Ohio Department of Medicaid

30 Day Change Notice

Effective Date: October 1, 2022

Date of Notice: 9/1/2022

Ohio Department of Medicaid

30 Day Change Notice

Effective Date: October 1, 2022

ADDITIONAL SHORT-ACTING OPIOID CRITERIA FOR NEW STARTS

• The system will defines “new start” as having no opioid claims less than a 1-day supply of opioids in the previous 90 days
• Initial short-acting requests can be authorized up to 90 days
  • Length of authorization depending is dependent on the indication, previous patient utilization, and requested length of therapy (could be more restrictive)
  • To exceed acute opioid limits, patient must have, documentation of the following must be provided:
    • Diagnosis code must be submitted and which must should be for somatic type pain
    • Inadequate clinical response to Trialed and failed non-pharmacologic treatments and/or non-opioid analgesics ineffective or contraindicated
    • Prescriber attestation that the benefits and risks of opioid therapy have been discussed with patient (attestation documented on prior authorization form)
    • Prescriber attestation that OARRS has checked (attestation documented on prior authorization form)
  • Exemptions to the additional criteria:
    • Patients receiving short-acting opioids for certain conditions are exempt from these requirements: active cancer treatment, palliative care, and end-of-life/hospice care, sickle cell, severe burn, traumatic crushing of tissue, amputation, or major orthopedic surgery
    • Prescriber attestation that patient is not opioid naive will exempt patients from these requirements, for example: (i.e., new to Medicaid or was on a higher dose in hospital)
    • If patient is newly eligible for Medicaid and there is no prior claims data
    • If patient was on a higher dose in the hospital

Effective July 1, 2018, patients with short acting opioid therapy will be limited to 30 MED per prescription and a maximum of 7 days per prescription. Prior authorization will be required to exceed these limits.

ADDITIONAL ALL LONG-ACTING OPIOIDS CRITERIA REQUIRE PRIOR AUTHORIZATION:

• Initial long-acting requests can be authorized up to (90 days approval)
  • Documentation of the following must should be provided: as part of prior authorization form)
    • All other causes of pain:
    • Request is a daily dose equivalent of ≤ 80 MED
    • Inadequate clinical response to documented failure of both non-opioid pharmacologic and non-pharmacologic treatments
    • History of short-acting opioids for ≥ 60 days

Date of Notice: 9/1/2022

Ohio Department of Medicaid

30 Day Change Notice

Effective Date: October 1, 2022

ADDITIONAL TRANSMUCOSAL FENTANYL CRITERIA FOR:

• Diagnosis of cancer pain; and
• Must be prescribed by an oncologist, pain specialist, or hospice/palliative prescriber and
• Must currently be taking a long-acting opioid at therapeutic dose of any of the following for at least ≥7 days without adequate pain relief:
  • ≥ 60 mg oral morphine/day or ≥ 8 mg oral hydromorphone/day or
  • ≥ 25 mcg/hr transdermal fentanyl or ≥ 25 mg oral oxymorphone/day or
  • ≥ 30 mg oral oxycodone/day or Equianalgesic dose of another opioid and

QL – Transmucosal Fentanyl: is </= 4 doses units per day

Blood Formation, Coagulation, and Thrombosis Agents: Colony Stimulating Factors LENGTH OF AUTHORIZATIONS: Approval Authorization based upon diagnosis below

ALL AUTHORIZATIONS: Must be prescribed in accordance with FDA approved labeling

NON-PREFERRED CRITERIA:

• Must provide documentation of medical necessity beyond convenience Requests require reasoning for why the patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions, contraindications, or intolerances) OR
  • For any nonsolid oral dosage formulation: must provide documentation of medical necessity for why patient cannot be changed to a solid oral dosage formulation
• Must have had an inadequate clinical response as the patient failed a therapeutic trial of at least 14 days with one preferred drug medication?
• Will the medication be used for an approved FDA indication and duration?
  • For non-preferred extended-release formulations: must provide documentation of an inadequate clinical response with its immediate release formulation (if available)
  • For non-preferred brand names that have preferred generics, requests must provide documentation of an inadequate clinical response or allergy to two or more generic labelers (if available)

