Effective December 1, 2022: Pharmacy and Biopharmacy Policies

Atogepant (Qulipta) (CP.PHAR.566)

Ambetter

Policy updates include:

• Added criteria for concurrent use with Botox requiring supportive evidence from published studies or clinical practice guidelines, positive response with Botox monotherapy, and continued migraine burden

Baloxavir Marboxil (Xofluza) (CP.PMN.185)

Ambetter

Policy updates include:

• Updated to reflect pediatric expansion from age at least 12 years to age at least 5 years, removed requirement for weight ≥ 40 kgs

Cannabidiol (Epidiolex) (CP.PMN.164)

Ambetter

Policy updates include:

• Removed neurologist prescriber requirement

Carfilzomib (Kyprolis) (CP.PHAR.309)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added new indication in combination with Sarclisa plus dexamethasone and Darzalex Faspro plus dexamethasone for MM after one to three lines of therapy
• Per NCCN Compendium added additional MM uses as primary therapy in combination with dexamethasone, lenalidomide, and Darzalex
• Added previously treated MM combination regimens
• Added criteria set for systemic light chain amyloidosis

Darolutamide (Nubeqa) (CP.PHAR.435)

Ambetter

Policy updates include:

• Added additional indication for mHSPC per updated prescribing information

Eptinezumab (Vyepti) (CP.PHAR.489)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added criteria for concurrent use with Botox requiring supportive evidence from published studies or clinical practice guidelines, positive response with Botox monotherapy, and continued migraine burden
• Revised initial approval duration from 3 to 6 months

Eptinezumab (Vyepti) (HIM.PA.SP64)

Ambetter

Policy updates include:

• Added criteria for concurrent use with Botox requiring supportive evidence from published studies or clinical practice guidelines, positive response with Botox monotherapy, and continued migraine burden
• Revised initial approval duration from 3 to 6 months

Erenumab-aaoe (Aimovig) (CP.PHAR.128)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added criteria for concurrent use with Botox requiring supportive evidence from published studies or clinical practice guidelines, positive response with Botox monotherapy, and continued migraine burden

Erenumab-aaoe (Aimovig) (HIM.PA.SP65)

Ambetter

Policy updates include:

• Added criteria for concurrent use with Botox requiring supportive evidence from published studies or clinical practice guidelines, positive response with Botox monotherapy, and continued migraine burden

Fedratinib (Inrebic) (CP.PHAR.442)

Ambetter

Policy updates include:

• Added off-label criteria for myeloid or lymphoid neoplasm with eosinophilia and Janus kinase 2 arrangement per NCCN category 2A recommendation

Fremanezumab-vfrm (Ajovy) (CP.PHAR.403)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added criteria for concurrent use with Botox requiring supportive evidence from published studies or clinical practice guidelines, positive response with Botox monotherapy, and continued migraine burden
• Revised initial approval duration from 3 to 6 months for every 3 month dosing frequency
• Removed redirection to Aimovig

Fremanezumab-vfrm (Ajovy) (HIM.PA.SP66)

Ambetter

Policy updates include:

• Added criteria for concurrent use with Botox requiring supportive evidence from published studies or clinical practice guidelines, positive response with Botox monotherapy, and continued migraine burden
• Revised initial approval duration from 3 to 6 months for every 3 month dosing frequency

Galcanezumab-gnlm (Emgality) (CP.PHAR.404)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added criteria for concurrent use with Botox requiring supportive evidence from published studies or clinical practice guidelines, positive response with Botox monotherapy, and continued migraine burden
• Removed redirection to Aimovig

Galcanezumab-gnlm (Emgality) (HIM.PA.SP67)

Ambetter

Policy updates include:

• Added criteria for concurrent use with Botox requiring supportive evidence from published studies or clinical practice guidelines, positive response with Botox monotherapy, and continued migraine burden

Inebilizumab-cdon (Uplizna) (CP.PHAR.458)

Ambetter

Policy updates include:

• Removed redirection to Enspryng

Inhaled Agents for Asthma and COPD (HIM.PA.153)

Ambetter

Policy updates include:

• Revised AirDuo Digihaler, AirDuo RespiClick, Dulera redirection to include only Symbicort authorized generic rather than both brand and generic

Inotuzumab Ozogamicin (Besponsa) (CP.PHAR.359)

Ambetter

Policy updates include:

• For Philadelphia chromosome-positive disease removal of requirement of intolerant or refractory to TKI per NCCN

Ivosidenib (Tibsovo) (CP.PHAR.137)

Ambetter

Policy updates include:

• Per NCCN, added chondrosarcoma as a coverable off-label diagnosis

Ketorolac Nasal Spray (Sprix) (CP.PMN.282)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Pain Management (must meet all):
  • Prescribed for the short term management of pain
  • Age ≥ 18 years
  • Failure of generic ketorolac tablets, unless contraindicated, clinically significant adverse effects are experienced, or inability to swallow tablets (e.g. dysphagia, esophagitis, mucositis, or uncontrollable nausea/vomiting)
  • Total prescribed ketorolac treatment duration, including other formulations (i.e., intramuscular, intravenous, or oral), will not exceed 5 days
  • Dose does not exceed both of the following:
    • 8 sprays (4 in each nostril) per day
    • 5 bottles total
  • Approval duration: 14 days (5 days total ketorolac treatment duration)
• Continued Approval Criteria: Pain Management (must meet all):
  • Re-authorization is not permitted. Members must meet the initial approval criteria

Leuprolide Acetate (Lupron, Lupron Depot, Eligard, Lupaneta Pack, Fensolvi, Camcevi) (CP.PHAR.173)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Updated FDA-approved indication to include non-palliative treatment of advanced prostate cancer

Methoxsalen (Uvadex) (HIM.PA.17)

Ambetter

Policy updates include:

• Per NCCN, added Folotyn, gemcitabine, liposomal doxorubicin, Keytruda, and alemtuzumab as alternative prior therapy options

Obinutuzumab (Gazyva) (CP.PHAR.305)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added criteria for FL for first- and second-line therapy, maintenance therapy, and as a rituximab substitute as supported by NCCN
• Replaced “in combination with bendamustine” for second-line treatment in marginal zone lymphoma with “in combination with chemotherapy” as NCCN supports several regimens

Omaveloxolone (RTA-408) (CP.PHAR.590)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Fredreich’s Ataxia (must meet all):
  • Diagnosis of FA confirmed by FXN gene mutation on genetic testing
  • Prescribed by or in consultation with a neurologist
  • Age ≥ 16 years
  • Documentation of recent (within the last 30 days) baseline Modified Functional Assessment Rating Scale (mFARS) score between 20 and 80
  • Member has the ability to swallow capsules
  • Dose does not exceed 150 mg (1 capsule) per day.
  • Approval duration: 6 months
• Continued Approval Criteria: Fredreich’s Ataxia  (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters: FA symptoms, maximal exercise testing, or mFARS score
  • If request is for a dose increase, new dose does not exceed 150 mg per day
  • Approval duration: 6 months

Omburtamab (Omblastys) (CP.PHAR.585)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial approval criteria: Neuroblastoma (must meet all):
  • Diagnosis of high-risk neuroblastoma with central nervous system or leptomeningeal metastases
  • Prescribed by or in consultation with an oncologist
  • Age ≤ 17 years
  • Disease is relapsed/refractory after ≥ 2 lines of systemic therapy
  • Member has not yet received any doses of Omblastys (for members who have already received at least one dose, refer to the Continued Therapy Section II below)
  • Request meets one of the following:
    • Dose does not exceed two doses of 50 mCi each, spaced four weeks apart
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
  • Approval duration: 3 months (2 doses only)
  • Continued Therapy: Neuroblastoma (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Omblastys for a covered indication
  • Member has received only one dose of Omblastys within the last 4 weeks and is in need of a second dose to complete the treatment regimen
  • Member has not experienced any objective disease progression by week 5 after the first dose was administered
  • If request is for a dose increase, request meets one of the following:
    • New dose does not exceed 50 mCi
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
  • Approval duration: 1 month (1 dose only)

OnabotulinumtoxinA (Botox) (CP.PHAR.232)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added criteria for concurrent use with CGRP therapy requiring supportive evidence from published studies or clinical practice guidelines, positive response with CGRP monotherapy, and continued migraine burden

Pegcetacoplan (Empaveli, APL-2) (CP.PHAR.524)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added pre-emptive criteria for intravitreal pegcetacoplan (APL-2) for GA secondary to AMD

Pexidartinib (Turalio) (CP.PHAR.436)

Ambetter

Policy updates include:

• Added off-label criteria for histiocytic neoplasms per NCCN category 2A recommendation

Rimegepant (Nurtec ODT) (CP.PHAR.490)

Ambetter

Policy updates include:

• Added criteria for concurrent use with Botox requiring supportive evidence from published studies or clinical practice guidelines, positive response with Botox monotherapy, and continued migraine burden

