the first 3 months of treatment, lab
results must show an improvement in liver function and there
must be no evidence of biliary obstruction or cholestasis
•
Current labs (within 30 days of request) have been submitted
for the following:
ALT/AST
Revision/Review Date 10/2025 GGT (serum gamma glutamyltransferase) ALP (Alkaline phosphatase) Bilirubin INR Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Agents Drugs Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase)
If the request is for an immunoglobulin for CIDP, please refer to the Immune Globulins criteria Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions Per FDA-approved labeling Prescriber Restrictions Prescribed by or in consultation with a neurologist or neuromuscular specialist. Coverage Duration If all of the criteria are met, the initial request will be approved for 3 months. For continuation of therapy, the request will be approved for 12 months. Other Criteria
Date: 10/2025
Initial Authorization:
• Diagnosis of CIDP confirmed by electrodiagnostic test results (e.g.
electromyography or nerve conduction studies)
• Patient has progressive or relapsing/remitting disease course for ≥2
months
• Patient has an inadequate response, significant intolerance, or
contraindication to intravenous immunoglobulin (IVIG) or
subcutaneous immunoglobulin (SCIG)
• Medication is prescribed at an FDA approved dose
Re-Authorization:
• Documentation or provider attestation of significant clinical
improvement in neurologic symptoms or stabilization of disease
• Medication is prescribed at an FDA approved dose
If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name Field Description Prior Authorization Group Description
Complement Inhibitors Drugs Empaveli (pegcetacoplan), Fabhalta (iptacopan), Izervay (avacincaptad pegol injection), Soliris (eculizumab), Syfovre (pegcetacoplan injection), Ultomiris (ravulizumab), Voydeya (danicopan), PiaSky (crovalimab-akkz), BKEMV (eculizumab-aeeb), Epysqli (eculizumab- aagh) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, the Drug Package Insert, and/or per the standard of care guidelines Exclusion Criteria N/A Required Medical Information
See “other criteria” Age Restrictions According to package insert Prescriber Restrictions Prescriber must be a hematologist, nephrologist, neurologist, oncologist, ophthalmologist, or other appropriate specialist. Coverage Duration If the criteria are met, the criteria will be approved as follows:
Initial Requests • 3 months: eculizumab (Soliris, BKEMV, Epysqli), Ultomiris (ravulizumab), Empaveli (pegcetacoplan), Voydeya (danicopan) • 6 months: Fabhalta (iptacopan). PiaSky (crovalimab-akkz) • 12 months: Syfovre (pegcetacoplan), Izervay (avacincaptad pegol)
Reauthorization • 6 months: eculizumab (Soliris, BKEMV, Epysqli), Ultomiris (ravulizumab), Empaveli (pegcetacoplan), Voydeya (danicopan) • 12 months: Syfovre (pegcetacoplan), Fabhalta (iptacopan), PiaSky (crovalimab-akkz) No Reauthorization Izervay (avacincaptad pegol) Other Criteria
Initial Authorization: • The request is for a dose that is FDA approved or in nationally recognized compendia in accordance with the patient’s diagnosis, age, body weight, and concomitant medical conditions; AND • For Fabhalta (iptacopan), eculizumab (Soliris, BKEMV, Epysqli), Ultomiris (ravulizumab), Empaveli (pegcetacoplan), PiaSky (crovalimab-akkz), and Voydeya (danicopan) o Documentation patient complies with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria.
• For Soliris or BKEMV, patient must have a documented trial and failure or intolerance to Epysqli or a medical reason why Epysqli cannot be used.
Paroxysmal Nocturnal Hemoglobinuria (PNH):
• Documentation of diagnosis by high sensitivity flow cytometry
• Hemoglobin (Hgb) < 10.5 g/dL for Empaveli (pegcetacoplan),
or Hgb < 10 g/dL for Fabhalta (iptacopan)
• For Voydeya (danicopan):
o Member has been receiving eculizumab (Soliris,
BKEMV, Epysqli) or Ultomiris (ravulizumab) therapy
for at least 6 months
o Member has clinically evident extravascular hemolysis
[defined as anemia (Hgb ≤9.5 gram/deciliter) with
absolute reticulocyte count ≥120 x 10^9/liter] despite
treatment with eculizumab (Soliris, BKEMV, Epysqli) or
Ultomiris (ravulizumab)
o Voydeya (danicopan) will be used as add-on therapy to
eculizumab (Soliris, BKEMV, Epysqli) or Ultomiris
(ravulizumab)
Generalized Myasthenia Gravis (gMG): • Refer to the “Myasthenia Gravis Agents” policy
Neuromyelitis Optica Spectrum Disorder (NMOSD) • Refer to the “Neuromyelitis Optica Spectrum Disorder (NMOSD) Agents” policy
Atypical Hemolytic Uremic Syndrome (aHUS)/Complement- Mediated HUS) • Documentation of confirmed diagnosis as evidenced by complement genotyping and complement antibodies; OR • Provider attestation treatment is being used empirically and delay in therapy will lead to unacceptable risk to the patient
Geographic Atrophy (GA): • If the request is for Syfovre (pegcetacoplan injection), member must be ≥ 60 years of age • If the request is for Izervay (avacincaptad pegol injection), member must be ≥ 50 years of age • Diagnosis of GA secondary to age-related macular degeneration (AMD) • Absence of choroidal neovascularization (CNV) in treated eye • Best-corrected visual acuity (BCVA) of 24 letters (approximately 20/320) or better using Early Treatment Diabetic Retinopathy Study (ETDRS)
Revision/Review Date 4/2025 • GA lesion size ≥ 2.5 and ≤ 17.5 mm2 with at least 1 lesion ≥ 1.25 mm2
Re-Authorization: • Re-authorization may be considered for all agents included in these criteria with the exception of Izervay (avacincaptad pegol injection), which is only indicated for a 12 month duration • Provider has submitted documentation of clinical response to therapy (e.g., reduction in disease severity, improvement in quality of life scores, increase in Hgb, reduced need for blood transfusions, slowing of growth rate of GA lesions, etc.); AND • The request is for a dose that is FDA approved or in nationally recognized compendia in accordance with the patient’s diagnosis, age, body weight, and concomitant medical condition; AND • If the request is for aHUS/Complement Mediated HUS o Documentation of confirmed diagnosis as evidenced by complement genotyping and complement antibodies Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Cobenfy Drugs Cobenfy (xanomeline and trospium chloride) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions 18 years of age and older Prescriber Restrictions Prescriber must be a psychiatrist or in consultation with a psychiatrist Coverage Duration If all of the criteria are met, the initial request will be approved for 6 months. For continuation of therapy, the request will be approved for 12 months. Other Criteria
Revision/Review
Date: 3/2026
Initial Authorization:
• Diagnosis of schizophrenia, consistent with the Diagnostic and Statistical Manual
of Mental Disorders, Fifth Edition (DSM-5) criteria.
• Documented trial and failure with two alternative preferred antipsychotic agents,
or a medical reason is provided for not using any typical or atypical antipsychotic
agents.
• Medication is prescribed at an FDA approved dose.
• Provider attestation is provided patient does not have any of the following:
o Moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic
impairment
o Untreated Narrow-Angle Glaucoma
o Urinary Retention
o Gastric Retention
Re-Authorization:
• Documentation or provider attestation of positive clinical response (i.e.
improvement in positive and/or negative symptoms of schizophrenia)
• Medication is prescribed at an FDA approved dose
If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name
Field Description
Prior Authorization
Group Description
Corlanor
Drugs
Corlanor (ivabradine)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional (USP
DI), the Drug Package Insert (PPI), or disease state specific standard of
care guidelines.
Exclusion Criteria
Pregnancy
Required Medical
Information
See “Other Criteria”
Age Restrictions
See “Other Criteria”
Prescriber
Restrictions
Prescribed by or in consultation with a cardiologist
Coverage Duration
If all of the conditions are met, the request will be approved for 12
month duration.
Other Criteria
Revision/Review
Date 2/2026
Heart Failure in Adult Patients:
- Member is aged 18 years or older
- Member has a diagnosis of stable symptomatic chronic heart failure (NYHA functional class II-IV) with a left ventricular ejection fraction ≤ 35%
- Member is in sinus rhythm with a resting heart rate ≥ 70 beats per minute (bpm)
- Member is currently being prescribed, or documentation has been provided that the member is not able to tolerate, an evidence based beta-blocker (i.e., bisoprolol, carvedilol, metoprolol succinate) at maximally tolerated dose Heart Failure in Pediatric Patients:
- Member is aged 6 months to less than 18 years of age
- Member has stable heart failure (NYHA/Ross functional class II- IV) due to dilated cardiomyopathy and a left ventricular ejection fraction ≤ 45%
- Member is in sinus rhythm with an elevated resting heart rate Medical Director/Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Corticosteroids for Duchenne Muscular Dystrophy (DMD) Drugs Agamree (vamorolone) Deflazacort (Emflaza) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions Patient must be 2 years of age or older Prescriber Restrictions Prescribed by a neurologist, provider who specializes in the treatment of DMD, or in consultation with a neurologist of provider who specialized in the treatment of DMD Coverage Duration If all of the conditions are met, the initial request will be approved for a 6 month duration. For reauthorization, the request will be approved for 12 months. Other Criteria Revision/Review Date: 2/2026 Initial Authorization: • Confirmed diagnosis of Duchenne Muscular Dystrophy (such as documented mutation of dystrophin gene, genetic sequencing indicating mutations attributed to Duchene Muscular Dystrophy, muscle biopsy indicating absence of dystrophin protein, etc.), and copies of testing were submitted with request • Trial and failure with prednisone for at least 3 months, and documented medical reason why prednisone cannot be continued • The request is for an FDA approved dose • If the request is for deflazacort or Agamree, the member has a trial and failure of or documented medical reason why Emflaza cannot be used Reauthorization: • Documentation or attestation of clinical benefit (such as improved muscle strength, muscle function, or overall symptom improvement) • The request is for an FDA approved dose Physician/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Crenessity
Drugs
Crenessity (crinecerfont)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug
Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
• Patients with non-classic congenital adrenal hyperplasia (CAH)
• Patients with adrenal insufficiency due to causes other than 21-
hydroxylase deficiency
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescribed by, or in consultation with, an endocrinologist or other
specialist experienced in managing congenital adrenal hyperplasia
Coverage Duration
If all the criteria are met, the initial request will be approved for 6
months. For continuation of therapy, the request will be approved for 12
months.
Other Criteria
Initial Authorization:
• Medically confirmed diagnosis of classic 21-hydroxylase
deficiency congenital adrenal hyperplasia (CAH)
• Patient is currently on stable regimen of glucocorticoid therapy
at a supraphysiological dose (i.e. >13 mg/m2/day in
hydrocortisone dose equivalents for adults and >12 mg/m2/day
in hydrocortisone dose equivalents for pediatric patients 4-17
years old)
• Medication is prescribed at an FDA approved dose according to
package insert (patient’s current weight must be provided)
• For all adults and pediatric patients weighing ≥55 kg or patients
weighing ≥20 kg if CYP3A4 dose adjustment is required:
capsule formulation is requested, or documentation is provided
that patient is unable to swallow capsule whole
• Dosing requests for capsule formulations will employ strategies
to minimize the total number of capsules used daily (i.e.
“doubling up” on lower strength capsules to achieve a higher
dose when the requested dose strength exists will not be
authorized).
Re-Authorization:
• Documentation is provided that patient has successfully
achieved a reduction in glucocorticoid dosage from baseline.
Date: 4/2025 • Medication is prescribed at an FDA approved dose according to package insert (patient’s current weight must be provided) • For all adults and pediatric patients weighing ≥55 kg or patients weighing ≥20 kg if CYP3A4 dose adjustment is required: capsule formulation is requested, or documentation is provided that patient is unable to swallow capsule whole • Dosing requests for capsule formulations will employ strategies to minimize the total number of capsules used daily (i.e. “doubling up” on lower strength capsules to achieve a higher dose when the requested dose strength exists will not be authorized). If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name Field Description Prior Authorization Group Description Crinone Drugs Crinone (micronized progesterone) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria Diagnosis or treatment of infertility Required Medical Information See “other criteria” Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration If the criteria are met, the request will be approved for 30 single use applicators per 30 days until the end of pregnancy if the diagnosis is the prevention of spontaneous preterm delivery (singleton pregnancy and prior preterm birth or short cervix), or for up to 6 single use applicators if the diagnosis is secondary amenorrhea. Other Criteria Revision/Review Date 7/2025 Prevention of spontaneous preterm delivery: • Patient has singleton pregnancy and prior preterm birth or short cervix Secondary Amenorrhea: • Patient has a diagnosis of secondary amenorrhea • Patient has tried and failed, or has contraindication or intolerance to, oral progestin therapy (e.g. medroxyprogesterone acetate, norethindrone acetate tablets, micronized progesterone) • If the request is for Crinone 8% gel the patient has tried and failed, or has a contraindication or intolerance to, Crinone 4% gel Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Ctexli (chenodiol)
Drugs
Ctexli (chenodiol)
Covered Uses
Medically accepted indications are defined using the following sources: the Food and Drug
Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United
States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug
Package Insert (PPI), or disease state specific standard of care guidelines.
Exclusion Criteria
Concurrent use with Chobalm (cholic acid)
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber Restrictions
Prescribed by or in consultation with a neurologist, endocrinologist, or specialist in metabolic
disorders.
Coverage Duration
If all the criteria are met, the initial request will be approved for 6 months. For continuation of
therapy, the request will be approved for 12 months.
Other Criteria
Date: 7/2025
Initial Authorization:
•
Medication is prescribed at an FDA approved dose
•
Diagnosis of cerebrotendinous xanthomatosis (CTX) confirmed by genetic testing that
detects variants in the CYP27A1 gene (copies of test must be submitted with request)
Re-Authorization:
•
Documentation or provider attestation of positive clinical response (i.e. stabilization of
cognitive development, improvement in laboratory abnormalities [i.e. urine 23S-pentol and
plasma cholestanol], etc.)
•
Medication is prescribed at an FDA approved dose
If all of the above criteria are not met, the request is referred to a Medical Director/Clinical
Reviewer for medical necessity review.
Prior
Authorization
Group Description
Inhaled Antibiotics and Cystic Fibrosis Agents
Drug(s)
Preferred products:
tobramycin 300 mg/5 mL (generic Tobi podhaler)
Non-preferred/Unlisted products: tobramycin 300 mg/4 mL, Bronchitol
(mannitol), Cayston (aztreonam lysine), Arikayce (amikacin), Kitabis Pak
(tobramycin), TOBI Podhaler (tobramycin), Pulmozyme (dornase alfa),
Bethkis (tobramycin) or any newly marketed inhalation for treatment of
cystic fibrosis
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug Package
Insert (PPI), and/or per standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
See “Other Criteria”
Prescriber
Restrictions
Prescriber is a pulmonologist or infectious disease specialist
Coverage Duration If all of the conditions are met the request will be approved for 12
months.
Other Criteria
Review/Revision
Date: 2/2026
For all Requests:
•
Request is for an FDA approved indication and within dosing
guidelines
•
The request is appropriate for member (e.g. age/weight)
For Arikayce Requests: member has refractory Mycobacterium avium
complex (MAC) lung disease AND there is a documented medical reason
(e.g. contraindication, intolerance, hypersensitivity, etc.) why parenteral
amikacin cannot be used
For Bronchitol (mannitol) requests: member has documented trial and
failure or medical reason for not using generic hypertonic saline
nebulization solution (sodium chloride 3% or 7%)
Requests for Non-Preferred Agents: Member has a documented treatment
failure with a preferred agent OR has a documented medical reason
(intolerance, hypersensitivity, contraindication, etc.) why they are not able
to use a preferred agent
Medical Director/clinical reviewer must override criteria when, in his/her
professional judgement, the requested item is medically necessary.
Prior Authorization
Group Description
Cystic Fibrosis transmembrane conductance regulator (CFTR)
Modulators
Drug(s)
Kalydeco, Kalydeco Granules (ivacaftor), Orkambi, Orkambi Granules
(lumacaftor/ivacaftor), Symdeko (tezacaftor/ivacaftor), Trikafta
(elexacaftor/tezacaftor/ivacaftor), Alyftrek (vanzacaftor/ tezacaftor/
deutivacaftor) or any newly marketed CFTR modulator to treat cystic
fibrosis
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), and/or per standard of care
guidelines.
Exclusion Criteria
See “Other Criteria”
Required Medical
Information
See “Other Criteria”
Age Restrictions
See “Other Criteria”
Prescriber
Restrictions
Prescriber is pulmonologist or specializes in the treatment of cystic
fibrosis
Coverage Duration
If all of the conditions are met the initial request will be 6 months.
Reauthorization requests will be 12 months.
Other Criteria
Review/Revision
Date 2/2026
Initial criteria:
•
Documentation provided includes a copy of the FDA-cleared cystic
fibrosis (CF) mutation test OR documentation from the National
Cystic Fibrosis Registry (e.g. screen shot) with member’s genetic
mutations
•
The request is for an FDA approved indication for the member’s
genotype and within dosing guidelines
•
The request is appropriate for member (e.g. age/weight) based on
FDA-approved package labeling, peer reviewed medical literature
and nationally-recognized compendia.
Reauthorization:
•
Based on prescriber’s assessment, patient continues to benefit from
therapy
•
The request is within FDA dosing guidelines
Medical Director/clinical reviewer must override criteria when, in
his/her professional judgement, the requested item is medically
necessary.
Field Name
Field Description
Prior Authorization
Group Description
Dalfampridine
Drugs
dalfampridine (Ampyra) tablets
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug
Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
•
History of seizures
Moderate or severe renal impairment (creatinine clearance ≤
50mL/minute)
Required Medical
Information
See “other criteria”
Age Restrictions
Patient must be 18 years of age or older
Prescriber
Restrictions
Prescriber must be a neurologist
Coverage Duration
If all of the conditions are met, the initial request will be approved for 6
month duration. Requests for reauthorization will be approve for 12
months.
Other Criteria
Initial Authorization:
•
Baseline creatinine clearance (within 60 days of request)
•
Patient has diagnosis of multiple sclerosis (MS)
•
Patient is ambulatory AND has a walking impairment
•
Baseline 25 foot walk was submitted with request
•
Documentation was submitted (consistent with pharmacy
claims data, OR for new members to the health plan, consistent
with chart notes) that patient is currently being treated with a
disease modifying therapy (DMT) for MS (e.g.
immunomodulator, interferon, immunosuppressive), or
documentation of a medical reason (intolerance,
hypersensitivity) as to why patient is unable to use one of these
agents to treat their medical condition
•
Drug is being requested at an FDA approved dose
Re-authorization:
•
Prescriber attests patient’s walking has improved with
dalfampridine therapy
•
Documentation was submitted patient is on a DMT for MS (e.g.
immunomodulator, interferon, immunosuppressive), or
documentation of a medical reason (intolerance,
hypersensitivity) as to why patient is unable to use one of these
agents to treat their medical condition
•
Drug is being requested at an FDA approved dose
Revision/Review Date 2/2026 Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization
Group Description
Danazol
Drugs
danazol capsules
Covered Uses
Medically accepted indications are defined using the following sources: the
Food and Drug Administration (FDA), Micromedex, American Hospital
Formulary Service (AHFS), United States Pharmacopeia Drug Information
for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or
disease state specific standard of care guidelines.
Exclusion Criteria
Pregnancy
Required Medical
Information
See “other criteria”
Age Restrictions
According to package insert
Prescriber Restrictions
See “other criteria”
Coverage Duration
If the criteria are met, the request will be approved for 6 months. If the
provider states that the requested medication is for a chronic or long-term
condition for which the medication may be necessary for the life of the
patient, the request will be approved for 12 months.
Other Criteria
Revision/Review
Date:
10/2025
ENDOMETRIOSIS
• Diagnosis of endometriosis
• One of the following:
o
Documented trial and failure or medical reason for not using an
analgesic pain reliever (e.g., NSAIDs, COX-2 inhibitors) taken
in combination with a hormonal contraceptive (e.g.
estrogen/progestin, progestin only)
o
Documented trial and failure of a gonadotropin-releasing
hormone (GnRH) agonist or a GNRH antagonist
• Prescriber is a gynecologist
HEREDITARY ANGIOEDEMA:
•
Confirmed diagnosis of hereditary angioedema (HAE)
•
Prescriber is an immunologist, allergist, rheumatologist, or hematologist
Medical Director/clinical reviewer must override criteria when, in his/her
professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Daraprim
Drugs
pyrimethamine (Daraprim)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug Package
Insert (PPI), or disease state specific standard of care guidelines.
Exclusion Criteria
Patients with documented megaloblastic anemia due to folate deficiency.
Required Medical
Information
See “Other Criteria”
Age Restrictions
N/A
Prescriber
Restrictions
Prescriber must be an appropriate specialist or documentation has been
provided that prescriber has consulted with an appropriate specialist (i.e.
infectious disease, OB/GYN).
Coverage Duration
If all of the conditions are met, congenital toxoplasmosis requests will be
approved for 12 months, and all other requests will be approved for 3
months at a time.
Other Criteria
Revision/
Review Date
10/2025
Congenital Toxoplasmosis
•
Diagnosis of congenital toxoplasmosis
Acquired Toxoplasmosis
•
Diagnosis of acquired toxoplasmosis
•
Prescribed in combination with leucovorin and either a
sulfonamide or clindamycin
Patients with Human Immunodeficiency Virus (HIV)/Acquired
Immunodeficiency Syndrome (AIDS)
•
Diagnosis of Toxoplasmosis
OR
•
Both of the following:
o
Medication is being prescribed for one of the following:
Toxoplasmosis prophylaxis
Cystoisosporiasis
Pneumocystis jiroveci pneumonia
prophylaxis/treatment
o
Documented medical reason why (e.g. intolerance,
hypersensitivity, contraindication)
sulfamethoxazole/trimethoprim cannot be used
Hematopoietic Cell Transplantation Recipients
•
Medication prescribed for Toxoplasmosis prophylaxis
•
Documentation of medical reason why
sulfamethoxazole/trimethorprim cannot be used
Medical Director/clinical reviewer must override criteria when, in
his/her professional judgement, the requested item is medically
necessary.
Field Name
Field Description
Prior Authorization
Group Description
Daybue (trofinetide)
Drugs
Daybue (trofinetide)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescribed by or in consultation with a neurologist or geneticist
Coverage Duration
If all the criteria are met, the initial request will be approved for 3
months. For continuation of therapy, the request will be approved for 6
months.
Other Criteria
Revision/Review
Date 7/2025
Initial Authorization:
• Medication is prescribed at an FDA approved dose
• Diagnosis of classic or typical Rett Syndrome (RTT)
• Documentation or attestation of mutation of the MECP2 gene
• Documentation of patient weight
• Documentation or provider attestation of all the following:
o RTT Clinical Severity Scale rating of 10–36
o Clinical Global Impression–Severity (CGI-S) score of ≥4
o Baseline Rett Syndrome Behavior Questionnaire (RSBQ)
score
Re-Authorization:
• Documentation or provider attestation of positive clinical response
(i.e., decrease from baseline in RSBQ score, decrease in Clinical
Global Impression–Improvement (CGI-I, etc.)
• Medication is prescribed at an FDA approved dose
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Dendritic Cell Tumor Peptide Immunotherapy Drugs Provenge (sipuleucel-T) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria Small cell/neuroendocrine prostate cancer Required Medical Information See “Other Criteria” Age Restrictions See “Other Criteria” Prescriber Restrictions Prescriber must be an oncologist or urologist Coverage Duration If all the criteria are met, the request will be approved for 3 doses per lifetime Other Criteria Revision/Review Date 4/2025 Initial Authorization: • Metastatic castrate resistant (hormone-refractory) prostate cancer (mCRPC) (consistent with medical chart history) o Evidenced by soft tissue and/or bony metastases o Patient does NOT have M0CRPC (defined as CRPC whose only evidence of disseminated disease is an elevated serum PSA) is not authorized Visceral metastases (e.g. liver, lung, adrenal, peritoneal, brain) • Patient is not currently being treated with systemic immunosuppressants (e.g. chemotherapy, corticosteroids) or, if the patient is being treated with immunosuppressants, the prescriber has provided a valid medical reason for combination therapy • Eastern Cooperative Oncology Group (ECOG) score 0-1 • Serum testosterone <50 ng/dL (e.g. castration levels of testosterone) • Predicted survival of at least six months Reauthorization: • Treatment exceeding 3 doses per lifetime will not be authorized Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Dificid (fidaxomicin)
Drugs
Dificid (fidaxomicin)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug Package
Insert (PPI), or disease state specific standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “other criteria”
Age Restrictions
N/A
Prescriber
Restrictions
Prescribed by, or in consultation with, an infectious disease specialist or
gastroenterologist
Coverage Duration
If the criteria are met, the request will be approved for up to a 10-day
duration.
Other Criteria
Revision/Review
Date: 7/2025
Authorization for initial Clostridium difficile infection:
- Documentation provided for intolerance or medical reason why patient is unable to use oral vancomycin
- Dose requested follows FDA labeling Authorization for recurrent Clostridium difficile infection:
- Documentation provided that patient has tried oral vancomycin for management of Clostridium difficile infection
- Dose requested follows FDA labeling Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization Group Description Dojolvi Drugs Dojolvi (triheptanoin) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions N/A Prescriber Restrictions Prescriber is a specialist in the treatment of the indicated condition Coverage Duration Initial: 6 months Renewal: 12 months Other Criteria Revision/Review Date: 2/2026 Initial Authorization: • Member has a molecularly confirmed diagnosis of a long-chain fatty acid oxidation disorder (LC-FAOD) • Documentation of at least two of the following: o Disease specific elevation of acylcarnitines on a newborn blood spot or in plasma o Low enzyme activity in cultured fibroblasts o One or more known pathogenic mutations in either the CPT2, ACADVL, HADHA, or HADHB gene • Attestation or documentation member will not be receiving any other medium-chain triglyceride products while taking Dojolvi • Documentation of member’s daily caloric intake (DCI) • Dose is within FDA-indicated limits and does not exceed 35% of DCI Re-Authorization: • Documentation submitted indicating the member has experienced a clinical benefit (e.g. increased left ventricular ejection fraction, reduced left ventricular wall mass, reduced maximum heart rate, decreased incidence of rhabdomyolysis) • Documentation of member’s DCI • Dose is within FDA-indicated limits and does not exceed 35% of DCI Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior
Authorization
Group
Description
Dosage Form Optimization Criteria
Covered Uses
All medically accepted indications. Medically accepted indications are defined using
the following compendia resources: the Food and Drug Administration (FDA)
approved indication(s) (Drug Package Insert), American Hospital Formulary Service
Drug Information (AHFS-DI), and DRUGDEX Information System. The reviewer
may also reference disease state specific standard of care guidelines.
Scope
Requests for drugs on the plan’s formulary with a restriction that requires a trial of a
specific drug
Coverage
Duration
12 Months
Criteria
Revision/Review Date: 2/2026
Requests for the following non-preferred drugs require a trial and failure, or documented medical reason why the dosage forms listed below cannot be used:
Drug Member must try and fail, prior to approval Opipza Film Two preferred products, one of which must be aripiprazole solution Metronidazole 125mg tablet One-half of a metronidazole 250mg tablet Allpourinol 200mg tablet Two allopurinol 100mg tablets Carbamazepine 200 mg chew tablet Two carbamazepine 100mg chew tablets Labetalol 400 mg tablet Two labetalol 200mg tablets Metaxalone 640mg tablet Metaxalone 400mg or 800mg tablet Raldesy 10 mg/mL oral solution trazodone tablet Tezruly oral solution terazosin capsule Topiramate 50mg (sprinkle) capsules Two topiramate 25mg capsules Tramadol 75mg tablet Tramadol 50mg tablet Inzirqo 10 mg/mL oral suspension Diuril oral suspension For members over 10 years of age: Oral disintegrating tablet (i.e. risperidone oral tablet disintegrating) Solid oral dosage form (i.e. risperidone tablet) Zanaflex 8mg capsule Tizanidine tablet Enbumyst 0.5mg spray Two preferred loop diuretics, one of which must be a bumetanide tablet Escitalopram 15mg capsule Escitalopram tablets Kerendia 40mg tablet Two preferred products, one of which must be a preferred spironolactone product Lopressor 10mg/mL oral solution Preferred metoprolol product AND propranolol solution
Tonmya 2.8mg tablet SL Cyclobenzaprine tablet Subvenite 10mg/mL Preferred lamotrigine product Lasix Onyu 80mg/2.67mL kit Preferred furosemide product Javadin 0.02mg/mL solution Preferred clonidine product Metoprolol tartrate 12.5mg tablet Metoprolol tartrate 25mg tablet
Medical Director/clinical reviewer may override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Dose Rounding Limit Exception Criteria
Drugs
Bevacizumab products (Avastin, Mvasi, Zirabev, Vegzelma,
Alymsys, Avzivi, Jobvene) for oncologic indications
Covered Uses
All medically accepted indications. Medically accepted indications are
defined using the following compendia resources: the Food and Drug
Administration (FDA) approved indication(s) (Drug Package Insert),
American Hospital Formulary Service Drug Information (AHFS-DI),
and DRUGDEX Information System. The reviewer may also reference
disease state specific standard of care guidelines.
Scope
Requests for drugs exceeding the health plan’s dose rounding limits.
For members 18 years of age and older, the dose will be rounded down
to the nearest whole vial size if the rounded dose falls within 10% of
the requested dose.
Criteria
• If the drug is subject to other criteria, the member must meet
criteria for approval.
• The provider has submitted justification why the dose-rounding
will be inadequate based on the member’s condition and treatment
history. Exceptions may include but are not limited to:
o Member previously demonstrated a suboptimal or
partial response to therapy at a rounded dose
o Rounded dose is unavailable due to manufacturer
supply/shortage issues
o Provider has a documented medical reason why dose
rounding is inappropriate for the member
Medical Director/clinical reviewer may override criteria when, in his/her professional judgement, the requested item is medically necessary.
Coverage Duration
6 months
Revision/Review
Date
2/2026
Field Name Field Description Prior Authorization Group Description Duvyzat Drugs Duvyzat (givinostat) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions According to package insert Prescriber Restrictions Prescribed by or in consultation with a neurologist or provider who specializes in the treatment of Duchenne Muscular Dystrophy (DMD) Coverage Duration If all the criteria are met, the initial request will be approved for 12 months. For continuation of therapy, the request will be approved for 12 months. Other Criteria Review/Revision Date: 7/2025 Initial Authorization: • Medication is prescribed at an FDA approved dose according to body weight • Genetically confirmed diagnosis of DMD and copies of testing were submitted with request • Patient has been stable on baseline corticosteroids for at least 6 months • Patient is ambulatory • Patient’s platelet count is ≥ 150 x 109/L Re-Authorization: • Documentation or provider attestation of positive clinical response (such as improved muscle function, muscle strength, or disease stabilization) • Patient is on concurrent corticosteroid treatment • Patient is ambulatory • Medication is prescribed at an FDA approved dose according to body weight If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Prior Authorization
Group Description
DPP-4 Inhibitors Step Therapy
Drugs
Preferred DPP-4 Inhibitors:
Januvia (sitagliptin) tablet
Janumet, Janumet XR (sitagliptin/metformin) tablet
Tradjenta (linagliptin) tablet
Jentadueto (linagliptin/metformin) tablet
And any other newly-marketed DPP-4 inhibitor that is preferred on the PDL
Covered Uses
Medically accepted indications are defined using the following sources: the
Food and Drug Administration (FDA), Micromedex, American Hospital
Formulary Service (AHFS), United States Pharmacopeia Drug Information
for the Healthcare Professional (USP DI), or the Drug Package Insert (PPI).
Exclusion Criteria
Ν/Α
Required Medical
Information
N/A
Age Restrictions
Age appropriate per labeling
Prescriber Restrictions N/A
Coverage Duration
If the criteria are met, the request will be approved for 12 months.
Step Therapy
Criteria
Revision/Review
Date: 4/2025
•
Documentation of a trial and failure or intolerance to metformin or a metformin
combination product in the last 90 days
•
New members to the plan who are stable on a DPP-4 inhibitor do not require a trial
of metformin
If all of the criteria are not met, the request will be referred to a Medical
Director or clinical reviewer for medical necessity review.
Field Name Field Description Prior Authorization Group Description Elevidys Drugs Elevidys (delandistrogene moxeparvovec-rokl) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria • Any deletion in exon 8 and/or exon 9 in the Duchenne Muscular Dystrophy (DMD) gene • Concurrent use with an exon skipping drugs (such as Exondys 51, Amondys 45, Vyondys 53, Viltepso) Required Medical Information See “Other Criteria” Age Restrictions According to package insert Prescriber Restrictions Prescribed by or in consultation with a neurologist or provider who specializes in the treatment of DMD Coverage Duration If all the criteria are met, the initial request will be approved for a one-time treatment.
Other Criteria
Revision/Review
Date: 12/2025
Initial Authorization:
•
Medication is prescribed at an FDA approved dose
•
Documentation of weight
•
Genetically confirmed diagnosis of DMD and copies of testing were
submitted with request
•
Attestation patient is ambulatory
•
Attestation patient has anti-recombinant adeno-associated virus serotype
rh74 (anti-AAVrh74) total binding antibody titers of less than 1:400
•
Attestation prescriber has assessed the safety and monitoring
requirements in the labeling and determined the patient is an appropriate
candidate for Elevidys, including:
o liver function
o platelet counts and troponin-Ilevels
o current or recent infections
o recent vaccinations
If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name
Field Description
Prior Authorization
Group Description
Emergency Use Authorization (EUA) Drugs/Products for
COVID-19
Drugs
Any drug/product approved by EUA for COVID-19
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Emergency Use Authorization for the drug/product in
question, and the Drug Package Insert (PPI).
Exclusion Criteria
See “Other Criteria”
Required Medical
Information
See “Other Criteria”
Age Restrictions
As outlined within current FDA Emergency Use Authorization
(EUA) guidelines
Prescriber Restrictions N/A
Coverage Duration
As outlined within current FDA Emergency Use Authorization
(EUA) guidelines
Other Criteria
Revision/Review
Date 2/2026
Emergency Use Authorization for COVID-19 related drugs/products
(all must apply):
•
The requested drug/product has a currently active Emergency
Use Authorization as issued by the U.S. Food and Drug
Administration.
•
Use of the requested drug/product is consistent with the
current terms and conditions of the emergency use
authorization (such as appropriate age/weight, formulation,
disease severity, concurrent use with other medications or
medical interventions, etc.).
•
Attestation that the provider is not requesting reimbursement
for ingredient cost of drug when drug is provided by U.S.
government at no charge
Medical Director/clinical reviewer must override criteria when, in
his/her professional judgement, the requested item is medically
necessary.
Field Name Field Description Prior Authorization Group Description Encelto Drugs Encelto (revakinagene taroretcel-lwey) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions According to package insert Prescriber Restrictions Prescriber must an ophthalmologist or specialist in the treatment of macular telangiectasia (MacTel) type 2 Coverage Duration If all criteria are met, the request will be approved for a single implant per eye per lifetime. Other Criteria Revision/Review Date: 7/2025 Initial Authorization • Confirmed diagnosis of idiopathic MacTel type 2 • Inner segment (IS)/outer segment (OS) photoreceptor (PR) break (loss) in ellipsoid zone (EZ) between 0.16 and 2.00 mm2 measured by spectral domain-optical coherence tomography (SD-OCT) • Best corrected visual acuity (BCVA) score of 54 letters or better (20/80 or better Snellen equivalent) measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart • Prescriber attests that member has no evidence of neovascular MacTel type 2 • Member has not previously received an Encelto implant for treated eye Reauthorizations are not permitted, as members are limited to a single implant per eye per lifetime. Medical Director/clinical reviewer may override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Endari
Drugs
L-Glutamine (Endari)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional (USP
DI), the Drug Package Insert (PPI), or disease state specific standard of
care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescriber must be a hematologist or sickle cell specialist
Coverage Duration
If all of the conditions are met, requests will be approved for a 12
months.
Other Criteria
Revision/Review
Date 2/2026
Initial:
•
Member has diagnosis of sickle cell disease
•
Documentation was provided that the patient had 2 or more
crises in the last 12 months
•
Documentation was provided the member has been on
hydroxyurea at the maximum tolerated dose and was compliant
within the last 6 months (or a medical reason was provided why
patient is unable to use hydroxyurea)
•
Request is for an FDA approved dose
Reauthorization:
•
Prescriber attests member had reduction in number of sickle
cell crises
•
Request is for an FDA approved dose
Physician/clinical reviewer must override criteria when, in his/her
professional judgment, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Enzyme Replacement Therapy for Acid Sphingomyelinase
Deficiency (ASMD)
Drugs
Xenpozyme (olipudase alfa-rpcp)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
N/A
Prescriber
Restrictions
Prescribed by, or in consultation with, a specialist experienced in the
treatment of ASMD
Coverage Duration
If all the criteria are met, the initial request will be approved for 6
months. For continuation of therapy, the request will be approved for 12
months.
Other Criteria
Date: 2/2026
Initial Authorization:
•
Medication is prescribed at an FDA approved dose
•
Member has a diagnosis of ASMD confirmed by one of the
following:
o
Deficiency in acid sphingomyelinase (ASM) enzyme activity
(as measured by peripheral blood leukocytes, cultured skin
fibroblasts, or dried blood spots)
o
Sphingomyelin phosphodiesterase-1 (SMPD1) gene
mutation
•
Member has a clinical presentation consistent with ASMD type B or
type A/B
•
Documentation of members height and weight
•
Documentation of baseline ALT and AST within 1 month prior to
initiation of treatment
Re-Authorization:
•
Documentation or provider attestation of positive clinical response
(i.e. improvement in splenomegaly, hepatomegaly, pulmonary
function, etc.)
•
Medication is prescribed at an FDA approved dose
If all of the above criteria are not met, the request is referred to a
Medical Director/Clinical Reviewer for medical necessity review.
Field Name
Field Description
Prior Authorization
Group Description
Enzyme Replacement Therapies for Fabry Disease
Drugs
Fabrazyme (agalsidase beta)
Elfabrio (peguniigalsidase alfa)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), and the Drug
Package Insert (PPI).
Exclusion Criteria
N/A
Required Medical
Information
See “other criteria”
Age Restrictions
According to the FDA approved prescribing information
Prescriber
Restrictions
Prescribed by or in consultation with a geneticist, cardiologist,
nephrologist or specialist experienced in the treatment of Fabry disease
Coverage Duration
Initial Authorization: If the criteria are met, the request will be approved
for a 6-month duration.
Reauthorization: If the criteria are met, the request will be approved for a
12-month duration.
