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Pharmacy Medical Policy Drug Management & Retail Pharmacy Prior Authorization Policy Table of Contents
• Policy: Commercial • Policy History • Endnotes
• Policy: Medicare • Information Pertaining to All Policies • Forms • Coding Information • References

Policy Number: 049 BCBSA Reference Number: None Related Policies • Quality Care Dosing guidelines apply to the following medications and can be found in Medical Policy,

621A

Prior Authorization Information

Policy ☒ Prior Authorization ☐ Step Therapy ☒ Quality Care Dosing ☐ Administrative Reviewing Department Pharmacy Operations: Tel: 1-800-366-7778 Fax: 1-800-583-6289 To request for coverage: Providers may call, fax, or mail the attached form (Formulary Exception/Prior Authorization form) to the address below.
Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Tel: 1-800-366-7778 Fax: 1-800-583-6289

Individual Consideration for the atypical patient: Policy for requests that do not meet clinical criteria of this policy, see section labeled Individual Consideration
Policy Last Updated 5/2026 Pharmacy (Rx) or Medical (MED) benefit coverage ☒ Rx ☐ MED Policy applies to Commercial members with BCBSMA formulary:
• Managed Care (HMO/POS) • PPO/EPO
• Indemnity
• MEDEX with Rx plans • Managed Blue for Seniors Policy does NOT apply to: • Medicare Advantage
Provider Documentation Requirements: Documentation from the provider to support a reason preventing trial of formulary alternative(s) must include the name and strength of alternatives tried and failed (if alternatives were

2 tried, including dates if available) and specifics regarding the treatment failure. Documentation to support clinical basis preventing switch to formulary alternative should also provide specifics around clinical reason. We may also use prescription claims records to establish prior use of formulary alternatives or to show if step therapy criteria has been met. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of preferred formulary medications or that step therapy criteria has been met. Other documentation requirements, if any, are outlined in prior authorization criteria.

Please refer to the chart below for the formulary and step status of the medications affected by this policy.

Standard Formulary

Drug

Formulary Status Aqneursa (levacetylleucine) PA Required Arikayce (amikacin) PA Required bexarotene gel PA Required Brinsupri (brensocatib)
PA Required Bylvay (odevixibat) PA Required Daybue (trofinetide) PA Required Dojolvi (triheptanoin) PA Required Duvyzat (givinostat) PA Required Eohilia (budesonide)

PA Required Filspari (sparsentan)

PA Required Firdapse (amifampridine)

PA Required Gattex (teduglutide)
PA Required Iqirvo (elafibranor)

PA Required Isturisa (osilodrostat) PA Required Joenja (leniolisib) PA Required Livdelzi (seladelpar) PA Required Livmarli (maralixibat) PA Required Miplyffa (arimoclomol) PA Required Oxervate (cenegermin) PA Required Pyrukynd (mitapivat) PA Required Recorlev (levoketoconazole) PA Required Rezdiffra (resmetirom) PA Required Sephience (sepiapterin)
PA Required Skyclarys (omaveloxolone) PA Required Sohonos (palovarotene) PA Required Targretin Gel (bexarotene) PA Required

3 Tarpeyo (budesonide) PA Required Tavneos (avacopan) PA Required Vanrafia (atrasentan)
PA Required Viberzi (eluxadoline) PA Required Vijoice (alpelisib) PA Required Vivjoa (oteseconazole) PA Required Voxzogo (vosoritide) PA Required Vykat XR (diazoxide choline) PA Required Xifaxan (rifaximin) PA Required Xolremdi (mavorixafor) PA Required Zelsuvmi (berdazimer) PA Required Zokinvy (lonafarnib)
PA Required Prior Authorization Criteria
Aqneursa We may cover Aqneursa (Levacetylleucine) for the treatment of Niemann-Pick disease type C (NPC) when ALL of the following criteria are met: • Patient weights at least 33 pounds or 15 kg, AND • Patient is not using Miplyffa (arimoclomol) in combination with Aqneursa, AND • Diagnosis of NPC1 or NPC2, confirmed by genetic testing demonstrating one of the following: o Mutations in both alleles of NPC1 or NPC2 OR o Mutation in one allele AND either a positive filipin-staining or elevated cholestane triol/oxysterols (>2× ULN) Arikace We may cover Arikayce (amikacin suspension) for the treatment of adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease when ALL of the following criteria are met: • Diagnosis of Mycobacterium avium complex (MAC) lung disease, AND • Minimum of 6 consecutive months of a multidrug background regimen therapy, AND • The drug is prescribed by a board-certified or board eligible Pulmonologist, or an Infectious Disease Specialist
Bexarotene gel Bexarotene gel—See Targretin (bexarotene)