SUBSEQUENT AUTHORIZATION CRITERIA:

• Must provide documentation of patient’s clinical response to treatment and ongoing safety monitoring

Date of Notice: 9/1/2022

Ohio Department of Medicaid

30 Day Change Notice

Effective Date: October 1, 2022

ADDITIONAL BACLOFEN SOLUTION CRITERIA:

• Must provide documentation of trial with baclofen tablets or justification why a non-solid oral dosage form is indicated

ADDITIONAL CARISOPRODOL (SOMA) CRITERIA:

• Clinical criteria must be met for Soma/Carisoprodol products—approvable only if Must provide medical justification that no other muscle relaxant or agent to treat fibromyalgia, or any musculoskeletal condition, would serve the clinical needs of the patient.

SUBSEQUENT AUTHORIZATION CRITERIA:

• Must provide documentation of patient’s clinical response to treatment and ongoing safety monitoring

Dermatological: Topical Acne Products LENGTH OF AUTHORIZATIONS: 365 Days

ALL AUTHORIZATIONS: Must be prescribed in accordance with FDA approved labeling

NON-PREFERRED CRITERIA:

• Must provide documentation of medical necessity beyond convenience Requests require reasoning for why the patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions, contraindications, or intolerances) OR
  • For any nonsolid oral dosage formulation: must provide documentation of medical necessity for why patient cannot be changed to a solid oral dosage formulation
• Must have had an inadequate clinical response to no less than a of at least 30 days or (90 days for retinoids) trial of at least three (3) preferred drugs medications not requiring prior approval
  • Acceptable reasons include allergies, contraindications, drug drug interactions, intolerance, or history of unacceptable/toxic side effects
  • For non-preferred extended-release formulations: must provide documentation of an inadequate clinical response with its immediate release formulation (if available)
  • For non-preferred brand names that have preferred generics, requests must provide documentation of an inadequate clinical response or allergy to two or more generic labelers (if available)

CLINICAL CRITERIA: ADDITIONAL TRETINOIN/BENZOYL PEROXIDE (TWYNEO) CRITERIA

• Must provide documentation for patient’s inability to use the individual drugs

ADDITIONAL INFORMATION

• Patient diagnosis skin cancer—may approve retinoid if the patient has a history of skin cancer
• Tazarotene (Tazorac) - Patient diagnosis psoriasis— May be authorized with a diagnosis of psoriasis approve tazarotene (Tazorac)

Date of Notice: 9/1/2022

Ohio Department of Medicaid

30 Day Change Notice

Effective Date: October 1, 2022

• Patient diagnosis acne vulgaris—may approve retinoid if the patient has a history of at least 30 days of therapy with alternative therapy (benzoyl peroxide, sodium sulfacetamide or antibiotic) in the previous 90 days

SUBSEQUENT AUTHORIZATION CRITERIA:

• Must provide documentation of patient’s clinical response to treatment and ongoing safety monitoring

AR- All topical retinoids: A PA is required require prior authorization for patients aged 24 years and older

Endocrine Agents: Androgens LENGTH OF AUTHORIZATIONS: 365 Days

ALL AUTHORIZATIONS: Must be prescribed in accordance with FDA approved labeling

CLINICAL PA CRITERIA:

• All products within this category require submission of Must provide documentation of lab work to support the need for testosterone supplementation

NON-PREFERRED CRITERIA:

• Must provide documentation of medical necessity beyond convenience Requests require reasoning for why the patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions, contraindications, or intolerances) OR
  • For any nonsolid oral dosage formulation: must provide documentation of medical necessity for why patient cannot be changed to a solid oral dosage formulation
• The requested medication may be approved if There Must have has had been a therapeutic failure-an inadequate clinical response to no less than a of at least 90-days trial of with all preferred drugs medications not requiring prior approval.
  • Acceptable reasons include allergies, contraindications, drug drug interactions, intolerance, or history of unacceptable/toxic side effects
  • For non-preferred extended-release formulations: must provide documentation of an inadequate clinical response with its immediate release formulation (if available)
  • For non-preferred brand names that have preferred generics, requests must provide documentation of an inadequate clinical response or allergy to two or more generic labelers (if available)

ADDITIONAL INFORMATION Use limited to FDA-approved indications in those 18-years and older.

SUBSEQUENT AUTHORIZATION CRITERIA:

• Must provide documentation of patient’s clinical response to treatment and ongoing safety monitoring

Gastrointestinal Agents: Unspecified GI LENGTH OF AUTHORIZATIONS: 365 Days

ALL AUTHORIZATIONS: Must be prescribed in accordance with FDA approved labeling

Date of Notice: 9/1/2022

Ohio Department of Medicaid

30 Day Change Notice

Effective Date: October 1, 2022

STEP THERAPY CRITERIA-all agents listed

• Must have had an inadequate clinical response to preferred alternatives, including no less than a at least 14-days trial of with at least two preferred drugs medications not requiring prior approval

NON-PREFERRED CRITERIA:

• Must provide documentation of medical necessity beyond convenience Requests require reasoning for why the patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions, contraindications, or intolerances) OR
  • For any nonsolid oral dosage formulation: must provide documentation of medical necessity for why patient cannot be changed to a solid oral dosage formulation
• Must have had an inadequate clinical response of to preferred alternatives, including no less than a at least 14-days trial of with at least three preferred drugs medications not requiring prior approval, if indicated for diagnosis
  • Acceptable reasons include allergies, contraindications, drug drug interactions, intolerance, or history of unacceptable/toxic side effects
  • For non-preferred extended-release formulations: must provide documentation of an inadequate clinical response with its immediate release formulation (if available)
  • For non-preferred brand names that have preferred generics, requests must provide documentation of an inadequate clinical response or allergy to two or more generic labelers (if available)

ADDITIONAL INFORMATION:

• Patient must be 18-years or older

ADDITIONAL METHYLNALTREXONE (RELISTOR) AND NALDEMEDINE (SYMPROIC) CRITERIA:

• RELISTOR and SYMPROIC requires Must have a history of chronic pain requiring continuous opioid therapy for ≥84 days or longer. Electronic PA will approve with a history of 90 days of opioid therapy in the previous 90 days, in addition to trials of preferred products

ADDITIONAL RIFAMYCIN DELAYED-RELEASE (AEMCOLO) CRITERIA:

• AEMCOLO initial approval criteria for Travelers’ Diarrhea (TD) (must meet all):
  • Diagnosis of TD
  • Maximum authorization approval duration is will be for 3 days
  • Must have the inability to take, or failure of, any of the following:
    • Azithromycin (generic Zithromax)
    • Ciprofloxacin (generic Cipro)
    • Levofloxacin (generic Levaquin)
    • Ofloxacin (generic Floxin)
    • Xifaxan-Rifaximin (Xifaxan)

ADDITIONAL SOMATROPIN INJECTION (ZORBITIVE) AND TEDUGLUTIDE (GATTEX) CRITERIA:

• ZORBITIVE and GATTEX require a diagnosis of short bowel syndrome (SBS) and Must have evidence of specialized parenteral nutritional support

Date of Notice: 9/1/2022

Ohio Department of Medicaid

30 Day Change Notice

Effective Date: October 1, 2022

• GATTEX requires evidence of parenteral nutrition support at least three times per 7 days and Must have documentation of appropriate colonoscopy and lab assessment (bilirubin, alkaline phosphatase, lipase, and amylase) at least 180 days prior to initiation
• MYTESI requires a diagnosis of non-infectious diarrhea and evidence of concurrent HIV antiviral therapy
  • MYTESI will be limited to no more than 2 tablets per day