Other Criteria
Initial Authorization: • Male members must have a documented diagnosis of Fabry disease confirmed by one of the following:
- An undetectable (<1%) alpha galactosidase A (alpha-Gal- A) activity level OR
A deficient alpha-Gal- activity level AND a documented detection of pathogenic mutations in the galactosidase alpha (GLA) gene by molecular genetic testing • Female members must have a documented diagnosis of Fabry disease confirmed by detection of pathogenic mutations in the GLA gene by molecular genetic testing AND evidence of clinical manifestation of the disease (e.g. kidney, neurologic, cardiovascular, gastrointestinal) • Member must not be using concurrently with Galafold (migalastat) • Documentation of the member’s current weight • Request is for an FDA-approved dose
Re-Authorization:
Revision/Review Date: 7/2025 • Documentation that member has experienced an improvement in symptoms from baseline including but not limited to: decreased pain, decreased gastrointestinal manifestations, decrease in proteinuria, stabilization of increase in eGFR, reduction of left ventricular hypertrophy (LVH) on echocardiogram, or improved myocardial function, or has remained asymptomatic • Member must not be using concurrently with Galafold (migalastat) • Documentation of the member’s current weight • Request is for an FDA-approved dose
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Eohilia Drugs Eohilia (budesonide) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions According to package insert Prescriber Restrictions Prescribed by or in consultation with a gastroenterologist, allergist, immunologist, or other provider who specializes in the treatment of eosinophilic esophagitis (EoE) Coverage Duration If all criteria are met, the request will be approved for 3 months Reauthorization requests for maintenance therapy will not be approved as Eohilia has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks. Requests for subsequent courses for induction therapy will be handled on a case-by-case basis Other Criteria Revision/Review Date: 4/2025 • Diagnosis of EoE as confirmed by esophageal biopsy indicating ≥15 eosinophils per high-power field (eos/hpf) • Member must have experienced dysphagia for at least 4 days over a 2-week period • Documented trial and failure, intolerance, or contraindication to one proton pump inhibitor (PPI) at a maximally tolerated dose for a minimum of 8 weeks • Documented trial and failure, intolerance, or contraindication to an inhaled corticosteroid that can be swallowed (i.e., fluticasone, etc.) • Request is for an FDA-approved dose Medical Director/clinical reviewer may override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization Group Description Epidiolex (cannabidiol) Drugs Epidiolex (cannabidiol) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, the Drug Package Insert, and/or per the standard of care guidelines Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions Member must be ≥ 1 year old Prescriber Restrictions Prescriber must be neurologist or specialist in treatment of seizure disorder. Coverage Duration If the criteria are met, the request will be approved for a 6 month duration. Other Criteria Revision/Review Date: 10/2025 Initial: • Clinical diagnosis of Lennox-Gastaut syndrome, Dravet syndrome or Tuberous Sclerosis complex • Member has a trial and failure of two antiepileptic drugs • Member is currently taking a stable dose of at least one other antiepileptic medication • Member’s Weight • Dose is within FDA approved limits Reauthorization: • Documentation has been provided that demonstrates reduction or stabilization of seizure frequency • Dose is within FDA approved limits • Member’s weight Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization
Group Description
Erythropoiesis-Stimulating Agents (ESAs)
Drugs
Preferred:
Retacrit (epoetin alfa-epbx) (Pfizer labeler)
Mircera (methoxy peg-epoetin beta)
Non-Preferred:
Aranesp (darbepoetin alfa-polysorbate 80)
Epogen (epoetin alfa)
Retacrit (epoetin alfa-epbx) (Vifor labeler)
Procrit (epoetin alfa)
Covered Uses
Medically accepted indications are defined using the following sources: the Food and
Drug Administration (FDA), Micromedex, American Hospital Formulary Service
(AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber Restrictions
N/A
Coverage Duration
If criteria are met, the request will be approved as follows:
•
1 month if the member is deficient in iron, vitamin B12, or folate; and in the
perisurgical setting
•
3 months for all other requests
•
If the provider attests that the medication is for a chronic or long-term condition,
reauthorization will be approved for 12 months.
Other Criteria
Existing ESA users who are NEW to the plan:
•
Documentation of current dose
•
Drug is being prescribed for an FDA-approved indication at an FDA-approved
dose or is otherwise supported by the compendia or standard-of-care guidelines
•
The member’s hemoglobin (Hgb) is within the following indication-specific range:
o
Anemia of CKD: < 11 g/dl
o Anemia related to cancer: < 12 g/dl o Zidovudine-related anemia in members with HIV: < 12 g/dl o Ribavirin-induced anemia: < 12 g/dl Requests for Initial Therapy • Drug is being prescribed for an FDA-approved indication at an FDA-approved dose or is otherwise supported by the compendia or standard-of-care guidelines • All lab results submitted must have been drawn within 30 days of request • The following lab values have been submitted: o hemoglobin (Hgb) o hematocrit (HCT) • The following lab results must be submitted and demonstrate normal values, otherwise, the member MUST be receiving, or is beginning, therapy to correct the deficiency: o serum ferritin > 100 ng/mL o transferrin saturation (TSAT > 20%) o vitamin B12 level > 223 pg/mL o folate level > 3.1 ng/mL • For requests for non-preferred ESAs, documentation must be provided as to why preferred products are not medically appropriate for the member. Requests for anemia of CKD: • Hgb < 10 g/dL For anemia related to cancer: • Receiving myelosuppressive therapy for palliative treatment for at least two months (members receiving myelosuppressive therapy with curative intent should not receive ESAs) AND documented symptomatic anemia with Hgb < 10 g/dL • OR Member has symptomatic anemia related to myelodysplastic syndrome AND documented serum erythropoietin level < 500 mU/mL For zidovudine-related anemia in members with HIV: • The member must currently be receiving highly active antiretroviral therapy (HAART) • Erythropoietin level < 500 mU/mL • Member is receiving a dose of zidovudine ≤ 4,200 mg/week For ribavirin-induced anemia: • Member is currently receiving ribavirin • Hgb < 12 g/dL
Revision/Review Date: 10/2025 For members undergoing surgery to reduce the need for allogenic blood transfusion: • Perioperative hemoglobin must be < 13 g/dL and > 10 g/dL • The member is scheduled for an elective, non-cardiac, nonvascular surgery. Reauthorization: • All submitted lab results have been drawn within 30 days of the reauthorization request • The following lab results must be submitted and demonstrate normal values, otherwise, the member MUST be receiving, or is beginning, therapy to correct the deficiency: o Serum ferritin level > 100 ng/mL o Transferrin saturation (TSAT) > 20% o vitamin B12 level > 223 pg/mL o folate level > 3.1 ng/mL • The member’s hemoglobin is within the following indication-specific range: o Anemia of CKD: < 11 g/dL o Anemia related to cancer: < 12 g/dL o Zidovudine-related anemia in members with HIV: ≤ 12 g/dL o Ribavirin-induced anemia: ≤ 12 g/dL • An increase in dose has not occurred more than once every 4 weeks For requests that fall outside of these parameters, or if the criteria are not met, the request will be referred to a Medical Director/clinical reviewer for medical necessity review.
Field Name Field Description Prior Authorization Group Description Fecal Microbiota Drugs Rebyota (fecal microbiota, live-jslm) Vowst (fecal micromiota spores, live-brpk) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria Treatment of Clostridioides difficile infection (CDI) Required Medical Information See “Other Criteria” Age Restrictions According to package insert Prescriber Restrictions N/A Coverage Duration If all the criteria are met, the request will be approved for 1 treatment course Other Criteria Date: 7/2025 • Medication is prescribed at an FDA approved dose • Diagnosis of at least 1 recurrent episode of CDI (≥2 total CDI episodes) • Current episode of CDI must be controlled (˂3 unformed/loose stools/day for 2 consecutive days) • Positive stool test for C. difficile within 30 days before prior authorization request • Administration will occur 24–72 hours following completion of antibiotic course for CDI treatment • For Vowst only: attestation patient will bowel cleanse using magnesium citrate or polyethylene glycol electrolyte solution the day before the first dose of Vowst Rebyota and Vowst are limited to 1 treatment course If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name
Field Description
Prior Authorization
Group Description
Epidermolysis Bullosa Agents
Drugs
Vyjuvek (beremagene geperpavec-svdt), Filsuvez (birch triterpenes)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
• Other forms of epidermolysis bullosa, such as epidermolysis
bullosa simplex, kindler epidermolysis bullosa
• Concurrent use of Vyjuvek and Filsuvez
Required Medical
Information
See “Other Criteria”
Age Restrictions
Per prescribing information
Prescriber
Restrictions
Prescriber must be a dermatologist, geneticist, or specialist experienced
in the treatment of epidermolysis bullosa.
Coverage Duration
If all of the criteria are met, the initial request will be approved for two
(2) months. Subsequent requests will be approved for six (6) months.
Other Criteria
Initial Authorization: • Patient has a diagnosis of dystrophic or junctional epidermolysis bullosa, with genetic mutation(s) confirmed via genetic testing. • Requested product is FDA approved for the patient’s epidermolysis bullosa subtype • Documentation is provided that wound(s) to be treated are clean with adequate granulation tissue, excellent vascularization, and do not appear infected • Documentation is provided that there is no evidence of, or history of squamous cell carcinoma in the wound(s) to be treated • Medication is prescribed at an FDA approved dose, and maximum dispensable amount is not exceeded o Vyjuvek: Requests exceeding more than one vial per week will not be approved. o Filsuvez: documentation of size of treatment area(s) and frequency of dressing changes is required. One tube of Filsuvez covers up to 250 cm2 surface area per single use tube. Requests exceeding a quantity sufficient to cover the treatment area more than once daily will not be approved. Rounding to the next whole tube size necessary is allowed. Re-Authorization:
Revision/Review Date: 4/2025 • Documentation or provider attestation of positive clinical response (i.e. improvement in wound appearance, wound closure, healing, etc.) • Documentation indicating need for continued treatment is needed (either to partially healed wounds or to other wound sites) • Documentation is provided that wound(s) to be treated are clean with adequate granulation tissue, excellent vascularization, and do not appear infected • Documentation is provided that there is no evidence of, or history of squamous cell carcinoma in the wound(s) to be treated • Medication is prescribed at an FDA approved dose, and maximum dispensable amount is not exceeded. o Vyjuvek: Requests exceeding more than one vial per week will not be approved. o Filsuvez: documentation of size of treatment area(s) and frequency of dressing changes is required. One tube of Filsuvez covers up to 250 cm2 surface area per single use tube. Requests exceeding a quantity sufficient to cover the treatment area more than once daily will not be approved. Rounding to the next whole tube size necessary is allowed.
If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
• Documentation is provided that wound(s) to be treated are clean with adequate granulation tissue, excellent vascularization, and do not appear infected • Documentation is provided that there is no evidence of, or history of squamous cell carcinoma in the wound(s) to be treated • Medication is prescribed at an FDA approved dose, and maximum dispensable amount is not exceeded. o Vyjuvek: Requests exceeding more than one vial per week will not be approved. o Filsuvez: documentation of size of treatment area(s) and frequency of dressing changes is required. One tube of Filsuvez covers up to 250 cm2 surface area. Requests exceeding a quantity sufficient to cover the treatment area more than once daily will not be approved.
If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name Field Description Prior Authorization Group Description Forzinity (elamipretide) Drugs Forzinity (elamipretide) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria See “Other Criteria” Required Medical Information See “Other Criteria” Age Restrictions N/A Prescriber Restrictions Prescribed by a cardiologist, endocrinologist, hematologist, geneticist, neurologist, or other provider specializing in the treatment of Barth Syndrome. Coverage Duration If the criteria are met, the request will be approved for up to 6 months for initial requests, and 12 months for renewal requests; if the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.
Other Criteria
Revision/Review
Date: 2/2026
Initial Authorization:
• Diagnosis of Barth Syndrome confirmed via identification of mutations in the
TAZ gene per genetic testing
• Patient’s current weight is provided with the request and is ≥ 30 kg
• Pediatrics: patient does not have renal impairment
• Adults: patient is not on dialysis
• Requested dose is within FDA approved dosing guidelines
Renewal Requests:
• Patient has not experienced a serious hypersensitivity reaction to Forzinity
• Documentation or provider attestation of clinical benefit (i.e. 6-minute walk
test, Total Fatigue Score on the Barth syndrome Symptom Assessment, muscle
strength, cardiac function, etc.)
Medical Director/clinical reviewer must override criteria when, in his/her
professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Galafold Drugs Galafold (migalastat) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), and the Drug Package Insert (PPI). Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions Members should be greater than or equal to 18 years of age Prescriber Restrictions Prescribed by or in consultation with a geneticist, cardiologist, nephrologist or specialist experienced in the treatment of Fabry disease Coverage Duration Initial Authorization: If the criteria are met, the request will be approved for a 6-month duration. Reauthorization: If the criteria are met, the request will be approved for a 12-month duration. Other Criteria Initial Authorization: • Member has a documented diagnosis of Fabry disease • Documentation member has an amenable galactosidase alpha (GLA) gene variant based on in vitro assay data • Member will not be using Galafold concurrently with enzyme replacement therapy (e.g., Fabrazyme) • Documented baseline eGFR ≥ 30 mL/min • Request is for an FDA-approved dose Re-Authorization: • Documentation that member has experienced an improvement in symptoms from baseline including but not limited to: decreased pain, decreased gastrointestinal manifestations, decrease in proteinuria, stabilization of increase in eGFR, reduction of left ventricular hypertrophy (LVH) on echocardiogram, or improved myocardial function • Member must not be using concurrently with other enzyme replacement therapy (e.g., Fabrazyme) • Documented eGFR ≥ 30 mL/min • Request is for an FDA-approved dose
Revision/Review Date: 10/2025 If the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review. Physician/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Agents to Treat Gaucher’s Disease
Drugs
Cerdelga (eliglustat), Cerezyme (imiglucerase), Vpriv
(velaglucerase alfa), Elelyso (taliglucerase alfa), miglustat (Zavesca)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), and the Drug Package Insert (PPI).
Exclusion Criteria
None
Required Medical
Information
See “Other Criteria”
Age Restrictions
Per package insert
Prescriber Restrictions
Prescriber is a specialist in treatment of Gaucher’s Disease (e.g.
endocrinologist, hematologist or geneticist), or is in consultation
with a specialist
Coverage Duration
If all of the conditions are met, the request will be approved with 6-
month duration.
Other Criteria
Initial Authorization: Cerezyme, Vpriv, Elelyso, or miglustat initial authorization: • Patient has a confirmed diagnosis of Gaucher’s disease, type 1 (GD1) • Request is for an FDA approved dose
Cerdelga initial authorization:
• Patient has a confirmed diagnosis of Gaucher’s disease,
type 1 (GD1) and is a CYP2D6 extensive metabolizer
(EM), intermediate metabolizer (IM) or poor metabolizer
(PM), as detected by an FDA-approved test.
• Patient is not concomitantly taking Class IA (e.g.
quinidine, procainamide) or Class III antiarrhythmic (e.g.
amiodarone, sotalol).
• For EMs or IMs, patient is not concomitantly taking a
moderate or strong CYP2D6 inhibitor (e.g. fluoxetine,
bupropion) WITH a moderate or strong CYP3A inhibitor
(fluconazole, ketoconazole).
• For IMs and PMs, patient is not concomitantly taking a
strong CYP3A inhibitor.
• Patient has no pre-existing cardiac disease or long QT
syndrome.
• For EM’s, patient does not have moderate or severe
hepatic impairment
• For IM’s or PMs, patient does not have any degree of
hepatic impairment.
Revision/Review Date 4/2025
Re-Authorization criteria for all agents:
• Documentation has been provided that patient has obtained
clinical benefit from medication (e.g. increased platelet
count, improvement in anemia, PFT’s, improvement in
radiographic scans, improved quality of life)
• Request is for an FDA approved dose
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Gene Therapy for Hemophilia B Drugs Hemgenix (etranacogene dezaparvovec) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria Patient has previously received treatment with Hemgenix or Beqvez Required Medical Information See “Other Criteria” Age Restrictions Patient must be 18 years of age or older Prescriber Restrictions Prescriber must be a hematologist Coverage Duration If all the criteria are met, the initial request will be approved for a one- time treatment for one gene therapy agent for Hemophilia B. Other Criteria Date: 7/2025 Initial Authorization: • Diagnosis of Hemophilia B (congenital Factor IX deficiency) with ONE of the following: o Currently using Factor IX prophylaxis therapy o Has current or historical life-threatening hemorrhage o Has repeated, serious spontaneous bleeding episodes • Documentation that patient has ≤2% of normal circulating Factor IX) • Prescriber attests they have performed liver health assessments • Documented Factor IX inhibitor titer test showing the patient is negative for Factor IX inhibitors • Patient’s weight • Medication is prescribed at an FDA approved dose The safety and effectiveness of repeat administration of Hemgenix has not been evaluated and will not be approved. Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Generalized Pustular Psoriasis (GPP) Agents
Drugs
Spevigo (spesolimab-abzo)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
Per package insert
Prescriber
Restrictions
Prescribed by or in consultation with a dermatologist or geneticist
Coverage Duration
Acute Flares (IV vial): If all of the criteria are met, the request will be
approved for up to 2 doses.
Maintenance Treatment (SQ syringe): If all criteria are met, the initial
request will be approved for 12 months. Reauthorization requests will be
approved for 12 months.
Other Criteria
Initial Authorization
•
Diagnosis of generalized pustular psoriasis (GPP)
•
If request is for an acute GPP flare (IV vial), member must be
experiencing an acute flare of GPP of moderate to severe intensity as
defined by having all of the following:
o
Generalized Pustular Psoriasis Physician Global Assessment
(GPPPGA) total score of 3 or greater
o
Presence of fresh pustules (new appearance or worsening of
pustules)
o
GPPPGA pustulation sub score of 2 or greater
o
At least 5% of body surface area covered with erythema and
the presence of pustules
•
If request is for maintenance treatment of GPP (SQ syringe),
member must have all of the following:
o
History of at least two GPP flares in the past year of
moderate to severe intensity
o
GPPPGA score of 0 or 1
o
Documented trial and failure, intolerance, or contraindication
to TWO of the following: oral retinoids, methotrexate, and
cyclosporine
•
Medication is prescribed at an FDA approved dose
Date: 7/2025 Reuathorization • If request is for an acute GPP flare (IV vial), member must have achieved a clinical response, defined as achieving a GPPPGA score of 0 or 1, to previous treatment but is now experiencing a new flare • If request is for maintenance treatment of GPP (SQ syringe), member must have documentation of positive clinical response to therapy (i.e. reduction in GPP flares) • Medication is prescribed at an FDA approved dose If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Prior Authorization Group Description GLP-1 Receptor Agonists for Diabetes Drugs Preferred (Requires Prior Authorization): Trulicity (dulaglutide) Ozempic (semaglutide)
Non-preferred: Bydureon BCise (exenatide) Byetta (exenatide) Rybelsus (semaglutide) Soliqua (insulin glargine/lixisenatide) Xultophy (insulin degludec/liraglutide) Liraglutide Victoza (liraglutide) Mounjaro (tirzepatide)
Covered Uses
Medically accepted indications are defined using the following sources: the Food and Drug
Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS),
United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI),
the Drug Package Insert (PPI), or disease state specific standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “other criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
N/A
Coverage Duration
If the criteria are met, the request will be approved with up to a 12 month duration for; if the
criteria are not met, the request will be referred to a clinical reviewer for medical necessity
review.
Other Criteria
Revision/Review
Date 4/2026
Initial Authorization:
•
Medication is prescribed at an FDA approved dose
•
Presumed or documented diagnosis of diabetes mellitus, type II.
•
For a non-preferred agent: Member has a documented treatment failure with TWO
preferred agents OR has a documented medical reason (intolerance,
hypersensitivity, contraindication, etc.) why they are not able to use two preferred
agents
Reauthorization:
• Documentation or provider attestation of positive clinical response (i.e., improvement in hemoglobin A1C, fasting blood sugar, etc.) • Medication is prescribed at an FDA approved dose
Prior Authorization Group Description Gonadotropin Releasing Hormone (GNRH) Agonists Drug(s) IF DIAGNOSIS IS CANCER, USE ONCOLOGY CRITERIA If Diagnosis is Gender Dysphoria, use Medications without Drug or Class Specific Criteria
Preferred: Lupron Depot (leuprolide acetate), Lupron Depot-Ped 1-month (leuprolide acetate), leuprolide acetate 22.5mg vial, Fensolvi (leuprolide acetate), Synarel (nafarelin acetate), Trelstar (triptorelin pamoate)
Non-Preferred: Triptodur (triptorelin pamoate), Supprelin LA (histrelin acetate), Lupron Depot- Ped (leuprolide acetate) 3-month and 6-month, any newly marketed GnRH agonist Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), and/or per the National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology (ASCO), the American College of Obstetricians and Gynecologists (ACOG), or the American Academy of Pediatrics (AAP) standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions According to package insert if not detailed in “Other Criteria” Prescriber Restrictions Prescriber must be a specialist in the appropriate field to treat the member’s condition. Coverage Duration If all of the conditions are met, the request will be approved for up to 12 months if diagnosis is central precocious puberty, and up to 6 months as indicated below for other indications as recommended per FDA approved indications and/or as defined by the medical compndium or standard of care guidelines. Other Criteria
INITIAL AUTHORIZATION for ALL REQUESTS: • The medication is being prescribed for an FDA approved/standard of care guideline indication and within FDA approved/standard of care dosing guidelines.
AND the member meets the following for the respective diagnosis:
Central precocious puberty (CPP) • Onset of secondary sexual characteristics occurred when member was aged less than 8 years for females or aged less than 9 years for males • Diagnosis is confirmed by a pubertal response to a GnRH stimulation test and/or measurement of gonadotropins (FSH/LH) and bone age advanced beyond chronological age. o Patients with low or intermediate basal levels of LH should have a GnRH stimulation test to clarify the diagnosis. o If basal levels of LH are markedly elevated [e.g. more than 0.3mlU/ml (where IU- International units)] in a child with precocious puberty, then a diagnosis of CPP can be made without proceeding to a GnRH stimulation test. • Brain magnetic resonance imaging (MRI) has been performed for all boys with CPP and for girls with onset of secondary sexual characteristics before the age of six years of age to rule out a tumor. • If the request is for a non-preferred drug, the member has had a documented trial and failure with a preferred drug, or a documented medical reason (e.g. intolerance, hypersensitivity, contraindication) was submitted why the member is not able to use a preferred drug
Endometriosis • For all therapies except Lupron, Lupron Depot, or Lupron Depot-Ped, member is ≥ 18 years of age AND • Member has a confirmed diagnosis (e.g. laparoscopy, etc.) of endometriosis • Documented trial and failure or medical reason for not using an analgesic pain reliever (e.g., NSAIDs, COX-2 inhibitors) taken in combination with combined estrogen progestin oral contraceptive pills (OCPs): o If one of the following drugs has been tried previously, a trial of OCPs is not required: progestins, Orilissa (elagolix), danazol, or aromatase inhibitors (anastrazole, letrozole) • If the request is for a non-preferred drug, the member has had a documented trial and failure with a preferred drug, or a documented medical reason (e.g. intolerance, hypersensitivity, contraindication) was submitted why the member is not able to use a preferred drug • Approval is 6 months Uterine leiomyomas (Fibroids) • Member has a confirmed diagnosis (e.g. pelvic examination, etc.) • If the request is for a non-preferred drug, the member has had a documented trial and failure with a preferred drug, or a documented medical reason (e.g. intolerance, hypersensitivity, contraindication) was submitted why the member is not able to use a preferred drug • Approval is 3 months
Endometrial thinning • Member has a confirmed diagnosis (e.g. pelvic examination, etc.) • Documentation indicates patient is scheduled for endometrial ablation for dysfunctional uterine bleeding.
Revision/Review Date: 2/2026 • If the request is for a non-preferred drug, the member has had a documented trial and failure with a preferred drug, or a documented medical reason (e.g. intolerance, hypersensitivity, contraindication) was submitted why the member is not able to use a preferred drug • Approval is 3 months REAUTHORIZATION for all requests: • The medication is being prescribed for an FDA approved indication and within FDA approved dosing guidelines. • Documentation was provided supporting continued treatment (e.g. patient still has symptoms), and medication is being continued as recommended in package insert or standard of care guidelines. AND meets the following per diagnosis: Central precocious puberty (CPP) • If the medication reauthorization is for central precocious puberty, the child is male and < 12 years or female and < 11 years of age OR a documented medical reason to continue treatment was provided with request, and includes current height and bone age Endometriosis • Prescriber has evaluated patient for osteoporosis (e.g. Dexascan), and patient is receiving “add back” hormonal therapy (norethindrone acetate 5 mg daily alone or with conjugated estrogen therapy) or an oral bisphosphonate AND calcium and vitamin D supplementation. • The patient has not received cumulative doses of the GnRH agonist greater than 12 months of therapy. Fibroids • The patient has not received cumulative doses of the GnRH agonist greater than 6 months of therapy NOTE: Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Prior Authorization Group Description Gonadotropin Releasing Hormone Receptor Antagonists Drugs Preferred: Orilissa (elagolix), Myfembree (relugolix, estradiol, and norethindrone acetate)
Non-Preferred: Oriahnn (elagolix, estradiol, and norethindrone acetate)
Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, the Drug Package Insert, and/or per the standard of care guidelines
Exclusion Criteria
•
Pregnancy
•
History of osteoporosis
•
History of hepatic impairment (Myfembree, Oriahnn), or severe
hepatic impairment (Orilissa)
Required Medical
Information
See “Other Criteria”
Age Restrictions
Member must be >18 years of age
Prescriber Restrictions
Prescriber is a obstetrician/gynecologist
Coverage Duration
If the criteria are met, the request will be approved as outlined
below:
• Initial Authorization: 6 months
•
Reauthorization: 6 months
•
6 months for patients with moderate hepatic impairment requesting
150 mg once daily dosing.
Other Criteria
Initial Authorization for all requests:
•
Medication is prescribed at an FDA approved dose
•
If patient is of childbearing potential, prescriber attests the patient is
not currently pregnant
•
Prescriber attests the patient does not have a history of osteoporosis
•
Prescriber attests they have reviewed the patient’s liver function
For a diagnosis of endometriosis associated with moderate to severe pain • Request is for Orilissa or Myfembree only • Documented trial and failure or medical reason for not using an analgesic pain reliever (e.g., NSAIDs, COX-2 inhibitors) taken in combination with combined estrogen progestin oral contraceptive pills (OCPs): o If one of the following drugs has been tried previously, a trial of OCPs is not required: progestins, gonadotropin- releasing hormone (GnRH) agonists, danazol, or aromatase inhibitors (e.g. anastrozole, letrozol)
For a diagnosis of heavy menstrual bleeding associated with uterine leiomyomas (fibroids):
Revision/Review Date: 2/2026 • Request is for Oriahnn or Myfembree only • Documented trial and failure or medical reason for not using estrogen- progestin contraceptive therapy • If one of the following drugs has been tried previously, a trial of estrogen-progestin contraceptive therapy is not required: o gonadotropin-releasing hormone (GnRH) agonists, o progestin-releasing intrauterine device o tranexamic acid • If the request is from Oriahnn, there is a documented trial and failure of Myfembree, or medical reason why Myfembree cannot be used Reauthorization: • Medication is prescribed at an FDA approved dose • Maximum lifetime treatment duration based on previous dosing and/or hepatic functioning has not been exceeded • Documentation or provider attestation of positive clinical response (e.g., reduction in pain, reduced menstrual bleeding). Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization
Group
Growth Hormone (GH) for Growth Failure or GH Deficiency
Drug(s)
Preferred products:
•
Norditropin FlexPro (somatropin)
•
Genotropin cartridge, Genotropin MiniQuick (somatropin)
•
Ngenla (somatrogon)
•
Sogroya (somapacitan-beco)
Non-preferred/unlisted products:
•
Humatrope (somatropin)
•
Skytrofa (lonapegsomatropin-tcgd)
•
Nutropin AQ (somatropin)
•
Omnitrope (somatropin)
•
Zomacton (somatropin)
•
Any newly marketed growth hormone agent
Covered Uses
Medically accepted indications are defined using the following sources: the
Food and Drug Administration (FDA), Micromedex, American Hospital Formulary
Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare
Professional (USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria Treatment of idiopathic short stature (ISS) not a covered benefit and will not be
approved
Required Medical
Information
See other criteria
Age Restrictions According to package insert
Prescriber
Restrictions
Prescribed by or in consultation with an endocrinologist or specialist in the stated
diagnosis
Coverage Duration If all of the conditions are met, the initial request will be approved for 12
months.
Other Criteria Revision/Review Date: 2/2026 Initial Authorization • If diagnosis is for growth failure associated with chronic kidney disease (CKD), documentation that: o Either pretreatment height is less than -1.88 standard deviations (SD) below the mean for age or the height velocity for age is less than 3rd percentile and persists beyond 3 months o AND epiphyses are open • If diagnosis is for growth failure associated with Prader -Willi Syndrome, Noonan Syndrome, Turner’s syndrome, or short stature homeobox- containing gene (SHOX) mutation, or other underlying genetic cause, documentation of confirmatory genetic testing is provided. • If diagnosis is adult-onset GH deficiency (AO-GHD), documentation of one of the following: o Insulin Growth Factor (IGF-1) deficiency (< -2 SD below reference range for age and gender) and multiple (≥3) pituitary hormone deficiencies (MPHD) o Evidence of genetic defects affecting the hypothalamic pituitary axis (HPA) o Evidence of hypothalamic pituitary structural brain defects o Positive results of GH stimulatory test (e.g. insulin tolerance test [ITT], glucagon, arginine, clonidine, or macimorelin). • If diagnosis childhood-onset GH deficiency (CO-GHD), o And patient is currently pediatric, documentation of all of the following is required: IGF-1 and insulin-like growth factor binding protein-3 (IGFBP-3) deficiency (less than 0 SD below reference range for age and gender) with prescriber attestation of growth failure AND Provider attests that MRI or CT has been completed to exclude possibility of a pituitary tumor AND Provider attests that member’s epiphyses are open o And patient is currently adult, documentation of one of the following: If diagnosis is idiopathic isolated GHD, documentation was provided that indicates GH therapy is still medically necessary (IGF-1 retesting during the transition period after a minimum 1 month of therapy discontinuation reveals continued GH deficiency) Diagnosis is GHD associated with MPHD, genetic defect affecting the HPA axes, or patient with hypothalamic pituitary structural brain defect • Requests for Non-Preferred Agents: Member has a documented treatment failure with at least TWO of the preferred agents OR has a documented medical reason (intolerance, hypersensitivity, contraindication, etc.) why they are not able to use any of the preferred agents. Reauthorization • Documentation of diagnosis (Note: ISS is not a covered benefit) • Documented IGF-1 levels do not exceed upper limit of normal (ULN) (> 2 SD above reference range for age and gender)*, or if the IGF-1 levels exceed ULN, the dose has been reduced
• In CO-GHD, growth response (as demonstrated by length/height and calculated height velocity within previous 6 months).
*IGF-1 levels are highly age and gender specific. In the event the form provides a value and not the corresponding reference range, refer to published reference ranges for interpretation.
Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Hemangeol (propranolol)
Drugs
Hemangeol (propranolol HCl) oral solution, 4.28 mg/mL
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug
Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
See “Other Criteria”
Prescriber
Restrictions
N/A
Coverage Duration
If all of the conditions are met, initial requests will be approved for up
to 12 months. Subsequent authorizations will be approved for up to 6
months.
Other Criteria
Revision/Review
Date 10/2025
Initial Authorization (all must apply):
•
Member has a diagnosis of proliferating infantile hemangioma
which requires systemic therapy
•
Member is at least 5 weeks corrected gestational age
•
Member’s weight is at least 2 kg
•
Request is for FDA approved dose (member’s weight must be
provided with the request)
Renewal Authorization (all must apply):
•
Request is for FDA approved dose (member’s weight must be
provided with the request)
•
Documentation is provided to support continued use of
Hemangeol solution beyond the initial 12 month authorization
period (ex. rebound growth or recurrence of infantile
hemangioma, medical justification of extended length of
therapy due to patient’s condition, etc.)
Physician/clinical reviewer must override criteria when, in his/her
professional judgment, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Primary Hemophagocytic Lymphohistiocytosis (HLH) Agents
Drugs
Gamifant (emapalumab-lzsg)
Covered Uses
Medically accepted indications are defined using the following sources: the
Food and Drug Administration (FDA), Micromedex, American Hospital
Formulary Service (AHFS), United States Pharmacopeia Drug Information for
the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease
state specific standard of care guidelines.
Exclusion Criteria
Members who have undergone hematopoietic stem cell transplantation (HSCT)
Required Medical
Information
“See Other Criteria”
Age Restrictions
N/A
Prescriber Restrictions Hematologist, Oncologist, Immunologist, Transplant Specialist, or other
specialist experienced in the treatment of immunologic disorders
Coverage Duration
Initial Authorization: 1 month
Reauthorization: 3 months
Other Criteria
Revision/Review
Date 4/2025
Gamifant will only be approved for members who have not yet received
HSCT and will be discontinued at the initiation of HSCT
Initial Authorization
•
Member has a diagnosis of Primary HLH
•
Prescriber attests that member has not achieved a satisfactory response to or
is intolerant to conventional HLH therapy (e.g. etoposide, dexamethasone) or
has recurrent disease
•
Prescriber attests that the member is a candidate for hematopoietic stem cell
transplant (HSCT)
•
Member has been screened for latent tuberculosis infection
•
Member has or will receive prophylactic pre-medications (e.g. antivirals,
antibiotics, antifungals) for Herpes Zoster, Pneumocystis jirovecii, and other
fungal infections
•
Dosing is consistent with FDA approved labeling
Reauthorization
•
Member continues to meet initial authorization criteria
•
Member is receiving prophylactic pre-medications (e.g. antivirals,
antibiotics, antifungals) for Herpes Zoster, Pneumocystis jirovecii, and other
fungal infections
Medical Director/clinical reviewer must override criteria when, in his/her
professional judgement, the requested item is medically necessary.
Prior Authorization Group Description Subcutaneous Treatments for Hemophilia Drugs Hemlibra (emicizumab-kxwh), Hympavzi (marstacimab-hncq), Alhemo (concizumab-mtci), Qfitlia (fitusiran)
Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions According to package insert Prescriber Restrictions Prescriber must be a hematologist Coverage Duration If the criteria are met, requests will be approved for 6 months. If the provider states that the requested medication is for a chronic or long- term condition for which the medication may be necessary for the life of the patient, the request will be approved for 12 months.
Other Criteria
Initial Authorization:
Documentation submitted indicates the following:
• The member’s weight
• The drug is being requested for an FDA-approved indication
and the dose is within FDA-indicated limits
• Diagnosis of hemophilia A or hemophilia B AND one of the
following
o Member has tried Factor VIII or Factor IX products and
is not well-managed due to limited venous access or
treatment failure (attestation must be submitted from
prescriber)
o Request is for routine prophylaxis in patients with a
diagnosis of hemophilia A or hemophilia B WITH
inhibitors and history of spontaneous or traumatic
bleeding episode
o Request is for routine prophylaxis in patients with a
diagnosis of hemophilia A or hemophila B WITHOUT
inhibitors and patient requires management with Factor
VIII or Factor IX products at a total weekly dose of
100 U/kg (attestation must be submitted by prescriber) • If the request is for Hympavzi, Qfitlia, or Alhemo for hemophila A, the member must also have a trial and failure or intolerance to Hemlibra
Re-Authorization:
Revision/Review Date: 4/2025 • Documentation submitted indicating the member has experienced a clinical benefit from the medication (e.g. reduction in bleeding episodes, improved quality of life) • The member’s weight • Dose is within FDA-indicated limits
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization
Group Description
Bleeding Disorder Blood Products
Drugs
Preferred: Afstyla, Alphanate, Alphanine SD, Alprolix, Benefix, Hemofil M,
Humate-P, Ixinity, Jivi, Koate, Kovaltry, Mononine, Novoeight, Nuwiq,
Profilnine, Rixubis, Wilate, Xyntha, Xyntha Solofuse, Obizur, Feiba,
NovoSeven, Rebinyn
Non-Formulary/Non-preferred: Advate, Adynovate, Altuviiio, Eloctate,
Esperoct, Kogenate FS, Recombinate, Vonvendi, Idelvion,, Vonvendi,
Coagadex, Corifact RT, Tretten, Sevenfact Hympavzi, and any newly marketed
blood product indicated for a bleeding disorder
Covered Uses
Medically accepted indications are defined using the following sources: the
Food and Drug Administration (FDA), Micromedex, American Hospital
Formulary Service (AHFS), United States Pharmacopeia Drug Information for
the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease
state specific standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
Patient must be age appropriate per package insert
Prescriber
Restrictions
Prescriber must be a hematologist
Coverage Duration
If all of the criteria are met, the request will be approved for 1 month. If the
provider states that the requested medication is for a chronic or long-term
condition for which the medication may be necessary for the life of the patient,
the request will be approved for 12 months.
Other Criteria
Revision/Review
Date: 2/2026
•
Patient has a diagnosis of a bleeding disorder, and the type of deficiency has
been provided
•
The drug is being used for an FDA-approved indication at an FDA
approved dose or the indication/dose are otherwise supported by treatment
guidelines.
•
Requests for Non-Preferred Agents: Member has a documented treatment
failure with at least two of the preferred agents OR has a documented
medical reason (intolerance, hypersensitivity, contraindication, etc.) why
they are not able to use preferred agents.
Medical Director/clinical reviewer must override criteria when, in his/her
professional judgement, the requested item is medically necessary.
Prior Authorization Group Description Hepatitis C Antiviral Agents Drugs Preferred products: • Mavyret (glecaprevir/pibrentasvir) • ribavirin • sofosbuvir/velpatasvir (Epclusa) 400-100 mg tablets Preferred sofosbuvir/velpatasvir, and ribavirin products do not require prior authorization for up to 12 weeks of therapy per year. Mavyret does not require prior authorization for up to 16 weeks of therapy per year Non-preferred/unlisted products: • Epclusa (sofosbuvir/velpatasvir) 200-50 mg tablets • Epclusa (sofosbuvir/velpatasvir) pellet packets • Epclusa (brand) 400-100 mg tablets • Harvoni tablets, pellet packets • ledipasvir/sofosbuvir (Harvoni) tablets • Peg-Intron (peginterferon alfa-2b) • Pegasys (peginterferon alfa‐2a) • Sovaldi (sofosbuvir) tablets, pellet packets • Vosevi (sofosbuvir/ velpatasvir/voxilaprevir) • Zepatier (elbasvir/grazoprevir) • Any other newly marketed antiviral agent for the treatment of Hepatitis C Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions Per drug package insert Prescriber Restrictions See “Other Criteria”: For treatment-experienced members, prescriber must be a specialist in hepatology, gastroenterology, infectious disease, HIV, or liver l Coverage Duration If the criteria are met, requests will be approved for a 28 day supply for a duration of 6 months.