4 Brinsupri We may cover Brinsupri (brensocatib) for the treatment of patients for the treatment of non-cystic fibrosis bronchiectasis when ALL of the following criteria are met:

Initial Approval

• Documented diagnosis of bronchiectasis confirmed by a chest computed tomography (CT) scan
AND • The patient does not have bronchiectasis due to cystic fibrosis (CF) AND • Age 12 years or older AND • Prescribed by a board-certified or board eligible Pulmonologist AND • The patient is currently a non-smoker and has not smoked in the last 12 weeks AND • Patient has had ONE of the following: o For adults: At least two pulmonary exacerbations in the past 12 months requiring an antibiotic prescription, emergency room visit, or hospitalization, OR o For patients 12-17 years of age: At least one pulmonary exacerbation in the past 12 months requiring an antibiotic prescription, emergency room visit, or hospitalization

Continuation of Therapy

• The patient has had improvement in the frequency, severity, or duration of pulmonary exacerbations.
Bylvay We may cover Bylvay (odevixibat) for the treatment of pruritus when ALL of the following criteria are met: • Age is greater than or equal to three (3) months, AND
• Confirmed diagnosis of progressive familial intrahepatic cholestasis (PFIC) with molecular genetic testing, AND • Molecular genetic testing does not indicate PFIC type 2 with ABCB11 variants encoding for nonfunction or absence of BSEP-3, AND • Presence of moderate to severe pruritis, AND • Drug-induced pruritus has been ruled out, AND • No history of liver transplant, AND • No history of biliary diversion surgery within the past 6 months, AND • No clinical evidence of decompensated cirrhosis
OR • Age is greater than or equal to twelve (12) months, AND
• Confirmed diagnosis of Alagille syndrome (ALGS), AND • For the treatment of cholestatic pruritus Daybue We may cover Daybue (trofinetide) for the treatment of Rett syndrome when ALL of the following criteria are met:

5 • diagnosis of Rett syndrome (mutations in MECP2 are not universal), AND • Age is equal to or greater than 2 years

Note: If approved the Prior Authorization will be granted for up to one (1) year. Dojolvi We may cover Dojolvi (triheptanoin) for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD) when ALL of the following criteria are met: • molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD), AND • The drug is prescribed by a board-certified or board eligible Endocrinologist, or a board-certified or board eligible Geneticist, AND • Frequent severe major medical episodes of hypoglycemia, rhabdomyolysis, or exacerbation of cardiomyopathy requiring emergency room visits, acute care visits, or hospitalizations OR Severe susceptibility to hypoglycemia or recurrent symptomatic hypoglycemia requiring intervention
Duvyzat We may cover Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy (DMD) when ALL of the following criteria are met: • Age is equal to or greater than 6 years, AND • Genetically confirmed diagnosis of Duchenne muscular dystrophy (DMD), AND • Patient is ambulatory upon initiation of therapy, AND • Patient is stable on baseline corticosteroids for 6 months, AND • The drug is prescribed by a board-certified or board eligible specialist (e.g. neurologist) with experience in the treatment of DMD
Eohilia We may cover Eohilia (budesonide) for eosinophilic esophagitis (EoE) when ALL of the following criteria are met: • Age is equal to or greater than 11 years, AND • Documentation of Diagnosis of eosinophilic esophagitis (EoE), AND • Four (4) or more episodes of dysphagia in a two (2) week period. Filspari We may cover Filspari (sparsentan) for the treatment of Primary Immunoglobulin A nephropathy (IgAN) when ALL of the following criteria are met: • Age is equal to or greater than 18 years, AND • Diagnosis of biopsy verified Primary Immunoglobulin A nephropathy (IgAN). Firdapse We may cover Firdapse (amifampridine) for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) when ALL of the following criteria are met: • Diagnosis of Lambert-Eaton myasthenic syndrome (LEMS), AND • Age is equal to or greater than 6 years

Note: If approved the Prior Authorization will be granted for up to one (1) year.