SUBSEQUENT AUTHORIZATION CRITERIA:

• Re-authorization of these therapies requires Must provide documentation evidence of patient’s clinical response to treatment improved condition and ongoing safety monitoring (i.e. measured by total volume, total calories, or decreased frequency of specialized parenteral nutrition support, improvement in symptoms)

Date of Notice: 9/1/2022

Ohio Department of Medicaid

30 Day Change Notice

Effective Date: October 1, 2022

• For non-preferred brand names that have preferred generics, requests must provide documentation of an inadequate clinical response or allergy to two or more generic labelers (if available)

ADDITIONAL CRITERIA: All products in this class require Clinical Prior Authorization:

• Prior first-generation therapy appropriate for diagnosis; and
• Diagnosis of one of the following: 365 days approval
  • Rheumatoid Arthritis
  • Plaque Psoriasis
  • Psoriatic Arthritis
  • Polyarticular Juvenile Idiopathic Arthritis
  • Crohn’s Disease
  • Ankylosing Spondylitis
  • Psoriasis
  • Uveitis
  • Cryopyrin-Associated Periodic Syndrome
  • Giant Cell Arteritis
  • Hidradenitis Suppurativa

ADDITIONAL ATOPIC DERMATITIS CRITERIA: Clinical Criteria for Moderate to Severe Atopic Dermatitis

• Patient must have a diagnosis of moderate to severe atopic dermatitis AND
• Must be prescribed by or in consultation with a dermatologist or allergist/immunologist AND
• Patient has Must have at least 10% body surface area (BSA) involvement AND with Prescribed in accordance with its FDA-approved labeling AND
• Patient has had inadequate clinical response or contraindication to two of the following: topical corticosteroids, topical calcineurin inhibitors (e.g. Elidel), or topical PDE-4 inhibitors e.g. Eucrisa) unless OR atopic dermatitis is severe and involves greater than >25% of BSA
• Initial authorization is limited to 180 days with re-authorization of up to 365 days granted following demonstration of improvement in patient condition with therapy (e.g. reduced BSA affected).

ADDITIONAL PLAQUE PSORIASIS CRITERIA:

• For patients with a diagnosis of moderate to severe plaque psoriasis currently receiving phototherapy, an inadequate clinical response of at least 90 days must be shown prior to initial authorization for preferred drugs Humira or Enbrel will only be approved if there is an

ADDITIONAL ULCERATIVE COLITIS CRITERIA:

• Diagnosis of Moderate-Severe Ulcerative Colitis (UC) (Humira, Simponi, and Xeljanz only): initial authorization approval 56 days, reapprovals 365 days
• Humira may be approved if there is an inadequate clinical response to at least 90 days of therapy with both 5-ASA and immunosuppressants.
• Initial approval for Humira will be for 56 days. If an inadequate clinical response after 90 is not seen in 56 days with one TNF inhibitor, further TNF inhibitors will not be approved authorized. If there is an initial clinical response to Humira after 56 days of therapy, but no improvement in the progression of ulcerative colitis symptoms after 180 days, Simponi or Xeljanz may be approved
  • Quantity limits for UC diagnosis:
    • Humira – 7 pens/syringes during the first 30 days, then 2 pens/syringes per 30 days
    • Simponi – 3 pens/syringes during the first 30 days, then 1 pen/syringe per 30 days
    • Xeljanz – 60 pills per 30 days

SUBSEQUENT AUTHORIZATION CRITERIA:

• Must provide documentation of patient’s clinical response to treatment and ongoing safety monitoring

Date of Notice: 9/1/2022

Ohio Department of Medicaid 30 Day Change Notice Effective Date: October 1, 2022

ADDITIONAL DARUNAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR (SYMTUZA) CRITERIA:

• Symtuza request Must provide clinical justification documentation for patient’s inability to use the individual drugs (Prezcobix and Descovy)