Other Criteria Initial requests must meet ALL of the following requirements: • Request must be for a FDA-approved/AASLD guideline recommended indication, at an approved dose and duration, appropriate for the member (e.g. age/weight). • Provider attests that they have documentation of a complete Hepatitis B screening (sAg and cAb) o If positive quantitative HBV DNA results and if there is detectable HBV DNA, a treatment plan for Hepatitis B consistent with AASLD recommendations o If negative, documentation of a hepatitis B immunization plan or counseling to receive the hepatitis B immunization series • Provider attests that they have documented HIV screening and if the member has confirmed HIV, documentation was provided they are being treated with antiretroviral therapy, or a reason is provided with rationale for not treating HIV • Provider attests that all potential drug interactions with concomitant medications have been addressed (including discontinuation of the interacting drug, dose reduction, or counseling of the member of the risks associated with the use of both medications). • Provider attests if member is actively abusing alcohol or IV drugs, or has a history of abuse that they have counseled member regarding the risks of alcohol or IV drug abuse, and an offer of referral for substance abuse disorder treatment has been made. • Provider attests that member is committed to treatment plan, including lab monitoring and SVR12 lab testing will be completed and submitted to health plan. • The following are required before treatment (copies of labs required): o Detectable HCV RNA viral load o Fibrosis level o Treatment history o CBC (only if regimen contains ribavirin and hemoglobin must be be at least 10g/dL) o TSH (only if regimen contains interferon) o Pregnancy test (as applicable) o If member is cirrhotic, documentation of Child Turcotte Pugh Class (Class A, Class B, Class C). • If treatment naïve and request is for Zepatier, documentation of RASs (resistance-associated substitutions, previously called RAVs) must be provided
Revision/Review Date: 10/2025 • If treatment experienced: o Prescriber must be a specialist in hepatology, gastroenterology, infectious disease, HIV, or liver transplant o Documentation of genotype (and subtype if provided) o Documentation of RASs testing for: Zepatier or Harvoni genotype1a requests • If request is for a non-preferred agent, documentation of medical necessity was provided including a medical reason why member is not able to use a preferred agent. • If request is for sofosbuvir/velpatasvir, or a ribavirin product for a duration greater than 12 weeks of therapy per year, or for Mavyret for a duration greater than 16 weeks of therapy per year, documentation of medical necessity was provided including a medical reason why treatment beyond that duration is required. Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization Group Description
Hereditary Angioedema Treatment Drugs Preferred: Berinert (C1 Esterase Inhibitor), danazol (Danocrine), icatibant (Firazyr), Haegarda (C1 Esterase Inhibitor), Cinryze (C1 Esterase Inhibitor), Ruconest (C1 Esterase Inhibitor), Takhzyro (lanadelumab-flyo), Kalbitor (ecallantide), Orladeyo (berotralstat)
Non-Preferred:
Ekterly (sebetralstat)
Andembry (garadacimab-gxii)
Dawnzera (donidalorsen)
Firazyr (icatibant)
Sajazir (icatibant)
Any newly marketed agent for hereditary angioedema
For danazol requests, refer to the “Danazol” policy
Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information
See “Other Criteria” Age Restrictions According to package insert Prescriber Restrictions
Prescriber is an immunologist, allergist, rheumatologist, or hematologist
Coverage Duration
If criteria are met, the request will be approved as follows:
•
Acute treatment: 1 + 5 refills
•
Pre procedural prophylaxis: 1 treatment
•
Long-term prophylaxis:
o Initial:6 months,
o Reauthorization: 12 months
Other Criteria
All requests MUST meet the following requirements:
• Drug is being requested at an FDA approved dose
• The patient is not taking ACE inhibitors or estrogen replacement
containing oral contraceptives/hormone replacement therapy
Diagnosis of one of the following: • HAE with deficient or dysfunctional C1INH (e.g. type I, type II, or acquired C1NH deficiency) • HAE with normal C1INH:
o If known origin, documentation of results of confirmatory genetic test (e.g. mutations in gene for factor XII, angiopoietin-1, plasminogen, kininogen-1, myoferlin, heparan sulfate-glucosamine 3-O-sulfotransferase 6) o If unknown origin (U-HAE), documentation of a prolonged trial of high-dose non-sedating antihistamines
For acute treatment: • The patient is receiving only one agent for the treatment of acute attacks • If the request is for a non-preferred agent, the member has documented trial and failure of, or a documented medical reason why the member cannot use, a preferred agent
For prophylaxis: • Pre-procedural: Documentation that patient will be undergoing a medical, surgical, or dental procedure associated with mechanical impact to the upper aerodigestive tract • Long-Term: The patient has a history of at least two severe attacks per month (e.g. with swelling of the face, throat, or GI tract) or at least one laryngeal attack and chart notes have been submitted indicating the date and severity of attack. The patient is only receiving one medication for long-term prophylaxis • If the request is for a non-preferred agent o And the patient has a C1INH deficiency or dysfunction, documented trial and failure of or medical reason why patient cannot use a preferred agent o And the patient has HAE with normal C1INH, documented trial and failure of, or documented medical reason why patient cannot use danazol (note: danazol may require prior authorization)
Re-authorization Criteria:
For acute treatment:
•
Documentation was submitted that the patient has experienced a clinical benefit
from HAE medication
•
The patient is receiving no other medications for acute treatment
•
The medication is being prescribed at an FDA-approved dose
Revision/Review Date:
1/2026
For prophylaxis:
• Documentation was submitted that the patient has experienced a
clinical benefit from prophylactic therapy as demonstrated by a
reduced number of attacks
• The medication is being prescribed at an FDA approved dose
• The patient is receiving no other medications for prophylaxis
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Hormone Replacement Therapy (estrogen-only oral and vaginal
products)
Drugs
FORMULARY STATUS Preferred, Pays at Point-of-Sale
Estradiol (Estrace) oral tablet
Estradiol (Estrace) vaginal cream
Estradiol (Vagifem, Yuvafem) vaginal tablet
FORMULARY STATUS Preferred, Requires Step Therapy
Premarin (estrogens, conjugated) oral tablet
Premarin (estrogens, conjugated) vaginal cream
Menest (estrogens, esterified) oral tablet
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug
Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “other criteria”
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage Duration
If the criteria are met, the request will be approved with up to a 12
month duration.
Other Criteria
Revision/Review
Date 10/2025
For all requests:
•
The request is for an FDA approved indication.
Initial authorization for Premarin and Menest oral tablet
•
Documented trial and failure or intolerance with estradiol oral
tablet
•
If the request is for the treatment of moderate to severe
symptoms of vulvar and vaginal atrophy or atrophic vaginitis
due to menopause, must also have documented trial and failure
or intolerance with estradiol vaginal cream OR estradiol vaginal
tablet
Initial authorization for Premarin vaginal cream
•
Documented trial and failure or intolerance with estradiol
vaginal cream OR estradiol vaginal tablet
Medical Director/clinical reviewer must override criteria when, in
his/her professional judgement, the requested item is medically
necessary.
Field Name Field Description Prior Authorization Group Description Hydroxyprogesterone caproate (generic Delalutin) Drugs Hydroxyprogesterone caproate (generic Delalutin) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria Pregnancy Required Medical Information See “Other Criteria” Age Restrictions According to package insert Prescriber Restrictions Prescriber must be a gynecologist or in consultation with a gynecologist Coverage Duration If all the criteria are met, the initial request will be approved for up to 6 months. For continuation of therapy, the request will be approved for up to 6 months. Other Criteria Date: 4/2025 Initial Authorization: • Medication is prescribed at an FDA approved dose • If request is for preterm birth, do not approve • Request is for one of the following indications: o Amenorrhea or abnormal uterine bleeding due to hormonal imbalance o Production of secretory endometrium and desquamation o Test for endogenous estrogen production o Advanced uterine adenocarcinoma Re-Authorization: • Documentation or provider attestation of clinical benefit • Medication is prescribed at an FDA approved dose If all the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Prior Authorization Group Description Hyaluronic Acid Derivatives Drug(s) Euflexxa, Gel-One, Gelsyn-3, GenVisc 850, Hyalgan, Supartz FX, TriVisc, Visco-3, Durolane, Hymovis, Monovisc, Orthovisc, Synvisc, Synvisc-One, Triluron, sodium hyaluronate 1% syringe, or any newly marketed agent For Medical Reviews Only Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), or the Drug Package Insert (PPI). Exclusion Criteria N/A Required Medical Information See other criteria Age Restrictions According to package insert Prescriber Restrictions Prescriber is a rheumatologist, orthopedist, sports medicine specialist, or physiatrist Coverage Duration If all of the criteria are met, the request will be approved for one complete course of treatment (based on the FDA labeled dose of the drug requested). Other Criteria Revision/Review Date: 2/2026 Initial Authorization: • A diagnosis of Osteoarthritis (OA)/Degenerative joint disease (DJD) of the knee. • Documentation (in claim history or provider statement) that the member has had trials of at least 2 alternatives (e.g. acetaminophen- containing products, topical NSAIDs, oral NSAIDs, other oral analgesics, etc.) without improvement in pain/function or has a medical reason (intolerance, hypersensitivity, contraindication, etc.) for not being able to utilize these therapies. • Documentation has been provided that the member has tried and failed two intra-articular steroid injections, per affected knee, or the member has a medical reason for not being able to utilize steroid injections. Reauthorization: • Documentation was submitted that the patient had a response to the treated knee(s) that lasted at least 6 months (e.g. decreased joint pain or stiffness, improved range of motion, etc.) • Documentation was submitted that the patient has a return of symptoms of osteoarthritis that has not responded to acetaminophen- containing products, oral or topical NSAIDs, or other oral analgesics; or has a medical reason (intolerance, hypersensitivity, contraindication, etc.) for not being able to utilize these therapies. Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization Group
Description
Ileal bile acid transporter inhibitor (IBAT)
Drugs
Bylvay (odevixibat), Livmarli (maralixibat)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA),
Micromedex, American Hospital Formulary Service (AHFS),
United States Pharmacopeia Drug Information for the
Healthcare Professional (USP DI), the Drug Package Insert
(PPI), or disease state specific standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “other criteria”
Age Restrictions
Per prescribing information
Prescriber Restrictions
Prescribed by or in consultation with a gastroenterologist or
hepatologist
Coverage Duration
If the conditions are met, the request will be approved for a 6
month duration for initial requests and a 12 month duration for
renewal requests.
Other Criteria
Initial Authorization:
Progressive Familial Intrahepatic Cholestasis
• Diagnosis of progressive familial intrahepatic cholestasis
(PFIC)
o For Bylvay: PFIC type 1 or 2 with confirmed
biallelic mutations via genetic testing
o For Livmarli: PFIC type 1, 2, 3, 4, or 6, with
confirmed biallelic mutations via genetic testing
• Documentation that patient does not have an ABCB11
variant that results in non-functional or complete absence
of bile salt export pump protein
• Documented history of moderate to very severe pruritus
• Documentation of patient’s weight
• Prescriber attests to monitor liver function tests and fat
soluble vitamin (FSV) levels during treatment
• Baseline serum bile acid level is provided
• Documentation of trial and failure OR contraindication
to at least TWO of the following:
o Ursodiol
o Cholestyramine or colesevelam
o Rifampin
o Fibrates (ex. fenofibrate)
• The prescribed dose is within FDA approved dosing
guidelines
Revision/Review Date: 7/2025 Alagille Syndrome • Diagnosis of Alagille syndrome (ALGS) • Documented history of moderate to very severe pruritus • Documentation of trial and failure OR contraindication to at least TWO of the following:: o Ursodiol o Cholestyramine or colesevelam o Rifampin o Fibrates (ex. fenofibrate) • Prescriber attests that the member has cholestasis • Baseline serum bile acid level is provided • Documentation of patient’s weight • Prescriber attests to monitor liver function tests and fat soluble vitamin (FSV) levels during treatment • The prescribed dose is within FDA approved dosing guidelines
Reauthorization:
• Documentation of clinical benefit indicating each of the
following:
o An improvement in pruritus (e.g. improved
observed scratching, decreased sleep
disturbances/nighttime awakenings due to
scratching, etc.)
o Reduction in serum bile acid level from baseline
• Documentation of patient’s weight
• Prescriber attests to monitor liver function tests and FSV
levels during treatment
• Prescriber attests that patient has had no evidence of
hepatic decompensation (e.g. variceal hemorrhage,
ascites, hepatic encephalopathy, portal hypertension,
etc.)
• The prescribed dose is within FDA approved dosing
guidelines
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Immunoglobulin A (IgA) Nephropathy Agents Drugs Fabhalta (iptacopan), Filspari (sparsentan), Tarpeyo (budesonide), Vanrafia (atrasentan), Voyxact (sibenprenlimab-szsi) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria For Filspari and Vanrafia only: • Pregnancy Required Medical Information See “Other Criteria” Age Restrictions According to package insert Prescriber Restrictions Prescribed by or in consultation with a nephrologist Coverage Duration If the criteria are met, the criteria will be approved as follows:
Initial requests: • 6 months: Fabhalta • 9 months: Filspari, Tarpeyo, Vanrafia, Voyxact Reauthorization: • 12 months: Fabhalta, Filspari, Vanrafia, Voyxact • Reauthorization requests for Tarpeyo will not be allowed as the safety and efficacy of subsequent courses have not been established Other Criteria
Initial Authorization:
• Diagnosis of primary IgA nephropathy verified by biopsy
• Member is on an ACE inhibitor or ARB at a maximally tolerated dose OR
there is a medical reason that they cannot be on one
• Member is on an SGLT2 inhibitor at a maximally tolerated dose OR there is a
medical reason that they cannot be on one
• Member has proteinuria (defined as total urine protein ≥0.5 g/day)
• Member has an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73
m2
• Medication is prescribed at an FDA approved dose
• For Fabhalta:
o Documentation patient complies with the most current Advisory
Committee on Immunization Practices (ACIP) recommendations for
vaccinations against encapsulated bacteria
o Member is at risk for disease progression as defined by a urine protein-
to-creatinine ratio (UPCR) ≥ 1.5 g/g
Date: 2/2026
o Documentation of trial and failure, intolerance, or contraindication to
Filspari
• For Filspari:
o Documentation of baseline liver function
o Attestation that member will discontinue use of renin-angiotensin-
aldosterone system (RAAS) inhibitors, endothelin receptor antagonists,
and/or aliskiren upon initiation of Filspari
• For Vanrafia:
o Member is at risk for disease progression as defined by a urine protein-
to-creatinine ratio (UPCR) ≥ 1.5 g/g
o Documentation of trial and failure, intolerance, or contraindication to
Filspari
• For Voyxact:
o Documentation of trial and failure, intolerance, or contraindication to
Tarpeyo
Re-Authorization:
• Documentation of positive clinical response (e.g. decrease in UPCR,
stabilization of eGFR)
• Medication is prescribed at an FDA approved dose
• For Filspari:
o Documentation of liver function
Reauthorization requests will not be allowed as the safety and efficacy of subsequent courses of Tarpeyo have not been established
If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name Field Description Prior Authorization Group Description Increlex Drugs Increlex (mecasermin [recombinant human insulin-like growth factor- 1]) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), and the Drug Package Insert (PPI). Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions ≥ 2 years to < 18 years Prescriber Restrictions Prescribed by or in consultation with an Endocrinologist or specialist in the treatment of pediatric growth disorders Coverage Duration If all of the conditions are met, the request will be approved for 12 months. Other Criteria Revision/Review Date 7/2025 Initial Authorization • Member has a diagnosis of one of the following o Growth hormone (GH) gene deletion with the development of neutralizing antibodies to GH o Severe primary insulin-like growth factor-1 (IGF-1) deficiency as defined as: Height and basal IGF-1 standard deviation scores ≤ - 3.0 Normal or elevated GH levels • Member does not have a closed epiphyses • Member does not have known or suspected malignancies • Request is for an FDA-approved dose Reauthorization • Growth velocity must be ≥ 2 cm in the past year • Member does not have a closed epiphyses • Member does not have known or suspected malignancies • Request is for an FDA-approved dose Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Immune Globulins Drugs Preferred Octagam (IV) (Immune Globulin) Privigen (IV) (Immune Globulin) Bivigam (IV) (Immune Globulin) Gammagard liquid (IV or SQ) (Immune Globulin) Gammagard SD (IV) (Immune Globulin) Gamunex-C (IV or SQ) (Immune Globulin) Xembify (SQ) (Immune Globulin-klhw)
Non-Preferred/Non-Formulary Cuvitru (SQ) (Immune Globulin) Hizentra (SQ) (Immune Globulin) Alyglo (IV) (Immune Globulin) Asceniv (IV) Immune Globulin) Flebogamma (IV) (Immune Globulin) Gammaked (IV or SQ) (Immune Globulin) Gammaplex (IV) (Immune Globulin) Asceniv (IV) (Immune Globulin-slra) Cutaquig (SQ) (Immune Globulin-hipp) Panzyga (IV) (Immune Globulin-ifas) Hyqvia (SQ) (Immune Globulin Human/Recombinant Human Hyaluronidase) Or any newly marketed immune globulin
Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions According to package insert Prescriber Restrictions See “other criteria” Coverage Duration If the criteria are met the request will be approved for a 3 month duration unless otherwise specified in the diagnosis specific “Other Criteria” section below. Other Criteria
All Requests: • Documentation of diagnosis confirmed by a specialist • Member has tried and failed, or has a documented medical reason
for not using, all other standard of care therapies as defined per recognized guidelines • Member’s height and weight are provided • Dosing will be calculated using ideal body weight (IBW), unless ONE of the following: o If the member’s actual weight is less than their IBW, then dosing will be calculated using their actual weight o If the member’s body mass index (BMI) is ≥30 kg/m2 OR if their actual weight is greater than 20% of their IBW, then dosing will be calculated using adjusted body weight (adjBW) • Requests for Non-Preferred Agents: Member has a documented treatment failure with at least one of the preferred agents OR has a documented medical reason (intolerance, hypersensitivity, contraindication, etc.) why they are not able to use any of the preferred agents.
Primary Immunodeficiency*: • Patient’s IgG level is provided and below normal for requested indication, or a documented specific antibody deficiency is provided • Clinically significant deficiency of humoral immunity as evidenced by ONE of the following: o Inability to produce an adequate immunologic response to specific antigens. o History of recurrent infections despite prophylactic antibiotics • Dose is consistent with FDA approved package labeling, nationally recognized compendia, or peer-reviewed literature • If criteria is met, approve for 6 months.
*Primary Immunodeficiency includes, but is not limited to, the following: Congenital agammaglobulinemia, hypogammaglobulinemia (Common Variable Immunodeficiency, CVID), severe combined immunodeficiency (SCID), Wiskott-Aldrich syndrome, X-linked agammaglobulinemia or Bruton’s agammaglobulinemia, hypergammaglobulinemia, X-linked hyper IgM syndrome
Idiopathic Thrombocytopenic Purpura, acute and chronic:
• Acute:
o Patient has active bleeding, requires an urgent invasive
procedure, is deferring splenectomy, has platelet counts <
20,000/ul and is at risk for intra-cerebral hemorrhage or
has life threatening bleeding, or has an inadequate
increase in platelets from corticosteroids or is unable to
tolerate corticosteroids
o Dose does not exceed 1g/kg daily for up to 2 days, or 400mg/kg daily for 5 days • Chronic: o Duration of illness is greater than 12 months o Member has documented trial and failure of corticosteroids and splenectomy, or has a documented medical reason why they are not able to use corticosteroids or member is at high risk for post- splenectomy sepsis. o Dose does not exceed 1g/kg daily for up to 2 days, or 400mg/kg daily for 5 days • If criteria is met, approve for up to 5 days.
Kawasaki disease:
• Immunoglobulin is being given with high dose aspirin unless
contraindicated
• Requested dose does not exceed a single 2g/kg dose
• If criteria is met, approve for 1 dose
Chronic B-cell lymphocytic leukemia: • The patient has had recurrent infections requiring IV antibiotics or hospitalization and has a serum IgG of <500 mg/dL • Dose does not exceed 500mg/kg every 3-4 weeks • If criteria is met, approve for 3 months.
Bone marrow transplantation:
• The patient has bacteremia or recurrent sinopulmonary
infections and their IgG level is < 400mg/dL
• Dose does not exceed 500mg/kg/wk for the first 100 days post-
transplant
• Dose does not exceed 500 mg//kg every 3-4 weeks 100 days
after transplant
• If criteria is met, approve for 3 months.
Pediatric HIV: • Patient is < 13 years of age • Either patient’s IgG level is < 400mg/dL or • If patient’s IgG level is ≥ 400 mg/dL than significant deficiency of humoral immunity as evidenced by ONE of the following: o Inability to produce an adequate immunologic response to specific antigens. o History of recurrent bacterial infections despite prophylactic antibiotics • Dose does not exceed 400mg/kg/dose every 2-4 weeks • If criteria is met, approve for 3 months.
Multifocal motor neuropathy (MMN): • Duration of symptoms has been at least 1 month with disability. • Nerve conduction studies were completed to rule out other possible conditions and confirms the diagnosis of MMN. • Dose does not exceed 2.4 g/kg/month administered over 2 to 5 days. • If criteria is met, approve for up to 5 days for 6 months.
Chronic inflammatory demyelinating polyneuropathy (CIDP): • Duration of symptoms has been at least 2 months with disability. • Nerve conduction studies or a nerve biopsy were completed in order to rule out other possible conditions, and confirms the diagnosis of CIDP. • Patient has tried and failed, or has a documented medical reason for not using, corticosteroids. o If the patient has severe and fulminant or pure motor CIDP a trial of corticosteroids is not required • Dose is consistent with FDA approved package labeling, nationally recognized compendia, or peer-reviewed literature
Guillain-Barre syndrome: • Patient has severe disease with the inability to walk without aid • Onset of symptoms within the last 4 weeks • Dose does not exceed 2g/kg administered over 2-5 days • If criteria is met, approve for up to 5 days.
Myasthenia Gravis: • Acute: o Patient has an acute myasthenic exacerbation (i.e. acute episode of respiratory muscle weakness, difficulty swallowing, etc.) or is in preparation for thymoma surgery to prevent myasthenic exacerbation o Dose does not exceed 2 g/kg administered over 2-5 days o If criteria is met, approve for up to 5 days • Chronic: o Diagnosis of refractory generalized myasthenia gravis o Patient has tried and failed, or has a documented medical reason for not using 2 or more immunosuppressive therapies (i.e. corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil) o Dose does not exceed 2 g/kg/month administered over 2-5 days
Revision/Review Date 10/2025 o If criteria is met, approve for 3 months
Dermatomyositis (DM):
• One of the following:
o Bohan and Peter score of 3 (i.e. definite DM)
o Bohan and Peter score of 2 (i.e. probable DM) AND
concurring diagnostic evaluation by ≥ 1 specialist (e.g.
neurologist, rheumatologist, dermatologist)
• Patient does NOT have any of the following:
o Cancer (CA) associated myositis defined as myositis
within 2 years of CA diagnosis (except basal or squamous
cell skin cancer or carcinoma in situ of the cervix that has
been excised and cure)
o Active malignancy
o Malignancy diagnosed within the previous 5 years
o Breast CA within the previous 10 years
• For a diagnosis of DM, one of the following:
o Member has tried and failed, or has a documented medical
reason for not using both of the following:
methotrexate (MTX) OR azathioprine
rituximab.
o Member has severe, life-threatening weakness or
dysphagia
• For a diagnosis of cutaneous DM (i.e. amyopathic DM,
hypomyopathic DM):
o Member has tried and failed, or has a documented medical
reason for not using all of the following: MTX and
mycophenolate mofetil.
• Dose does not exceed 2 g/kg administered over 2-5 days every 4
weeks.
• If criteria is met, approve for up to 3 months.
If criteria is met, the request will be approved for the duration listed above. If the criteria is not met, the request is referred to a Medical Director/Clinical reviewer for medical necessity review.
Medical Director/Clinical Reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary
Field Name
Field Description
Prior Authorization
Group Description
Immunosuppressants for Lupus Nephritis
Drugs
Lupkynis (voclosporin)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), and the Drug
Package Insert (PPI).
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
Member must be 18 years of age or older
Prescriber
Restrictions
Prescriber must be rheumatologist, nephrologist or other specialist in
the treatment of autoimmune disorders
Coverage Duration
If all of the criteria are met, the initial request will be approved for 6
months. For continuation of therapy, the request will be approved for
12 months.
Other Criteria
Revision/Review
Date 4/2025
Initial Authorization
•
Member must have a diagnosis of systemic lupus erythematosus
(SLE) with a kidney biopsy indicating a histologic diagnosis of
lupus nephritis (LN) Class III, IV, or V
•
Documentation that the member has a baseline eGFR > 45
mL/min/1.73m2
•
Documentation of the member’s urine protein/creatinine ratio
(UPCR) is provided
•
Member is concurrently being treated with background
immunosuppressive therapy, or has a medical reason for not using
background immunosuppressive therapy
•
Member is NOT concurrently being treated with cyclophosphamide
•
Medication is prescribed at an FDA approved dose
Reauthorization
•
Documentation of improvement in renal function (i.e. reduction in
UPCR or no confirmed decrease from baseline eGFR ≥ 20%)
•
Medication is prescribed at an FDA approved dose
Medical Director/clinical reviewer must override criteria when, in
his/her professional judgement, the requested item is medically
necessary.
Prior Authorization Group
Description
Infliximab Products
Drugs
PREFERRED:
infliximab (unbranded)
Avsola (infliximab-axxq)
NON-PREFERRED :
Remicade (infliximab)
Inflectra (infliximab-dyyb)
Renflexis (infliximab-abda)
Zymfentra (infliximab-dyyb)
Or any newly-marketed infliximab biosimilar/follow-on biologic
Covered Uses
Medically accepted indications are defined using the following sources: the Food
and Drug Administration (FDA), Micromedex, American Hospital Formulary
Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare
Professional (USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
N/A
Age Restrictions
According to package insert
Prescriber Restrictions
Prescribed by, or in consultation with, a specialist in the treatment of the
applicable disease
Coverage Duration
If all of the conditions are met, the request will be approved for 12 months.
Other Criteria
Initial Authorization for All Indications:
•
The request is for an approved indication
•
The medication is being prescribed at an appropriate FDA-approved dose (for
age and weight)
•
If the request is for a non-preferred product, documented (consistent with
pharmacy claims/medical record data/chart notes, physician attestation)
adequate trial of a preferred infliximab product.
Requests for Crohn’s Disease:
•
If the member has a diagnosis of severe-fulminant, moderate-severe, or
perianal/fistulizing Crohn’s disease – approve
•
If the member has a diagnosis of mild-to-moderate/low-risk Crohn’s disease,
the following is required: an adequate trial or a documented medical reason
for not using conventional therapy to manage the condition (e.g. sulfasalazine,
budesonide ER (Uceris), azathioprine, 6-mercaptopurine, or methotrexate)
Requests for Ulcerative Colitis:
•
If the member has a diagnosis of moderate-severe ulcerative colitis – approve.
•
If the member has a diagnosis of mild-moderate ulcerative colitis, the
following is required: an adequate trial of, or medical reason for not using,
conventional therapy to manage the condition (e.g. oral aminosalicylates,
Revision/Review Date:
10/2025
azathioprine, 6-mercaptopurine, or oral corticosteroids)
Requests for Plaque Psoriasis:
•
The member has had an adequate trial of, or medical reason for not using, a
therapy in 3 of the following categories, at least one of which must be either
systemic therapy or phototherapy (consistent with pharmacy claims/medical
chart data):
o
Topical steroids
o
Topical calcipotriene, calcitriol, or tazarotene
o
Topical tacrolimus or pimecrolimus
o
Topical anthralin, coal tar, or salicylic acid
o
Oral methotrexate or cyclosporine
o
Oral acitretin
o
UVB phototherapy or PUVA (oral psoralen or topical methoxsalen
plus UVA therapy)
Requests for Psoriatic Arthritis:
•
The member has had an adequate trial of, or medical reason for not using
(consistent with pharmacy claim/medical chart data):
o
At least one non-steroidal anti-inflammatory drug (NSAID) or
cyclooxygenase-2 (COX-2) inhibitor AND
o
At least one conventional DMARD (e.g. leflunomide, methotrexate,
sulfasalazine) OR
o
Member has axial symptoms/disease or enthesitis (i.e involving the
plantar fascia and Achilles tendon insertion) and has tried and failed
NSAID therapy
Requests for Rheumatoid Arthritis:
•
The member has had an adequate trial or a documented medical reason for not
using a conventional DMARD (e.g. methotrexate, leflunomide, sulfasalazine,
hydroxychloroquine)
Requests for Axial Spondyloarthritis (Ankylosing Spondylitis or Non-
Radiographic Axial Spondyloarthritis):
•
The member has had an adequate trial and failure or medical reason for not
using two different nonsteroidal anti-inflammatory drugs (NSAIDs) or
cyclooxegenase-2 (COX-2) inhibitors, each for at least two weeks
Reauthorization:
•
The member has been receiving the medication and there is documentation
that a clinical benefit was observed.
Continuation of Therapy:
•
Members with history (within the past 90 days) of a preferred infliximab
product are not required to try the above-mentioned conventional therapies
prior to receiving infliximab.
Medical Director/Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Prior Authorization
Group
Description
Injectable/Infusible Bone-Modifying Agents for Osteoporosis and Paget’s
Disease
Drugs
Preferred products:
Jubbonti (denosumab-bbdz), teriparatide
Non-preferred/non-formulary products:
Prolia (denosumab), Forteo (teriparatide), Conexxence (denosumab-bnht),
Stoboclo (denosumab-bmwo), Bildyos (denosumab-nxxp), pamidronate,
teriparatide (Forteo), teriparatide (biosimilar), zoledronic acid (Reclast), Tymlos
(abaloparatide), Evenity (romosozumab-aqqg), ibandronate (Boniva) IV, Prolia
biosimilars, or any other newly marketed agent
Covered Uses
Medically accepted indications are defined using the
following sources: the Food and Drug Administration
(FDA), Micromedex, American Hospital Formulary Service (AHFS), United
States Pharmacopeia Drug Information for the Healthcare Professional (USP
DI), the Drug Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
N/A
Required Medical
Information
“See other criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescriber must be an endocrinologist, rheumatologist, orthopedist, or
obstetrician/gynecologist
Coverage Duration
If all of the conditions are met, requests will be approved for
1 year.
TERIPARATIDE/FORTEO/TYMLOS REQUESTS WILL
ONLY BE APPROVED FOR A TOTAL DURATION OF
24 MONTHS
EVENITY WILL ONLY BE APPROVED FOR A TOTAL DURATION OF
12 MONTHS
Other Criteria
For all requests:
•
The medication is FDA-approved for indication and is being requested at an
FDA approved dose
If the diagnosis is postmenopausal or male osteoporosis: • If the request is for male osteoporosis or high-risk postmenopausal osteoporosis with no prior fractures, the member must have a documented (consistent with pharmacy claims) adequate trial of an oral bisphosphonate or has a medical reason (e.g. intolerance, hypersensitivity, contraindication, etc.) for not using an oral bisphosphonate • If the request is for very high-risk postmenopausal osteoporosis or postmenopausal osteoporosis with prior fractures, a documented trial and failure of an oral bisphosphonate will not be required. Very high risk is defined as having one or more of the following: o History of fracture in the past 12 months o Multiple fractures o Fractures while on drugs causing skeletal harm (e.g. long-term glucocorticoids) o Very low T scores (< -3.0) o High risk for falls o History of injurious falls o Very high fracture probability as determined by fracture risk assessment tool (FRAX) (e.g. major osteoporosis fracture >30%, hip fracture > 4.5%) • Documentation was submitted indicating the member is postmenopausal woman or a male member over 50 years of age and one of the following applies: o A bone mineral density (BMD) value consistent with osteoporosis (T-scores equal to or less than –2.5) o Has had an osteoporotic fracture o A T-score between -1 and -2.5 at the femoral neck or spine and a 10 year hip fracture probability >3% or a 10 year major osteoporosis- related fracture probability >20% (based on the US-adapted WHO absolute fracture risk model) • If the request is for a non-preferred product, a trial and failure of, contraindication to, or medical reason for not using a preferred product is required • If the request is for Evenity (romosozumab), the member does not have history of heart attack or stroke within the preceding year If the diagnosis is Paget’s disease: • The member has a documented (consistent with pharmacy claims) adequate trial of an oral bisphosphonate or has a medical reason (e.g. intolerance, hypersensitivity, contraindication, etc.) for not using an oral bisphosphonate • Documentation (within 60 days of request) was submitted including member’s serum alkaline phosphatase level of ≥ two times the upper limit of normal AND the member is symptomatic or there is documentation of active disease If the diagnosis is glucocorticoid-induced osteoporosis:
Revision/Review Date: 2/2026 • The member has a documented (consistent with pharmacy claims) adequate trial of an oral bisphosphonate or has a medical reason (e.g. intolerance, hypersensitivity, contraindication, etc.) for not using an oral bisphosphonate • For members ≥ 40 years of age on long-term glucocorticoid therapy: o Dosage of the oral glucocorticoid therapy is equivalent to a dose greater than 2.5 mg of prednisone daily o Member has a moderate to very high risk of fracture based on ONE of the following: History of osteoporotic fracture BMD less than or equal to -1 at the hip or spine FRAX 10-year risk for major osteoporotic fracture greater than or equal to 10% (with glucocorticoid adjustment) FRAX 10-year risk for hip fracture greater than 1% (with glucocorticoid adjustment) • For adult members (all ages) receiving HIGH dose glucocorticoid therapy: o Member has a moderate to very high risk of fracture based on ONE of the following: History of prior fracture(s) Glucocorticoid dose ≥ 30mg/day or cumulative ≥ 5 grams/year Continuing glucocorticoid treatment ≥ 7.5mg/day for ≥ 6 months AND BMD Z score < -3 OR significant BMD loss (> least significant change of DXA) • If the request is for a non-preferred product, a trial and failure of, contraindication to, or medical reason for not using a preferred product is required Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Prior
Authorization
Group Description
Injectable/Infusible Bone-Modifying Agents for Oncology Indications
Drugs
Preferred Bone-Modifying Agent(s): Jubbonti (denosumab-bbdz), Wyost
(denosumab-bbdz), pamidronate disodium, zoledronic Acid,
Non-preferred Bone-Modifying Agent(s): Prolia (denosumab), Xgeva
(denosumab), Bomyntra (denosumab-bnht), Conexxence (denosumab-
bnht), Osenvelt (denosumab-bmwo), Stoboclo (denosumab-bmwo),
Bildyos (denosumab-nxxp), Bilpreyda (denosumab-nxxp) any newly
marketed drug in the class
Covered Uses
The request is for an FDA approved indication or for a medically
accepted indications as defined or as supported by the medical
compendia (Micromedex, American Hospital Formulary Service (AHFS),
United States Pharmacopeia Drug Information for the Healthcare
Professional (USP DI) , Drug Package Insert) as defined in the Social
Security Act 1927, or per the National Comprehensive Cancer Network
(NCCN), the American Society of Clinical Oncology (ASCO), or the
National Institutes of Health
(NIH) Consensus Panel standard of care guidelines.
Exclusion Criteria N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescriber is an oncologist
Coverage
Duration
If the criteria are met, the request may be approved for 6 months. If the
provider states that the requested medication is for a chronic or long-
term condition for which the medication may be necessary for the life of
the patient, the request will be approved for 12 months.
Other Criteria
•
For non-preferred medications, a trial and failure of TWO
preferred agents, or a medical reason for not using TWO
preferred products is required in addition to the criteria
below
•
The request is for an approved/accepted indication at an
approved dose
Revision/ Review Date: 2/2026 • If the request is for Xgeva (denosumab) or an Xgeva biosimilar (denosumab) for treating giant cell tumor of bone, documentation has been submitted that the tumor is unresectable or that surgical resection is likely to result in morbidity (e.g. denosumab therapy is being used to aid in the possibility of resection with tumor shrinkage), or that disease has recurred. • If the request is for Prolia (denosumab) or a Prolia biosimilar for prostate cancer, approve. Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Insulin-Like Growth Factor-1 Receptor (Igf-1r) Antagonists For
Thyroid Eye Disease
Drugs
Tepezza (teprotumumab-trbw)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
Member must be 18 years age or older
Prescriber Restrictions
Prescriber must be an ophthalmologist, endocrinologist, or
specialist with expertise in the treatment of Grave’s disease
with thyroid eye disease.
Coverage Duration
If all of the criteria are met, the request will be approved for up to 24
weeks of treatment (8 total infusions). Retreatment requests will not
be allowed beyond the 8 dose limit.
Other Criteria
Initial Authorization:
Tepezza is approved when all of the following are met: • Dosing does not exceed dosing guidelines as outlined in the package insert • Patient has a confirmed diagnosis of Graves’ disease • Documentation of moderate-severe thyroid eye disease as evidenced by one or more of the following: o Lid retraction of >2mm o Moderate or severe soft-tissue involvement o Proptosis ≥3mm above normal values for race and sex o Periodic or constant diplopia • Patient must be euthyroid or thyroxine and free triiodothyronine levels are less than 50% above or below normal limits (submit laboratory results with request) • Patients of reproductive potential: attestation the patient is not pregnant, and appropriate contraception methods will be used before, during, and 6 months after the last infusion • Patient has had a trial and therapy failure of, or contraindication to: o For active disease: oral or IV glucocorticoids o For chronic/inactive disease: rehabilitative surgery
Revision/Review Date 7/2025 Re-authorization: • Retreatment or renewal requests beyond a total of 24 weeks of treatment (8 total infusions) will not be allowed. Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Insulin Pumps Drugs Omnipod Dash Intro Kit, Omnipod Dash Pods, Omnipod 5 G6 Intro Kit, Omnipod 5 G6 Pods, OmniPod GO This policy does not apply to pumps reviewed and/or covered by the Medical Benefit including, but not limited to V-Go 24-hour disposable system and t:slim X2, and continuous glucose monitor/insulin pumps such as MiniMed. Requests for these products are referred to the plan’s Utilization Management team for review. Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria None Required Medical Information See “Other Criteria” Age Restrictions None Prescriber Restrictions Prescribed by or in consultation with an endocrinologist, a certified diabetes care and education specialist (CDCES), or an obstetrician/gynecologist Coverage Duration If all of the criteria are met, the request will be approved for 12 months. Other Criteria Initial Authorization • Diagnosis – diabetes • One of the following o Type 1 diabetes or other insulin-deficient forms of diabetes (e.g. cystic- fibrosis related diabetes) o Treatment with multiple daily doses (≥ 3) of insulin o Pregnancy o Continuation of therapy for patient new to plan o For OmniPod GO: trial and failure of a long-acting insulin or a medical reason why long-acting insulin cannot be used (adherence, etc.) Reauthorization • One of the following: o Type 1 diabetes or other insulin-deficient form of diabetes o Prescriber attests member has benefited from, and has continued need for, therapy with an insulin pump o Initial approval was based on continuation of therapy for patient new to plan. o For OmniPod GO: continuous use of approved insulin compatible with
Revision/Review Date 10/2025 device • Continuation of therapy based on a diagnosis of pregnancy alone is not eligible for reauthorization Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization
Group Description
InPen
Drugs
InPen
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
None
Required Medical
Information
See “Other Criteria”
Age Restrictions
Age 7 years and older
Prescriber
Restrictions
Prescribed by or in consultation with an endocrinologist
Coverage Duration
If all of the criteria are met, the request will be approved 1 system
per year
Other Criteria
Revision/Review
Date: 2/2026
Initial Authorization
•
Patient has a diagnosis of diabetes and requires use of insulin
•
Treatment with multiple daily doses (≥ 3) of insulin
•
Medical justification supports necessity of the digital
component (i.e., rationale why insulin dose/usage cannot be
calculated/tracked manually such as member has an
intellectual disability, or no caregivers are available to assist
with insulin dose calculation)
Reauthorization
•
Patient has a diagnoses of diabetes and requires use of insulin
•
Continued use of multiple daily doses (≥ 3) of insulin
•
Medical justification supports continued necessity of the
digital component
Medical Director/clinical reviewer must override criteria when,
in his/her professional judgement, the requested item is
medically necessary.
Field Name Field Description Prior Authorization Group Description Janus Kinase Inhibitors for Nonsegmental Vitiligo Drugs Opzelura (ruxolitinib) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), and the Drug Package Insert (PPI) Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions
12 years of age Prescriber Restrictions Prescribed by or in consultation with a dermatologist, immunologist, or specialist experienced in treatment of vitiligo Coverage Duration If criteria are met, the request will be approved with up to a 6 month duration. All reauthorization requests will be approved up to 12 months in duration. Other Criteria Initial Authorization o Diagnosis of nonsegmental vitiligo o Documentation of depigmented lesions including measurements and locations is provided o Prescriber attests that the total body vitiligo area (facial and nonfacial) being treated does not exceed 10% BSA o Trial and failure of, or intolerance to, ALL of the following: o Topical corticosteroids o Topical calcineurin inhibitors o Targeted phototherapy o Prescriber attests that the member will not concomitantly use therapeutic biologics, other Janus kinase inhibitors, potent immunosuppressants, or phototherapy for repigmentation purposes o Request is for an FDA-approved dose A MAXIMUM OF ONE 60 GRAM TUBE OF OPZELURA PER WEEK OR ONE 100 GRAM TUBE EVERY TWO WEEKS MAY BE APPROVED Reauthorization o Prescriber attests that the member has experienced a clinical benefit (e.g. reduction in size or quantity of or stabilization of existing depigmented lesions; absence of new depigmented lesions)
Revision/Review Date 10/2025 o Request is for an FDA-approved dose Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description HIF-PH Inhibitors for CKD Anemia Drugs Vafseo (vadadustat) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria Diagnosis of uncontrolled hypertension Required Medical Information See “Other Criteria” Age Restrictions Member must be at least 18 years of age Prescriber Restrictions Prescriber must be a hematologist or nephrologist Coverage Duration If all conditions are met, the request will be approved with a 6-month duration. Other Criteria Initial Authorization: • Member has a diagnosis of chronic kidney disease (CKD) and has been undergoing dialysis for minimum time required by FDA-approved labeling • Member has a documented hemoglobin between 8.0 and 11.0 g/dL • Member has documentation of trial and failure, intolerance, contraindication, or inability to use erythropoietin stimulating agents (ESA) • The following lab results must be submitted and demonstrate normal values, otherwise, the member MUST be receiving, or is beginning therapy, to correct the deficiency: o Serum ferritin level (> 100ng/mL) o Transferrin saturation (TSAT) (> 20%) • Provider attests that member has no history of myocardial infarction, cerebrovascular event, or acute coronary syndrome in the past 3 months • Member will not be receiving concurrent treatment with an ESA • Request is for an FDA-approved dose • All submitted lab results have been drawn within 30 days of the request Reauthorization: • All submitted lab results have been drawn within 30 days of the reauthorization request. • Member has a documented increase in hemoglobin from baseline
Revision/ Review Date: 2/2026 • The following lab results must be submitted and demonstrate normal values, otherwise, the member MUST be receiving, or is beginning therapy, to correct the deficiency: o Serum ferritin level (> 100ng/mL) o Transferrin saturation (TSAT) (> 20%) • Member will not be receiving concurrent treatment with an ESA • Request is for an FDA-approved dose Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary
Field Name
Field Description
Prior Authorization
Group Description
Joenja
Drugs
Joenja (leniolisib)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), and the Drug
Package Insert (PPI).