6 Gattex We may cover Gattex (teduglutide) for the treatment of Short Bowel Syndrome when ALL of the following criteria are met: Initial Criteria

1. Confirmed diagnosis of Short Bowel Syndrome (SBS)
   AND

2. Age ≥ 1 year old AND

3. Currently receiving specialized nutritional support such as dietary adjustments, enteral feedings, parenteral nutrition, or micronutrient supplementation

   Continuation Criteria

4. Patient has achieved or maintained a positive clinical response to therapy, as observed by any ONE of the following: a. At least a 20% reduction in parenteral support (PS) calories from baseline b. At least a 20% reduction in parenteral support (PS) volume from baseline c. If a 20% decrease in parenteral support calories or volume cannot be achieved, an improvement in hydration status that has positive end-organ impact, resulting in improved quality of life Iqirvo We may cover Iqirvo (elafibranor) for primary biliary cholangitis (PBC) when ALL of the following criteria are met:

   • Age is equal to or greater than 18 years, AND • Diagnosis of PBC confirmed by two (2) of the following: o Biochemical evidence of cholestasis based on alkaline phosphatase (ALP) elevation (as defined by the performing laboratory’s reference values)
   o Presence of antimitochondrial antibody (AMA), or other PBC-specific autoantibodies, including sp100 or gp210, if AMA is negative
   o Histologic evidence of PBC seen on biopsy
   AND • Inadequate response for at least 12 months to ursodeoxycholic acid (UDCA) [recommended dose is 13–15 mg/kg/day] or intolerance to UDCA, AND • Member does not have decompensated cirrhosis, AND • The drug is prescribed by a board-certified or board eligible gastroenterologist, AND • Not used in combination with Ocaliva ® (obeticholic acid) or Livdelzi ® (seladelpar)

   Isturisa We may cover Isturisa (osilodrostat) for the treatment of adults for the treatment of Cushing’s Disease when ALL of the following criteria are met: • Age is equal to or greater than 18 years, AND • Confirmed documented diagnosis of Cushing’s disease (NOT Cushing’s Syndrome), AND
   • The drug is prescribed by a board-certified or board eligible endocrinologist, AND
   • Documentation of failed pituitary surgery or contraindication to pituitary surgery, AND
   • Prescriber attests to the monitoring of Cortisol levels during titration and maintenance phase to ensure appropriate dose and adequate clinical response, AND • This medication is not FDA approved for the treatment of Cushing’s Syndrome.

7 Joenja We may cover Joenja (leniolisib) for activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) when ALL of the following criteria are met: • Age is equal to or greater than 12 years, AND • Documented APDS/PASLI-associated PIK3CD/PIK3R1 mutation without concurrent use of immunosuppressive medication Livdelzi We may cover Livdelzi (seladelpar) for primary biliary cholangitis (PBC) when ALL of the following criteria are met: • Age is equal to or greater than 18 years, AND • Diagnosis of PBC confirmed by two (2) of the following: o Biochemical evidence of cholestasis based on alkaline phosphatase (ALP) elevation (as defined by the performing laboratory’s reference values)
o Presence of antimitochondrial antibody (AMA), or other PBC-specific autoantibodies, including sp100 or gp210, if AMA is negative
o Histologic evidence of PBC seen on biopsy
AND • Inadequate response for at least 12 months to ursodeoxycholic acid (UDCA) [recommended dose is 13–15 mg/kg/day] or intolerance to UDCA, AND • Member does not have decompensated cirrhosis, AND • The drug is prescribed by a board-certified or board eligible gastroenterologist, AND • Not used in combination with Ocaliva ® (obeticholic acid) or Iqirvo ® (elafibranor)

Livmarli We may cover Livmarli (maralixibat) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) when ALL of the following criteria are met: • Age is equal to or greater than 3 months of age, AND • Confirmed documented diagnosis of Alagille Syndrome (ALGS), AND
• Presence of moderate to severe pruritis, AND • Does not have chronic diarrhea requiring ongoing intravenous fluid or nutritional intervention, AND • No history of liver transplant, AND • No history of surgical interruption of enterohepatic circulation (for example, partial external biliary diversion [PEBD] surgery), AND • No clinical evidence of decompensated cirrhosis
OR • Age is equal to or greater than 12 months of age, AND • Confirmed documented diagnosis of progressive familial intrahepatic cholestasis (PFIC), AND • Does not have PFIC type 2 with specific ABCB11 variants. Miplyffa We may cover Miplyffa (arimoclomol) for the treatment of Niemann-Pick disease type C (NPC) when ALL of the following criteria are met: • Patient is at least 2 years of age, AND • Patient is not using Aqneursa (Levacetylleucine) in combination with Miplyffa, AND • Diagnosis of NPC1 or NPC2, confirmed by genetic testing demonstrating one of the following:

8 o Mutations in both alleles of NPC1 or NPC2 OR o Mutation in one allele AND either a positive filipin-staining or elevated cholestane triol/oxysterols (>2× ULN) Oxervate We may cover Oxervate (cenegermin) eye drops for the treatment of adults with neurotrophic keratitis when ALL of the following criteria are met: • Diagnosis of neurotrophic keratitis, AND • The approval is given for Eight (8) weeks of treatment Note: If approved the Prior Authorization will be limited to one (1) course of an 8-week treatment per the FDA label. Pyrukynd We may cover Pyrukynd (mitapivat) for the treatment of adults with pyruvate kinase (PK) deficiency when ALL of the following criteria are met: • Diagnosis of pyruvate kinase (PK) deficiency, AND • Patient has at least two mutant alleles in the PKLR gene, of which at least one is a missense mutation. Recorlev We may cover Recorlev (levoketoconazole) when ALL of the following criteria must be met: • The patient has hypercortisolemia and confirmed Cushing’s syndrome, AND • The patient is  18 years old, AND • The patient has had surgery, and it was not curative or surgery is contraindicated, AND • Documentation of baseline urinary free cortisol, AND • Documentation of baseline live enzyme function tests Rezdiffra We may cover Rezdiffra (resmetirom) when ALL of the following criteria must be met: Initial Approval

1. The patient has a diagnosis of metabolic dysfunction-associated steatohepatitis (MASH), previously known as noncirrhotic nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis consistent with stages F2 and F3 fibrosis and is confirmed by ONE of the following non-invasive tests (NIT):
   a) vibration-controlled transient elastography [VCTE],
   b) magnetic resonance elastography [MRE] or by historical liver biopsy AND
2. The patient is ≥ 18 years old. AND
3. Physician attestation or documentation that the member is actively engaged in a comprehensive lifestyle modification plan that includes a reduced calorie diet, increased physical activity, and behavioral modifications prior to initiation of therapy. Continuation of therapy We may renew the coverage of Rezdiffra for the treatment of MASH if ALL the following criteria are met:

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1. The patient has achieved or maintained a positive clinical response to therapy, such as MASH resolution with no worsening of liver fibrosis or improvement in liver fibrosis. AND

2. Physician attestation or documentation that the member is actively engaged in a comprehensive lifestyle modification plan that includes a reduced calorie diet, increased physical activity, and behavioral modifications prior to initiation of therapy. Sephience (sepiapterin) We may cover Sephience (sepiapterin) for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU) when ALL of the following criteria must be met: Initial Approval

   • Documented diagnosis of phenylketonuria (PKU) AND • The patient is  1 month old AND • Drug will be used in conjunction with a Phe-restricted diet AND • Sephience will not be used in conjunction with another PKU drug (e.g. generic sapropterin, Kuvan, Palynziq) AND • Patient has tried and failed at least ONE of the following: o A sapropterin product (e.g. generic sapropterin tablet/packet, Javygtor, Zelvysia) in conjunction with a Phe-restricted diet o Palynziq Continuation of Therapy • Patient has achieved or maintained a 30% decrease in phenylalanine levels from baseline AND • Sephience will be used in conjunction with a Phe-restricted diet Skyclarys We may cover Skyclarys (omaveloxolone) for the treatment of Friedreich's ataxia when ALL of the following criteria must be met: • The patient has a genetically confirmed diagnosis of Friedreich's Ataxia, AND • The patient is  16 years old, AND • The drug is prescribed by a board-certified or board eligible Neurologist.

   Length of Approval: If approved, a prior authorization will be granted for SIX (6) months. Length of Approval: If approved, a prior authorization will be granted for TWELVE (12) months.