SUBSEQUENT AUTHORIZATION CRITERIA:

• Must provide documentation of patient’s clinical response to treatment and ongoing safety monitoring

AR - Isentress chewable tablet: a PA is required for patients over 11 years old 12 years and older

Respiratory Agents: Monoclonal Antibodies-Anti-IL/Anti-IgE LENGTH OF AUTHORIZATIONS: Initial: 180 days; Subsequent: 365 days

ALL AUTHORIZATIONS: Must be prescribed in accordance with FDA approved labeling

CLINICAL PA CRITERIA:

• Must be prescribed by or in consultation with an applicable specialist (i.e., allergist/immunologist, pulmonologist, or otolaryngologist)
• For Asthma – Must have had uncontrolled asthma symptoms and/or exacerbations despite at least 30 days adherence to therapy with:
  • Medium dose preferred ICS/LABA inhaler for 6 years and older (patients 6-11 years old) OR Medium dose preferred ICS/LABA inhaler medium dose ICS/LABA inhaler with tiotropium or high dose ICS/LABA inhaler for (patients 12 years and older)
• For Chronic Rhinosinusitis with Nasal Polyposis – Must have Patient had an inadequate clinical response, intolerance or contraindication of at least 30 days to one oral corticosteroid AND 30-day trial to one nasal corticosteroid spray
• For Chronic Urticaria – Patient has Must have had an inadequate clinical response of at least tried and failed two 14-days with two different antihistamines

NON-PREFERRED MEDICATION CRITERIA:

• Must provide documentation of medical necessity beyond convenience Requests require reasoning for why the patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions, contraindications, or intolerances) OR
  • For any nonsolid oral dosage formulation: must provide documentation of medical necessity for why patient cannot be changed to a solid oral dosage formulation
• There Must have had been an inadequate clinical response of Non-preferred medications will be approved for patients with uncontrolled asthma symptoms and/or exacerbations despite at least 90 days adherence to therapy with one a preferred drug agent
  • Acceptable reasons include allergies, contraindications, drug drug interactions, intolerance, or history of unacceptable/toxic side effects
  • For non-preferred extended-release formulations: must provide documentation of an inadequate clinical response with its immediate release formulation (if available)
  • For non-preferred brand names that have preferred generics, requests must provide documentation of an inadequate clinical response or allergy to two or more generic labelers (if available)

Ohio Department of Medicaid 30 Day Change Notice Effective Date: October 1, 2022

ADDITIONAL ASTHMA CRITERIA Clinical for

• Patient must have a diagnosis of moderate to severe asthma AND
• Prescribed by or in consultation with an allergist/immunologist or pulmonologist AND
• Prescribed in accordance with its FDA-approved labeling AND
• Preferred medications will be approved for patients with

SUBSEQUENT AUTHORIZATION CRITERIA:

• Initial authorization is limited to 180 days
• Re-authorization of up to 365 days granted following Must provide documentation of demonstration of patient’s clinical response to treatment improvement in patient condition with therapy and ongoing safety monitoring (i.e. PFT improvement, reduced affected BSA)

Clinical Criteria for Moderate-to-Severe Atopic Dermatitis

• Patient must have a diagnosis of moderate to severe atopic dermatitis AND
• Patient has minimum body-surface area (BSA) involvement of at least 10% AND
• Prescribed by or in consultation with a dermatologist or allergist/immunologist AND
• Prescribed in accordance with its FDA-approved labeling AND
• Patient has had inadequate response or contraindication to two of the following: topical corticosteroids, topical calcineurin inhibitors [e.g. Elidel], or topical PDE-4 inhibitors [e.g. Eucrisa™] unless atopic dermatitis is severe and involves greater than 25% of BSA
• Initial authorization is limited to 180 days with re-authorization of up to 365 days granted following demonstration of improvement in patient condition with therapy (e.g. reduced BSA affected).

Date of Notice: 9/1/2022