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
Per prescribing information.
Prescriber
Restrictions
Prescriber must be an immunologist, hematologist, medical geneticist,
or other prescriber who specializes in the treatment of genetic or
immunologic disorders.
Coverage Duration
If the criteria are met, requests will be approved with up to a 6-month
duration. Thereafter, reauthorization requests will be approved with up
to a 12-month duration.
Other Criteria
Revision/Review
Date 7/2025
Initial Authorization:
•
Documentation of APDS/PASLI-associated PIK3CD/PIK3R1
mutation, confirmed by genetic testing.
•
Documentation of nodal and/or extranodal lymphoproliferation,
history of repeated oto-sino-pulmonary infections and/or organ
dysfunction (e.g., lung, liver)
•
Prescriber attests that the member is not currently taking
immunosuppressive medication
•
Prescriber attests that female patients have been advised of the
potential risk to a fetus, will use effective contraception and have
had a negative pregnancy test prior to initiation of treatment
•
Medication is being prescribed at an FDA approved dose
Reauthorization:
•
Documentation has been submitted indicating member has
experienced a clinical benefit from treatment (e.g., decreased
lymph node size, increase in percentage of naïve B cells)
•
Prescriber attests that female patients will use effective
contraception and have had a negative pregnancy test
•
Medication is being prescribed at an FDA approved dose
Medical Director/clinical reviewer must override criteria when,
in his/her professional judgement, the requested item is medically
necessary.
Prior Authorization
Group Description
Agents for Homozygous Familial Hypercholesterolemia (HoFH)
Drugs
Evkeeza (evinacumab-dgnb)
Juxtapid (lomitapide)
Please refer to the “Proprotein Convertase Subtilisin/kexin 9
(PCSK9) Inhibitors” policy for requests for medications in that
class
Covered Uses
Medically accepted indications are defined using the following sources: the
Food and Drug Administration (FDA), Micromedex, American Hospital
Formulary Service (AHFS), United States Pharmacopeia Drug Information
for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or
disease state specific standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
N/A
Age Restrictions
According to package insert
Prescriber Restrictions
Prescribed by cardiologist or specialist in treatment of lipid disorders.
Coverage Duration
If all of the above conditions are met, the initial request will be approved
for up to a 6 month duration, and the reauthorization request will be
approved for a 12 month duration.
Other Criteria
Initial Authorization:
•
Documentation of a diagnosis of homozygous familial
hypercholesterolemia (HoFH) via either:
o
Genetic confirmation of two mutant alleles at the LDL
receptor, ApoB, PCSK9 or ARH adaptor protein gene locus;
OR
o
A clinical diagnosis of HoFH which includes: untreated LDL-
C >500 mg/dL (>13 mmol/L) or treated LDL-C ≥300 mg/dL
(>8 mmol/L), AND
Cutaneous or tendon xanthoma before age 10 years,
OR
Elevated LDL-C levels consistent with heterozygous
FH in both parents.
•
Patient has tried and failed atorvastatin 40mg-80mg or rosuvastatin
20-40mg (consistently for 3 months via claim history or chart notes).
If patient is not able to tolerate atorvastatin or rosuvastatin,
documentation was provided that patient is taking another statin at the
highest tolerated dose, or a medical reason was provided why the
member is not able to use these therapies.
•
If prescriber indicates member is “statin intolerant”, documentation
was provided including description of the side effects, duration of
therapy, “wash out”, re-trial, and then change of agents.
•
Patient has tried and failed ezetimibe at a maximal tolerated dose or a
medical reason was provided why the member is not able to use
ezetimibe
•
Member has documented trial and failure with PCSK9 inhibitor for at
least 3 months, or a medical reason has been provided, why member is
unable to use a PCSK9 inhibitor indicated for HoFH to manage their
condition.
Revision/Review Date 2/2026 • Documentation was provided indicating provider has counseled member on smoking cessation and following a “heart healthy diet”. • Documentation was provided of current LDL level Reauthorization: • Documentation submitted indicates that the member has obtained clinical benefit from the medication including repeat fasting lipid panel lab report, and the member has achieved or maintained a LDL reduction from the levels immediately prior to initiation of treatment with Juxtapid or Evkeeza. • The patient’s claim history shows consistent therapy (monthly fills). Medical Director/Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Ketamine
Drugs
Ketamine (Ketalar)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
N/A
Prescriber Restrictions
Depression: N/A
Complex Regional Pain Syndrome (CRPS): pain management
specialist
Coverage Duration
Initial: 4 weeks
Continuation of therapy: 6 months
Other Criteria
Depression
Initial Authorization:
•
Diagnosis of major depressive disorder (MDD) or treatment-
resistant depression (TRD)
•
Documented trial and failure of two preferred oral
antidepressants (e.g. SSRIs, SNRIs, TCAs) of at least a
minimum effective dose for four (4) weeks or longer OR a
medical justification as to why the patient cannot use preferred
alternative(s).
Re-authorization:
•
Documentation was submitted indicating the member has
clinically benefited from therapy.
CRPS
Initial Authorization:
•
Diagnosis of CRPS (may also be termed reflex sympathetic
dystrophy, algodystrophy, causalgia, Sudeck atrophy, transient
osteoporosis, and acute atrophy of bone)
•
Patient has tried and failed at least 8 weeks treatment with or
continues to receive physical therapy (PT) and/or occupational
therapy (OT).
•
Patient has tried and failed at least two of the following:
o
NSAIDs
o
Anticonvulsants (e.g. gabapentin, pregabalin)
o
Antidepressants (e.g. SNRIs, TCAs)
Revision/Review Date 4/2025 o Bisphosphonate (in the setting of abnormal uptake on bone scan) Re-authorization: • Patient has demonstrated clinical benefit. Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Kebilidi (eladocagene exuparvovec-tneq)
Drugs
Kebilidi (eladocagene exuparvovec-tneq)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
Previous treatment with gene therapy
Required Medical
Information
See “Other Criteria”
Age Restrictions
N/A
Prescriber
Restrictions
Prescriber must be a geneticist or neurologist.
Coverage Duration
If all the criteria are met, the request will be approved for one treatment
per lifetime (4 infusions).
Other Criteria
Review/Revision
Date: 4/2025
Initial Authorization:
• Medication is prescribed at an FDA approved dose
• Documentation of genetically confirmed diagnosis of aromatic L-
amino acid decarboxylase (AADC) deficiency evidenced by
biallelic mutations in the DDC gene (copy of genetic test submitted
with request)
• Documentation of skull maturity confirmed by neuroimaging
• Patient has classic clinical characteristics (e.g. oculogyric crises,
hypotonia, developmental delay) of AADC deficiency that are not
well-managed by symptomatic control drugs (i.e. dopamine
agonists, monoamine oxidase inhibitor, pyridoxine, etc.)
If all of the above criteria are not met, the request is referred to a
Medical Director/Clinical Reviewer for medical necessity review.
Prior Authorization
Group Description
Kisunla
Drugs
Kisunla (donanemab-azbt)
Covered Uses
Medically accepted indications are defined using the following sources: the Food
and Drug Administration (FDA), Micromedex, American Hospital Formulary
Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare
Professional (USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
Patients with moderate to severe Alzheimer’s Disease (AD)
Patients with neurodegenerative disease caused by a condition other than AD
Required Medical
Information
See “Other Criteria”
Age Restrictions
Age 60-85 years
Prescriber
Restrictions
Prescriber must be a neurologist
Coverage Duration
For initial authorization: the request will be approved in accordance with the FDA-
indicated titration schedule for up to 6 months
For reauthorization: if all of the conditions are met, the request will be approved for 6
months.
Other Criteria
Initial Authorization • Diagnosis of mild cognitive impairment (MCI) caused by AD or mild AD dementia consistent with Stage 3 or Stage 4 Alzheimer’s disease as evidenced by at least one of the following: o Clinical Dementia Rating Global (CDR-G) score of 0.5-1.0 o Mini-Mental State Examination (MMSE) score ≥ 20 and ≤ 28 o Montreal Cognitive Assessment (MoCA) score of ≥16 • The request is for an FDA approved dose • Documentation of BOTH of the following: o Recent, within past year, positive results for the presence of beta- amyloid plaques on a positron emission tomography (PET) scan or cerebrospinal fluid testing o Recent, within past year, baseline Magnetic Resonance Imaging (MRI) scan • Physician has assessed baseline disease severity utilizing an objective measure/tool (i.e., integrated Alzheimer's Disease Rating Scale [iADRS], Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog], Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living [ADCS-iADL], Clinical Dementia Rating-Sum of Boxes [CDR-SB], etc.) • No recent (past 1 year) history of stroke, seizures or transient ischemic attack (TIA), or findings on neuroimaging that indicate an increased risk for intracerebral hemorrhage Reauthorization • The request is for an FDA approved dose • Patient continues to have a diagnosis of MCI caused by AD or mild AD dementia consistent with Stage 3 or Stage 4 Alzheimer’s disease as evidenced by at least one of the following: o CDR-G score of 0.5-1.0 o MMSE score of 20-28
Revision/ Review Date: 10/2025 o MoCA score of ≥16 • Provider attestation of safety monitoring and management of amyloid related imaging abnormalities (ARIA) and intracerebral hemorrhage, as recommended per the manufacturer’s prescribing information • Documentation that member has experienced clinical benefit from the medication (i.e., stabilization or decreased rate of decline in symptoms from baseline on CDR-SB, iADRS, ADAS-Cog, or ADCS-iADL scales) • No recent (past 1 year) history of stroke, seizures or TIA Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Lamzede
Drugs
Lamzede (velmanase alfa-tycv)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug
Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
N/A
Required Medical
Information
“See Other Criteria”
Age Restrictions
N/A
Prescriber
Restrictions
Prescribed by or in consultation with a specialist in the treatment of
alpha-mannosidosis or other lysosomal storage disorders
Coverage Duration
If all of the criteria are met, the request will be approved for 12 months
Other Criteria
Revision/Review
Date 4/2025
Initial Authorization
•
Diagnosis of alpha-mannosidosis as confirmed by one of the
following:
o
Deficiency in alpha-mannosidase enzyme levels or
activity in blood leukocytes
o
DNA testing
•
Prescriber attests that medication will only be used to treat non-
central nervous system manifestations of alpha-mannosidosis
•
Patient’s weight
•
Dosing is consistent with FDA-approved labeling or is supported by
compendia or standard of care guidelines
Reauthorization
•
Patient has demonstrated a clinical response (i.e., reduction in serum
oligosaccaride concentrations, stabilization or improvement in 3-
minute stair climbing test [3MSCT], 6-minute walking test [6-
MWT], forced vital capacity [FVC], etc.)
•
Prescriber attests that medication will only be used to treat non-
central nervous system manifestations of alpha-mannosidosis
•
Patient’s weight
•
Dosing is consistent with FDA-approved labeling or is supported by
compendia or standard of care guidelines
Medical Director/clinical reviewer must override criteria when, in
his/her professional judgement, the requested item is medically
necessary.
Field Name
Field Description
Prior Authorization
Group Description
Lenmeldy
Drugs
Lenmeldy (atidarsagene autotemcel)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional (USP
DI), the Drug Package Insert (PPI), or disease state specific standard
of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescribed by a neurologist, hematologist/oncologist, or geneticist
Coverage Duration
If all the criteria are met, the initial request will be approved for a one-
time treatment.
Other Criteria
Revision/Review
Date: 7/2025
Initial Authorization:
•
Member has diagnosis of one of the following metachromatic
leukodystrophies (MLD):
o
Pre-symptomatic late infantile (PSLI) MLD
o
Pre-symptomatic early juvenile (PSEJ) MLD
o
Early symptomatic early juvenile (ESEJ) MLD
•
Documentation patient has both of the following:
o
Arylsulfatase A (ARSA) activity below the normal range
(normal range 31-198 nmol/mg/h)
o
Identification of two disease-causing ARSA alleles
•
Medication is prescribed at an FDA approved dose
The safety and effectiveness of repeat administration of Lenmeldy
has not been evaluated and will not be approved.
If all the above criteria are not met, the request is referred to a
Medical Director/Clinical Reviewer for medical necessity review.
Field Name
Field Description
Prior Authorization
Group Description
Leqembi
Drugs
Leqembi (lecanemab-irmb)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug
Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
Patients with moderate to severe Alzheimer’s Disease (AD)
Patients with neurodegenerative disease caused by a condition other
than AD
Required Medical
Information
See “Other Criteria”
Age Restrictions
age 50-90 years
Prescriber
Restrictions
Prescriber must be a neurologist
Coverage Duration
For initial and reauthorizations: if all of the conditions are met, the
request will be approved for 6 months.
Other Criteria
Initial Authorization • Diagnosis of mild cognitive impairment (MCI) caused by AD or mild AD consistent with Stage 3 or Stage 4 Alzheimer’s disease as evidenced by at least one of the following: o Clinical Dementia Rating Global (CDR-G) score of 0.5- 1.0 and a Memory Box score of 0.5 or greater o Mini-Mental State Examination (MMSE) score ≥ 22 and ≤ 30 o Wechsler Memory Scale IV-Logical Memory (subscale) II (WMS-IV LMII) score at least 1 standard deviation below age-adjusted mean • The request is for an FDA approved dose • Documentation of BOTH of the following: o Recent, within past year, positive results for the presence of beta-amyloid plaques on a positron emission tomography (PET) scan or cerebrospinal fluid testing o Recent, within past year, baseline Magnetic Resonance Imaging (MRI) scan • Physician has assessed baseline disease severity utilizing an objective measure/tool (i.e., Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog-14], Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory-Mild Cognitive Impairment version [ADCS-ADL- MCI], Clinical Dementia Rating Sum of Boxes [CDR-SB], etc.)
Revision/Review Date 7/2025 • No recent (past 1 year) history of stroke, seizures or transient ischemic attack (TIA), or findings on neuroimaging that indicate an increased risk for intracerebral hemorrhage. Reauthorization • The request is for an FDA approved dose • Patient continues to have a diagnosis of mild cognitive impairment (MCI) caused by AD or mild AD consistent with Stage 3 or Stage 4 Alzheimer’s disease as evidenced by at least one of the following: o CDR-G score of 0.5-1.0 and a Memory Box score of 0.5 or greater o MMSE score of 22-30 o Wechsler Memory Scale IV-Logical Memory (subscale) II (WMS-IV LMII) score at least 1 standard deviation below age-adjusted mean • Provider attestation of safety monitoring and management of amyloid related imaging abnormalities (ARIA) and intracerebral hemorrhage, as recommended per the manufacturer’s prescribing information. • Documentation that member has experienced clinical benefit from the medication (such as: stabilization or decreased rate of decline in symptoms from baseline on CDR-SB, ADAS-Cog14, or ADCS MCI-ADL scales) • No recent (past 1 year) history of stroke, seizures, or TIA Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Lodoco
Drugs
Lodoco (colchicine) tablets
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
Per FDA approved prescribing information
Prescriber
Restrictions
Prescriber must be, or in consultation with a specialist in the
treatment of cardiovascular disease, such as a cardiologist
Coverage Duration
If all of the criteria are met, the request will be approved for 12
months.
Other Criteria
Revision/Review
Date: 2/2026
•
Patient has established atherosclerotic disease or multiple risk
factors for cardiovascular disease
•
Patient is currently receiving statin therapy, or documentation has
been provided that the member has a medical reason statin
therapy is not appropriate
•
Documentation is provided that guideline directed medical
therapies targeted to patient’s specific risk factors are being
maximized, such as medications targeted at reduction in
cholesterol, blood pressure, antiplatelet therapies, and diabetes
•
Patient does not have pre-existing blood dyscrasias (ex.
leukopenia, thrombocytopenia)
•
Patient does not have renal failure (CrCl less than 15 ml/min) or
severe hepatic impairment
•
Patient is not currently taking medications contraindicated for
concurrent use with Lodoco
o
Strong CYP3A4 inhibitors (ex. atazanavir, clarithromycin,
darunavir/ritonavir, indinavir, itraconazole, ketoconazole,
lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir,
saquinavir, telithromycin, tipranavir/ritonavir)
o
P-glycoprotein inhibitors (ex. cyclosporine, ranolazine)
Physician/clinical reviewer must override criteria when, in
his/her professional judgment, the requested item is medically
necessary.
Field Name
Field Description
Prior Authorization
Group Description
Topical mTOR Kinase Inhibitors
Drugs
Hyftor (sirolimus topical gel)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional (USP
DI), and the Drug Package Insert (PPI).
Exclusion Criteria
Member concomitantly taking an oral mTOR inhibitor
Required Medical
Information
See “Other Criteria”
Age Restrictions
Member must be 6 years or older
Prescriber
Restrictions
Prescriber must be a dermatologist, medical geneticist, neurologist, or
other prescriber who specializes in the treatment of genetic or
dermatologic disorders.
Coverage Duration
If the criteria are met, requests will be approved with up to a 3 month
duration. Thereafter, reauthorization requests will be approved with up
to a 6 month duration.
Other Criteria
Revision/Review
Date 4/2025
Initial Authorization:
•
Member has a confirmed diagnosis of tuberous sclerosis complex
(TSC)
•
Member has at least 3 facial angiofibromas measuring 2 mm or
larger in diameter
•
Documentation of a comprehensive dermatologic evaluation has
been provided
•
Prescriber attests that the member is not a candidate for laser
therapy or surgery
•
Medication is being prescribed at an FDA approved dose
Reauthorization:
•
Documentation has been provided indicating that the member has
experienced a clinical benefit from treatment (e.g. improvement in
size and color of angiofibromas)
•
Documentation of a comprehensive dermatologic evaluation has
been provided
•
Prescriber attests that the member is not a candidate for laser
therapy or surgery
•
Medication is being prescribed at an FDA approved dose
Field Name Field Description Prior Authorization Group Description MEK Inhibitors for Neurofibromatosis Type 1 (NF1) Drugs Gomekli (mirdametinib), Koselugo (selumetinib) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria Prior use of a MEK inhibitor Required Medical Information See “Other Criteria” Age Restrictions Per package insert Prescriber Restrictions N/A Coverage Duration If all of the criteria are met, the initial request will be approved for 6 months. For continuation of therapy, the request will be approved for 12 months. Other Criteria Date: 7/2025 Initial Authorization: • Documentation of neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas (PN) not amenable to complete resection • Drug will be given as monotherapy • Medication is prescribed at an FDA approved dose Re-Authorization: • Documentation or provider attestation of positive clinical response (i.e. no evidence of progressive disease) • Medication is prescribed at an FDA approved dose If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name
Field Description
Prior Authorization
Group Description
Mucopolysaccharidosis II (Hunter Syndrome) Agents
Drugs
Elaprase (idursulfase)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional (USP
DI), the Drug Package Insert (PPI), or disease state specific standard of
care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
“See Other Criteria”
Age Restrictions
Patient is ≥ 16 months of age
Prescriber
Restrictions
Prescribed by or in consultation with a specialist in the management
Mucopolysaccharidosis II (geneticist, endocrinologist, neurologist,
rheumatologist, etc.)
Coverage Duration
Initial Authorization: 6 months
Reauthorization: 12 months
Other Criteria
Revision/Review
Date 7/2025
Initial Authorization
•
Diagnosis of Mucopolysaccharidosis II as confirmed by one of the
following:
o
Enzyme assay demonstrating a deficiency of iduronate
2-sulfatase activity
o
Genetic testing
•
Patient’s weight
•
Dosing is consistent with FDA-approved labeling or is supported
by compendia or standard of care guidelines
Reauthorization
•
Patient has demonstrated a beneficial response (i.e., stabilization or
improvement in 6-minute walk test [6-MWT], forced vital capacity
[FVC]), urinary glycosaminoglycan (GAG) levels, liver volume,
spleen volume, etc.)
•
Patient’s weight
•
Dosing is consistent with FDA-approved labeling or is supported
by compendia or standard of care guidelines
Medical Director/clinical reviewer must override criteria when, in
his/her professional judgement, the requested item is medically
necessary.
Field Name
Field Description
Prior Authorization
Group Description
Mucopolysaccharidosis VI (Maroteaux-Lamy Syndrome) Agents
Drugs
Naglazyme (galsulfase)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug
Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
N/A
Required Medical
Information
“See Other Criteria”
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage Duration
Initial: 6 months
Renewal: 12 months
Other Criteria
Revision/Review Date 10/2025 Initial Authorization • Diagnosis of Mucopolysaccharidosis VI as confirmed by one of the following: o Enzyme assay demonstrating a deficiency in N- acetygalactosamine 4-sulfatase (arylsulfatase B) enzyme activity o DNA testing • Patient’s weight • Dosing is consistent with FDA-approved labeling or is supported by compendia or standard of care guidelines
Reauthorization • Patient has demonstrated a beneficial response (i.e., stabilization or improvement in 12-minute walk test [12-MWT], 3-minute stair climb test, urinary glycosaminoglycan (GAG) levels, etc.) • Patient’s weight • Dosing is consistent with FDA-approved labeling or is supported by compendia or standard of care guidelines Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Multaq Drugs Multaq (dronedarone) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria Pregnancy Required Medical Information See “other criteria” Age Restrictions N/A Prescriber Restrictions Request must be from a cardiologist or electrophysiologist. Coverage Duration If the criteria are met, the request will be approved with up to a 12 month duration. Other Criteria Revision/Review Date 4/2025 • Diagnosis of paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL) with a recent episode. • Must not have NYHA Class IV heart failure or symptomatic heart failure with recent decompensation requiring hospitalization or referral to a specialized heart failure clinic • Must have AF that can be cardioverted into normal sinus rhythm, or is currently in sinus rhythm • Prescriber attests women of childbearing potential have been counseled regarding appropriate contraceptives Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Myasthenia Gravis Agents
Drugs
Rystiggo (rozanolixizumab), Soliris (eculizumab), Ultomiris
(ravulizumab),Vyvgart (efgartigimod), Vyvgart Hytrulo (efgartigimod
alfa and hyaluronidase), Zilbrysq (zilucoplan), BVEMV (eculizumab-
aeeb), Epysqli (eculizumab-aagh)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescribed by or in consultation with a neurologist or rheumatologist
Coverage Duration
If all of the criteria are met, the initial request will be approved for 6
months. For continuation of therapy, the request will be approved for
12 months.
Other Criteria
Initial Authorization:
• Diagnosis of generalized myasthenia gravis (gMG)
• Patient has a positive serological test for one of the following:
o Anti-AChR antibodies
o Anti-muscle-specific tyrosine kinase (MuSK) antibodies
(Rystiggo only)
• Patient has a Myasthenia Gravis Foundation of America (MGFA)
clinical classification of class II, III or IV
• For adults: patient has tried and failed, or has contraindication, to
one of the following:
o Two (2) or more conventional therapies (i.e.
acetylcholinesterase inhibitors, corticosteroids, non-
steroidal immunosuppressive therapies)
o Failed at least 1 conventional therapy and required chronic
plasmapheresis or plasma exchange or intravenous
immunoglobulin
• For eculizumab in patients 6-17 years: one of the following:
o Trial and failure of at least 1 conventional therapy (i.e.
acetylcholinesterase inhibitors, corticosteroids, non-
steroidal immunosuppressive therapies)
o Patient requires maintenance plasma exchange or
intravenous immunoglobulin to control symptoms
•
Medication is prescribed at an FDA approved dose
Revision/Review Date: 4/2025 • Patient is not using agents covered by this policy concurrently (i.e. no concurrent use of Vyvgart, Vyvgart Hytrulo, Rystiggo, Soliris, Ultomiris, BKEMV, Epysqli or Zilbrysq) • For Vyvgart Hytrulo, patient has tried and failed, or has contraindication, to Vyvgart • Requests for Soliris (eculizumab), BKEMV (eculizimab-aeeb), Epysqli (eculizumab-aagh), Ultomiris (ravulizumab), and Zilbrysq (zilucoplan) will also require all of the following: o For adults: patient has tried and failed, or has contraindication, to Vyvgart, Vyvgart Hytrulo, or Rystiggo. Additionally, if the request is for Soliris or BKEMV, member must also have a documented trial and failure or intolerance to Epysqli or a medical reason why Epysqli cannot be used. o All ages: documentation patient complies with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal infections in patients receiving a complement inhibitor.
Re-Authorization:
• Provider has submitted documentation of clinical response to
therapy (e.g., reduction in disease severity, improvement in
quality-of-life scores, MG-ADL scores, etc).
• Medication is prescribed at an FDA approved dose.
If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Prior
Authorization
Group
Description
Self-administered Disease Modifying Therapies (DMTs) for Multiple
Sclerosis (MS)
Drugs
Preferred: dimethyl fumarate (generic), teriflunomide, glatiramer, Glatopa
(glatiramer), Avonex (interferon beta-1a), Rebif (interferon beta-1a),
fingolimod, Briumvi (ublituximad-xiiv), Kesimpta (ofatumumab)
Non-preferred: Copaxone (glatiramer acetate), Gilenya (fingolimod),
Tecfidera (dimethyl fumarate), Aubagio (teriflunomide), Extavia (interferon
beta-1b), Plegridy (peginterferon beta-1a), Mayzent (siponimod),
Mavenclad (cladribine), Vumerity (diroximel fumarate), Zeposia
(ozanimod), Bafiertam (monomethyl fumarate), Ponvory (ponesimod),
Tascenso ODT (fingolimod), Betaseron (interferon beta-1b), or any other
newly marketed self-administered DMT for MS indicated for the listed
diagnoses
Covered Uses
Medically accepted indications are defined using the following sources: the
Food and Drug Administration (FDA), Micromedex, American Hospital
Formulary Service (AHFS), United States Pharmacopeia Drug Information
for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or
disease state specific standard of care guidelines.
Exclusion
Criteria
Primary Progressive MS (PPMS)
Mavenclad: Clinically Isolated Syndrome (CIS)
Required
Medical
Information
See “Other Criteria”
Age Restrictions Patient must be age appropriate per prescribing information (PI)
Prescriber
Restrictions
Prescriber must be a neurologist
Coverage
Duration
If all of the criteria are met, the request will be approved for 12 months for
all agents except Mavenclad (cladribine).
If all of the criteria for Mavenclad (cladribine) are met, the request will be
approved for 1 course at a time with a lifetime maximum of 2 yearly
treatment courses [1 course = (1 cycle per 30 days) two times].
Other Criteria
Initial Authorization
o
For all requests, the medication is being prescribed at a dose that is
consistent with FDA-approved package labeling, nationally recognized
compendia, or peer-reviewed literature.
Clinically Isolated Syndrome (CIS)
o Diagnosis of CIS
o If the request is for a preferred agent, approve.
o
If the request is for Gilenya: Healthcare Provider (HCP)-
confirmed history of chickenpox, results of varicella zoster virus (VZV) antibody testing and, if negative, documentation of VZV vaccination o If the request is for Tascenco ODT (fingolimod) 0.25mg, the member must meet both of the following criteria: o Healthcare Provider (HCP)-confirmed history of chickenpox, results of varicella zoster virus (VZV) antibody testing and, if negative, documentation of VZV vaccination o Member weighs 40 kg or less o If the request is for a non-preferred agent, then the member must have a documented trial of at least TWO chemically distinct preferred agents or have a documented medical reason (e.g. contraindication, intolerance, hypersensitivity, etc.) for not utilizing these therapies AND o If the request is for Bafiertam (monomethyl fumarate) or Vumerity (diroximel fumarate), the patient has a trial and failure of or documented medical reason for not using dimethyl fumarate (Tecfidera). o If the request is for Mayzent (siponimod), Tascenso ODT (fingolimod), Ponvory (ponesimod), or Zeposia (ozanimod), documentation of the following is required: Healthcare Provider (HCP)-confirmed history of chickenpox, results of varicella zoster virus (VZV) antibody testing and, if negative, documentation of VZV vaccination Additionally, for Mayzent, the following is required: Results of CYP2C9 genotyping and • patient does not have CYP2C9 3/3 (CONTRAINDICATED) • if patient has CYP2C9 1/3 or 2/3, dose does not exceed 1 mg daily o If the request is for Tascenso ODT (fingolimod) 0.5mg, the patient has a trial and failure of or documented medical reason for not using fingolimod (Gilenya) Relapsing Remitting MS (RRMS) and Secondary Progressive MS (SPMS) o Diagnosis of RRMS or SPMS o If the request is for a preferred agent, approve. o If the request is for Gilenya: o Healthcare Provider (HCP)-confirmed history of chickenpox, results of varicella zoster virus (VZV) antibody testing and, if negative, documentation of VZV vaccination o If the request is for Tascenco ODT (fingolimod) 0.25mg the member must meet both of the following criteria: o Healthcare Provider (HCP)-confirmed history of chickenpox, results of varicella zoster virus (VZV) antibody testing and, if
Revision/Review Date: 2/2026 negative, documentation of VZV vaccination o Member weighs 40 kg or less o If the request is for a non-preferred agent, then the member must have a documented trial of at least TWO chemically distinct preferred agents or have a documented medical reason (e.g. contraindication, intolerance, hypersensitivity, etc.) for not utilizing these therapies AND o If the request is for Bafiertam (monomethyl fumarate) or Vumerity (diroximel fumarate), the patient has a trial and failure of or documented medical reason for not using dimethyl fumarate (Tecfidera). o If the request is for Mavenclad (cladribine), documentation of the following: Patient’s current weight Results of VZV antibody testing and, if negative, documentation of VZV vaccination If the patient has not tried at least one of the preferred therapies listed above but has a documented medical reason for not utilizing these therapies, the patient has tried and failed at least one other DMT for MS o If the request is for Mayzent (siponimod), Tascenso ODT, Ponvory (ponesimod), or Zeposia (ozanimod): Healthcare Provider (HCP)-confirmed history of chickenpox, results of varicella zoster virus (VZV) antibody testing and, if negative, documentation of VZV vaccination Additionally, for Mayzent, the following is required: Results of CYP2C9 genotyping and • patient does not have CYP2C9 3/3 (CONTRAINDICATED) • if patient has CYP2C9 1/3 or 2/3, dose does not exceed 1 mg daily o If the request is for Tascenso ODT (fingolimod) 0.5mg, the patient has a trial and failure of or documented medical reason for not using fingolimod (Gilenya) Reauthorization CIS o The medication is being prescribed at a dose that is consistent with FDA-approved package labeling, nationally recognized compendia, or peer-reviewed literature o Documentation was provided that the prescriber has reviewed the risks and benefits of continuing DMT versus stopping. RRMS and SPMS
o The medication is being prescribed at a dose that is consistent with FDA-approved package labeling, nationally recognized compendia, or peer-reviewed literature o Documentation was provided that the prescriber has evaluated the member and recommends continuation of therapy (clinical benefit). o If the request is for Mavenclad (cladribine), patient’s current weight is required AND NO MORE THAN 2 COURSES IN TOTAL WILL BE APPROVED.
Continuation of Therapy: Members with history (within the past 90 days or past 12 months for Mavenclad [cladribine]) of a non-preferred product are not required to try a preferred agent prior to receiving the non-preferred product for continuation of therapy.
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization
Group Description
Healthcare professional (HCP) administered Disease Modifying
Therapies (DMTs) for Multiple Sclerosis (MS)
Drugs
Preferred: Tysabri (natalizumab), Ruxience (rituximab-pvvr) ), Rituxan
(rituximab), Riabni (rituximab-arrx), Truxima (rituximab-abbs), Rituxan
Hycela (rituximab/hyaluronidase), Briumvi (ublituximab)
Non-preferred/Non-formulary: Ocrevus (ocrelizumab), Ocrevus
Zunovo (ocrelizumab-hyaluronidase-ocsq), Lemtrada (alemtuzumab),
Tyruko (natalizumab-sztn)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug
Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
Tysabri, Tyruko, Briumvi:
•
Primary Progressive MS (PPMS)
Lemtrada:
•
PPMS
•
Clinically Isolated Syndrome (CIS)
Required Medical
Information
See “Other Criteria”
Age Restrictions
Patients must be age appropriate per PPI, nationally recognized
compendia, or peer-reviewed medical literature
Prescriber
Restrictions
Prescriber must be a neurologist
Coverage Duration
If all of the criteria are met, the request will be approved for 12 months.
Other Criteria
Initial Authorization
Clinically Isolated Syndrome (CIS), Relapsing Remitting MS (RRMS),
Secondary Progressive MS (SPMS)
o
Diagnosis of CIS, RRMS, or SPMS
o
The medication is being prescribed at a dose consistent with
FDA-approved package labeling, nationally recognized
compendia, or peer-reviewed medical literature
o
If the request is for a natalizumab product, documentation of the
following
o
Patient does not have a history of progressive multifocal
leukoencephalopathy (PML)
o
Documentation consistent with pharmacy claims data indicating
the patient is not currently using any antineoplastic,
immunosuppressant, or immunomodulating medications
o
If the request is for a natalizumab product, documented trial and
failure of Tysabri (natalizumab), or medical reason (e.g.
intolerance, hypersensitivity, contraindication) why the patient
cannot use Tysabri (natalizumab)
Revision/Review Date: 2/2026 o If the request is for a rituximab product or a non-preferred/non- formulary drug, documented trial of at least TWO of the following is required: o teriflunamide o Avonex o Briumvi o Kesimpta o Dimethyl fumarate o glatiramer o Glatopa o fingolimod o Rebif o Or a documented medical reason (e.g. contraindication, intolerance, hypersensitivity, etc.) for not utilizing these therapies. OR For patients with “highly active” MS requesting Lemtrada or a rituximab product, a trial with fingolimod alone is acceptable. o If the request is for Ocrevus (ocrelizumab), Ocrevus Zunovo (ocrelizumab-hyaluronidase-ocsq), Briumvi (ublituximab) or a rituximab product, documentation of the following is required: o Attestation that the patient has been screened for and does not have active hepatitis B virus (HBV) Primary Progressive Multiplate Sclerosis (PPMS) o Diagnosis of PPMS o The medication is being prescribed at a dose consistent with FDA-approved package labeling, nationally recognized compendia, or peer-reviewed medical literature o If the request is for Ocrevus (ocrelizumab), Ocrevus Zunovo (ocrelizumab-hyaluronidase-ocsq), or a rituximab product, documentation of the following has been submitted o Attestation that the patient has been screened for and does not have active HBV Reauthorization CIS o The medication is being prescribed at a dose consistent with FDA- approved package labeling, nationally recognized compendia, or peer-reviewed medical literature o Documentation was provided that the prescriber has reviewed the risks and benefits of continuing DMT versus stopping. RRMS or SPMS, or PPMS o Documentation that the prescriber has evaluated the member and recommends continuation of therapy (clinical benefit)
o The medication is being prescribed at a dose consistent with
FDA-approved package labeling, nationally recognized
compendia, or peer-reviewed medical literature
o If the request is for Lemtrada (alemtuzumab), documentation of
the following
o At least 12 months has or will have elapsed since
previous treatment
o If the request is for a natalizumab product, documentation of the
following has been submitted
o Patient does not have a history of PML
o Documentation consistent with pharmacy claims data was
submitted indicating the patient is not currently using any
antineoplastic, immunosuppressant, or immunomodulating
medications
Continuation of Therapy: Members with history (within the past 180 days or past 12 months for Lemtrada [alemtuzumab]) of a non-preferred product are not required to try a preferred agent prior to receiving the non-preferred product for continuation of therapy. Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization
Group Description
Biologic Agents for Nasal Polyposis
Drugs
Preferred Drugs:
Dupixent (dupilumab)
Xolair (omalizumab)
Nucala (mepolizumab)
Tezspire (mepolizumab)
Non-Preferred Drugs:
and any newly-approved biologic agent for nasal polyposis
Covered Uses
Medically accepted indications are defined using the following sources: the Food and Drug
Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS),
United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI),
the Drug Package Insert (PPI), or disease state specific standard of care guidelines.
Exclusion Criteria
Use of Dupixent, Xolair, or Nucala concomitantly or with another pulmonary biologic
(e.g. Fasenra, Cinqair)
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber Restrictions
Prescribed by or in consulation with an allergist or otolaryngologist
Coverage Duration
If all of the criteria are met, the initial request will be approved for 6 months. For
continuation of therapy the request will be approved for 6 months.
Other Criteria
Xolair: For asthma and urticaria, please refer to the “Xolair for Asthma, Urticaria, and IgE-Mediated Food Allergy” policy
Dupixent: For atopic dermatitis, please refer to the “Agents for Atopic Dermatitis” policy; For asthma, please refer to the “Pulmonary Biologics for Respiratory and Eosinophilic Conditions” policy
Nucala & Tezspire: For asthma or other eosinophilic conditions, please refer to the “Pulmonary Biologics for Respiratory and Eosinophilic Conditions” policy
Initial Authorization: • Diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP) • Medication is being prescribed at an FDA approved dosage • Documentation of ONE of the following: o Trial and failure, or medical reason for not using, all of the following therapies: an intranasal corticosteroid a systemic corticosteroid o Prior surgery for nasal polyps • Patient is currently using an intranasal corticosteroid, will be prescribed at an intranasal corticosteroid, or has a documented medical reason for not using an intranasal corticosteroid • For requests for non-preferred drugs, a trial and failure of, or documented medical reason for not using, a preferred drug is required.
Re-authorization: • Medication is prescribed at an FDA-approved dosage • Member will continue to use an intranasal corticosteroid, or has a medical reason for not using an intranasal corticosteroid
Revision/Review Date 2/2026 • Documentation has been provided that demonstrates a clinical benefit (e.g. improvements in symptom severity, nasal polyp score [NPS], sino-nasal outcome test- 22 [SNOT-22], nasal congestion score [NCS]), ], nasal obstruction symptom visual analogue scale [VAS])
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Natriuretic Peptides for Achondroplasia
Drugs
Voxzogo (vosoritide)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
Hypochondroplasia or short stature condition other than achondroplasia
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to FDA approved prescribing information
Prescriber
Restrictions
Prescribed by, or in consultation with, an endocrinologist, medical
geneticist, or other specialist for the treatment of achondroplasia
Coverage Duration
If all of the criteria are met, the initial request will be approved for 6
months. For continuation of therapy, the request will be approved for 12
months.
Other Criteria
Revision/Review
Date: 4/2025
Initial Authorization:
•
Member has a diagnosis of achondroplasia as confirmed via genetic
testing
•
Prescriber attests patient has open epiphyses
•
Documentation of baseline growth velocity
•
Medication is prescribed at an FDA approved dose
Re-Authorization:
•
Documentation of positive clinical response to therapy (as
demonstrated by improvement over baseline in annualized growth
velocity)
•
Prescriber attests patient has open epiphyses
•
Medication is prescribed at an FDA approved dose
If all of the above criteria are not met, the request is referred to a
Medical Director/Clinical Reviewer for medical necessity review.