10 Sohonos We may cover Sohonos (palovarotene) for the treatment of Fibrodysplasia Ossificans Progressiva (FOP) when ALL of the following criteria must be met: • The patient has a genetically (ACVR1) confirmed diagnosis of Fibrodysplasia Ossificans Progressiva (aka Myositis Ossificans Progressiva or Stoneman disease), AND • The patient is born male  10 years old OR born female  8 years old, AND • The drug is prescribed by a specialist in rare connective tissue diseases.

Targretin We may cover Targretin (bexarotene) OR Bexarotene Gel for the topical treatment of cutaneous lesions in patients with cutaneous T-cell lymphoma (CTCL) when ALL of the following criteria are met: • Diagnosis of refractory or persistent cutaneous T-cell lymphoma (CTCL), AND • The Member has Stage IA or IB, AND • Document previous other therapies or a clinical rational for not using other therapies. Tarpeyo We may cover Tarpeyo (budesonide) to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) when ALL of the following criteria are met: • Age is equal to or greater than 18 years, AND • Diagnosis of primary immunoglobulin A nephropathy (IgAN), AND • Document urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g
Tavneos We may cover Tavneos (avacopan) for adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) when ALL of the following criteria are met: • Age is equal to or greater than 18 years, AND • Diagnosis of granulomatosis with polyangiitis [GPA] or microscopic polyangiitis [MPA], AND • Used with glucocorticoids as part of standard therapy
Note: If approved the Prior Authorization will be granted for up to one (1) year.

Vanrafia We may cover Vanrafia (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) when all of the following criteria are met: • Age is equal to or greater than 18 years, AND • Diagnosis of primary immunoglobulin A nephropathy (IgAN), AND • Document urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g
Viberzi We may cover Viberzi (eluxadoline) for the treatment of irritable bowel syndrome with diarrhea (IBS-D) when all of the following criteria are met: • Age is equal to or greater than 18 years, AND • Diagnosis of irritable bowel syndrome with diarrhea (IBS-D).

11 Vijoice We may cover Vijoice (avacopan) for patients with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) when ALL of the following criteria are met:
• Age is equal to or greater than two (2) years, AND • Diagnosis of PIK3CA-Related Overgrowth Spectrum (PROS), AND • Patient requires systemic therapy. Vivjoa We may cover Vivjoa (oteseconazole) for patients with recurrent vulvovaginal candidiasis (RVVC) with a history of RVVC which are NOT of reproductive potential when all of the following criteria are met: • Age is equal to or greater than 12 years, AND • Diagnosis of recurrent vulvovaginal candidiasis (RVVC), AND
• Patient has a history of RVVC (≥3 acute VVC episodes within 12 months), AND • Patient is not of reproductive potential (i.e., history of tubal ligation, salpingo-oophorectomy, hysterectomy, or postmenopausal)
Note: If approved the Prior Authorization will be granted for up to one (1) year. Voxzogo We may cover Voxzogo (vosoritide) for adults and pediatric patients with achondroplasia when ALL of the following criteria are met: • Age is greater than or equal to 4 months of age, AND • Diagnosis of achondroplasia, AND • Confirmed open epiphyses. Vykat XR We may cover Vykat XR (diazoxide choline) to treat hyperphagia in adults and pediatric patients with Prader-Willi Syndrome when ALL of the following criteria are met: • Age is greater than or equal to 4 years of age, AND • Documented diagnosis of Prader-Willi Syndrome, AND • Patient is being treated for moderate to severe hyperphagia, AND • Physician attestation or documentation that the member will be using medication as an adjunct to a comprehensive weight management plan including a reduced-calorie diet, increased physical activity and behavioral modifications Xdemvy We may cover Xdemvy (lotilaner) for the treatment of Demodex blepharitis when ALL of the following criteria are met: • Confirmed diagnosis of Demodex blepharitis, AND • The drug is prescribed by a board-certified or board eligible optometrist or ophthalmologist or an Infectious Disease Specialist
Xifaxan We may cover Xifaxan (rifaximin) when the patient has met ALL of the below criteria: • Patient has a confirmed Diagnosis of travelers’ diarrhea (TD) caused by noninvasive strains of

Escherichia Coli, AND

12 • Age is equal to or greater than 12 years.

  OR

• Patient has a confirmed diagnosis of irritable bowel syndrome with Diarrhea (IBS-D) or Small Intestinal Bacterial Overgrowth (SIBO), AND • Age is equal to or greater than 18 years.