Setmelanotide (Imcivree) (CP.PHAR.491)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Updated criteria to include new FDA approved indication of obesity due to BBS
• Revised creatinine clearance and positive response requirements per prescribing information
• For POMC, PCSK1, or LEPR deficiency, removed initial maintenance approval duration of 6 months as weight loss should be evaluated after 4 months per prescribing information (requests for continued maintenance therapy may be approved using the continued approval criteria)

Step Therapy (HIM.PA.109)

Ambetter

Policy updates include:

• Aadded Ubrelvy requiring step through two 5HT1B/1D-agonist migraine medications (e.g., sumatriptan, rizatriptan, zolmitriptan)

Stiripentol (Diacomit) (CP.PMN.184)

Ambetter

Policy updates include:

• Updated the policy to reflect the new indication expansion to patients ≥ 6 months of age and weighing ≥ 7 kg

Suvorexant (Belsomra) (CP.PMN.109)

Ambetter

Policy updates include:

• Modified initial approval duration from 6 to 12 months

Tafasitamab-cxix (Monjuvi) (CP.PHAR.508)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added NCCN-supported category 2A indications of AIDS-related B-cell lymphomas, follicular lymphoma (grade 1-2), high-grade B-cell lymphomas, post-transplant lymphoproliferative disorders, and histologic transformation of lymphomas to DLBCL

Tapinarof (Vtama) (CP.PMN.283)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Plaque Psoriasis (must meet all):
  • o   Diagnosis of plaque psoriasis
  • o   Prescribed by or in consultation with a dermatologist or rheumatologist
  • o   Age ≥ 18 years
  • o   Member has ≤ 20% body surface area involvement
  • o   Member meets one of the following:
    • Failure of both of the following used concurrently, unless clinically significant adverse effects are experienced or all are contraindicated:
• Medium to ultra-high potency topical corticosteroid
• Calcipotriene, calcitriol, or tazarotene
  • For face or intertriginous areas (e.g., genitals, armpits, forearms, and groin): Failure of a topical calcineurin inhibitor, unless contraindicated or clinically significant adverse effects are experienced
  • Request does not exceed 1 tube per month.
  • Approval duration: 12 months
• Continued Approval Criteria: Plaque Psoriasis (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is responding positively to therapy
  • If request is for a dose increase, new dose does not exceed 1 tube per month
  • Approval duration: 12 months

Thioguanine (Tabloid) (CP.PHAR.437)

Ambetter

Policy updates include:

• Added off-label indication Glioma (pilocytic astrocytoma) per NCCN

Tisotumab vedotin-tftv (Tivdak) (CP.PHAR.561)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added criterion for single-agent therapy per NCCN
• Removed the no more than two prior systemic regimens in the recurrent or metastatic setting criterion as neither NCCN nor the PI restrict previous number of therapies

Tofersen (BIIB067) (CP.PHAR.591)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial approval criteria: Amyotrophic Lateral Sclerosis (ALS) (must meet all):
  • Diagnosis of ALS with both of the following:
    • Muscle weakness attributed to ALS
    • Documentation of SOD1 mutation
  • Prescribed by or in consultation with a neurologist
  • Age ≥ 18 years
  • Percent predicted slowed vital capacity (SVC) ≥ 45%
  • Prescribed concurrently with riluzole (at up to maximally indicated doses), unless contraindicated or clinically significant adverse effects are experienced
  • Dose does not exceed the FDA-approved maximum dose
  • Approval duration: 6 months
• ·        Continued Therapy: ALS (must meet all):
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria
  • Member is responding positively to therapy
  • Prescribed concurrently with riluzole (at up to maximally indicated doses), unless contraindicated or clinically significant adverse effects are experienced
  • If request is for a dose increase, new dose does not exceed the FDA-approved maximum dose
  • Approval duration: 12 months

Topical Immunomodulators (CP.PMN.107)

Ambetter

Policy updates include:

• Added off-label indication for plaque psoriasis as supported by AAD-NPF guidelines

Ubrogepant (Ubrelvy) (CP.PHAR.476)

Ambetter

• Policy retired. Ubrelvy will be added to step therapy policy HIM.PA.109

Venetoclax (Venclexta) (CP.PHAR.129)

Ambetter

Policy updates include:

• For BPDCN, added option of relapsed/refractory disease per NCCN; added criteria for off-label NCCN-supported indications of systemic light chain amyloidosis and Waldenström macroglobulinemia/lymphoplasmacytic lymphoma

Vortioxetine (Trintellix) (CP.PMN.65)

Ambetter

Policy updates include:

• Added vilazodone (generic Viibryd) to list of redirect options