Field Name
Field Description
Prior Authorization
Group Description
Neuromyelitis Optica Spectrum Disorder (NMOSD) Agents
Drugs
Step 1: Rituximab (Rituxan, Truxima, Riabni, Ruxience),
Step 2: Enspryng (satralizumab-mwge)
Uplizna (inebilizumab-cdon)
Step 3: Soliris (eculizumab)
Ultomiris (ravulizumab-cwyz)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
For Enspryng, Uplizna, Soliris, Ultomiris: Anti-aquaporin-4 (AQP4)
antibody negative neuromyelitis optica spectrum disorder (NMOSD)
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber Restrictions Prescribed by or in consultation with a specialist who is experienced
in the treatment of NMOSD (such as immunologist, neurologist or
hematologist)
Coverage Duration
If all of the conditions are met, requests will be approved for 12
months.
Other Criteria
Initial Authorization:
For rituximab (Rituxan, Truxima, Riabni, or Ruxience):
• Member has a diagnosis of NMOSD
• Documentation indicating that the patient has been screened
for HBV (hepatitis B virus) prior to initiation of treatment
• Dosing is supported by compendia or standard of care
guidelines
• If the request is for any medication other than Ruxience
(rituximab-pvvr) or Riabni (rituximab-arrx), there is a
documented trial and failure of Ruxience or Riabni, or
medical reason why (e.g. intolerance, hypersensitivity,
contraindication) they cannot be used
For Enspryng:
• Member has a diagnosis of anti-aquaporin-4 (AQP4) antibody
positive NMOSD
• Provider attests to completion of the following assessments
prior to the first dose of Enspryng as outlined in the
prescribing information:
o Hepatitis B virus screening
o Tuberculosis screening
o Liver transaminase screening o Patient has not received live or attenuated-live virus vaccines within 4 weeks before the start of Enspryng therapy • Documented trial and failure of rituximab (Rituxan, Truxima, Riabni, or Ruxience), azathioprine, or mycophenolate mofetil, or medical reason why (e.g., intolerance, hypersensitivity, contraindication) they cannot be used • Dosing is consistent with FDA-approved labeling or is supported by compendia or standard of care guidelines
Exceptions: Requests for drugs in step 2 (Enspryng, Uplizna) may be approved without a trial and failure of rituximab (Rituxan, Truxima, Riabni, Ruxience), azathioprine, or mycophenolate if the member has been using Soliris or Ultomiris
For Uplizna:
• Member has a diagnosis of anti-aquaporin-4 (AQP4) antibody
positive NMOSD
• Provider attests to completion of appropriate assessments
prior to the first dose of Uplizna as outlined in the prescribing
information:
o Hepatitis B virus screening
o Quantitative serum immunoglobulins
o Tuberculosis screening
o Patient has not received live or attenuated-live virus
vaccines within 4 weeks before the start of Uplizna
therapy
• Documented trial and failure of rituximab (Rituxan, Truxima,
Riabni, or Ruxience), azathioprine, or mycophenolate mofetil
or medical reason why (e.g., intolerance, hypersensitivity,
contraindication) they cannot be used
• Dosing is consistent with FDA-approved labeling or is
supported by compendia or standard of care guidelines
Exceptions: Requests for drugs in step 2 (Enspryng, Uplizna) may be approved without a trial and failure of rituximab (Rituxan, Truxima, Riabni, Ruxience), azathioprine, or mycophenolate if the member has been using Soliris or Ultomiris
For Soliris/Ultomiris: • Member has a diagnosis of anti-aquaporin-4 (AQP4) antibody positive NMOSD
Revision/Review Date 10/2025 • Documentation patient complies with most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria. • Antimicrobial prophylaxis with oral antibiotics (penicillin, or macrolides if penicillin-allergic) for two weeks if the meningococcal vaccine is administered < 2 weeks before starting therapy or a documented medical reason why the patient cannot receive oral antibiotic prophylaxis. • Documented trial and failure of, or medical reason why (e.g. intolerance, hypersensitivity, contraindication) why the following cannot be used (one from each bullet below): o Rituximab (Rituxan, Truxima, Riabni, or Ruxience), azathioprine, or mycophenolate mofetil o Enspryng o Uplizna • Dosing is consistent with FDA-approved labeling or is supported by compendia or standard of care guidelines
Reauthorization:
• Documentation that the prescriber has evaluated the member
and recommends continuation of therapy (clinical benefit)
• Request is for an FDA approved/medically accepted dose
Physician/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Medications without Drug or Class Specific Criteria
Drugs
•
Medications without drug or class specific prior authorization
criteria
•
Brand drugs and reference biologics when a therapeutic
equivalent generic drug or biosimilar/interchangeable
biologic is available
The Oncology Drugs prior authorization criteria will be applied
to oncology drugs without drug or class specific criteria
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber Restrictions
N/A
Coverage Duration
If all of the conditions are met, requests will be approved for up to
12 months (depending on the diagnosis and usual treatment
duration).
Other Criteria
Initial Authorization:
All Requests:
•
The drug is requested for an appropriate use (per the
references outlined in “Covered Uses”)
•
The dose requested is appropriate for the requested use (per
the references outlined in “Covered Uses”)
•
Patient meets one of the three following criteria:
o
Documented trial and failure or intolerance of two
alternative formulary/preferred medications
appropriate for the requested use (per the references
outlined in “Covered Uses” or has a medical reason
why these drug(s) cannot be used [e.g. intolerance,
contraindication]). For medications where there is
only one preferred agent, only that agent must have
been ineffective or not tolerated.
o
No other preferred medication has a medically
accepted use for the patient’s specific diagnosis as
referenced in the medical compendia.
o
All other preferred medications are contraindicated
based on the patient’s diagnosis, other medical
conditions, or other medication therapy.
Revision/Review Date 10/2025 Brand drugs with a therapeutically equivalent (A-rated) generic drug currently available: • The provider either verbally or in writing has submitted a medical or member specific reason why the brand name drug is required based on the member’s condition or treatment history; AND if the member had side effects or a reaction to the generic drug, the provider has completed and submitted an FDA MedWatch form to justify the member’s need to avoid this drug. The MedWatch form must be included with the prior authorization request Form FDA 3500 – Voluntary Reporting Reference biologic drugs with either a biosimilar or interchangeable biologic drug currently available: • The prescriber has verbally or in writing submitted a medical or member specific reason why the reference biologic is required based on the member’s condition or treatment history; AND if the member had side effects or a reaction to two (if available) biosimilar or interchangeable biologics, the provider has completed and submitted an FDA MedWatch form to justify the member’s need to avoid these drugs. The MedWatch form must be included with the prior authorization • The currently available biosimilar product(s) does not have the same appropriate use (per the references outlined in “Covered Uses”) as the reference biologic drug being requested Form FDA 3500 – Voluntary Reporting Reauthorization: • Documentation of provider attestation that demonstrates a clinical benefit • The requested drug is for a medically accepted dose as outlined in Covered Uses Physician/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Nemluvio for Prurigo Nodularis Drugs Nemluvio (nemolizumab-ilto) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions 18 years of age and older Prescriber Restrictions Prescriber must be an allergist, immunologist, or a dermatologist. Coverage Duration If all the criteria are met, the initial request will be approved for 6 months. For continuation of therapy, the request will be approved for 12 months. Other Criteria Date: 2/2026 Initial Authorization: • Diagnosis of severe prurigo nodularis (PN) with ≥ 6 weeks of pruritus • Member has ≥ 20 PN lesions • Documentation of member weight • Member has a ≥ 2-week trial of one of the following: o Moderate potency or higher topical corticosteroid (TCS) o Topical calcineurin inhibitor (TCI) • Medication is prescribed at an FDA approved dose Re-Authorization: • Documentation or provider attestation of positive clinical response (reduced nodular lesion count, decreased pruritis, etc.) • Documentation of member weight • Medication is prescribed at an FDA approved dose If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name Field Description Prior Authorization Group Description Niemann-Pick Disease Type C Drugs Miplyffa (arimoclomol), Aqneursa (levacetylleucine) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria Concomitant use of Miplyffa and Aqneursa Required Medical Information See “other criteria” Age Restrictions According to package insert Prescriber Restrictions Prescriber must be a neurologist, geneticist, or specialist in the treatment of Niemann-Pick disease type C (NPC) Coverage Duration If all criteria are met, the request will be approved for 12 months. Other Criteria Revision/Review Date: 2/2026 Initial Authorization • Diagnosis of NPC as confirmed by genetic testing demonstrating one of the following: o Mutations in both alleles of NPC1 gene or NPC2 gene o Mutation in one allele of NPC1 or NPC2 AND either a positive filipin-staining or elevated cholestane triol/oxysterols (>2x the upper limit of normal) • Documentation that member has at least one neurological sign of NPC (i.e., cognitive decline, vertical supranuclear gaze palsy, ataxia, seizures, etc.) • Documentation that member is ambulatory • For Miplyffa, prescriber must also attest that member will use in combination with miglustat • Member’s weight • Request is for an FDA-approved dose Reauthorization • Documentation of positive clinical response to therapy (i.e., improvement or stabilization in ambulation, fine motor skills, swallowing, or speech) • Member’s weight • Request is for an FDA-approved dose Medical Director/clinical reviewer may override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Ohtuvayre
Drugs
Ohtuvayre (ensifentrine)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
• Primary diagnosis of asthma
• Concomitant use of oral PDE4 inhibitors
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Ohtuvayre must be prescribed by or in consultation with a
pulmonologist
Coverage Duration
If all of the criteria are met, the initial request will be approved for a 6
month duration and reauthorization requests will be approved for up to a
12 month duration
Other Criteria
Revision/Review
Date: 10/2025
Initial Authorization:
• Diagnosis of chronic obstructive pulmonary disease (COPD)
• Documentation of a pre- and post-albuterol FEV1/FVC ratio of
<0.70
• Documentation of a score of ≥ 2 on the Modified Medical
Research Council (mMRC) Dyspnea Scale or a score of ≥ 10 on
the COPD Assessment Test (CAT)
• Documented trial, intolerance, or contraindication to treatment
with a long-acting beta-2 agonist (LABA) plus a long-acting
muscarinic antagonist (LAMA) (or a documented medical
reason must be provided why the member is unable to use these
therapies)
• The drug is being prescribed at an FDA approved dose
Re-Authorization:
• The drug is being prescribed at an FDA approved dose
• Documentation of clinical benefit from the medication (e.g.
improvement in symptoms and exacerbations, improvement in
mMRC or CAT, improvement in FEV1/FVC ratio, etc.)
If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name Field Description Prior Authorization Group Description Omisirge Drugs Omisirge (omidubicel-onlv) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria Patient has previously received this medication Required Medical Information See “Other Criteria” Age Restrictions According to package insert Prescriber Restrictions Prescribed by or in consultation with an oncologist Coverage Duration If all the criteria are met, the initial request will be approved for a one- time treatment. Other Criteria Review/Revision Date: 7/2025 Initial Authorization: • Patient has a hematologic malignancy planned for umbilical cord blood transplantation (UCBT) following myeloablative conditioning • Prescriber attests that the patient is eligible for myeloablative allogeneic hematopoietic stem cell transplantation (HSCT) AND does not have a readily available matched related donor, matched unrelated donor, mismatched unrelated donor, or haploidentical donor • Patient has not received a prior allogenic HSCT • Patient does not have known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine material The safety and effectiveness of repeat administration of Omisirge have not been evaluated and will not be approved. Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization Group Description Opioid-Containing Products Drugs
- Opioids > 50 Morphine Milligram Equivalents (MME) per day
- All short-acting opioids greater than 7 days
All long-acting opioids (defined as no history of long-acting opioids in the previous 90 days) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria Members taking buprenorphine-containing products for opioid dependence Required Medical Information See “Other Criteria” Age Restrictions per package insert Prescriber Restrictions N/A
Coverage Duration If the criteria are met, the request will be approved for up to 6 months.
Requests for members with cancer, sickle cell disease, or hospice care may be approved for up to 12 months.Other Criteria If the member has cancer, sickle cell disease, or is in hospice care, only the following criteria apply: • If the request is for a non-preferred medication, the member must meet non-preferred criteria.
• Prescriber attests to checking the Delaware Prescription Monitoring Program (PMP) for member history • For transmucosal fentanyl products (Subsys, Actiq, Lazanda, Fentora, Abstral), all of the following apply: o The medication is being requested for breakthrough cancer pain
o Documentation that the member is opioid-tolerant. (Opioid tolerance is defined as current use of one the following oral morphine 60 mg/day, transdermal fentanyl 25 mcg/hour, oral oxycodone 30 mg/day, oral hydromorphone 8 mg/day, oral oxymorphone 25 mg/day, oral hydrocodone 60 mg/day, or an equianalgesic dose of another opioid for at least one week).
o If the member is being newly-initiated on transmucosal fentanyl, the lowest dose of the respective formulation is being prescribed. (Data do not support an equianalgesic dosing of transmucosal fentanyl in relation to other opioids or between different transmucosal formulations).Initial Authorization: • The diagnosis is pain AND • For short-acting opioids, if the request is for above the aforementioned limits, the provider must supply detailed clinical information on the condition and medical documentation that necessitates exceeding the limits. • For oxycodone 15 mg, 20 mg, and 30 mg, approve if the member has an excluded medical condition (cancer, sickle cell, or is on hospice) or the member is on a dose of a long-acting medication that requires a high breakthrough pain dosage. The dosage of breakthrough pain medication should not exceed 10% of the total daily dose of long- acting opioids. • For long-acting opioids, the diagnosis is chronic pain that requires daily, around the clock opioid medication AND the provider attests that the member is treatment experienced with a history of a short-acting opioid.
Revision/Review Date: 6/2025 • The prescriber has justified medical necessity for dosing above 50 MME per day (e.g. active tapering) or greater than a 7 day supply of short-acting opioids • The member has tried and failed non-pharmacologic treatment (e.g. physical therapy, behavioral therapy) AND two non-opioid containing pain medications (e.g. acetaminophen, non-steroidal anti- inflammatory drugs (NSAIDs), select antidepressants, anticonvulsants). • The member is not taking a benzodiazepine. If member is taking a benzodiazepine, prescriber has provided documentation as to why and has discussed risks of using opioids and benzodiazepines together. • The member is not taking a muscle relaxant. If member is taking a muscle relaxant, prescriber has provided documentation as to why and has discussed risks of using opioids and muscle relaxants together • Prescriber attests urine drug screens will be completed every 6 months and if illicit drugs are found, identifying the patient as high risk, the heightened risk of overdose will be explained to the patient. • If member has a high-risk condition stated in the CDC guidelines (ex. sleep apnea or other causes of sleep-disordered breathing, renal or hepatic insufficiency, older adults, pregnant women, depression or other mental health conditions, alcohol or other substance use disorders) prescriber attests to discussing heightened risks of opioid use and has educated member on naloxone use and has considered prescribing naloxone. • Prescriber attests to discussing with the member the level of risk for opioid abuse/overdose with the dose/duration prescribed. • Prescriber attests to discussing history of substance abuse and the risks associated with opioid overdose/abuse. • Prescriber has the member’s signature on file acknowledging education regarding the risks of opioid therapy. • Prescriber attests that the member has entered into a pain management agreement (members in a facility are exempt from this requirement). • Prescriber attests to checking the Delaware Prescription Monitoring Program (PMP) for member history. • If the request is for a non-preferred opioid, member must meet above criteria and ONE of the following: o Documented trial and failure or intolerance with at least two preferred opioid medications o No other preferred medication has a medically accepted use for the member’s specific diagnosis as referenced in the medical compendia. Reauthorization: • If the member’s daily opioid dose exceeds 50 MME or the quantity requested exceeds the limits noted above, the dose requested has been titrated down from the previous authorization. If not, the prescriber has explained medical necessity for continued dosing above 50 MME per day and/or above the quantity limits or proposed a plan for titration going forward. • Member is not taking a benzodiazepine. If member is taking a benzodiazepine, prescriber has provided documentation as to why and has discussed risks of using opioids and benzodiazepines together. • Member is not taking a muscle relaxant. If member is taking a muscle relaxant, prescriber has provided documentation as to why and has discussed risks of using opioids and muscle relaxants together.
• Urine drug screens have been completed every 6 months and the dates have been submitted with the request. If illicit drugs are found, prescriber attests to identifying member as high risk and explained heightened risk of overdose to member. If opioids are not found on urine drug screen, prescriber attests to why member needs to continue therapy. • If member has a high-risk condition stated in the CDC guidelines (ex. sleep apnea or other causes of sleep-disordered breathing, renal or hepatic insufficiency, older adults, pregnant women, depression or other mental health conditions, alcohol or other substance use disorders) prescriber attests to discussing heightened risks of opioid use and has educated member on naloxone use and has considered prescribing naloxone. • Prescriber attests to checking the Delaware Prescription Monitoring Program (PMP) for member history Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization Group Description Opioid Use Disorder Treatment Drugs Preferred products: • Brixadi weekly (buprenorphine) • Brixadi monthly (buprenorphine) • Buprenorphine tablets • Buprenorphine/naloxone tablets • Buprenorphine/naloxone films • Naltrexone • Vivitrol • Sublocade Doses exceeding the daily quantity limit will require prior authorization Non-Preferred products: • Lucemyra • Suboxone films • Zubsolv • Any other newly marketed agent Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions According to package insert Prescriber Restrictions N/A Coverage Duration Preferred products initial authorization for doses that exceed the daily quantity limit: up to one month Lucemyra: maximum of 16 tablets per day for no more than 14 days Other non-preferred products and pregnant members: 12 months
Other Criteria
Revision/Review Date:
2/2026
Initial Authorization for dosing that exceeds the daily quantity
limit of oral buprenorphine products :
•
Diagnosis of opioid dependence or opioid use disorder
•
May approve dosage up to 24 mg/day (Suboxone or
buprenorphine) or 17.1-4.2 mg (Zubsolv) on an initial prescription
if ONE of the following applies:
o
Patient is filling an opioid use disorder agent for the first
time and requires a dose that exceeds the quantity limit for
the first month of induction
o
Member is pregnant
Dosing that exceeds the daily quantity limit, following the one month
induction will be denied, unless member is pregnant. Members are
expected to titrate down to the daily quantity limit after a one month
induction process.
Authorization of Lucemyra:
•
Prescriber attests to review of the Delaware Prescription
Monitoring Program (PMP)
•
Member is undergoing abrupt opioid discontinuation and requires
agent to mitigate opioid withdrawal symptoms
•
Documentation of trial and failure of or
contraindication/intolerance to clonidine tablets or clonidine patch
•
Documentation provided that the member is undergoing a
comprehensive treatment program for opioid use disorder
treatment (not required if the prescriber is Board Certified in
Addiction Medicine)
Authorization of non-preferred buprenorphine products:
•
Prescriber attests to review of the Delaware Prescription
Monitoring Program (PMP)
•
Diagnosis of opioid dependence or opioid use disorder
•
The member has a documented trial of or contraindication to at
least two preferred drugs for opioid dependence
Medical Director/clinical reviewer must override criteria when, in
his/her professional judgment, the requested item is medically
necessary.
Field Name
Field Description
Prior Authorization
Group Description
Oxervate
Drugs
Oxervate (cenegermin-bkbj)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), and the Drug Package Insert (PPI).
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
N/A
Prescriber Restrictions
Prescribed by, or in consultation with, an ophthalmologist or
optometrist
Coverage Duration
If all of the criteria are met, the request will be approved for a one-
time 8-week treatment course. Additional treatment beyond 8-
weeks will not be authorized.
Other Criteria
Revision/Review
Date 10/2025
•
Documented diagnosis of Stage 2 or 3 neurotrophic keratitis
•
Documented treatment failure with at least one conventional
non-surgical treatment for neurotrophic keratitis (i.e., artificial
tear products, therapeutic soft contact lenses)
Medical Director/clinical reviewer must override criteria when,
in his/her professional judgement, the requested item is
medically necessary.
Field Name Field Description Prior Authorization Group Description Palynziq Drugs Palynziq (pegvaliase-pqpz) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria None Required Medical Information See “other criteria” Age Restrictions None Prescriber Restrictions Specialist experienced in the treatment of phenylketonuria (PKU). Coverage Duration Initial Authorizations: 12 months Dose Increases (to 40 mg or 60 mg daily): 16 weeks Reauthorization: 12 months Other Criteria INITIAL AUTHORIZATION: • Documentation of a confirmed diagnosis of Phenylketonuria (PKU); AND • Documentation the member’s blood phenylalanine (Phe) level is greater than 600 micromol/L(include lab results; must be within the past 90 days) • Documentation or prescriber attestation that the member has attempted control of PKU through a Phe restricted diet with Phe-free medical products/foods in conjunction with dietician or nutritionist. (Examples include Phenyl-Free [phenylalanine free diet powder], Loplex, Periflex, Phlex- 10, PKU 2, PKU 3, XPhe Maxamaid, XPhe Maxamum) • Member has previously received sapropterin (Kuvan) and either had an inadequate response, was a non-responder (defined as members who were dosed at 20 mg/kg/day and did not have a decrease in blood Phe level after 1 month), or has a documented medical reason why sapropterin (Kuvan) cannot be used • The medication is being prescribed at a dose no greater than the FDA approved maximum initial dose of 20 mg SQ once daily. DOSE INCREASES: • Documentation of recent blood Phe level results (within the past 90 days). • Confirmation Phe control has not been achieved after adequate timeframe on the current dosing regimen:
Revision/Review Date: 4/2025 o For requests for a dose of 40 mg per day, the patient has been on 20 mg once daily continuously for at least 24 weeks and has not achieved adequate control o For requests for a dose of 60 mg per day, the patient has been on 40 mg once daily continuously for at least 16 weeks and has not achieved adequate control • The medication is being prescribed at an FDA approved dose (maximum of 60 mg once daily). REAUTHORIZATION: • Documentation of recent blood Phe level results (within the previous 90 days); AND • The medication is being prescribed at an FDA approved dose; AND • Member has achieved a reduction in blood phenylalanine concentration from pre-treatment baseline.. Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Peanut Allergy Immunotherapy Agents (FDA Approved)
Drugs
Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp]
capsule/sachet
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug
Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
Use of Palforzia concomitantly with Xolair
Required Medical
Information
See “Other Criteria”
Age Restrictions
Initiation: Patient is age 1-17 years.
Up dosing and maintenance: Patient is age ≥ 1 year
Prescriber
Restrictions
Prescriber is a specialist in the area of allergy/immunology
Coverage Duration
6 months
Other Criteria
Initial Authorization:
Palforzia is approved when all of the following criteria are met:
•
Patient has a confirmed diagnosis of peanut allergy
•
For patients starting initial dose escalation (new to therapy)
o
Patient has not had severe or life-threatening
anaphylaxis within the previous 60 days
•
Patient will follow a peanut-avoidant diet
•
Patient has been prescribed and has acquired (as demonstrated
by pharmacy claims or documentation) injectable epinephrine
•
No history of eosinophilic esophagitis or other eosinophilic
gastrointestinal disease
•
Patient does not have uncontrolled asthma
Criteria for Re-Authorization:
Palforzia is approved for re-authorization when all of the following
criteria are met
•
Patient will follow a peanut-avoidant diet
•
Patient is able to tolerate initial dose escalation
•
Patient is able to comply with the daily dosing requirements
•
Patient does not have recurrent asthma exacerbations or
persistent loss of asthma control
•
Patient has been prescribed and has acquired (as demonstrated
by pharmacy claims or documentation) injectable epinephrine
Medical Director/clinical reviewer must override criteria when, in
Revision/Review Date 4/2025 his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Anti-Parkinson’s Agents for OFF Episodes
Drugs
Step 1: Xadago (safinamide), Ongentys (opicapone)
Step 2: Nourianz (istradefylline), Inbrija (levodopa) inhalation,
apomorphine (Apokyn) Step 3: Vyalev (foscarbidopa and foslevodopa),
Onapgo (apomorphine) or any other newly marketed agent
Covered Uses
Medically accepted indications are defined using the following sources:
The Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug
Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
• Inbrija or Vyalev: Concurrent use with a nonselective monoamine
oxidase (MAO) inhibitor (such as phenelzine or tranylcypromine)
• Onapgo and Apokyn: Concurrent use with 5HT3 antagonists,
including antiemetics (e.g. ondansetron, granisetron, dolasetron,
palonosetron) and alosetron; concurrent use with other apomorphine
products
• Concurrent use of Vyalev and Onapgo
Required Medical
Information
See Other Criteria
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescriber is a neurologist or is working in consultation with a
neurologist
Coverage Duration
If the criteria are met, the initial requests will be approved for up to a 6
month duration and reauthorization requests will be approved for 12
months.
Other Criteria
Initial Authorization:
All agents:
• Diagnosis of Parkinson’s disease
• Dosing is appropriate as per labeling or is supported by
compendia or standard of care guidelines
• Patient is currently taking and will continue to take
carbidopa/levodopa (does not apply to Vyalev)
• Attestation or documentation patient is experiencing symptom
fluctuations or off episodes while taking carbidopa/levodopa
where attempts have been made to adjust the carbidopa/levodopa
dose and/or formulation in order to manage symptoms without
success
• Documented trial and failure (or contraindication) to at least
two of the following adjunctive medication classes:
o COMT-inhibitors (e.g., entacapone)
o Dopamine agonists (e.g., ropinirole, pramipexole)
Revision/Review Date: 7/2025 o MAO-B inhibitors (e.g., rasagiline, selegiline) If the request is for a step 2 agent: • Patient must also have a documented trial and failure or medical reason why a preferred step 1 agent cannot be used • If the request is for Inbrija, patient does not have asthma, COPD, or other chronic underlying lung disease
If the request is for a step 3 agent: • Patient must have a documented trial and failure or medical reason why a preferred step 1 agent, and a non-preferred step 2 agent cannot be used • Prescriber attestation or documentation that the patient has advanced stage Parkinson’s disease, and the patient is experiencing a minimum of 2.5 hours of “off” time per day • If the request is for Vyalev, patient is taking ≥400 mg of levodopa/day
Re-authorization: • Documentation or provider attestation of positive clinical response (i.e. increase in “on” time without troublesome dyskinesia, decreased “off” time) • Dosing is appropriate as per labeling or is supported by compendia or standard of care guidelines
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization Group
Description
Phenylalanine Hydroxylase Activators
Drugs
sapropterin (Kuvan), Sephience (sepiapterin)
Covered Uses
Medically accepted indications are defined using the following sources: the Food and Drug
Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United
States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), and the
Drug Package Insert).
Exclusion Criteria
None
Required Medical
Information
See “other criteria”
Age Restrictions
None
Prescriber Restrictions
Specialist experienced in treating Phenylketonuria (PKU)
Coverage Duration
Initial: If the criteria are met, the request will be approved for one month
Reauthorization: If the criteria are met, sapropterin will be approved for 1 month for
patients who require a dose increase to 20 mg/kg/day due to non-responsiveness.
Sephience requests will be approved for a duration of 1 month for patients who require a
dose increase from their previous dose (up to a max dose of 60 mg/kg/day) due to non-
responsiveness. For all other patients the request will be approved for a duration of 6
months. If the provider states that the requested medication is for a chronic or long-term
condition for which the medication may be necessary for the life of the patient, the
request will be approved for 12 months.
Other Criteria
Revision/Review Date:
10/2025
INITIAL AUTHORIZATION:
•
Documentation of a confirmed diagnosis of phenylketonuria (PKU)
•
Documentation of the patient’s baseline blood Phe level (within 30 days of the request)
•
Documentation or prescriber attestation that the patient is currently utilizing a Phe
restricted diet
•
For Sephience: Documented trial and failure, intolerance, or contraindication to
sapropterin in combination with Phe- restricted diet
•
Documentation of the patient’s current weight
•
The medication is being prescribed at an FDA-approved dose
PA CRITERIA FOR REAUTHORIZATION:
For sapropterin: Patients dosed at 20mg/kg/day (from initial auth) and did not have a
decrease in Phe level of at least 30% from baseline, are considered NON RESPONDERS and
NO ADDITIONAL TREATMENT will be authorized.
For Sephience: Patients that were dosed at 60 mg/kg/day and did not have a decrease in
Phe from baseline, are considered NON RESPONDERS and NO ADDITIONAL TREATMENT will
be authorized.
•
Documentation of the patient’s current weight
•
Documentation of updated blood Phe level results showing reduction in Phe level from
baseline
•
The medication is being prescribed at an FDA approved dosage.
Clinical reviewer/Medical Director must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Prior Authorization
Group Description
Proprotein Convertase Subtilisin/kexin 9 (PCSK9) Monoclonal Antibodies (mAbs)
Drugs
Preferred: Repatha (evolocumab), Praluent (alirocumab)
Non-preferred: Leqvio (inclisiran), Any PCSK9 inhibitor new to market
Covered Uses
Medically accepted indications are defined using the following sources: the Food
and Drug Administration (FDA), Micromedex, American Hospital Formulary
Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare
Professional (USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “other criteria”
Age Restrictions
See “Other Criteria”
Prescriber
Restrictions
Prescriber must be cardiologist or specialist in treatment of lipid disorders
Coverage Duration
If the criteria are met, the initial request will be approved for up to a 3 month
duration, and the reauthorization request will be approved for up to a 12 month
duration;
Other Criteria
Initial Authorization
For All Requests:
•
Request is appropriate for member (e.g. age) as indicated in package labeling
or standard of care guidelines
•
Patient has tried and failed atorvastatin 40mg-80mg or rosuvastatin 20-40mg
(consistently for 3 months via claim history or chart notes). If patient is not
able to tolerate atorvastatin or rosuvastatin, documentation was provided
that patient is taking another statin at the highest tolerated dose, or a
medical reason was provided why the member is not able to use these
therapies.
•
Patient has tried and failed ezetimibe at a maximal tolerated dose or a
medical reason was provided why the member is not able to use this therapy.
•
If prescriber indicates member is “statin intolerant”, documentation was
provided including description of the side effects, duration of therapy, “wash
out”, re-trial, and then change of agents.
•
Documentation was provided indicating provider has counseled member on
smoking cessation and following a “heart healthy diet”.
•
If the request is for a non-preferred agent, documentation was provided of
trial and failure, or a medical reason has been provided, why member is
unable to use the preferred agent to manage their condition
AND the member meets the following for the respective diagnosis:
Familial Hypercholesterolemia (FH):
•
Member has a diagnosis of familial hypercholesterolemia as evidenced by one
of the following:
Revision/ Review Date 10/2025 o Documentation provided including two fasting lipid panel lab reports with abnormal low density lipoprotein (LDL) levels ≥190 for FH in adults or ≥160 for FH in children. o Results of positive genetic testing for an LDL-C-raising gene defect (LDL receptor, apoB, or PCSK9) o LDL remains above goal despite maximally tolerated LDL-lowering therapy Hyperlipidemia (Primary OR Secondary Atherosclerotic Cardiovascular Disease [ASCVD] Prevention) • If the diagnosis is primary severe hyperlipidemia (i.e. LDL ≥190 mg/dL) o LDL remains ≥ 100 mg/dL despite maximally tolerated LDL-lowering therapy • If the diagnosis is secondary ASCVD prevention o LDL remains ≥ 55 mg/dL or non-HDL (i.e. total cholesterol minus HDL) ≥ 85 mg/dL despite maximally tolerated LDL-lowering therapy o And ONE of the following: Documented history of multiple major ASCVD events (acute coronary syndrome within past 12 months, history of myocardial infarction, history of ischemic stroke, symptomatic peripheral artery disease) Documented history of 1 major ASCVD event (acute coronary syndrome within past 12 months, history of myocardial infarction, history of ischemic stroke, symptomatic peripheral artery disease) AND multiple high-risk conditions (age ≥ 65 years, history of coronary artery bypass graft or percutaneous coronary intervention, diabetes mellitus, hypertension, chronic kidney disease, current smoker, or congestive heart failure) Reauthorization for all indications: • Documentation submitted indicates that the member has obtained clinical benefit from the medication including repeat fasting lipid panel lab report, and the member has had a reduction in LDL from baseline • The patient’s claim history shows consistent therapy (i.e. monthly fills) Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Treatments for Plasminogen Deficiency Type 1 (PLD1)
Drugs
Ryplazim (human plasma-derived plasminogen)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional (USP
DI), and the Drug Package Insert (PPI).
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
N/A
Prescriber
Restrictions
Prescriber must be a hematologist, medical geneticist, or other
specialist in the treatment of rare blood or genetic disorders
Coverage Duration
If all of the criteria are met, the initial request will be approved for 12
weeks. Reauthorization requests will be approved for 12 weeks if the
member has not had a documented positive response to therapy and for
12 months if the member has had a documented positive response to
therapy.
Other Criteria
Initial Authorization
•
Member must have a diagnosis of PLD1 (i.e.
hypoplasminogenemia)
•
Member must have a documented history of lesions or other
symptoms consistent with the diagnosis (e.g. ligneous
conjunctivitis, oral, respiratory, gastrointestinal, urogenital,
integumentary, or central nervous system manifestations)
•
Member must have baseline plasminogen activity levels ≤ 45%
o
If the member received plasminogen supplementation with
fresh frozen plasma, prescriber attests that a 7-day washout
period was performed before obtaining baseline
plasminogen activity levels.
•
The request is for an FDA approved dose
Reauthorization
•
ONE of the following is true:
o
Member has a documented positive response to therapy
(e.g. reduction in number or size of lesions, no new or
recurring lesions)
o
Member has not had a documented positive response to
therapy and ONE of the following:
If confirmed plasminogen activity levels are ≥ 10%
above baseline, then appropriate dosing frequency
adjustments must be made.
If confirmed plasminogen activity levels are < 10%
above baseline, then appropriate dosing frequency
Revision/Review Date 4/2025 adjustments must be made AND the prescriber must provide a medical justification as to why therapy should be continued. • The request is for an FDA approved dose Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Rezdiffra
Drugs
Rezdiffra (resmetirom)
Covered Uses
Medically accepted indications are defined using the following sources: the
Food and Drug Administration (FDA), Micromedex, American Hospital
Formulary Service (AHFS), United States Pharmacopeia Drug Information
for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or
disease state specific standard of care guidelines.
Exclusion Criteria
•
Patients with decompensated cirrhosis
o
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescriber must be a hepatologist, gastroenterologist, endocrinologist, or a
specialist in the treatment of liver disease.
Coverage Duration
If all of the criteria are met, the initial and reauthorization requests will be
approved for up to a 12 month duration
Other Criteria
Review/Revision
Date: 10/2025
Initial Authorization:
•
Diagnosis of noncirrhotic nonalcoholic steatohepatitis (NASH) with
moderate to advanced liver fibrosis
•
Documentation of stage F2 to F3 fibrosis confirmed by biopsy or a
noninvasive test (NIT)
•
Prescriber attestation to providing lifestyle counseling on nutrition and
exercise
•
Prescriber attestation that member avoids excess alcohol intake
•
The drug is being prescribed at an FDA approved dose according to
the member’s weight
Re-Authorization:
•
The member has clinically benefited from the medication (e.g. the
resolution of steatohepatitis and no worsening of liver fibrosis, or at
least one stage improvement in liver fibrosis and no worsening of
steatohepatitis)
•
The member continues to have a fibrosis stage of ≤ 3
•
The drug is being prescribed at an FDA approved dose according to
the member’s weight
If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Prior Authorization
Group Description
Proton Pump Inhibitors (PPIs)
Drugs
Preferred
•
omeprazole capsule (Rx)
•
pantoprazole tablet
•
Protonix (pantoprazole) packet for oral solution (for members age 10 and
younger)
Non-Preferred (Require PA)
•
esomeprazole
•
esomeprazole strontium
•
Protonix (pantoprazole) packet for oral solution (for members 11 and older)
•
Nexium (esomeprazole) packet for oral suspension
•
Nexium 24HR OTC
•
lansoprazole (all forms)
•
omeprazole OTC (all forms)
•
omeprazole/sodium bicarbonate
•
Konvomep (omeprazole/sodium bicarbonate)
•
Prilosec (omeprazole) suspension packets
•
rabeprazole 20mg tablets
•
rabeprazole 10mg sprinkle capsules
•
Dexilant (dexlansoprazole)
Covered Uses
Medically accepted indications are defined using the following sources: the
Food and Drug Administration (FDA), Micromedex, American Hospital
Formulary Service (AHFS), United States Pharmacopeia Drug Information for
the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or
disease state specific standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “other criteria”
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage Duration
If the criteria are met, the request will be approved with for up to 12 months.
Other Criteria
Initial Authorization
•
Presumed or documented diagnosis of peptic ulcer disease,
H. pylori infection, gastritis, gastroesophageal reflux disease (GERD),
erosive esophagitis, Barrett’s esophagus or hypersecretory disease
including Zollinger-Ellison syndrome.
•
Non-preferred drugs require a documented trial and failure of, or
medical reason for not using, two preferred drugs for a minimum of 3
weeks of therapy EACH within the last 120 days.
•
For requests for liquid dosage forms in members over 10 years of age,
documentation as to why the member is unable to use a solid dosage
form.
Doses Greater Than Once Daily After Meeting Criteria For PPI:
Revision/Review Date: 10/2025 • Confirmed diagnosis of GERD, erosive esophagitis, H. pylori infection, peptic ulcer disease, or hypersecretory disease (e.g. Zollinger-Ellison syndrome). OR • Evaluation made by gastroenterologist and / or otolaryngologist recommending higher doses of PPI. Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Primary Hyperoxaluria Agents Drugs Oxlumo (lumasiran) Rivfloza (nedosiran) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), and the Drug Package Insert (PPI). Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions According to package insert Prescriber Restrictions Prescriber must be a nephrologist, urologist, hepatologist, endocrinologist or consultation with one of these specialists Coverage Duration If all of the criteria are met, the initial request will be approved for 6 months. For continuation of therapy, the request will be approved for 12 months. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review. Other Criteria
Initial Authorization • Diagnosis of primary hyperoxaluria type 1 (PH1) confirmed by one of the following: o Genetic testing confirming at least one mutation at the AGXT gene o Liver biopsy demonstrating absent or significantly reduced AGT activity • Metabolic testing demonstrating one of the following: o Oxlumo or Rivfloza Increased urinary oxalate excretion (≥ 0.5 mmol/1.73 m2per day[45 mg/1.73 m2per day]) Increased urinary oxalate:creatinine ratio relative to normative values for age o Oxlumo only: Increased plasma oxalate level (≥ 20 μmol/L) • For Rivfloza: member has relatively preserved kidney function (e.g., EGFR ≥ 30 mL/min/1.73 m2) • Member is concurrently using pyridoxine or has tried and failed previous pyridoxine therapy for at least 3 months, or has a medical reason for not using pyridoxine • Member has no history of liver transplant • Medication is prescribed at an FDA approved dose
Revision/Review Date 2/2026 • Patient is not using Oxlumo and Rivfloza concurrently
Reauthorization • Members previously using pyridoxine will continue to use pyridoxine, or have a medical reason for not using pyridoxine • Documentation has been provided that demonstrates a clinical benefit (e.g. symptomatic improvement, reduction in urinary oxalate, urinary oxalate:creatinine ratio, or plasma oxalate levels from baseline) • Medication is prescribed at an FDA approved dose • Patient is not using Oxlumo and Rivfloza concurrently
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization Group Description Vasodilators for Pulmonary Arterial Hypertension (PAH) Drugs Preferred products: • ambrisentan tablets • bosentan tablets • sildenafil tablets • tadalafil tablets • Ventavis (iloprost) Non-preferred products: • Revatio suspension BRAND • Adcirca (tadalafil) • Adempas (riociguat) • Opsumit (macitentan) • Orenitram ER (treprostinil diolamine) • Tracleer (bosentan) tablets, tablets for suspension • Tyvaso, Tyvaso DPI (treprostinil) • Uptravi (selexipag) • Tadliq (tadalafil) oral suspension • Liqrev (sildenafil) • sildenafil suspension • Winrevair (sotatercept-csrk) • Opsynvi (macitentan and tadalafil) • Remodulin (treprostinil sodium) • treprostinil sodium (Remodulin) • Any other newly marketed PAH treatment agent Non-formulary products: • epoprostenol (Flolan/Veletri) • Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions According to package insert Prescriber Restrictions Prescribed by, or in consultation with, a pulmonologist or cardiologist Coverage Duration Orenitram, Tyvaso, Tyvaso DPI, Adempas, or Ventavis: 3 months for initial request Opsynvi: 4 months for initial request
Uptravi: Request will be approved for the titration pack for 28 days until the
highest tolerated dose (maintenance dose) is achieved. Once the member has
achieved maintenance dosing, further refills can be approved for a 6 month
duration.