  OR

• Patient is trying to reduce the risk of overt hepatic encephalopathy (HE) recurrence, AND • Age is equal to or greater than 18 years.

Note: If approved the Prior Authorization will be granted for up to one (1) year. Xolremdi We may cover Xolremdi (mavorixafor) for pediatric patients with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) when ALL of the following criteria are met: • Age is equal to or greater than 12 years of age, AND • Confirmed diagnosis of WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis), AND • Documentation of baseline absolute neutrophil count (ANC) and absolute lymphocyte count (ALC) unless this is a reauthorization where the documentation would be current.

Zelsuvmi (berdazimer) We may cover Zelsuvmi (berdazimer) for patients with molluscum contagiosum when ALL of the following criteria are met: • Age is ≥ 1 years old, AND • Confirmed diagnosis of molluscum contagiosum, AND • Prescribed by or in consultation with a dermatologist, AND • Member is experiencing itching or pain, has a concomitant bacterial infection, or has concomitant AD, or there is concern for contagion (e.g. other siblings, daycare) and lesions cannot be reasonably covered using a bandage.
Zokinvy We may cover Zokinvy (lonafarnib) when the patient has met ALL of the below criteria: • Confirmed diagnosis of one (1) of the following: o Hutchinson-Gilford progeria syndrome (HGPS) o Heterozygous LMNA mutation with progerin-like protein accumulation o Homozygous or compound heterozygous ZMPSTE24 mutations AND • Patient has a BSA of at least 0.39 m2, AND • Age is equal to or greater than 12 months of age, AND • Requested dose is appropriate for patient’s BSA.

Note: If approved the Prior Authorization will be granted for up to one (1) year.

We do not cover the medications listed above for other conditions not listed above. Appendix Formulary Status For non-covered medications, in addition to the prior authorization criteria, the member must also have had a previous treatment failure with, or contraindication to, at least two

13 covered formulary alternatives when available. See section on individual consideration for more information if you require an exception to any of these criteria requirements for an atypical patient. Member cost share consideration A higher non-preferred cost share may be applied if an exception request is approved for coverage of a non-preferred or a non-formulary/non-covered drug. Criteria Documentation Provider must submit supporting documentation (e.g., chart notes, lab results or other clinical information) to show that the member has met all approval criteria. Forms To request prior authorization using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm), click the link below: https://www.bluecrossma.org/medical- policies/sites/g/files/csphws2091/files/acquiadam- assets/023%20E%20Form%20medication%20prior%20auth%20instruction%20prn.pdf OR Print and fax, Massachusetts Standard Form for Medication Prior Authorization Requests #434 Individual Consideration (for Atypical Patients) Our medical policies are written for most people with a given condition. Each policy is based on peer reviewed clinical evidence. We also take into consideration the needs of atypical patient populations and diagnoses.
If the coverage criteria outlined is unlikely to be clinically effective for the prescribed purpose, the health care provider may request an exception to cover the requested medication based on an individual’s unique clinical circumstances. This is also referred to as “individual consideration” or an “exception request.”
Some reasons why you may need us to make an exception include: therapeutic contraindications; history of adverse effects; expected to be ineffective or likely to cause harm (physical, mental, or adverse reaction).
To facilitate a thorough and prompt review of an exception request, we encourage the provider to include additional supporting clinical documentation with their request. This may include: • Clinical notes or supporting clinical statements; • The name and strength of formulary alternatives tried and failed (if alternatives were tried) and specifics regarding the treatment failure, if applicable; • Clinical literature from reputable peer reviewed journals; • References from nationally recognized and approved drug compendia such as American Hospital Formulary Service® Drug Information (AHFS-DI), Lexi-Drug, Clinical Pharmacology, Micromedex or Drugdex®; and • References from consensus documents and/or nationally sanctioned guidelines

Providers may call, fax or mail relevant clinical information, including clinical references for individual patient consideration, to:

Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043 Phone: 1-800-366-7778 Fax: 1-800-583-6289 Samples Requests based exclusively on the use of samples will not meet coverage criteria for exception. Additional clinical information demonstrating medical necessity of the desired medication must be submitted by the requesting prescriber for review.