For all others: 6 months
All reauthorization requests will be approved for 6 months
Other Criteria
Revision/Review Date:
10/2025
Initial Authorization:
•
Member has a confirmed diagnosis that is indicated in the FDA approved
package insert or has other medically-accepted use
•
For Uptravi, Orenitram, Tyvaso, Tyvaso DPI, Ventavis, Remodulin,
Adempas, ONE of the following:
o
Documented trial and failure of one PDE-5 inhibitor (e.g.
sildenafil, tadalafil) AND one Endothelin Receptor Antagonist
(e.g. ambrisentan, bosentan)
o
Diagnosis of WHO Group 1 FC III with evidence of rapid disease
progression or FC IV (Uptravi, Orenitram, Tyvaso, Tyvaso DPI,
Ventavis, Remodulin ONLY)
o
Diagnosis of persistent/recurrent chronic thromboembolic
pulmonary hypertension (CTEPH) WHO Group 4 after surgical
treatment, or inoperable CTEPH (Adempas ONLY)
o
Diagnosis of PH-ILD WHO Group 3 (Tyvaso ONLY)
•
If the request is for Opsumit the patient must have a documented trial and
failure or intolerance to ambrisentan and bosentan, or a medical reason
was provided why these therapies are not appropriate for the patient.
•
If the request is for a non-preferred drug, member has a documented
treatment failure with at least two of the preferred drugs OR has a
documented medical reason (intolerance, hypersensitivity,
contraindication, etc.) why they are not able to use preferred drugs.
•
If the request is for Opsynvi, BOTH of the following:
o
Patient has been stable for at least 6 months on combination
therapy consisting of a PDE-5 inhibitor AND an ERA
o
Documentation is provided as to why patient is unable to take
individual pills for combination therapy (e.g. adherence due to pill
burden)
•
If the request is for Winrevair, ALL of the following:
o
Documented trial and failure of, or contraindication tocombination
therapy including one PDE-5 inhibitor AND one ERA OR Opsynvi
o
Documentation of platelet count of > 50,000/mm3
•
Documentation of the patient’s current weight, dosing, and titration
schedule is provided (as applicable)
•
The medication is prescribed at a dose that is within FDA-approved
guidelines.
Re-authorization:
•
Documentation has been submitted indicating the clinical benefit of
therapy (e.g. improvement in functional class, improvement in 6-minute
walk test, exercise capacity, or hemodynamics). • Documentation of the patient’s current weight, dosing, and titration schedule is provided (as applicable). The medication is being prescribed at a dose that is within FDA approved guidelines.
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Pyruvate Kinase Activators
Drugs
Pyrukynd (mitapivat)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug
Package Insert (PPI), or disease state specific standard of care
guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
Age ≥18 years
Prescriber
Restrictions
Prescribed by or in consultation with a hematologist
Coverage Duration
If the conditions are met, the request will be approved for a 6-month
duration for initial requests and a 6-month duration for renewal
requests.
**If the conditions are not met: may approve up to 14 days of a
Pyrukynd Taper Pack to allow for discontinuation tapering
Other Criteria
Initial Authorization:
•
The prescribed dose is within FDA approved dosing guidelines
•
Diagnosis of hemolytic anemia with pyruvate kinase deficiency
(PKD)
•
Documentation of at least two variant alleles in the pyruvate
kinase liver and red blood cell (PKLR) gene, of which at least
one is a missense variant
•
Documentation that the member is not homozygous for the
R479H variant
•
Documentation that the member does not have two non-
missense variants of the PKLR gene, without the presence of
another missense variant in the PKLR gene
•
Documentation of ONE of the following:
o
The member does not regularly require blood
transfusions (defined as requiring less than or equal to 3
red blood cell (RBC) transfusions in the past 52 weeks
and no transfusions in the past 3 months) AND
hemoglobin (Hb) level < 10 g/dL
o
The member has required more than or equal to 6 RBC
transfusions in the past 12 months
Documentation of the number of transfusions
and the number of red blood cell (RBC) units
transfused
Revision/Review Date: 7/2025 • Prescriber attests that the member does not have moderate or severe hepatic dysfunction and will monitor liver function monthly for the first 6 months of treatment • Prescriber attests that the member does not have a history of a prior bone marrow or stem cell transplant • The member is not concurrently using hematopoietic- stimulating agents (e.g. Procrit or Retacrit) • Prescriber attests the member is taking at least 0.8mg of folic acid daily Reauthorization: • The prescribed dose is within FDA approved dosing guidelines • For the first reauthorization, documentation of benefit: increase in Hb ≥1.5 g/dL over baseline OR a reduction in transfusions, defined as ≥33% reduction in the number of red blood cell (RBC) units transfused over baseline • For subsequent reauthorizations: documentation of benefit: stabilization in Hb levels OR a sustained reduction in transfusions • If the reauthorization criteria are not met, may authorize up to 14 days of a Pyrukynd Taper Pack to allow for tapering. To reduce the risk of acute hemolysis, abrupt discontinuation of Pyrukynd should be avoided. Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Qalsody Drugs Qalsody (tofersen) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria See “Other Criteria” Required Medical Information See “Other Criteria” Age Restrictions According to package insert Prescriber Restrictions Prescribed by or in consultation with a neurologist, neuromuscular specialist, or physician specializing in the treatment of amyotrophic lateral sclerosis (ALS) Coverage Duration If all the criteria are met, initial and renewal requests will be approved for 6 months Other Criteria Review/Revision Date: 7/2025 Initial Authorization: • Diagnosis of ALS • Documentation of genetic test confirming a mutation in the superoxide dismutase 1 (SOD1) gene • Member is not dependent on invasive ventilation or tracheostomy • Documentation of slow vital capacity (SVC) ≥ 50% • Medication is prescribed at an FDA approved dose Re-Authorization: • Documentation or provider attestation of positive clinical response (e.g., reduction in the mean concentration of neurofilament light [NfL] chains in the plasma, reduction in concentration of SOD1 in cerebrospinal fluid (CSF), or improvement in the Revised ALS Functional Rating Scale (ALSFRS-R) total score) • Member is not dependent on invasive ventilation or tracheostomy • Medication is prescribed at an FDA approved dose If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Prior Authorization Group Description Subcutaneous Treatments for Hemophilia Drugs Hemlibra (emicizumab-kxwh), Hympavzi (marstacimab-hncq), Alhemo (concizumab-mtci), Qfitlia (fitusiran)
Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions According to package insert Prescriber Restrictions Prescriber must be a hematologist Coverage Duration If the criteria are met, requests will be approved for 6 months. If the provider states that the requested medication is for a chronic or long-term condition for which the medication may be necessary for the life of the patient, the request will be approved for 12 months.
Other Criteria
Initial Authorization:
Documentation submitted indicates the following:
• The member’s weight
• The drug is being requested for an FDA-approved indication and the dose
is within FDA-indicated limits
• Diagnosis of hemophilia A or hemophilia B AND one of the following
o Member has tried Factor VIII or Factor IX products and is not
well-managed due to limited venous access or treatment failure
(attestation must be submitted from prescriber)
o Request is for routine prophylaxis in patients with a diagnosis of
hemophilia A or hemophilia B WITH inhibitors and history of
spontaneous or traumatic bleeding episode
o Request is for routine prophylaxis in patients with a diagnosis of
hemophilia A or hemophila B WITHOUT inhibitors and patient
requires management with Factor VIII or Factor IX products at a
total weekly dose of >100 U/kg (attestation must be submitted by
prescriber)
• If the request is for Hympavzi, Qfitlia, or Alhemo for hemophila A, the
member must also have a trial and failure or intolerance to Hemlibra
• If the request is for Qfitlia, prescriber must also attest to monitoring member
antithrombin (AT) levels, signs and symptoms of thrombotic events, and
Revision/Review Date: 7/2025 signs and symptoms of acute and recurrent gallbladder disease as recommended per the manufacturer’s prescribing information •
Re-Authorization:
• Documentation submitted indicating the member has experienced a clinical
benefit from the medication (e.g. reduction in bleeding episodes, improved
quality of life)
• The member’s weight
• Dose is within FDA-indicated limits
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description
Radicava
Drugs
Edaravone (Radicava), Radivaca ORS (edaravone)
and any other newly marketed agent
riluzole (Rilutek) is Preferred and does not require prior authorization Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, the Drug Package Insert, and/or per the standard of care guidelines Exclusion Criteria N/A Required Medical Information
See “other criteria” Age Restrictions N/A Prescriber Restrictions Prescriber must be a neurologist Coverage Duration If the criteria are met, requests will be approved for up to 6 month duration Other Criteria
Revision/Review Date 4/2025 Initial Authorization: • Member must have a diagnosis of ALS • Member must have a documented baseline evaluation of functionality using the revised ALS functional rating scale (ALSFRS-R) score ≥ 2 • Member’s disease duration is 2 years or less • Member has a baseline forced vital capacity (FVC) of ≥ 80% • Member has been on riluzole (Rilutek), is beginning therapy as an adjunct to treatment with Radicava, or provider has provided a medical reason why patient is unable to use riluzole • Dose is within FDA approved limits
Reauthorization: • Member is not ventilator-dependent • Provider documents clinical stabilization in symptoms (e.g. stabilization of ALSFRS-R score) • Dose is within FDA approved limits Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization
Group Description
Reblozyl (luspatercept-aamt)
Drugs
Reblozyl (luspatercept-aamt) vial for subcutaneous injection
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug Package
Insert (PPI), or disease state specific standard of care guidelines.
Exclusion Criteria
Members are excluded if they have hemoglobin S/beta-thalassemia,
isolated alpha-thalassemia.
Required Medical
Information
See “other criteria”
Age Restrictions
Member must be 18 years of age or older
Prescriber
Restrictions
Prescriber must be a hematologist or oncologist
Coverage Duration
Initial and reauthorization requests will be approved for 6 months.
Other Criteria
Criteria for initial approval:
•
Requested dose is appropriate per labeling
•
The member’s weight has been provided with the request
•
The member’s most recent hemoglobin level (within the last month)
has been provided with the request
•
Diagnosis appropriate per Covered Uses
•
For requests for anemia due to beta thalassemia, documentation of all
of the following is required:
o
Member requires regular red blood cell (RBC) transfusions
(defined as at least 6 RBC units received over the last 6
months).
•
For requests for anemia due to myelodysplastic syndrome,
documentation of all of the following is required:
o
Myelodysplastic Syndrome Revised International Prognostic
Scoring System (IPSS-R) categorization as very low, low, or
intermediate risk of progression.
o
Member has required transfusion of 2 or more RBC units
within an 8 week period in the last 4 months
o
Hemoglobin less than 10 g/dl
Reauthorization:
•
For diagnosis of anemia due to beta thalassemia, documentation of
the following:
o
Fewer transfusions compared with baseline
AND
o
A reduction in transfusion requirement of at least 2 RBC
units compared with baseline
•
Diagnosis of anemia due to myelodysplastic syndrome:
documentation of ONE of the following:
o
Hemoglobin increase of at least 1.5 g/dl from baseline over a
period of 8-12 weeks
Revision/ Review Date: 10/2025 OR o Reduction in red blood cell transfusion by at least 4 units over a period of 8-12 weeks compared with baseline transfusion requirement If the above conditions are not met, the request will be referred to a Medical Director for medical necessity review.
Prior Authorization
Group Description
Oral Retinoids
Drugs
Preferred:
Isotretinoin
Claravis (isotretinoin)
Zenatane (isotretinoin)
Amnesteem (isotretinoin)
Non-Preferred:
Absorica (isotretinoin)
Absorica LD (isotretinoin)
Or any newly marketed oral retinoid product
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional (USP
DI), the Drug Package Insert (PPI), or disease state specific standard
of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “other criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
N/A
Coverage Duration
If the criteria are met, the request will be approved with up to a 6
month duration.
Other Criteria
Revision/Review
Date: 10/2025
Initial Authorization
•
Diagnosis of moderate to severe recalcitrant nodular acne
AND
•
Documented treatment with a therapeutic trial and failure or
intolerance to one or more first line topical therapies (e.g.
topical antibiotics or topical retinoids) IN COMBINATION
WITH one or more first line oral therapies (e.g. doxycycline,
tetracycline, or minocycline) for at least 4 weeks (28 days) of
therapy of each drug in the previous 180 days.
•
If the request is for a non-preferred drug, documentation has
been provided that the member has tried and failed two
preferred drugs or has a medical reason why these drugs cannot
be used
Re-Authorization
•
Prescriber attests the member has experienced clinical benefit
from therapy (e.g. perceived improvement of acne) and
continued treatment with, or retreatment with, isotretinoin is necessary
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Papzimeos Drugs Papzimeos (zopapogene imadenovec) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria None Required Medical Information See “Other Criteria” Age Restrictions 18 years of age or older Prescriber Restrictions Prescribed by, or in consultation with a pulmonologist, otolaryngologist, oncologist, or other specialist in the treatment of recurrent respiratory papillomatosis Coverage Duration If the criteria are met, the request will be approved for up to a 12-week course of therapy. If the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review. Renewal requests or requests for more than a one-time course of therapy will not be approved. Other Criteria
Revision/Review Date: 2/2026 Initiation of Therapy: • Member has a diagnosis of recurrent respiratory papillomatosis • Documentation is provided confirming human papilloma type 6 or 11 • Member has a history of voice or airway symptoms which have required 3 or more clinically indicated interventions (surgical resection or laser ablation of disease) in the previous 12 months
Renewal Requests: Renewal requests or requests for more than a one-time course of therapy will not be approved.
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization
Group Description
Pulmonary Biologics for Respiratory and Eosinophilic Conditions
Drugs
Preferred:
•
Fasenra (benralizumab)
•
Dupixent (dupilumab) pens, syringes
•
Nucala (mepolizumab)
•
Tezspire (tezepelumab-ekko)
•
Non-Preferred/Non-Formulary:
•
Cinqair (reslizumab)
•
Exdensur (depemokimab),
•
Or any newly marketed agent
Covered Uses
Medically accepted indications are defined using the following sources: the
Food and Drug Administration (FDA), Micromedex, American Hospital
Formulary Service (AHFS), United States Pharmacopeia Drug Information for
the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease
state specific standard of care guidelines.
Exclusion Criteria
•
When being used for relief of acute bronchospasm or status asthmaticus
•
When used in combination with another monoclonal antibody for the
treatment of respiratory or eosinophilic conditions
Required Medical
Information
See “other criteria”
Age Restrictions
Per Package Insert
Prescriber
Restrictions
Prescriber must be an allergist, pulmonologist, immunologist, rheumatologist,
gastroenterologist, other provider who specializes in the treatment of asthma or
eosinophilic conditions, or in consultation with one of these specialists
Coverage Duration
If the above conditions are met, the initial request will be approved with a 4
month duration. All subsequent requests will be approved with a 6 month
duration.
Other Criteria
Initial Authorization:
Asthma:
•
Confirmed diagnosis of one of the following:
o Nucala, Fasenra, Exdensur, and Cinqair: Severe eosinophilic asthma
o Dupixent: Moderate-to-Severe eosinophilic asthma
o Tezspire: Severe asthma
•
Documentation has been provided of blood eosinophil count within ONE of
the following ranges:
o Nucala, Exdensur, and Dupixent: ≥ 150 cells/mcL (within 6 weeks
of request) OR ≥ 300 cells/mcL (within the past 12 months)
o Fasenra: ≥ 150 cells/mcL (within the past 12 months)
o Cinqair: ≥ 400 cells/mcL (within the past 12 months)
o Tezspire: No baseline blood eosinophil counts are required
•
The member has a documented baseline FEV1 < 80% of predicted with
evidence of reversibility by bronchodilator response. o If age is < 18 years, the member has a documented baseline FEV1 < 90% of predicted with evidence of reversibility by bronchodilator response • For Nucala, Fasenra, Cinqair and Dupixent: documentation has been provided indicating that the member continues to experience significant symptoms while compliant on a maximally tolerated inhaled corticosteroid with long-acting beta2 agonist (ICS/LABA) AND long-acting muscarinic antagonist (LAMA) (or a documented medical reason must be provided why the member is unable to use these therapies) and ONE of the following: o Nucala: ≥ 2 exacerbations in the past 12 months o Fasenra: ≥ 1 exacerbation in the past 12 months o Cinqair: ≥ 1 exacerbation in the past 12 months requiring systemic corticosteroids o Dupixent: ≥ 1 exacerbation in the past 12 months requiring systemic corticosteroids or hospitalization o Exdensur: ≥ 2 exacerbations in the past 12 months requiring systemic corticosteroids • The prescribed dose is within FDA approved dosing guidelines • For non-preferred drug requests: documented trial and failure of, or medical reason for not using, a preferred drug
Chronic Obstructive Pulmonary Disease (COPD) (Dupixent and Nucala only):
•
Confirmed diagnosis of COPD
•
Documentation has been provided of blood eosinophil count within one of
the following ranges:
o Dupixent: ≥ 300 cells/mcL (within the past 12 months)
o Nucala: ≥ 150 cells/mcL (within 6 weeks of request) OR ≥300
cells/mcL (within the past 12 months)
•
The member has a documented post-bronchodilator FEV1/FVC ratio < 0.7
and post-bronchodilator FEV1 of 20% to 80% predicted
•
Documentation has been provided indicating that that the member continues
to experience significant symptoms (i.e., chronic productive cough) while
compliant on maintenance triple therapy consisting of a long-acting
muscarinic antagonist (LAMA), long-acting beta2 agonist (LABA), and
inhaled corticosteroid (ICS) (or a documented medical reason must be
provided why the member is unable to use these therapies) and ONE of the
following:
o ≥ 2 exacerbations in the past 12 months, where systemic
corticosteroids were required for at least one of them
o ≥ 1 exacerbation in the past 12 months requiring hospitalization
•
The prescribed dose is within FDA approved dosing guidelines
Oral Corticosteroid Dependent Asthma: (Dupixent only)
•
Confirmed diagnosis of oral corticosteroid (OCS) dependent asthma with at
least 5 mg oral prednisone or equivalent per day for at least 4 weeks within
the last 3 months
•
The patient has a documented baseline FEV1 < 80% of predicted with
evidence of reversibility by bronchodilator response.
• Documentation has been provided indicating patient still is having significant symptoms with ≥ 1 exacerbations in the previous 12 months requiring additional medical treatment, (emergency room visits, hospital admissions) while compliant on a high-dose inhaled corticosteroid with a long-acting B2 agonist (ICS/LABA) AND a long-acting muscarinic antagonist (LAMA). If the patient has not utilized these therapies, a documented medical reason must be provided why patient is unable to do so. • The prescribed dose is within FDA approved dosing guidelines
Eosinophilic granulomatosis with polyangiitis (EGPA) (Nucala & Fasenra
only):
•
Confirmed diagnosis of EGPA and eosinophilic asthma lasting for ≥6
months
•
Member has a history of relapsing disease defined as at least one EGPA
relapse requiring additional corticosteroids or immunosuppressant or
hospitalization within the past 2 years OR member has a history of
refractory disease defined as failure to attain remission in the prior 6 months
following induction treatment with standard therapy
•
Member must be on a stable dose of oral corticosteroids for at least 4 weeks
prior to request
•
Member has a blood eosinophil count ≥1,000 cells/mcL OR > 10% of total
leukocyte count
•
Documented trial and failure, intolerance, or contraindication to
cyclophosphamide, azathioprine, methotrexate, rituximab, OR
mycophenolate mofetil
•
The prescribed dose is within FDA approved dosing guidelines
Hypereosinophilic Syndrome (HES) (Nucala only): • Confirmed diagnosis of FIP1 like 1-platelet derived growth factor receptor alpha (FIP1L1-PDGFRA)-negative HES lasting for ≥6 months without an identifiable non-hematologic secondary cause • Member has a history of two or more HES flares (worsening of HES-related symptoms necessitating therapy escalation or ≥2 courses of rescue oral corticosteroids) within the past 12 months • Member has a blood eosinophil count ≥1,000 cells/mcL • Documented trial and failure, intolerance, or contraindication to oral corticosteroids AND at least one second-line agent (e.g. hydroxyurea, interferon, imatinib, methotrexate, cyclophosphamide, cyclosporine, azathioprine) (member must be on stable dose of at least one agent for at least 4 weeks prior to request)
Eosinophilic Esophagitis (EoE) (Dupixent only): • Confirmed diagnosis of EoE by endoscopic biopsy • Documentation of baseline esophageal intraepithelial eosinophil count and Dysphagia Symptom Questionnaire (DSQ) scores • Member has a history of at least 2 episodes of dysphagia (with intakes of solids) per week in the last 4 weeks
Revision/Review Date: 2/2026 • Documented trial and failure, intolerance, or contraindication to one proton pump inhibitor at a maximally tolerated dose for a minimum of 8 weeks • The prescribed dose is within FDA approved dosing guidelines
Prurigo Nodularis (PN) (Dupixent only):
•
Confirmed diagnosis of PN lasting for at least three months prior to request
•
Member has a Worst-itch Numeric Rating Scale (WI-NRS) score of 7 or
higher indicating severe or very severe itching
•
Member has at least 20 PN lesions in total
•
Documented trial and failure, intolerance, or contraindication to at least two
of the following for a minimum of two weeks:
o One medium to super-high potency topical corticosteroid
o One topical calcineurin inhibitor
o UVB phototherapy or psoralen plus UVA phototherapy
•
The prescribed dose is within FDA approved dosing guidelines
Chronic Spontaneous Urticaria (CSU) (Dupixent only):
•
Confirmed diagnosis of CSU
•
Documented history of urticaria for at least 6 weeks
•
Member remains symptomatic despite a minimum two-week trial of a
formulary second generation H1 antihistamine at the maximum tolerated
dose; or has a medical reason for not utilizing a second-generation
antihistamine
•
The prescribed dose is within FDA approved dosing guidelines
Bullous Pemphigoid (Dupixent only):
•
Confirmed diagnosis of bullous pemphigoid
•
Member has a Bullous Pemphigoid Disease Area Index (BPDAI)
activity score ≥24
•
Member has a Peak Pruritus Numeric Rating Scale (NRS) score ≥4
•
Documented trial and failure, intolerance, or contraindication to at least
three of the following:
o High potency topical corticosteroids
o Oral corticosteroids
o Doxycycline
o Immunosuppressive therapies (ex. azathioprine, mycophenolate,
methotrexate, etc.)
• The prescribed dose is within FDA approved dosing guidelines
Re-Authorization:
- Documentation submitted indicates the member has clinically benefited from the medication (e.g. Asthma & COPD: improved FEV1, reduced exacerbations; HES: symptomatic improvement, reduced oral corticosteroid dose; EGPA: reduction in relapse frequency or severity, disease remission, symptomatic improvement, reduced oral corticosteroid dose; EoE: histological remission, improvement in DSQ scores; PN: improvement in WI-NRS score, symptomatic improvement; CSU: decrease in severe itching or urticaria activity;
bullous pemphigoid: sustained remission, improvement in Peak Pruritus NRS score))
The prescribed dose is within FDA approved dosing guidelines
Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Pompe Disease Agents Drugs Lumizyme (alglucosidase alfa) Nexviazyme (avalglucosidase alfa-ngpt) injection Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions According to FDA approved prescribing information Prescriber Restrictions Prescribed by, or in consultation with, a specialist in the treatment of Pompe disease, such as a genetic or metabolic specialist, neurologist, cardiologist, or pediatrician. Coverage Duration If all of the criteria are met, the request will be approved for 12 months. Other Criteria Initial Authorization: For infantile onset Pompe Disease (Lumizyme only): • Patient has a diagnosis of infantile-onset Pompe Disease, confirmed by one of the following: o Enzyme assay showing a deficiency of acid alpha- glucosidase (GAA) activity in the blood, skin, or muscle o Genetic testing showing a mutation in the GAA gene • Requested dose is appropriate per prescribing information (documentation of patient weight must be submitted with request) • Requested regimen will not be used in combination with other enzyme replacement therapies For late onset Pompe Disease (Lumizyme, Nexviazyme, or Pombiliti + Opfolda): • Patient has a diagnosis of late-onset (non-infantile) Pompe Disease, confirmed by one of the following: o Enzyme assay showing a deficiency of acid alpha- glucosidase (GAA) activity in the blood, skin, or muscle o Genetic testing showing a mutation in the GAA gene • Documentation patient has measurable signs or symptoms of Pompe disease • Results of a baseline 6-minute walk test (6MWT) and percent- predicted forced vital capacity (FVC) are provided (not required for patients who are not old enough to walk) • Requested dose is appropriate per prescribing information (documentation of patient weight must be submitted with request)
Revision/Review Date: 2/2026 • Requested regimen will not be used in combination with other enzyme replacement therapies (Exception: Pombiliti + Opfolda are to be used together) • Additionally for Nexviazyme: Patients < 30 kg must provide documentation of a trial and therapy failure of, or a medical reason why Lumizyme may not be used. • Additionally for Pombiliti + Opfolda: Patient must have trial and failure of another enzyme therapy (Lumizyme or Nexviazyme) Re-Authorization: • Documentation or provider attestation of positive clinical response to therapy o Infantile onset: provider attestation of member benefit o Late onset: improvement, stabilization, or slowing of progression of percent-predicted FVC and/or 6MWT • Requested dose is appropriate per prescribing information (documentation of patient weight must be submitted with request) • Requested regimen will not be used in combination with other enzyme replacement therapies (Exception: Pombiliti + Opfolda are to be used together) Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization Group Description Retinoic Acid Derivatives Drugs Preferred Agents: (will pay at POS for member < 30 years of age) • adapalene/benzoyl peroxide 0.1-2.5%, 0.3-2.5% gel • tretinoin 0.01%, 0.025% gel • tretinoin 0.025%, 0.05%, 0.1% cream • adapalene (Differin) 0.3% gel •
Non-Preferred Agents
•
adapalene (Differin) 0.1% gel, cream
•
Aklief (trifarotene) cream
•
Altreno (tretinoin) lotion
•
Arazlo (tazarotene) lotion
•
clindamycin/tretinoin (Ziana) gel
•
tazarotene (Fabior) foam
•
tazarotene (Tazorac) cream
•
tazarotene (Tazorac) gel
•
tretinoin 0.05% gel
Covered Uses
Medically accepted indications are defined using the following sources: the Food and
Drug Administration (FDA), Micromedex, American Hospital Formulary Service
(AHFS), United States Pharmacopeia Drug Information for the Healthcare
Professional (USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
Requests for cosmetic use such as fine wrinkles, mottled hyperpigmentation,
or facial skin roughness are excluded from coverage.
Required Medical
Information
N/A
Age Restrictions
9 to 30 years of age
Prescriber Restrictions
Limited to providers with an appropriate scope of practice
Coverage Duration
If the criteria are met, the request will be approved for a maximum of 50 g/30 days for
12 months.
Other Criteria
Revision/Review Date: 2/2026 Requests for members > 30 years of age: • Diagnosis of acne vulgaris or non-cosmetic, medically-accepted condition
Additional criteria for Non-Preferred Agents:
•
Diagnosis of acne vulgaris or non-cosmetic, medically-accepted condition
•
For acne, documented trial and failure of, or intolerance to, two preferred
topical acne medications. One of the two products must be a preferred
retinoic acid derivative product
•
For other medically accepted conditions, documented trial and failure of, or
intolerance to, one preferred topical medication
If the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.
Field Name Field Description Prior Authorization Group Description Rhapsido Drugs Rhapsido (remibrutinib) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions According to package insert Prescriber Restrictions Prescribed by, or in consultation with, an allergist, immunologist, or dermatologist Coverage Duration If all of the criteria are met, the initial request will be approved for 6 months. For continuation of therapy, the request will be approved for 12 months. Other Criteria
Date: 2/2026
Initial Authorization:
• Medication is prescribed at an FDA approved dose
• Diagnosis of chronic spontaneous urticaria for at least 6 weeks with
uncontrolled symptoms
• Patient has had at least a 2-week trial and failure of, or has a
contraindication to, at least two different H1 antihistamines (e.g.
cetirizine, levocetirizine, loratadine, desloratadine, fexofenadine) at
four times the standard FDA-approved dose
• Patient has had at least a 2-month trial of, or has a contraindication
to, Xolair (omalizumab)
Re-Authorization:
• Documentation or provider attestation of positive clinical response
(i.e. change from baseline in weekly itch severity score, etc.)
• Medication is prescribed at an FDA approved dose
If all of the above criteria are not met, the request is referred to a
Medical Director/Clinical Reviewer for medical necessity review.
Rituximab Drugs: Rituxan (rituximab) Rituxan Hycela (rituximab/hyaluronidase human, recombinant) Truxima (rituximab-abbs) Ruxience (rituximab-pvvr) Riabni (rituximab-arrx) RITUXIMAB WILL BE APPROVED IF THE FOLLOWING PRIOR AUTHORIZATION CRITERIA IS MET: MULTIPLE SCLEROSIS: • Refer to the “Healthcare Professional (HCP) administered/IV Disease Modifying Therapies (DMTs) for Multiple Sclerosis (MS)” policy NEUORMYELITIS OPTICA SPECTRUM DISORDER (NMOSD): • Refer to the “Neuromyelitis Optica Spectrum Disorder (NMOSD) Agents” policy RHEUMATOID ARTHRITIS: Initial Authorization • The medication is being recommended and prescribed by a rheumatologist. • The patient is an adult (≥18 y/o) and has a documented clinical diagnosis of rheumatoid arthritis. • The patient has a documented (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) adequate trial (including dates and doses) of 3 months or more of therapy with one conventional (non- biologic) DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) or has a documented medical reason (e.g. intolerance, hypersensitivity) for not utilizing any of these therapies to manage their medical condition. • The patient has a documented (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) adequate trial (including dates, doses) of 2 preferred biologics indicated for rheumatoid arthritis, or has documented medical reason (intolerance, hypersensitivity, etc.) for not taking the preferred therapies to manage their medical condition. • Documentation indicating that rituximab is being used concurrently with methotrexate, or a medical reason why methotrexate cannot be used
• Documentation indicating that the patient has been screened for Hepatitis B Virus (HBV) prior to initiation of treatment. • Rituximab is being prescribed at an FDA approved dosage. • If the request is for any medication other than Ruxience(rituximab-pvvr), or Riabni (rituximab-arrx), there is a documented trial and failure of Ruxience (rituximab-pvvr), or medical reason why (e.g. intolerance, hypersensitivity, contraindication) they cannot be used. If all of the above conditions are met, the request will be approved for up to a 1 month duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. Reauthorization • The member has been receiving rituximab and documentation is provided that a rheumatologist has reevaluated the member and recommends continuation of therapy. • Documentation was provided indicating that the patient had clinical benefit from receiving rituximab therapy. • At least 16 weeks (4 months) has elapsed since the previous course of rituximab therapy. • Documentation indicating that rituximab is being used concurrently with methotrexate, or a medical reason why methotrexate cannot be used. • Rituximab is being prescribed at an FDA approved dosage. If all of the above conditions are met, the request will be approved for up to a 1 year duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. PEMPHIGUS VULGARIS Initial Authorization • The medication is being recommended and prescribed by a rheumatologist or dermatologist • The patient is ≥ 18 years with a diagnosis of moderate to severe pemphigus vulgaris • Documentation the patient will be receiving P. jirovecii pneumonia (PJP) prophylaxis (ex. TMP/SMX, dapsone, atovaquone) or the prescriber has provided a medical reason for not prescribing PJP prophylaxis • Documentation indicating that the patient has been screened for HBV prior to initiation
of treatment • Rituximab is being prescribed at an FDA approved dose/frequency • Rituximab is being used in combination with a tapering course of glucocorticoids If all of the above conditions are met, the request will be approved for up to a 1 month duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. Reauthorization • Documentation of clinical benefits (e.g., absence of new lesions) with rituximab therapy was provided by a rheumatologist or dermatologist • Documentation the patient will continue to receive PJP prophylaxis (ex. TMP/SMX, dapsone, atovaquone) or the prescriber has provided a medical reason for not prescribing PJP prophylaxis • Rituximab is being prescribed at an FDA approved dose/frequency If all of the above conditions are met, the request will be approved for up to a 1 year duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. ONCOLOGY INDICATIONS Initial Authorization: • The medication is being recommended and prescribed by an oncologist. • The medication is being requested for a labeled indication or the an indication supported by a NCCN category 1 or 2A level of evidence • Documentation of CD20 positive disease • Documentation indicating that the patient has been screened for HBV prior to initiation of treatment. • Rituximab is being prescribed at a dose that is within FDA approved guidelines and/or is supported by the medical compendium as defined by the Social Security Act and/or the National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) standard of care guidelines. • If the request is for any medication other than Ruxience (rituximab-pvvr) there is a documented trial and failure of Ruxience (rituximab-pvvr), or medical reason why (e.g. intolerance, hypersensitivity, contraindication) Ruxience (rituximab-pvvr) cannot be used. • If the request is for Rituxan Hycela (rituximab/hyaluronidase human, recombinant),
o the patient has received at least one full dose of a rituximab product by intravenous infusion, o the medication is being requested for a malignant condition, and o there is a medical reason why the alternative rituximab product cannot be continued If all of the above conditions are met, the request will be approved for up to a 3 month duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. Reauthorization • The medication is being recommended and prescribed by an oncologist. • Rituximab is being prescribed at a dose that is within FDA approved guidelines and/or is supported by the medical compendium as defined by the Social Security Act and/or per the NCCN or ASCO standard of care guidelines. If all of the above conditions are met, the request will be approved for up to a 3 month duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. GRANULOMATOSIS WITH POLYANGIITIS (GPA) (WEGENER’S GRANULOMATOSIS) AND MICROSCOPIC POLYANGIITIS (MPA): Initial Authorization: • The medication is being recommended and prescribed by a rheumatologist or nephrologist. • The patient is 2 years of age or older and has a documented clinical diagnosis of GPA (Wegener’s Granulomatosis), eosinophilic granulomatosis with polyangiitis (EGPA), or MPA AND the prescriber indicates whether there is severe or non-severe disease. • Documentation indicating that rituximab is being used concurrently with glucocorticoids. • Documentation the patient will be receiving PJP prophylaxis (ex. TMP/SMX, dapsone, atovaquone) during treatment or the prescriber has provided a medical reason for not prescribing PJP prophylaxis • Documentation indicating that the patient has been screened for HBV prior to initiation of treatment. • Rituximab is being prescribed at an FDA approved dosage. • If the patient is 18 years of age or older, and the request is for any medication other than
Ruxience (rituximab-pvvr) or Riabni (rituximab-arrx), there is a documented trial and failure of Ruxience (rituximab-pvvr) or Riabni, or medical reason why (e.g. intolerance, hypersensitivity, contraindication) they cannot be used. If all of the above conditions are met, the request will be approved for up to a 1 month duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. Re-authorization: • The medication is being recommended and prescribed by a rheumatologist or nephrologist. • Documentation the patient will continue to receive PJP prophylaxis (ex. TMP/SMX, dapsone, atovaquone) or the prescriber has provided a medical reason for not prescribing PJP prophylaxis • Rituximab is being prescribed at an FDA approved dose. If all of the above conditions are met, the request will be approved for up to a 1 year duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. DERMATOMYOSITIS (DM) and POLYMYOSITIS (PM) Initial Authorization: • Rituximab is being recommended and prescribed by a neurologist, rheumatologist, or dermatologist. • Patient meets one of the following: o Bohan and Peter score indicating definite DM or PM o Bohan and Peter score indicating probable DM or PM AND concurring diagnostic evaluation by ≥ 1 specialist (e.g. neurologist, rheumatologist, dermatologist) • Patient does NOT have cancer associated myositis defined as myositis within 2 years of cancer diagnosis (except basal or squamous cell skin cancer or carcinoma in situ of the cervix that has been excised and cured) • One of the following: o Patient has a documented trial and failure of, or has a documented medical reason for not using methotrexate (MTX) OR azathioprine o Patient has severe, life-threatening weakness or dysphagia • Rituximab is prescribed at a dose per the medical compendia (Micromedex, American Hospital Formulary Service (AHFS), DrugPoints, the Drug Package Insert as defined in the Social Security Act and/or per the American Academy of Pediatrics (AAP) standard
of care guidelines and has a Class I or IIa recommendation). • If the request is for any medication other than Ruxience (rituximab-pvvr) there is a documented trial and failure of Ruxience (rituximab-pvvr), or medical reason why (e.g. intolerance, hypersensitivity, contraindication) Ruxience (rituximab-pvvr) cannot be used. If all of the above conditions are met, the request will be approved for up to a 1 month duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. Re-authorization: • Rituximab is being recommended and prescribed by a neurologist, rheumatologist, or dermatologist. • Documentation was provided indicating that the patient had clinical benefit from receiving rituximab therapy. • Rituximab is prescribed at a medically accepted dose per the medical compendia. If all of the above conditions are met, the request will be approved for up to a 3 month duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. OTHER MEDICALLY ACCEPTED INDICATIONS Initial Authorization: • The medication is prescribed for a non-FDA approved indication but is considered to be a medically accepted use of the medication per the medical compendia (Micromedex, American Hospital Formulary Service (AHFS), DrugPoints, the Drug Package Insert as defined in the Social Security Act and/or per the American Academy of Pediatrics (AAP) standard of care guidelines and has a Class I or IIa recommendation. • The medication is prescribed at a medically accepted dose per the medical compendia as defined above. • The medication is recommended and prescribed a specialist in the field to treat the member’s respective medical condition. • Documentation indicating that the patient has been screened for HBV prior to initiation of treatment. • Documentation was submitted indicating that the member has a documented (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) adequate trial (including dates, doses of medications) of ALL first line medical therapies as recommended by the medical compendia and standard care guidelines and/or has another documented medical reason (e.g. intolerance, contraindications, etc.) for not receiving or trying all first line medical treatment(s).
• If the request is for any medication other than Ruxience (rituximab-pvvr), there is a documented trial and failure of Ruxience (rituximab-pvvr), or medical reason why (e.g. intolerance, hypersensitivity, contraindication) Ruxience (rituximab-pvvr) cannot be used. If all of the above conditions are met, the request will be approved for up to a 3 month duration. If all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. Re-authorization: • The medication is prescribed at a medically accepted dose per the medical compendia • The medication is recommended and prescribed a specialist in the field to treat the member’s respective medical condition. • Documentation from medical chart was submitted indicating that the member has significantly clinically benefited from the medication. If all of the above conditions are met, the request will be approved for up to a 3 month duration. If all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. NOTE: Physician/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. Revision/Review Date: 7/2025
Field Name Field Description Prior Authorization Group Description Roctavian Drugs Roctavian (valoctocogene roxaparvovec-rvox) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria Prior use of gene therapy for Hemophilia A Required Medical Information See “Other Criteria” Age Restrictions Patient must be 18 years of age and older Prescriber Restrictions Prescriber must be a hematologist Coverage Duration If all of the criteria are met, the initial request will be approved for a one-time treatment. Other Criteria Revision/Review Date: 10/2025 Initial Authorization: • Diagnosis of severe hemophilia A (congenital factor VIII deficiency with factor VIII activity < 1 IU/dL) • Documentation of a current prophylactic regimen of Factor VIII infusions or bispecific monoclonal antibodies (i.e. Hemlibra) • Documented FDA-approved anti-AAV5 antibody test showing the patient is negative for anti-AAV5 antibodies • Documented Factor VIII inhibitor titer test showing the patient is negative for Factor VIII inhibitors • Prescriber attestation of performed liver health assessments • Patient weight • Medication is prescribed at an FDA approved dose The safety and effectiveness of repeat administration of Roctavian has not been evaluated and will not be approved. Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Rytelo Drugs Rytelo (imetelstat) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions Member must be 18 years of age and older Prescriber Restrictions Prescriber must be a hematologist or oncologist Coverage Duration If all of the criteria are met, the initial request will be approved for 6 months. For continuation of therapy, the request will be approved for 6 months. Other Criteria Revision/ Review Date: 10/2025 Initial Authorization: • Diagnosis of myelodysplastic syndromes (MDS) with transfusion- dependent anemia • Myelodysplastic Syndrome Revised International Prognostic Scoring System (IPSS-R) categorization as low or intermediate-1 risk of progression • Member has transfusion burden of 4 or more red blood cell (RBC) units within an 8-week period over the last 4 months • Prescriber attestation that complete blood cell count (CBC) will be obtained prior to initiation, weekly for first two cycles, and prior to each cycle thereafter • Member’s weight has been provided with request • Medication is prescribed at an FDA approved dose Re-Authorization: • Documentation or provider attestation of reduction in RBC transfusion burden as compared with baseline • Provider attestation that patient is tolerating the medication and is not experiencing any serious adverse reactions • Member’s weight has been provided with request • Medication is prescribed at an FDA approved dose If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name
Field Description
Prior Authorization
Group Description
Skyclarys
Drugs
Skyclarys (omaveloxolone)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
Per FDA-approved prescribing information
Prescriber
Restrictions
Prescriber must be a neurologist or in consultation with a neurologist or
specialist with expertise in treating patients with Friedreich’s Ataxia.
Coverage Duration
If all of the criteria are met, the initial request will be approved for 6
months. For continuation of therapy, the request will be approved for 12
months.
Other Criteria
Revision/Review
Date 7/2025
Initial Authorization:
•
Diagnosis of Friedreich’s Ataxia, confirmed via genetic testing
(must submit documentation)
•
Modified FARS score ≥20 and ≤80
•
Medication is prescribed at an FDA approved dose
Re-Authorization:
•
Documentation or provider attestation of positive clinical response
to Skyclarys therapy (i.e. improvement in symptoms, slowing of
disease progression, etc.)
•
Medication is prescribed at an FDA approved dose
Medical Director/clinical reviewer must override criteria when,
in his/her professional judgement, the requested item is medically
necessary.
Field Name
Field Description
Prior Authorization
Group Description
Sleep Disorder Therapy
Drugs
Formulary status: Preferred, Prior Authorization Required
•
modafinil (Provigil) tablets
•
armodafinil (Nuvigil) tablets
Formulary status: Non-preferred, Prior Authorization Required
•
Sunosi (solriamfetol) tablets
•
Wakix (pitolisant) tablets
•
Sodium oxybate solution
•
Xyrem (sodium oxybate) solution
•
Xywav (calcium, magnesium, potassium, and sodium oxybates)
Covered Uses
Medically accepted indications are defined using the following sources: the
Food and Drug Administration (FDA), Micromedex, American Hospital
Formulary Service (AHFS), United States Pharmacopeia Drug Information
for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or
disease state specific standard of care guidelines.
Exclusion Criteria
Wakix: severe hepatic impairment (Child-Pugh class C)
Sodium oxybate (Xyrem/Xyway/Lumryz): Succinic semialdehyde
dehydrogenase deficiency
Required Medical
Information
See “Other Criteria”
Age Restrictions
Per FDA approved prescribing information.
Prescriber
Restrictions
Prescribed by or in consultation with a sleep specialist, neurologist, or other
specialist in the treatment of the member’s diagnosis (does not apply for
diagnosis of shift-work disorder)
Coverage Duration
If the criteria are met, requests for modafinil, armodafinil, Sunosi, and
Wakix will be approved with up to a 12 month duration. Requests for
sodium oxybate products will be approved with up to a 3 month duration.
Other Criteria
For all requests:
•
Medication is being prescribed at an FDA approved dose
Modafinil/armodafinil initial authorization:
•
For a diagnosis of obstructive sleep apnea (OSA) documentation
that the member has been compliant with or is unable to use
positive airway pressure [continuous positive airway pressure
(CPAP), bilevel positive airway pressure (BPAP), or automatic
positive airway pressure (APAP)].
Sunosi initial authorization
•
Documented trial and failure of modafinil or armodafinil or a
documented medical reason for not utilizing these medications.
•
For members with OSA:
o Documentation that the member has been compliant with or
is unable to use positive airway pressure (CPAP, BPAP, or
APAP)
Wakix initial authorization:
Revision/Review Date: 1/2026 • For a diagnosis of narcolepsy without cataplexy: documented trial and failure of (or medical reason for not using), ALL of the following: o Modafinil o armodafinil o Sunosi (solriamfetol) For members under 18 years of age, no prerequisite medication trials are required • For a diagnosis of narcolepsy in members 18 years of age and older with cataplexy: documented trial and failure of, or medical reason for not using, the following: o Dextroamphetamine
Sodium Oxybate (Xyrem/Xywav) initial authorization
•
Medication is not being taken concurrently with sedative hypnotics
•
For a diagnosis of narcolepsy without cataplexy:
o Documented trial and failure of, or a medical reason for not
using, ALL of the following:
modafinil (not required for members under 18)
armodafinil (not required for members under 18)
Sunosi (solriamfetol) (not required for members
under 18)
Wakix (pitolisant)
o For Xyrem or Xywav: documented trial and failure of, or
medical reason for not using generic sodium oxybate.
•
For a diagnosis of narcolepsy with cataplexy:
o Documented trial and failure of each of, or medical reason
for not using BOTH of the following:
Dextroamphetamine (no required for members
under 18)
Wakix (pitolisant) (not required for members under
18)
o For Xyrem or Xywav: documented trial and failure of, or
medical reason for not using generic sodium oxybate.
•
For a diagnosis of idiopathic hypersomnia (Xywav only):
o Patient has a documented trial and failure of, or medical
contraindication to, ALL of the following:
Modafinil
armodafinil
Reauthorization: • Documentation has been submitted indicating member has experienced a clinical benefit from treatment (e.g. improvement on Epworth Sleepiness Score, reduction in frequency of cataplexy attacks)
• For a diagnosis of obstructive sleep apnea (OSA) documentation that the member continues to be compliant with or is unable to use positive airway pressure (CPAP, BPAP, or APAP) Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary
Field Name
Field Description
Prior Authorization
Group Description
Serostim (somatropin, mammalian derived)
Drugs
Serostim (somatropin, mammalian derived)
Covered Uses
Medically accepted indications are defined using the following sources: the Food and Drug
Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United
States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug
Package Insert (PPI), or disease state specific standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
N/A
Prescriber
Restrictions
Prescriber must be an HIV or infectious disease specialist
Coverage Duration
If all criteria are met, Serostim will be authorized for 12 weeks
Other Criteria
Revision/Review
Date: 72025
Initial Authorization:
•
Patient has been receiving optimal highly active antiretroviral therapy (HAART) for
at least three months prior to initiation
•
Prescriber attests that the patient has been evaluated for other possible causes of
wasting/cachexia (e.g. malignancies) or fat redistribution (e.g. diabetes mellitus,
lipodystrophy, etc.)
•
Request is for the FDA approved or medically accepted dosing
•
Documentation supporting all of the following must be provided:
o
Baseline and repeated evaluation every 3 months of patient’s weight (most
recent weight measurement must be within the past 3 months)
o
BMI and lean body mass measured by X-ray absorptionmetry (DEXA/DXA)
were provided with the request
o
Demonstrable weight loss of greater than 10% of the baseline body weight
associated with either chronic diarrhea (two or more loose stools per day for
greater than or equal to 1 month) or chronic weakness and fever for greater
than or equal to 1 month
o
Patient has had an insufficient response to a three month trial of an anabolic
steroid such as oxandolone
o
Patient has had an insufficient response to a three month trial of one of the
following agents: megestrol acetate, cyproheptadine, or dronabinol
Re-authorization:
•
The patient is receiving concomitant anti-HIV treatment
•
The prescriber has provided documentation of clinical benefit/response to Serostim.
•
Request is for FDA approved or medically accepted dosing
Medical Director/clinical reviewer must override criteria when, in his/her professional
judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Skysona Drugs Skysona (elivaldogene autotemcel) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria • Cerebral adrenoleukodystrophy secondary to head trauma • Positive for human immunodeficiency virus type 1 or 2 Required Medical Information See “Other Criteria” Age Restrictions See “Other Criteria” Prescriber Restrictions Prescriber must be a specialist in the disease being treated. Coverage Duration If all the criteria are met, the initial request will be approved for a one- time treatment. Other Criteria Revision/Review Date: 2/2026 Initial Authorization: • Member has a diagnosis of early, active cerebral adrenoleukodystrophy (CALD) defined as all of the following: o elevated very long chain fatty acid (VLCFA) levels o confirmed mutations in the ABCD1 gene o asymptomatic or mildly symptomatic (neurologic function score, NFS ≤ 1) o Gadolinium enhancement on brain magnetic resonance imaging (MRI) of demyelinating lesions and Loes scores of 0.5-9 • Member is a male 4-17 years of age • Medication is prescribed at an FDA approved dose • Member has not had a prior allogeneic hematopoietic stem-cell transplant (HSCT) • Member has no HLA-matched donor for HSCT Re-Authorization: The safety and effectiveness of repeat administration of Skysona have not been evaluated and will not be approved.
Field Name
Field Description
Prior Authorization
Group Description
SMN2 Splicing Modifiers for the Treatment of Spinal Muscular
Atrophy (SMA)
Drugs
Evrysdi (risdiplam)
Spinraza (nusinersen)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), and the Drug
Package Insert (PPI).
Exclusion Criteria
• For Spinraza: patient has previously received treatment with
Zolgensma
• Concomitant use of Evrysdi and Spinraza
Required Medical
Information
For Evrysdi: Patient’s body weight
Age Restrictions
N/A
Prescriber
Restrictions
Prescriber must be a neurologist
Coverage Duration
For Evrysdi: If all of the conditions are met, the request will be
approved for 6 months for initial approval, followed by 12 months for
reauthorization requests.
For Spinraza: If all of the conditions are met, the request will be approved for 6 months for 5 doses (4 loading doses and 1st maintenance dose) for initial approval, and 12 months for 3 additional maintenance doses for reauthorization requests.
If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review. Other Criteria
Initial approval
• Member has a confirmed diagnosis of SMA types I, II or III and
the molecular genetic test with mutation analysis was submitted
that is positive for the genetic deletion of the exon 7 of the
survival motor neuron (SMN1)
• For Spinraza: Documentation of genetic testing confirming
either two or three copies of the SMN2 gene OR four copies of
the SMN2 gene with symptomology of SMA
• For Evrysdi: Documentation of genetic testing confirming two to
four copies of the SMN2 gene
• Baseline motor function or motor milestone achievement was
Revision/Review Date 2/2026 submitted with request [e.g. CHOP Infant Test of Neuromuscular Disorders (CHOP-INTEND) or Hammersmith Infant Neurological Examination (HINE) for Type 1 or Hammersmith Functional Motor Scale Expanded Scores (HFMSE) for Type II and Type III, or 6 minute walk test in subjects able to walk, Revised Upper Limb Module (RULM), Motor Function Measure 32 (MFM-32)] • The request is for an FDA approved dose Reauthorization • Documentation of clinical response was submitted with request (e.g. improvement or stabilization in motor function/motor milestone achievement scores using CHOP-INTEND or HFMSE, 6 minute walk test, RULM, MFM-32 or HINE improvement in more categories of motor milestones than worsening, patient remains permanent ventilation free if no prior ventilator support) • The request is for an FDA approved dose
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Sohonos
Drugs
Sohonos (palovarotene)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
• Pregnancy
• Use in patients younger than 8 years of age for females and 10
years of age for males
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber Restrictions Prescribed by or in consultation with an orthopedic specialist or
provider who specializes in rare connective tissue diseases
Coverage Duration
If all of the criteria are met, the initial or reauthorization request will be
approved for up to 12 months taking into account patient specific
scenarios.
Other Criteria
Revision/Review Date: 2/2026 Initial Authorization: • Documented diagnosis of fibrodysplasia ossificans progressiva (FOP) • Documented genetic testing of ACVR1 R206H mutation • Attestation that patient is not pregnant and appropriate contraception methods will be used at least 1 month before treatment, during treatment, and 1 month after the last dose (if applicable) • Documentation of weight for patients younger than 14 years old • Medication is prescribed at an FDA approved dose
Re-Authorization:
• Documentation or provider attestation of clinical benefit (i.e.
volume reduction of heterotopic ossification) or worsening (i.e.
flare-up presence and/or worsening of flare-ups)
• Attestation that patient is not pregnant and appropriate
contraception methods will be used at least 1 month before
treatment, during treatment, and 1 month after the last dose (if
applicable)
• Documentation of weight for patients younger than 14 years old
• Medication is prescribed at an FDA approved dose
Physician/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Prior Authorization
Group Description
Somatostatin Analogs and Growth Hormone Receptor Antagonists
Drugs
Lanreotide (Somatuline Depot)
Octreotide (Sandostatin, Sandostatin LAR, Mycapssa)
Pasireotide (Signifor, Signifor LAR)
Pegvisomant (Somavert)
Covered Uses
Medically accepted indications are defined using the following sources: the
Food and Drug Administration (FDA) Drug Package Insert (PPI).
Non-FDA approved (i.e. off-label) uses; refer to the “Off-Label Use” policy
for non-oncology indications, and the “Oncology Drugs” policy for off label
oncology uses
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
Per FDA approved package insert
Prescriber
Restrictions
Prescriber must be a specialist with appropriate expertise in treating the
condition in question (such as an endocrinologist, neurologist/neurosurgeon,
oncologist, etc.). Consultation with appropriate specialist for the condition in
question is also acceptable.
Coverage Duration
If all of the criteria are met, the initial request will be approved for 6 months.
For continuation of therapy, the request will be approved for 12 months.
Other Criteria
Initial Authorization
For all FDA approved indications
•
Medication requested is for an FDA approved indication and dose
•
If the provider is requesting therapy with more than one somatostatin
analog, or a somatostatin analog and a growth hormone receptor
antagonist, then documentation must be submitted as to why patient is
unable to be treated with monotherapy, or a medical reason was
provided why monotherapy is not appropriate.
For Acromegaly
•
Patient has had an inadequate response to, or medical reason why,
surgical treatment cannot be used.
•
If the patient mild disease (e.g. mild signs and symptoms of growth
hormone excess, modest elevations in IGF-1) there is a documented
trial of a dopamine agonist (e.g. bromocriptine mesylate, cabergoline)
at a therapeutically appropriate dose or a documented medical reason
why a dopamine agonist cannot be used
•
Additionally for Mycapssa:
o
Patient has showed clinical response to and tolerates treatment
with octreotide or lanreotide therapy
o
Clinical justification is provided as to why patient cannot
continue use of injectable somatostatin analog therapy
•
Additionally for Somavert
o
Patient has had an inadequate response to therapy with a
somatostatin analog, or has a documented medical reason why
a somatostatin analog cannot be used
•
Additionally for Signifor LAR:
Revision/Review Date 4/2025 o Patient has had an inadequate response to therapy with either lanreotide (Somatuline Depot) or octreotide (Sandostain, Sandostatin LAR), or has a documented medical reason why these somatostatin analogs cannot be used. For Cushing’s Disease (pasireotide products only) • Patient must have had inadequate response or medical reason why surgical treatment cannot be used Reauthorization • Medication requested is for an FDA approved indication and dose • Documentation has been provided that demonstrates a clinical benefit (e.g. improvement in laboratory values, improvement or stabilization of clinical signs/symptoms, etc.) Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization
Group Description
Specialty Biologic Agents
Drugs
Preferred
Enbrel (etanercept)
Humira (adalimumab)
Taltz (ixekizumab)
Xeljanz IR (tofacitinib)
Kineret (anakinra)
Orencia (abatacept)
Otezla (apremilast) 30mg tablet, starter pack
Rinvoq (upadacitinib)
Tyenne (tocilizumab-aazg)
Xeljanz XR 11mg tablet (tofacitinib)
Entyvio (vedolizumab)
Pyzchiva (ustekinumab-ttwe)
Hadlima (adalimumab)
adalimumab adaz
Non-Preferred
Cosentyx (secukinumab)
Kevzara (sarilumab)
Actemra (tocilizumab)
Cimzia (certolizumab)
Simponi (golimumab)
Stelara (ustekinumab)
Hyrimoz (adalimumab)
Idacio (adalimumab)
Yuflyma (adalimumab)
adalimumab fkjp
adalimumab adbm
adalimumab aacf
Abrilada (adalimumab)
Bimzelx (bimekizumab-bkzx)
Steqeyma (ustekinumab-stba)
Otezla (apremilast) 20mg tablet,
starter pack
Tyruko (natalizumab-sztn)
Imuldosa (ustekinumab-srlf)
Otulfi (ustekinumab -aauz)
Selarsdi (ustekinumab-aekn)
Starjemza
adalimumab-bwwd
Ilaris (canakinumab)
Tremfya (guselkumab)
Siliq (brodalumab)
Tysabri (natalizumab)
Xeljanz XR 22mg tablet (tofacitinib)
Ilumya (tildrakizumab-asmn)
Olumiant (baricitinib)
Skyrizi (risankiizumab)
Sotyktu (deucravacitinib)
Amjevita (adalimumab)
Cyltezo (adalimumab)
Yusimry (adalimumab)
Hulio (adalimumab)
Simlandi (adalimumab)
Yesintek (ustekinumab-kfce)
Avtozma (tocilizumab-anoh)
Leqselvi (deuruxolitinib)
Ustekinumab
ustekinumab-aekn
ustekinumab-ttwe
ustekinumab-aauz
Or any newly marketed agent
The Oncology Drugs/Therapies prior authorization criteria will be applied to oncology drugs without drug or class specific criteria Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage Duration
If all of the conditions are met, requests will be approved for 12 months.
Other Criteria
Revision/Review
Date: 2/2026
•
The drug is being requested for an appropriate use (per the references
outlined in “Covered Uses”)
•
The dose requested is appropriate for the requested use (per the references
outlined in “Covered Uses”)
•
If the request is for a non-formulary/non-preferred drug, documentation has
been provided that the member has tried and failed two formulary/preferred
agents appropriate for the requested use (per the references outlined in
“Covered Uses”) or has a medical reason why these drug(s) cannot be used
(e.g. intolerance, contraindication)
•
If the request is for a reference biologic drug with a biosimilar or
interchangeable biologic drug, documentation of one of the following:
•
The provider has verbally, or in writing, submitted a member-
specific reason why the reference biologic is required based on the
member’s condition or treatment history; AND if the member had
side effects or a reaction to the biosimilar or interchangeable
biologic, the provider has completed and submitted an FDA
MedWatch form to justify the member’s need to avoid these drugs.
MedWatch form must also be included with the prior authorization
request.
Form FDA 3500 – Voluntary Reporting
•
The currently available biosimilar product does not have the same
appropriate use (per the references outlined in “Covered Uses”) as
the reference biologic drug being requested
•
If the request is for Stelara, a documented (consistent with pharmacy
claims/medical record data) adequate trial of Pyzchiva or a medical reason
as to why member is unable to utilize Pyzchiva
Reauthorization: • Documentation submitted indicates that the member has obtained clinical benefit from the medication. • The drug is being requested for an appropriate use and dose (per the references outlined in “Covered Uses”) • Requests for a non-preferred agent with a corresponding preferred biosimilar will require an adequate trial of the biosimilar or a medical reason as to why the member is unable to use the preferred biosimilar Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Spravato
Drugs
Spravato (esketamine)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug Package
Insert (PPI), or disease state specific standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
Patients must be 18 years age or older
Prescriber Restrictions N/A
Coverage Duration
If all of the criteria are met, the initial request will be approved for 4
weeks. For continuation of therapy the request will be approved for 6
months.
Other Criteria
Revision/Review Date 4/2025 Initial Authorization: • Member has a diagnosis of at least one of the following: o Major depressive disorder with treatment-resistant depression o Major depressive disorder with acute suicidal ideation or behavior • Medication is being prescribed at an FDA approved dosage. • If Spravato is being requested for a diagnosis of major depressive disorder with treatment-resistant depression (i.e. without suicidal ideation or behavior) the member has either: o Documented trial and failure of two preferred oral antidepressants (eg. SSRIs, SNRIs, TCAs) of at least a minimum effective dose for four (4) weeks or longer OR o Medical justification as to why the patient cannot use preferred alternative(s). • Requests for a diagnosis of major depressive disorder with acute suicidal ideation or behavior (not required for treatment resistant depression): o Prescriber attests Spravato will be used in conjunction with an oral antidepressant
Re-authorization: • Medication is prescribed at an FDA-approved dosage. • Medication is being used in conjunction with an oral antidepressant (not required for diagnosis of treatment resistant depression). • Documentation was submitted indicating the member has clinically benefited from therapy.
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Synagis (palivizumab)
Drugs
Synagis (palivizumab)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug Package
Insert (PPI), or disease state specific standard of care guidelines.
Exclusion Criteria
Members who have received Beyfortus (nirsevimab-alip) for the current
respiratory syncytial virus (RSV) season
Required Medical
Information
See “other criteria”
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage Duration
A maximum of 5 doses may be approved within the Respiratory
Syncytial Virus (RSV) season. Requests for additional doses will be
reviewed on a case-by case basis based on CDC surveillance reports,
state/local health department recommendations, and other current
medical literature.
Other Criteria
Must have documented medical reason for not using Beyfortus
(niresvimab) AND
Infants less than 1 year of age at the onset of the respiratory syncytial
virus (RSV) season (which typically starts November 1st, but may vary
seasonally) AND have one of the following indications:
•
Born at less than 29 weeks, 0 days gestation
•
Born at less than 32 weeks, 0 days gestation AND had chronic
lung disease of prematurity defined as greater than 21% oxygen
for at least 28 days after birth
•
Born at any gestational age with hemodynamically significant
heart disease including:
o
Cyanotic heart disease in consultation with a pediatric
cardiologist
o
Acyanotic Heart disease with one of the following:
On heart failure medication and expected to
require cardiac surgical procedure
Moderate to severe pulmonary hypertension
•
Cystic fibrosis with clinical evidence of chronic lung disease
(CLD) and/or nutritional compromise in the first year of life
•
Born at any gestational age with pulmonary abnormality or
neuromuscular disease that impairs the ability to clear secretions
from the lower airway
Revision/Review Date: 7/2025 Infants less than 2 years of age at the onset of the RSV season (which typically starts November 1st, but may vary seasonally) AND have one of the following indications: • Born at less than 32 weeks, 0 days AND had a diagnosis of chronic lung disease of prematurity at birth as defined above AND had continued need for one of the following respiratory interventions in the 6 months preceding RSV season: Chronic steroids, chronic diuretics, supplemental oxygen • Cystic fibrosis with manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest radiography or chest computed tomography that persist when stable) or weight for length less than the 10th percentile • Born at any gestational age and will be profoundly immunocompromised during the RSV season, including: o Solid organ or hematopoietic stem cell transplant recipient o Chemotherapy recipient • Born at any gestational age and receiving a cardiac transplant Medical Director/clinical reviewer may override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Tavneos
Drugs
Tavneos (avacopan)
Covered Uses
Medically accepted indications are defined using the following sources: the Food
and Drug Administration (FDA), Micromedex, American Hospital Formulary
Service (AHFS), United States Pharmacopeia Drug Information for the
Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state
specific standard of care guidelines.
Exclusion Criteria
Not Applicable
Required Medical
Information
See “Other Criteria”
Age Restrictions
≥18 years old
Prescriber
Restrictions
Prescribed by or in consultation with a rheumatologist or hematologist
Coverage Duration
If the conditions are met, the request will be approved for a 6-month duration for
initial requests and a 12-month duration for renewal requests.
Other Criteria
Revision/Review Date: 2/2026
Initial Authorization:
• Diagnosis of one of the following subtypes of severe active antineutrophil
cytoplasmic autoantibody (ANCA)-associated vasculitis: granulomatosis
with polyangiitis (GPA) or microscopic polyangiitis (MPA)
• Prescriber attestation that Tavneos will be prescribed in combination with
standard therapy (i.e. rituximab, cyclophosphamide, glucocorticoids, etc.)
unless there is documented trial and failure, intolerance, inability to use,
or contraindication to these therapies
• The prescribed dose is within FDA-approved dosing guidelines
• Documentation of baseline Birmingham Vasculitis Activity Score
(BVAS) score
• Prescriber attestation that the patient will have liver function tests before
treatment (ALT, AST, alkaline phosphate, and total bilirubin) and every 4
weeks after start of therapy for the first 6 months of treatment
• Prescriber attestation that the patient has been screened for and does not
have active hepatitis B virus (HBV) infection at baseline
Reauthorization:
• Documentation of remission (BVAS score of 0) OR improvement in
BVAS score
• Prescriber attestation that patient has no abnormality in liver function tests
(abnormality: ALT or AST >3 times the upper limit of normal and
bilirubin >2 times the upper limit of normal)
• Prescriber attestation that patient has no active HBV infection
• The prescribed dose is within FDA approved dosing guidelines
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Tecelra Drugs Tecelra (afamitresgene autoleucel) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria • Homozygous or heterozygous for HLA-A02:05P Required Medical Information See “Other Criteria” Age Restrictions According to package insert Prescriber Restrictions Prescriber must be an oncologist Coverage Duration If all of the criteria are met, the initial request will be approved for a one-time treatment. Other Criteria Date: 10/2025 Initial Authorization: • Diagnosis of unresectable or metastatic synovial sarcoma • Documentation that patient is HLA-A02:01P, -A02:02P, - A02:03P, or -A*02:06P positive • Documentation that the tumor expresses the MAGE-A4 antigen • Documentation of treatment with prior chemotherapy • Member must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 • Medication is being prescribed at an FDA approved dose The safety and effectiveness of repeat administration of Tecelra has not been evaluated and will not be approved. If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Prior Authorization
Group Description
Agents for Thrombocytopenia
Drugs
Preferred Thrombocytopenia Agent(s):
• Promacta (eltrombopag) tablet
• Nplate (romiplostim)
Non-Preferred Thrombocytopenia Agent(s):
• Alvaiz (eltrombopag)
• Doptelet (avatrombopag)
• Mulpleta (lusutrombopag)
• Promacta (eltrombopag) suspension
• Tavalisse (fostamatinib)
• Wayrilz (rilzabrutinib)
• eltrombopag
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional (USP
DI), the Drug Package Insert (PPI), or disease state specific standard of
care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “other criteria”
Age Restrictions
Per package insert
Prescriber Restrictions Prescriber must be a hematologist
Coverage Duration
If the criteria are met, the requests for Promacta, Alvaiz, Nplate,
Tavalisse, and Wayrilz will be approved for 12 months. Mulpleta will
be approved for a maximum of 7 days. Doptelet will be approved for
12 months if the request is for ITP or for a maximum of 5 days if the
request is for thrombocytopenia associated with chronic liver disease
in adult patients requiring elective surgery.
Other Criteria
Chronic immune (idiopathic) thrombocytopenia (ITP):
• Platelet count < 30,000 cells/microL
• Documented trial and failure, or intolerance, contraindication, to
ONE of the following:
• Glucocorticoids
• Intravenous immune globulin (IVIG)
• Rituximab
• splenectomy
• If the request is for Alvaiz, Doptelet, Wayrilz, eltrombopag, or
Tavalisse, the member has a documented trial and failure,
intolerance, or contraindication to Promacta or Nplate
Revision/Review Date
2/2026
Severe aplastic anemia (Promacta and Alvaiz only):
• Being prescribed in conjunction with at least one
immunosuppressive agent OR there is a documented trial and
failure, intolerance, or contraindication to at least one
immunosuppressive agent
• Platelet count < 20,000 cells/microL OR platelet cout < 30,000
cells/microL with bleeding OR reticulocyte count < 20,000
cells/microL OR absolute neutrophil count < 500 cells/microL
• If the request is for Alvaiz or eltrombopag the member has a
documented trial and failure, intolerance, or contraindication to
Promacta
Thrombocytopenia in patients with Hepatitis C infection (Promacta
and Alvaiz only):
• Diagnosis of chronic hepatitis C
• Platelet count < 50,000 cells/microL
• Documented treatment with interferon-based therapy AND
patient’s degree of thrombocytopenia prevents the initiation or
limits the ability to maintain interferon-based therapy
• If the request is for Alvaiz or eltrombopag the member has a
documented trial and failure, intolerance, or contraindication to
Promacta
Thrombocytopenia associated with chronic liver disease in adult patients requiring elective surgery (Doptelet and Mulpleta only): • Patient has a diagnosis of chronic liver disease and is scheduled to undergo a procedure • Platelet count < 50,000 cells/microL Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Transthyretin-mediated Amyloidosis Agents
Drugs
Preferred:
Polyneurpathy – Onpattro (patisiran), Amvuttra (vutrisiran), Wainua
(eplontersen)
Cardiomyopathy – Vyndaqel (tafamidis meglumine), Vyndamax (tafamidis),
Attruby (acoramidis)
Non-preferred:
Cardiomyopathy – Amvuttra (vutrisiran)
Or any other newly marketed agent
Covered Uses
Medically accepted indications are defined using the following sources: the Food
and Drug Administration (FDA), Micromedex, American Hospital Formulary
Service (AHFS), United States Pharmacopeia Drug Information for the
Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state
specific standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
Patient must be 18 years of age or older
Prescriber
Restrictions
Prescriber must be neurologist, cardiologist, or specialist in the treatment of
amyloidosis
Coverage Duration
If all of the criteria are met, the initial request will be approved for 6 months.
For continuation of therapy the request will be approved for 6 months.
Other Criteria
Initial Authorization:
• Regimen does not exceed FDA-approved dose/frequency
• Patient has not undergone a liver or heart transplant
• Requests for use multiple agents (different mechanism of action) in this
policy for mixed polyneuropathy-cardiomyopathy phenotypes will only
be considered if patient meets clinical criteria requirements for each
section.
Polyneuropathy-Type
If the request is for Onpattro, Amvuttra, or Wainua:
• Patient has diagnosis of polyneuropathy of hereditary transthyretin-
mediated amyloidosis as evidenced by documented transthyretin variant
by genotyping
• One of the following:
o Patient has baseline polyneuropathy disability (PND) score ≤ IIIb
o Patient has a baseline FAP Stage 1 or 2
o Patient has baseline neuropathy impairment (NIS) score ≥ 5 and ≤
130
• Patient has clinical signs/symptoms of neuropathy
Revision/Review Date:4/2025
Cardiomyopathy-Type
If the request is for Vyndaqel, Vyndamax, Attruby, or Amyuttra:
• Patient has a confirmed diagnosis of cardiomyopathy of wild-type or
hereditary transthyretin-mediated amyloidosis
• Documented amyloid deposit by biopsy or positive technetium 99m
pyrophosphate (Tc 99m PYP) cardiac imaging
• Patient has New York Heart Association (NYHA) functional class I, II, or
III heart failure symptoms.
• For Amvuttra, patient has contraindication to/or previous trial and failure
or continued clinical progression with use of Vyndaqel, Vyndamax or
Attruby
Re-authorization (for continuing and new patients to the plan) :
• Patient’s regimen does not exceed FDA-approved dose/frequency for the
agent
• Patient has not undergone a liver or heart transplant
• Requests for use multiple agents (different mechanism of action) in this
policy for mixed polyneuropathy-cardiomyopathy phenotypes will only
be considered if patient meets clinical criteria requirements for each
section.
• Documented positive clinical response to therapy from baseline
(stabilization/slowing of disease progression, improved neurological
impairment, motor functions, improved NIS score, stabilization/reduced
rate of decline in 6 minute walk test, etc.)
• If the request is for Vyndaqel/Vyndamax/Attruby/Amyuttra
o Patient has continued NYHA functional class I, II, or III heart
failure symptoms
Continuation of Therapy Provision:
Members with history (within the past 90 days) of a non-formulary product are
not required to try a formulary agent prior to receiving the non-formulary
product.
Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Type I Interferon (IFN) Receptor Antagonist
Drugs
Saphnelo (anifrolumab-fnia)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
•
Severe active central nervous system lupus
•
Active lupus nephritis
Required Medical
Information
See “Other Criteria”
Age Restrictions
≥ 18 years
Prescriber
Restrictions
Prescriber must be a rheumatologist or in consultation with a
rheumatologist
Coverage Duration
If all of the criteria are met, the initial request will be approved for 6
months. For continuation of therapy, the request will be approved for 12
months.
Other Criteria
Date: 10/2025
Initial Authorization:
•
Diagnosis of active moderate to severe systemic lupus
erythematosus (SLE)
•
Member has tried all of the following (or there is a medical reason
they cannot use these therapies) before Saphnelo:
o
Hydroxychloroquine + Glucocorticoids
o
One other immunosuppressant (i.e., methotrexate, azathioprine,
calcineurin inhibitors, or mycophenolate)
o
Benlysta (belimumab), if member has autoantibody-positive SLE
•
Prescriber attests member will not be using Saphnelo concurrently
with Benlysta
•
Medication is prescribed at an FDA approved dose
Re-Authorization:
•
Documentation or provider attestation of positive clinical response
(i.e., reduction in signs and symptoms of SLE, fewer flares, reduced
oral corticosteroid use, etc.)
•
Prescriber attests member will not be using Saphnelo concurrently
with Benlysta
•
Medication is prescribed at an FDA approved dose
If all of the above criteria are not met, the request is referred to a
Medical Director/Clinical Reviewer for medical necessity review.
Field Name
Field Description
Prior Authorization
Group Description
Urea Cycle Disorder Agents
Drugs
Preferred (PA required)
sodium phenylbutyrate (Buphenyl)
Pheburane (sodium phenylbutyrate)
Non-Preferred (PA required)
Olpruva (sodium phenylbutyrate)
Ravicti (glycerol phenylbutyrate)
Buphenyl (sodium phenylbutyrate)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
•
Ravicti: N-Acetylglutamate Synthetase (NAGS) deficiency is
not a covered diagnosis
Required Medical
Information
See “Other Criteria”
Age Restrictions
Per FDA approved prescribing information
Prescriber
Restrictions
Prescriber must be (or have prescribed in consultation with) a metabolic
disease specialist or healthcare provider experienced in the treatment of
urea cycle disorders.
Coverage Duration
If all of the criteria are met, the initial request will be approved for 3
months. For continuation of therapy, the request will be approved for 12
months.
Other Criteria
Initial Authorization (for all agents):
•
Medication is prescribed at an FDA approved dose.
•
Documentation of member’s current weight or body surface area
(depending on agent and patient in question).
•
Diagnosis of a urea cycle disorder confirmed by genetic testing or
enzyme analysis.
•
Provider attests patient’s condition is unable to be managed solely
with dietary protein restriction and/or amino acid supplementation.
•
Provider attests the requested medication will be used in conjunction
with ongoing dietary protein restriction and amino acid
supplementation (if appropriate).
•
Patient has not received a liver transplant.
•
Trial and failure of a preferred urea cycle disorder agent, or a
medical reason why this would be inappropriate must be provided.
Additionally for Olpruva:
Review Date: 7/2025 • Trial and failure of Pheburane is required before Olpruva will be considered, or a medical reason why this would be inappropriate must be provided. Requests for Olpruva due only to convenience of packaging will not be considered. Additionally for Ravicti: • Trial and failure of Pheburane or Olpruva is required before Ravicti will be considered, or a medical reason why this would be inappropriate must be provided. Reasons of taste/palatability will not be considered as a medical reason for waiving trial of Pheburane or Olpruva Re-Authorization: • Documentation or provider attestation of positive clinical response (i.e. stabilization of patient’s plasma ammonia levels). • Medication is prescribed at an FDA approved dose. If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name Field Description Prior Authorization Group Description Vascular Endothelial Growth Factor (VEGF) Inhibitors for Ophthalmic Conditions Drugs Preferred Vascular Endothelial Growth Factor (VEGF) Inhibitor(s): • Avastin (bevacizumab) • Byooviz (ranibizumab-nuna) • Cimerli (ranibizumab-eqrn)
Non-Preferred Vascular Endothelial Growth Factor (VEGF) Inhibitor(s): • Beovu (brolucizumab) • Eylea (aflibercept) • Eylea HD (aflibercept) • Lucentis (ranibizumab) • Susvimo (ranibizumab) • Vabysmo (faricimab) • Pavblu (aflibercept-ayyh) • Any newly marketed agent in this class Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions Approvable for adults 18 years of age and older only Eylea: approvable in pediatric patients for diagnosis of retinopathy of prematurity Prescriber Restrictions Ophthalmologist Coverage Duration If the above conditions are met, the request will be approved for 12 months. Other Criteria
Initial Authorization: Avastin: • Request is for compendia supported dosing for an ophthalmic indication
Byooviz or Cimerli: • Request is for an FDA-approved dosing regimen
Non-Preferred VEGF Inhibitor: • Request is for an FDA-approved dosing regimen; AND
Revision/Review
Date 10/2025
• Documented trial and failure with a preferred VEGF inhibitor
for all FDA-approved indications OR a medical justification for
not using a preferred VEGF inhibitor (e.g. experienced a severe
ADR such as hypersensitivity, arterial thromboembolism,
cerebrovascular accident, raised intraocular pressure, retinal
detachment).
• Requests for Eylea (aflibercept) may be approved for a
diagnosis of retinopathy of prematurity without a trial and
failure of a preferred VEGF inhibitor. Patients must have a
diagnosis of retinopathy of prematurity in at least one eye with
one of the following retinal findings:
o ROP Zone 1 Stage 1+, 2+, 3 or 3+, or
o ROP Zone II Stage 2+ or 3+, or
o AP-ROP (aggressive posterior ROP)
Re-Authorization: • Documentation or provider attestation of positive clinical response • Medication is prescribed at an FDA approved or compendia supported dose
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Veopoz
Drugs
Veopoz (pozelimab-bbfg)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
•
Patients with unresolved Neisseria meningitidis infection
•
Concurrent use of another complement inhibitor (i.e. Soliris)
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescribed by or in consultation with a physician with experience in
managing complement related disorders (i.e., gastroenterologist,
immunologist, cardiologist, etc.)
Coverage Duration
If all of the criteria are met, the initial request will be approved for 6
months. For continuation of therapy, the request will be approved for 12
months.
Other Criteria
Revision/Review
Date: 10/2025
Initial Authorization:
•
Medication is prescribed at an FDA approved dose
•
Diagnosis of CD55-deficient protein-losing enteropathy (PLE), also
known as CHAPLE disease
•
Documentation of hypoalbuminemia (serum albumin <3.5 g/dL)
•
Documentation of patient weight
Re-Authorization:
•
Documentation or provider attestation of positive clinical response
(i.e. symptom improvement, normalization of labs such as serum
albumin (3.5-5.5 g/dL) and IgG concentrations, reduced
hospitalizations and severe adverse events, increased quality of life,
etc.)
•
Documentation of patient weight
•
Medication is prescribed at an FDA approved dose
If all of the above criteria are not met, the request is referred to a
Medical Director/Clinical Reviewer for medical necessity review.
Field Name
Field Description
Prior Authorization
Group Description
Verquvo
Drugs
Verquvo (vericiguat)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional (USP
DI), the Drug Package Insert (PPI), or disease state specific standard of
care guidelines.
Exclusion Criteria
Pregnancy
Required Medical
Information
See “Other Criteria”
Age Restrictions
Patient must be 18 years or older
Prescriber
Restrictions
Prescribed by or in consultation with a cardiologist
Coverage Duration
If all of the conditions are met, the request will be approved for 12
month duration.