14 Specialty Blue Cross Blue Shield of Massachusetts (BCBSMA*) members (other than Medex®; Blue MedicareRx, Medicare Advantage plans that include prescription drug coverage) obtaining the medication from the Pharmacy benefit instead of the Medical benefit will be required to fill their prescriptions for medications listed as specialty at one of the providers in our retail specialty pharmacy network, see link below: Link to Specialty Pharmacy List

Policy History Date Action 5/2026 March P&T: Added Brinsupri and Sephience to the policy. 3/15/2026 January P&T: Vanrafia added to the policy. References updated. 1/15/2026 Removed hepatologist as a specialist from Iqirvo and and Livdelzi. November P&T: Zelsuvmi and Vykat XR added. 1/2026 Gattex added to the policy as well as formatting and references. 11/2025 Moved Litfulo to Medical Policy #010. Moved Attruby and Vyndaqel/Vyndamax to Medical Policy #137. Updated criteria for Rezdiffra. 9/15/2025 Moved Orladeyo to new Medical Policy #058.
8/1/2025 Updated Attruby criteria to align with other AATR-CM agents. Standardized abbreviations for wtATTR and hATTR under Vyndaqel/Vyndamax. 7/2025 Updated Orladeyo criteria, added Xdemvy ™ to the policy. 3/2025 Updated to add Aqneursa ™, Attruby ™ and Miplyffa ™ to the policy. 2/2025 Updated to add Iqirvo ® and Livdelzi ® to the policy. 1/2025 Update to add Viberzi ® to the policy and to apply full FDA approval Filspari label to the criteria. 9/2024 Updated to add Xolremdi ™ and Duvyzat ™ to the policy and to update the new age limit for Livmarli ® 8/2024 Updated to add new indication for Livmarli ® And clarified Tarpeyo ™ criteria and updated age for Voxzogo ™. 7/2024 Updated to add Rezdiffra ™ to the policy. 5/2024 Updated to add Eohilia ™ to the policy. 1/2024 Updated to add Sohonos ™ to the policy. 10/2023 Updated to add Litfulo ™ to the policy. 9/2023 Updated IC to align with 118E MGL § 51A. 7/2023 Updated Age for Livmarli ™ and clarified Xifaxan ® coding and added Filspari ™, Skyclarys ™, Daybue ™, and Joenja ® to the policy. 4/2023 Updated age for Firdapse ®. 1/2023 Updated to add Vijoice ™ and Xifaxan to the policy.
8/2022 Updated to add Bexarotene Gel to the policy 7/2022 Updated to add Pyrukynd to the policy. 4/2022 Updated to move Rinvoq ® to Step policy 010 and to add Recorlev ®. 2/2022 Updated to add Tarpeyo ™, Tavneos ™, Rinvoq ® , and Voxzogo ™ to the policy. 1/2022 Updated to add Livmarli ™ to the policy. 10/2021 Updated to add Bylvay ™ to the policy. 4/2021 Updated to add Zokinvy ® to the policy. 2/2021 Updated to add Orladeyo ™ to the policy. 10/2020 Updated to add Dojolvi ™ to the policy. 10/2020 Updated to add Targretin Gel to the policy. 9/2020 Updated to add Isturisa ® to the policy.

15 10/2019 Updated to add Vyndaqel ® & Vyndamax ® 8/2019 Updated to add Firdapse ® to the policy. 7/2019 Updated to add Oxervate ™ to the policy. 4/2019 Implementation of a new policy with a new to market medication Arikayce ®
References

1. Aqneursa ™ [package insert]. North Chicago, IL: AbbVie, Inc.: 7/2024.
2. Arikayce ® [package insert]. Bridgewater, NJ: Insmed, Inc.: 9/2018.
3. Brinsupri. [package insert]. Bridgewater, NJ: Insmed Incorporated.: August 2025
4. Bylvay ™ [package insert]. Boston, MA: Albireo Pharma, Inc.: 7/2021.
5. Daybue ™ [package insert]. San Diego, CA: Acadia Pharmaceuticals Inc.: 3/2023.
6. Dojolvi ™ [package insert]. Novato, CA: Ultragenyx Pharmaceutical Inc.: 6/2020.
7. Duvyzat ™ [package insert]. Concord, MA: ITF Therapeutics, LLC: 3/2024.
8. Eohilia ™ [package insert]. Lexington, MA: Takeda Pharmaceuticals America, Inc.: 5/2024.
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