Other Criteria
Revision/Review
Date 7/2025
- Medication is prescribed at an FDA approved dose
- The medication is being used for the treatment of symptomatic chronic heart failure with reduced ejection fraction (less than 45%)
- Documentation that the patient has had a previous hospitalization for heart failure or has required outpatient IV diuretics
- Member is currently being prescribed the following treatment regimens, or documentation has been provided that the member is not able to tolerate or has a contraindication to any of these agents: a. Angiotensin-converting enzyme (ACE) inhibitor OR angiotensin receptor blocker (ARB) OR angiotensin receptor/neprilysin inhibitor b. Mineralocorticoid receptor antagonist (e.g. spironolactone) c. Evidence based beta-blocker (i.e., bisoprolol, carvedilol, metoprolol succinate) d. Farxiga or Jardiance
- Patient is not concomitantly using a phosphodiesterase-5 (PDE-5) enzyme inhibitor (e.g. sildenafil)
- Negative pregnancy test (for females of reproductive age; as indicated) within 30 days of request
- Prescriber attests to discussing with females of reproductive potential the need to use effective forms of contraception during treatment and for one month after stopping treatment Medical Director/Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Vesicular Monoamine Transporter 2 (VMAT2) Inhibitors
Drugs
Preferred:
Austedo
tetrabenazine (Xenazine)
Ingrezza (valbenazine)
Non-preferred:
Austedo XR (deutetrabenazine)
Xenazine (tetrabenazine)
Any other newly marketed agent
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
Concurrent use of monoamine oxidase inhibitors (MAOIs )
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescribed by, or in consultation with, a neurologist or psychiatrist
Coverage Duration
If all of the criteria are met, the initial request will be approved for 6
months. For continuation of therapy, the request will be approved for 12
months.
Other Criteria
Initial Authorization:
•
Dose is within FDA-approved limits
•
Prescriber attests patient will not be receiving treatment with any
other VMAT2 inhibitor
For requests for non-preferred drugs, a trial and failure of, or
documented medical reason for not using, a preferred drug is required
For approval for use in Tardive Dyskinesia (TD):
•
Member must have clinical diagnosis of tardive dyskinesia that
has persisted for the last 90 days, with documented baseline
evaluation (e.g., Abnormal Involuntary Movement Scale
(AIMS), the Tardive Dyskinesia Rating Scale (TDRS), etc.)
•
For members on antipsychotics, the antipsychotic dose(s) must
have been stable for a continuous 90 day period at some point
prior to the request
•
Prescriber has attempted at least ONE of the following strategies
to manage the patient’s condition, or has provided a clinical
reason why NONE of the following are possible:
o
Reducing the dose of the drug responsible for causing
dyskinesia
Revision/Review Date: 10/2025 o Discontinuing the drug responsible for causing dyskinesia o For members on first generation antipsychotics, switching to a second generation antipsychotic o Trial of benzodiazepines • For VMAT2 inhibitors other than tetrabenazine, member has a documented medical reason (e.g., treatment failure, intolerance, hypersensitivity, contraindication) for not using tetrabenazine AND o For Austedo requests: Prescriber attests patient has no signs of hepatic impairment For patients at risk for QT prolongation, prescriber attests a baseline ECG has been obtained o For Ingrezza requests: Must be dosed at one capsule per day For approval for use in chorea associated with Huntington’s Disease (HD): • Patient must have diagnosis of moderate to severe Huntington’s with chorea, with documented baseline Total Maximal Chorea (TMC) score provided • For VMAT2 inhibitors other than tetrabenazine, member has a documented medical reason (e.g., treatment failure, intolerance, hypersensitivity, contraindication) for not using tetrabenazine AND o For Austedo requests: Prescriber attests patient has no signs of hepatic impairment For patients at risk for QT prolongation, prescriber attests a baseline ECG has been obtained o For Ingrezza requests: Must be dosed at one capsule per day Re-Authorization: • Documentation or provider attestation of positive clinical response (e.g., improvement from baseline in average scores on the previously submitted symptom rating scale, decrease in symptoms, etc.) • Medication is prescribed at an FDA approved dose If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name
Field Description
Prior Authorization
Group Description
Vijoice
Drugs
Vijoice (alpelisib)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
≥ 2 years
Prescriber
Restrictions
Prescribed by or in consultation with a geneticist,
dermatologist, vascular surgeon, hematologist/oncologist, or other
specialist in the treatment of PIK3CA-Related Overgrowth Spectrum
(PROS)
Coverage Duration
If all of the criteria are met, the initial request will be approved for 6
months. For continuation of therapy, the request will be approved for 12
months.
Other Criteria
Revision/Review
Date: 7/2025
Initial Authorization:
•
Diagnosis of PROS
•
Documented evidence of a mutation in the PIK3CA gene
•
Patient has at least one target lesion identified on imaging
•
Prescriber attests the patient’s condition is severe or life-threatening
and necessitates systemic treatment
•
Medication is prescribed at an FDA approved dose
Re-Authorization:
•
Documentation of a positive clinical response defined as the patient
achieving ALL of the following:
o
At least a 20% reduction in the sum of measurable target
lesion volume (1 to 3 lesions, via central review of imaging
scans)
o
None of the individual target lesions have ≥ 20% increase
from baseline
o
Absence of progression of non-target lesions
o
Absence of any new lesions
•
Prescriber attests the patient does not have any serious adverse
events or unacceptable toxicity
•
Medication is prescribed at an FDA approved dose
If all of the above criteria are not met, the request is referred to a
Medical Director/Clinical Reviewer for medical necessity review.
Field Name Field Description Prior Authorization Group Description Vimizim (elosulfase alfa) Drugs Vimizim (elosulfase alfa) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions Patient must be 5 years of age or older. Prescriber Restrictions Prescriber is, or is collaborating with another provider who is, a specialist in the treatment of Morquio A syndrome or other lysosomal storage disorders. Coverage Duration 6 months Other Criteria Initial Authorization (new to therapy): • Patient has confirmed diagnosis of mucopolysaccharidosis IVA (MPS IVA, or Morquio A syndrome) via one of the following: o Genetic testing o Analysis of N-Acetylgalactosamine 6-sulfatase (GALNS) activity in leukocytes or fibroblasts • Documentation of patient weight Patient must have completed a 6-minute walk test for baseline evaluation (must submit results with request) and be able to walk a minimum of 30 meters at baseline. Re-Authorization: • Patient shows signs of improvement from baseline in a 6-minute walk test (must submit results with request) Re-authorization for members new to the plan previously treated with Vimizim: • Patient has confirmed genetic diagnosis of mucopolysaccharidosis IVA (MPS IVA, or Morquio A syndrome) via one of the following: o Genetic testing o Analysis of N-Acetylgalactosamine 6-sulfatase (GALNS) activity in leukocytes or fibroblasts • Documentation of patient weight Patient must have completed a 6-minute walk test for baseline evaluation, and patient shows signs of improvement from baseline in a recent 6-minute walk test (must submit both results with request). • If a baseline 6-minute walk test was not completed prior to initiation of Vimizim therapy, then:
Revision/Review Date 7/2025 o A current test must be completed and patient must be able to walk a minimum of 30 meters (must submit results with request). o Continued authorizations for Vimizim for patients without a completed baseline 6-minute walk test evaluation prior to initiation of therapy must continue to be able to walk a minimum of 30 meters in subsequent evaluations. o If patient is established on Vimizim therapy prior to enrollment on the plan, but is not able to walk a minimum of 30 meters, then medical justification is required as to how the patient continues to receive benefit from Vimizim therapy. Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Voquezna Drugs Voquezna (vonoprazan), Voquezna Dual Pack (vonoprazan; amoxicillin), Voquezna Triple Pack (vonoprazan; amoxicillin; clarithromycin) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions Per package insert Prescriber Restrictions Prescribed by, or in consultation with, a gastroenterologist, infectious disease specialist, or other specialist with expertise in the treatment of erosive esophagitis or H. pylori infection Coverage Duration If the criteria are met, the request will be approved for up to the following: Healing of erosive esophagitis: Voquezna 20 mg once daily for up to 8 weeks Maintenance of healed erosive esophagitis: Voquezna 10 mg once daily for up to 6 months Treatment of H. pylori infection: 14 days For heartburn associated with non-erosive gastroesophageal reflux disease: Voquezna 10 mg once daily for 4 weeks Other Criteria
Initiation of Therapy: For erosive esophagitis (healing or maintenance of healed erosive esophagitis): • Patient has a diagnosis of endoscopy-confirmed erosive esophagitis (all grades) • Patient is H. pylori negative • Patient has a trial and failure of treatment with ≥ 8 weeks with two different formulary proton pump inhibitors at optimized dosing (double-dose or twice daily dosing), or a medical reason is provided why this is inappropriate. For the treatment of Helicobacter pylori (H. pylori) infection: • Patient has a confirmed H. pylori positive infection, plus one of the following clinical conditions: o dyspepsia lasting at least 2 weeks, functional dyspepsia, recent/new diagnosis of peptic ulcer, or a stable dose of long-term NSAID treatment
Revision/Review
Date: 7/2025
• Patient has a trial and failure of a generic, guideline recommended, first-line
regimen for H. pylori infection such as bismuth quadruple therapy (PPI +
bismuth subcitrate or subsalicylate + tetracycline + metronidazole), or a
medical reason is provided why this would be inappropriate.
For the relief of heartburn associated with non-erosive gastroesophageal reflux
disease:
• Patient has a diagnosis of symptomatic gastroesophageal reflux disease
(GERD) with heartburn as the predominant symptom
• Patient has a history of heartburn lasting at least 6 months, with symptoms
on at least four days per week
• Patient is H. pylori negative, and endoscopy has confirmed patient has no
esophageal erosions
• Prescriber attests patient has been educated about lifestyle modifications
related to GERD management (i.e. avoidance of trigger foods, weight loss
in overweight and obese patients, avoiding meals within 2-3 hours of
bedtime, tobacco cessation, etc.)
• Patient has a trial and failure of treatment with ≥ 8 weeks with two different
formulary proton pump inhibitors at optimized dosing (double-dose or twice
daily dosing), or a medical reason is provided why this is inappropriate.
Renewal Requests:
Use of Voquezna for longer than 8 weeks for healing of erosive esophagitis, longer
than 6 months for maintenance of healing in erosive esophagitis, or longer than 4
weeks for heartburn associated with non-erosive gastroesophageal reflux disease
will not be approved.
Renewal requests for Voquezna for treatment of H. pylori infection will not be
approved.
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Voriconazole (Vfend) Drugs Voriconazole (Vfend) tablets, oral suspension Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions 2 years of age and older. Prescriber Restrictions N/A Coverage Duration If the above conditions are met, the request will be approved with up to a 3 month duration depending upon the severity of the infection. Other Criteria Revision/Review Date 7/2025 Initial Authorization:
- Voriconazole is being used to treat invasive aspergillosis or a serious fungal infection caused by Scedosporium apiospermum and Fusarium species OR
- Voriconazole is being used to treat esophageal candidiasis, candidemia (nonneutropenics), or disseminated candidiasis of the skin, abdomen, kidney, bladder wall or wounds; AND o Documented trial and failure with a formulary treatment option (i.e. fluconazole or nystatin) or documented medical reason (e.g., recent discharge from hospital on oral voriconazole, intolerance, hypersensitivity, contraindication) for not using a formulary treatment option for relevant indications Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Vykat XR (diazoxide choline)
Drugs
Vykat XR (diazoxide choline)
Covered Uses
Medically accepted indications are defined using the following sources: the Food
and Drug Administration (FDA), Micromedex, American Hospital Formulary
Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare
Professional (USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescribed by or in consultation with an endocrinologist, psychiatrist, or other
physician with expertise in the treatment of Prader-Willi syndrome (PWS)
Coverage Duration
If all the criteria are met, the initial and reauthorization requests will be approved for
6 months.
Other Criteria
Revision/Review
Date: 7/2025
Initial Authorization:
• Medication is prescribed at an FDA approved dose
• Documentation of patient’s body weight
• Diagnosis of PWS confirmed by genetic testing (copies of test must be submitted
with request)
• Documentation patient experiences symptoms of hyperphagia related to PWS
(e.g. food-seeking behaviors, food aggression, etc.)
Re-Authorization:
• Documentation of positive clinical response in hyperphagic symptoms (i.e.
decrease in food-related aggression or food-seeking behavior, etc.)
• Medication is prescribed at an FDA approved dose
• Documentation of patient’s body weight
If all the above criteria are not met, the request is referred to a Medical
Director/Clinical Reviewer for medical necessity review.
Prior Authorization Group
Description
Weight Loss Agents (Non-GLP1 Agonists)
Drugs
Preferred:
Phentermine
Non-Preferred:
Adipex-P (phentermine)
Xenical (orlistat)
orlistat
amphetamine sulfate tab
benzphetamine
diethylpropion, diethylpropion ER
Evekeo tab
phendimetrazine, phendimetrazine ER
Lomaira (phentermine)
Imcivree (setmelanotide)
phentermine/topiramate ER capsule
Any newly-approved non-GLP 1 agonist medication indicated for obesity
or weight management
Note: Alli is not a covered benefit Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions Age appropriate per labeling Prescriber Restrictions Imcivree: Prescribed by or in consultation with medical geneticist, endocrinologist, or specialist in metabolic disorders N/A for all other agents Coverage Duration If the criteria are met, the request will be approved for 6 months, or 12 months for Imcivree.
Other Criteria
Revision/Review Date:
4/2026
Initial Authorization:
• Requested dose is appropriate per labeling
• Documentation of current weight and body mass index (BMI)
• BMI must be one of the following:
o BMI of 30 kg/m2 or more
o Pediatric patients must be considered obese per package insert
o BMI of 27 – 29.9 kg/m2 with one of the following weight-related
comorbidities (consistent with pharmacy claims data or chart
notes):
Cardiovascular disease (CVD)
Chronic kidney disease stage 3a or above
Heart failure
Hyperlipidemia
Hypertension
Moderate to severe obstructive sleep apnea (OSA) defined as
apnea–hypopnea index >15 without central or mixed sleep
apnea
Noncirrhotic metabolic dysfunction-associated steatohepatitis
(MASH) with moderate to advanced liver fibrosis (consistent
with stages F2 to F3 fibrosis)
Peripheral artery disease (PAD)
Type 2 diabetes
• Documentation of counseling regarding lifestyle changes and
behavioral modification (e.g., healthy diet and increased physical
activity)
• For Lomaira: trial and failure or medical reason for not using generic
phentermine
• For Imcivree, the patient meets one of the following:
o Diagnosis of Bardet-Biedl syndrome (BBS)
o Obesity is related to proopiomelanocortin (POMC), proprotein
convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor
(LEPR) deficiency AND:
Deficiency is documented by an FDA-approved genetic
test confirming variants in POMC, PCSK1, or LEPR
genes that are interpreted as pathogenic, likely pathogenic,
or of uncertain significance
POMC, PCSK1, or LEPR variants classified as benign or
likely benign will not be approved
• For requests for non-preferred drugs, a trial and failure of, or
documented medical reason for not using, a preferred drug is required
(does not apply for Imcivree)
Re-Authorization:
• Documentation of at least 5% reduction in body weight compared with baseline or 4% of baseline BMI for patients with continued growth potential • If a weight related comorbidity was previously noted, an objective improvement is documented (e.g. reduction in blood pressure, cholesterol, hemoglobin A1c, etc) • Medication is prescribed at an FDA approved dose
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization Group Description GLP1 agonists for weight loss and related conditions Drugs Preferred: Wegovy (semaglutide) injection Zepbound (tirzepatide) injection
Non-Preferred:
Wegovy (semaglutide) tablets
Saxenda (liraglutide)
Foundayo (orforglipron)
Any newly approved GLP 1 agonist medication indicated for weight related
conditions
Covered Uses
Medically accepted indications are defined using the following sources: the
Food and Drug Administration (FDA), Micromedex, American Hospital
Formulary Service (AHFS), United States Pharmacopeia Drug Information
for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or
disease state specific standard of care guidelines.
Exclusion Criteria
•
Concurrent use of any glucagon-like-peptide-1 receptor agonist
•
Personal or family history of medullary thyroid carcinoma
•
Multiple Endocrine Neoplasia syndrome type 2
Required Medical
Information
See “Other Criteria”
Age Restrictions
Age appropriate per labeling
Prescriber Restrictions
N/A
Coverage Duration
If the criteria are met, the request will be approved for 6 months; if the
criteria are not met, the request will be referred to a clinical reviewer for
medical necessity review.
Other Criteria
Initial Authorization (All Agents):
• Requested dose and formulation (injectable, tablet) is appropriate per
labeling
• Documentation of current weight and body mass index (BMI)
• Documentation of counseling regarding lifestyle changes and
behavioral modification (e.g., healthy diet and increased physical
activity)
• BMI must be one of the following:
o BMI of 30 kg/m2 or more
o Pediatric patients must be considered obese per package insert
o BMI of 27 - 29.9 kg/m2 with one of the following weight-
related comorbidities (consistent with pharmacy claims data or
chart notes):
Cardiovascular disease (CVD)
Chronic kidney disease stage 3a or above
Heart failure
Hyperlipidemia
Hypertension
Moderate to severe obstructive sleep apnea (OSA) defined as
apnea–hypopnea index > 15 without central or mixed sleep
Revision/Review Date:
4/2026
apnea
Peripheral artery disease (PAD)
Type 2 diabetes
• For requests for non-preferred drugs, a trial and failure of, or
documented medical reason for not using, a preferred drug is required
Wegovy Requests: For risk reduction of major adverse cardiovascular events (MACE) in adults with established CV disease and either obesity or overweight, the following must be met: • BMI of ≥ 27 kg/m2 with one of the following weight-related comorbidities (consistent with pharmacy claims data or medical chart history): coronary artery disease, diabetes, hypertension, or dyslipidemia
For the treatment of noncirrhotic metabolic dysfunction-associated
steatohepatitis (MASH), formerly known as nonalcoholic
steatohepatitis (NASH), with moderate to advanced liver fibrosis
(consistent with stages F2 to F3 fibrosis) in adults, all of the following must
be met:
• Diagnosis of noncirrhotic metabolic dysfunction-associated
steatohepatitis (MASH) with moderate to advanced liver fibrosis
• Documentation of stage F2 to F3 fibrosis confirmed by biopsy or a
noninvasive test (NIT)
Re-Authorization (MACE and MASH Indications):
•
Patient has demonstrated clinical benefit
•
Patient requires ongoing therapy as part of their treatment plan
•
Medication is prescribed at an FDA approved dose
Re-Authorization (All Other Indications):
•
Documentation of at least 5% reduction in body weight compared with
baseline or 4% of baseline BMI for patients with continued growth
potential
•
Medication is prescribed at an FDA approved dose
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization
Group Description
White Blood Cell Stimulators
Drugs
Short-acting G-CSFs
Nivestym (filgrastim-aafi)
Granix (TBO-filgrastim)
Neupogen (filgrastim) vials, syringes – PREFERRED
Zarxio (filgrastim-sndz)
Releuko (filgrastim-ayow)
Nypozi (filgrastim-txid)
Or any newly market agent
Long-acting G-CSFs
Ziextenzo (pegfilgrastim-bmez)
Fulphila (pegfilgrastim-jmdb) - PREFERRED
Nyvepria (pegfilgrastim-apgf) - PREFERRED
Udenyca (pegfilgrastim-cbqv)
Udenyca Onbody (pegfilgrastim-cbqv)
Neulasta (pegfilgrastim)
Neulasta Onpro (pegfilgrastim)
Rolvedon (eflapegrastim-xnst)
Stimufend (pegfilgrastim-fpgk)
Fylnetra (pegfilgrastim-pbbk)
Or any newly market agent
Other Hematopoietic Agents:
Aphexda (motixafortide)
Plerixafor (Mozobil)
Leukine (sargramostim)
or any newly marketed agent
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USPDI), the Drug Package
Insert (PPI), or disease state specific standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
N/A
Prescriber
Restrictions
Prescriber must be a hematologist, an oncologist, or an infectious disease
specialist
Coverage Duration
Initial authorization requests for all indications will be approved for 12 weeks.
Re-authorization requests for all indications, with the exception of chronic
neutropenia, will be approved for 12 weeks. Re-authorization requests for
chronic neutropenia will be approved for 24 weeks. If the provider attests that
the preferred medication is for a chronic or long-term condition,
reauthorization will be approved for 12 months.
Other Criteria
Initial Authorization:
• The drug is being used for an appropriate indication at an appropriate dose
per “Covered Uses.
• For ALL requests for treatment or prophylaxis of febrile neutropenia:
Documentation of the patient’s absolute neutrophil count (ANC) within the
last 30 day has been provided.
Revision/Review
Date: 7/2025
Requests for Non-Preferred Short-Acting G-CSFs:
• The member must have a documented treatment failure (e.g. failure to
reach and/or maintain target ANC, prolonged febrile neutropenia, or
infection requiring prolonged use) with the use of a preferred drug or has
another documented medical reason (intolerance, hypersensitivity, stem
cell collection, etc.) for not using preferred drug(s).
Requests for Non-Preferred Long-Acting G-CSFs:
• For Ziextenzo, Rolyedon, Stimufend, Fylnetra, Udenyca Onbody, or
Udenyca, requests: The member must have a documented treatment failure
(i.e. failure to reach and/or maintain target ANC, prolonged febrile
neutropenia or infection requiring prolonged anti-infection use) with an
adequate trial (including dates, doses of therapy) of both Fulphila AND
Nyvepria or has another documented medical reason (intolerance,
hypersensitivity, stem cell collection, etc.) for not using Fulphila AND
Nyvepria.
• For Neulasta or Neulasta Onpro requests: The member must have a
documented treatment failure (i.e. failure to reach and/or maintain target
ANC, prolonged febrile neutropenia or infection requiring prolonged anti-
infection use) with an adequate trial (including dates, doses of therapy) of
Fulphila AND Nyvepria AND either Ziextenzo, Stimufend, Udenyca
Onbody, or Udenyca or has another documented medical reason
(intolerance, hypersensitivity, stem cell collection, etc.) for not using these
therapies.
Requests for Other Hematopoietic Agents:
•
For Leukine requests: Documentation is submitted of the patient’s current
diagnosis, current body weight, body surface area (within 30 days of the
request).
•
For Plerixafor & Aphexda requests: Documentation must be submitted that
the patient is using the drug in combination with a granulocyte-colony
stimulating factor (G-CSF) agent. Requests for Aphexda must also have a
documented treatment failure (i.e. failure to reach and/or maintain target
ANC, prolonged febrile neutropenia or infection requiring prolonged anti-
infection use) with plerixafor
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Prior Authorization Group Description Xifaxan (rifaximin) Drugs Xifaxan (rifaximin) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines Exclusion Criteria N/A Required Medical Information See “other criteria” Age Restrictions Patient must be 18 years of age or older Prescriber Restrictions N/A Coverage Duration Hepatic Encephalopathy: If the criteria are met, for initial authorization, the request will be approved for 6 months. For re- authorization, the request will be approved for 12 months. Irritable Bowel Syndrome with diarrhea (IBS-D): If the criteria are met, the request will be approved for 14 days. For re-authorization, the request may be approved up to 2 more times for a 14 day duration. Other Criteria Revision/Review Date: 7/2025 Initial Authorization: Hepatic Encephalopathy • Patient has the diagnosis of hepatic encephalopathy • Patient will be using lactulose concurrently or has a medical reason for being unable to use lactulose Irritable Bowel Syndrome with diarrhea (IBS-D) • Patient has the diagnosis of moderate to severe IBS-D • Patient has tried and failed or has a contraindication or intolerance to one formulary tricyclic antidepressant Re-Authorization • Documentation indicating the member has clinically benefited from therapy. Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name Field Description Prior Authorization Group Description Xolremdi Drugs Xolremdi (mavorixafor) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions 12 years of age and older Prescriber Restrictions Prescriber must be an immunologist or a hematologist Coverage Duration If all of the criteria are met, the initial request will be approved for 6 months. For continuation of therapy, the request will be approved for 12 months. Other Criteria Date: 7/2025 Initial Authorization: • Diagnosis of WHIM (warts, hypogammaglobulinemia, infections and myelokathexis) syndrome confirmed by genotype variant of chemokine receptor 4 (CXCR4) and absolute neutrophil count (ANC) of ≤ 400 cells/µL • Documentation of baseline ANC and absolute lymphocyte count (ALC) • Documentation of member weight • Medication is prescribed at an FDA approved dose Re-Authorization: • Documentation or provider attestation of positive clinical response (i.e. improvement from baseline in ANC and/or ALC) • Documentation of member weight • Medication is prescribed at an FDA approved dose If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name Field Description Prior Authorization Group Description
Xolair for Asthma, Urticaria, and IgE-Mediated Food Allergy Drugs Preferred: Xolair (omalizumab)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex, the
Drug Package Insert, and/or per the standard of care guidelines
Exclusion Criteria
•
Use of Xolair concomitantly with another pulmonary biologic (e.g.
Fasenra, Nucala, Cinqair, Dupixent, Tezspire)
•
Use of Xolair concomitantly with Palforzia
•
Use of Xolair for emergency treatment of allergic reactions,
including anaphylaxis
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescribed by, or in consultation with, an allergist/immunologist,
pulmonologist, or dermatologist
Coverage Duration
If all of the conditions are met, the initial and reauthorization request
will be approved for up to a 6 month duration for renewal requests.
Other Criteria
For nasal polyposis, please refer to the “Biologic Agents for Nasal Polyposis” policy
Initial Authorization:
Asthma: • Member has at least a 6 month history of moderate to severe asthma • The drug is being prescribed at an approved dose according to member’s weight and IgE level • Member is taking maximally tolerated ICS/LABA combination in addition to a LAMA (e.g. tiotropium) for at least 3 months, or there is a documented medical reason why the member is unable to take these medications • Member’s asthma is uncontrolled as defined by having one of the following: o Frequent severe exacerbations requiring two or more bursts of systemic glucocorticoids (more than three days each) in the previous year o History of serious exacerbation: at least one hospitalization, intensive care unit stay, or mechanical ventilation in the previous year o Airflow limitation defined as a forced expiratory volume in 1 second (FEV1) less than 80% of predicted o Poor symptom control including at least THREE of the
Review/Revision
Date: 4/2025
following:
Asthma Control Questionnaire (ACQ)
consistently > 1.5 or Asthma Control Test (ACT)
< 20
Daytime asthma symptoms more than twice per
week
Use of an inhaled short acting B-2 agonist to
relieve asthma symptoms more than twice per
week (not including use prior to exercise)
Limited physical activity due to asthma
symptoms
Nighttime awakening due to asthma symptoms
• Member has a positive immediate response on RAST test and/or
skin prick test to at least 1 common allergen (e.g.
dermatophagoides farinae, dermatop hagoides pteronyssinus,
dog, cat, or cockroach) that is an asthma trigger (copy of results
required).
• Pre-treatment serum IgE levels must be greater than or equal to
30 IU/mL
Chronic Idiopathic Urticaria:
• The drug is prescribed at an approved dose
• Member has at least a 6 week history of urticaria
• Member requires oral corticosteroids to control symptoms
• The patient remains symptomatic despite a minimum two week
trial (or has medical reason for not utilizing) of two preferred
second generation H1 antihistamines at the maximum tolerated
dose
IgE-Mediated Food Allergy:
• Diagnosis of IgE-mediated food allergy with documented allergy
to one or more of the following foods:
o Peanut, milk, egg, wheat, cashew, hazelnut, or walnut
• Attestation Xolair will be used in conjunction with food allergen
avoidance
• The drug is being prescribed at an FDA approved dose according
to the member’s weight and IgE level
Re-Authorization:
• The drug is being prescribed at an approved dose • The member has experienced a clinical benefit from medication (e.g. decrease exacerbations, reduction in use of oral steroids,
decrease in skin manifestations or severe itching, improvement in pulmonary function tests, etc.)
If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name
Field Description
Prior Authorization
Group Description
Zevaskyn
Drugs
Zevaskyn (prademagene zamikeracel)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
Receipt of any prior chemical or biologic product for the treatment of
recessive dystrophic epidermolysis bullosa (RDEB), including Vyjuvek
and Filsuvez
Required Medical
Information
See “Other Criteria”
Age Restrictions
Per prescribing information
Prescriber
Restrictions
Prescriber must be a specialist experienced in the treatment of
epidermolysis bullosa.
Coverage Duration
If all of the criteria are met, the request will be approved for one
treatment cycle only.
Other Criteria
Revision/Review Date: 10/2025 Initial Authorization: • Patient has a diagnosis of RDEB with genetic testing confirming mutations in both COL7A1 genes • Presence of RDEB wounds with ALL of the following characteristics: o Open chronically for ≥6 months o Categorized as Stage 2 (partial-thickness) o Have an area of > 20 cm2 • Documentation is provided that there is no evidence of, or history of squamous cell carcinoma in the wound(s) to be treated • Medication is prescribed at an FDA approved dose
The safety and effectiveness of repeat administration of Zevaskyn to the same treatment site have not been evaluated and will not be approved.
If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name
Field Description
Prior
Authorization
Group Description
Zolgensma (onasemnogene abeparvovec-xioi)
Drugs
Zolgensma (onasemnogene abeparvovec-xioi)
Covered Uses
Medically accepted indications are defined using the following sources:
the Food and Drug Administration (FDA), Micromedex, American
Hospital Formulary Service (AHFS), United States Pharmacopeia Drug
Information for the Healthcare Professional (USP DI), the Drug Package
Insert (PPI), or disease state specific standard of care guidelines.
Exclusion Criteria
• Patient has previously received this medication
• Advanced spinal muscular atrophy (SMA) (e.g., complete paralysis
of limbs, permanent ventilator-dependence)
• Administration to premature neonates before reaching full-term
gestational age
Required Medical
Information
Patient’s body weight
Age Restrictions
Patient must be less than 2 years of age
Prescriber
Restrictions
Neurologist
Coverage Duration Authorization will be placed for 1 dose.
Other Criteria
Revision/Review
Date 1/2026
Patient must meet all of the following criteria:
• Diagnosis of Spinal Muscular Atrophy (SMA)
• Bi-allelic mutations in the survival motor neuron 1 (SMN1),
regardless of the number of SMN2 copies present
• Baseline anti-AAV9 antibody titers of ≤1:50 measured using an
enzyme-linked immunosorbent assay (ELISA)
• Dosing is consistent with FDA approved labeling
The safety and effectiveness of repeat administration of Zolgensma have not been evaluated and will not be approved.
Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Zoryve Foam
Drugs
Zoryve (roflumilast) topical foam
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
N/A
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescribed by or in consultation with a dermatologist
Coverage Duration
If the criteria are met, the request will be approved for up to 12 months.
Other Criteria
Review/Revision
Date:
1/2026
Initial Authorization:
For the diagnosis of seborrheic dermatitis:
• Diagnosis of seborrheic dermatitis
• Documented trial and failure of or intolerance to at least two of
the following therapies:
o Topical antifungals (i.e., ketoconazole, ciclopirox)
o Topical corticosteroids (i.e., betamethasone valerate,
clobetasol propionate, fluocinolone)
For the diagnosis of plaque psoriasis:
• Diagnosis of plaque psoriasis
• Documented trial and failure (minimum duration of 4 weeks) of
or intolerance to a topical steroid (e.g. betamethasone,
clobetasol, fluocinonide, desonide) OR
• Documented trial and failure of or intolerance to the use of a
topical corticosteroid in combination with one of the following
topical agents:
o Vitamin D analogs (e.g. calcitriol, calcipotriene)
o Tazarotene
o Calcineurin inhibitors (e.g. tacrolimus, pimecrolimus)
Re-Authorization:
• Documented positive clinical response to treatment (i.e.,
improvement in symptoms)
If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Field Name Field Description Prior Authorization Group Description Agents for the Treatment of Postpartum Depression Drugs Zurzuvae (zuranolone) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions According to package insert Prescriber Restrictions Prescriber must be a psychiatrist or an obstetrician-gynecologist. Coverage Duration If all of the criteria are met, the initial request will be approved for a 14- day course of Zurzuvae per postpartum period. Reauthorization will not be permitted. Other Criteria Revision/Review Date: 2/2026 Initial Authorization: • Prescriber attestation of severe postpartum depression (PPD) diagnosis and submission of validated screening tool result(s) (e.g. Edinburgh Postnatal Depression Scale, Hamilton Depression Rating Scale) that requires quick onset where the patient cannot wait 4-6 weeks for the standard of care antidepressants to take effect • Patient is ≤ 6 months postpartum with a major depressive episode without psychosis that began no earlier than the third trimester and no later than the first 4 weeks after delivery • Attestation that the provider warned the patient not to drive for at least 12 hours after each dose. • Medication is prescribed at an FDA approved dose Renewal Authorization: • Renewals will not be authorized Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
Field Name
Field Description
Prior Authorization
Group Description
Gene Therapy for Regular Red Blood Cell (RBC) Transfusion
Dependent Beta-Thalassemia
Drugs
Casgevy (exagamglogene autotemcel), Zynteglo (betibeglogene
autotemcel)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
Repeat use of same gene therapy agent
Trial of a different gene therapy agent after another has been used
Required Medical
Information
See “Other Criteria”
Age Restrictions
Per FDA approved prescribing information
Prescriber Restrictions Prescriber must be a hematologist
Coverage Duration
If all the criteria are met, the initial request will be approved for a
one-time treatment for one gene therapy agent.
Other Criteria
Revision/Review
Date: 2/2026
Initial Authorization:
•
Medication is prescribed at an FDA approved dose
•
Member has a diagnosis of transfusion dependent beta-
thalassemia
•
Member requires regular RBC transfusions defined as ONE of
the following:
o
History of ≥100 mL/kg/year of packed red blood cell
(pRBCs) in the past 2 years
o
History of ≥8 transfusions of pRBCs per year in the past 2
years
•
Patient has not had a prior HSCT or gene therapy treatment
•
If the request is for Zynteglo, a medical reason must be submitted
why the patient is unable to use Casgevy
•
Negative pregnancy test (if applicable)
The safety and effectiveness of repeat administration of Casgevy
or Zynteglo have not been evaluated and will not be approved.
Field Name
Field Description
Prior Authorization
Group Description
Gene Therapy for Sickle Cell Disease
Drugs
Casgevy (exagamglogene autotemcel), Lyfgenia (lovotibeglogene
autotemcel)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
Repeat use of same gene therapy agent
Trial of a different gene therapy agent after another has been used
Required Medical
Information
See “Other Criteria”
Age Restrictions
Per FDA approved prescribing information
Prescriber
Restrictions
Prescriber must be a hematologist in the treatment of sickle cell
disease
Coverage Duration
If all the criteria are met, the initial request will be approved for a one-
time treatment for one gene therapy agent. If the conditions are not
met, the request will be sent to a Medical Director/clinical reviewer
for medical necessity review.
Other Criteria
Review
Date: 2/2026
Initial Authorization:
•
Medication is prescribed at an FDA approved dose
•
Member has a diagnosis of sickle cell disease confirmed via
genetic testing
•
Member has received chronic transfusion therapy for prevention of
vaso-occlusive crises/events OR has experienced at least 4 vaso-
occlusive crises/events in the past 2 years
•
Documentation was provided that the member has been taking
hydroxyurea (or a medical reason was provided why the patient is
unable to use hydroxyurea)
•
Prescriber attestation that the member is clinically stable and
eligible to under HSCT
The safety and effectiveness of repeat administration of Casgevy
or Lyfgenia have not been evaluated and will not be approved.
Field Name Field Description Prior Authorization Group Description Tryngolza (olezarsen) Drugs Tryngolza (olezarsen) injection, for subcutaneous use Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria N/A Required Medical Information See “Other Criteria” Age Restrictions Member must be 18 years of age or older Prescriber Restrictions Prescriber must be an endocrinologist, lipidologist, or cardiologist experienced in, or in consultation with a specialist experienced in, familial chylomicronemia syndrome (FCS). Coverage Duration If all of the criteria are met, the initial request will be approved for 6 months. For continuation of therapy, the request will be approved for 12 months. Other Criteria
Date: 4/2025
Initial Authorization:
• Medication is prescribed at an FDA approved dose
• The member has undergone genetic testing to confirm a diagnosis of FCS
with ONE of the following results:
o The member has a pathogenic gene mutation in FCS-causing genes
(e.g., LPL, GPIHBP1, APOA5, APOC2, or LMF1)
o The member has inconclusive genetic results and has documentation
supporting the diagnosis of FCS by ONE of the following:
North America Familial Chylomicronemia Syndrome
(NAFCS) score ≥ 45
FCS score ≥ 10
History of acute pancreatitis
History of recurrent abdominal pain without other known
causes
• The member’s most recent triglyceride level is ≥880 mg/dL (10 mmol/L)
• The prescriber attests the member will follow a low-fat diet
Re-Authorization:
• Medication is prescribed at an FDA approved dose
• Documentation of a positive clinical benefit (e.g., reduction in fasting
triglyceride level from baseline, fewer acute pancreatitis events)
•
The prescriber attests the member will continue to follow a low-fat diet
If all of the above criteria are not met, the request is referred to a Medical
Director/Clinical Reviewer for medical necessity review.
Field Name
Field Description
Prior Authorization
Group Description
Tzield (teplizumab-mzwv)
Drugs
Tzield (teplizumab-mzwv)
Covered Uses
Medically accepted indications are defined using the following
sources: the Food and Drug Administration (FDA), Micromedex,
American Hospital Formulary Service (AHFS), United States
Pharmacopeia Drug Information for the Healthcare Professional
(USP DI), the Drug Package Insert (PPI), or disease state specific
standard of care guidelines.
Exclusion Criteria
Type 2 diabetes (T2D)
Required Medical
Information
See “Other Criteria”
Age Restrictions
According to package insert
Prescriber
Restrictions
Prescribed by or in consultation with an endocrinologist
Coverage Duration
If all the criteria are met, the initial request will be approved for a one-
time treatment.
Other Criteria
Review/
Revision Date:
2/2026
Initial Authorization:
•
Medication is prescribed at an FDA approved dose
•
Diagnosis of stage 2 type 1 diabetes (T1D) confirmed by presence
of at least two of the following autoantibodies:
o
Glutamic acid decarboxylase 65 (GAD) autoantibody
o
Insulin autoantibody (IAA)
o
Insulinoma-associated antigen 2 autoantibody (IA-2A)
o
Zinc transporter 8 autoantibody (ZnT8A)
o
Islet cell autoantibody (ICA)
•
Abnormal glucose on an oral glucose-tolerance test (or alternative
glycemic test if an oral glucose-tolerance test is not available)
If all of the above criteria are not met, the request is referred to a
Medical Director/Clinical Reviewer for medical necessity review.
Field Name Field Description Prior Authorization Group Description Yorvipath Drugs Yorvipath (palopegteriparatide) Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines. Exclusion Criteria Members with acute postsurgical hypoparathyroidism (HP) or those who are at increased risk for osteosarcoma Required Medical Information See “Other Criteria” Age Restrictions Member must be 18 years of age or older Prescriber Restrictions Prescriber must be an endocrinologist or in consultation with an endocrinologist. Coverage Duration If all of the criteria are met, the initial request will be approved for 6 months. For continuation of therapy, the request will be approved for 12 months. Other Criteria Date: 2/2026 Initial Authorization: • Confirmed diagnosis of chronic HP of postsurgical, autoimmune, genetic, or idiopathic origins, for at least 6 months • Provider attestation that patient is currently receiving conventional therapy, including active vitamin D (calcitriol) and elemental calcium, and that patient’s disease cannot be adequately controlled on conventional therapy alone • Current labs (within 60 days of request) have been submitted for the following: o Albumin-corrected serum calcium (must be > 7.8mg/dL to start therapy) o Serum vitamin D level (must be > 20 ng/mL to start therapy) • Medication is prescribed at an FDA approved dose Re-Authorization: • Documentation of a recent albumin-corrected serum calcium in the lower-half of the normal reference range or just below the normal reference range (~8–9 mg/dL) • ONE of the following: o Patient no longer requires active vitamin D or therapeutic doses of calcium, OR o Patient has had a significant reduction in required dosages of active vitamin D or therapeutic doses of calcium and is still actively titrating doses of Yorvipath • Medication is prescribed at an FDA approved dose If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.
Walk through this policy with us
Review how this policy can be converted into cited criteria, prior authorization checks, and operational automation.