Eptinezumab-jjmr (Vyepti) Form

Eptinezumab-jjmr (Vyepti™) a calcitonin gene-related peptide (CGRP) receptor antagonist.
FDA Approved Indication(s) Vyepti is indicated for the preventive treatment of migraine in adults. Policy/Criteria It is the policy of health plans affiliated with Centene Corporation® that Vyepti is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Migraine Prophylaxis (must meet all):

1. Diagnosis of episodic or chronic migraine;
   2. Provider’s attestation that member experiences ≥ 4 migraine days per month for at least 3 months;
   3. Age ≥ 18 years;
   4. Failure of at least 2 of the following oral migraine preventative therapies, each for 8 weeks and from different therapeutic classes, unless clinically significant adverse effects are experienced or all are contraindicated: antiepileptic drugs (e.g., divalproex sodium, sodium valproate, topiramate), beta-blockers (e.g., metoprolol, propranolol, timolol), antidepressants (e.g., amitriptyline, venlafaxine);
2. Failure of Aimovig® and Emgality®, unless clinically significant adverse effects are experienced or both are contraindicated;
   *Prior authorization may be required.

3. If currently receiving treatment with Botox® for migraine prophylaxis and request is for concurrent use of Botox and Vyepti (i.e., not switching from one agent to another), all of the following (a, b, and c): a. Sufficient evidence is provided from at least two high-quality, published studies in reputable peer-reviewed journals or evidence-based clinical practice guidelines that provide all of the following (i – iv): Case studies or chart reviews are not considered high-quality evidence i. Adequate representation of the member’s clinical characteristics, age, and diagnosis;
   ii. Adequate representation of the prescribed drug regimen;
   iii. Clinically meaningful outcomes such as a reduction in monthly migraine or headache days; iv. Appropriate experimental design and method to address research questions (see Appendix E for additional information); Page 1 of 7

   CLINICAL POLICY Eptinezumab-jjmr b. Member has experienced and maintained positive response to Botox monotherapy as evidenced by a ≥ 30% reduction in migraine days per month from baseline following at least 2 quarterly injection (6 months) of Botox monotherapy; c. Despite Botox monotherapy, member continues to experience ≥ 4 migraine days per month and/or severe migraine headaches that result in disability and functional impairment;

4. Vyepti is not prescribed concurrently with other injectable or oral CGRP inhibitors (e.g., Aimovig, Ajovy®, Emgality, Nurtec®, Qulipta™, Ubrelvy™);
5. Dose does not exceed 100 mg (1 vial) once every 3 months. Approval duration: 6 months B. Other diagnoses/indications (must meet 1 or 2):
6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or
7. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
   II. Continued Therapy A. Migraine Prophylaxis (must meet all):
8. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
9. Member has experienced and maintained positive response to therapy as evidenced by provider’s attestation of a reduction in migraine days per month from baseline;
   3. Vyepti is not prescribed concurrently with other injectable or oral CGRP inhibitors (e.g., Aimovig, Ajovy, Emgality, Nurtec, Qulipta, Ubrelvy);

10. If request is for a dose increase, new dose does not exceed one of the following (a or b): a. 100 mg (1 vial) once every 3 months; b. 300 mg (3 vials) once every 3 months if medical justification for higher dose is provided. Approval duration: 6 months Page 2 of 7

    CLINICAL POLICY Eptinezumab-jjmr B. Other diagnoses/indications (must meet 1 or 2):

11. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or

12. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – HIM.PA.154 for health insurance marketplace or evidence of coverage documents.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CGRP: calcitonin gene-related peptide FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen Migraine Prophylaxis Refer to prescribing information or Micromedex Dose Limit/ Maximum Dose Refer to prescribing information or Micromedex Anticonvulsants such as: divalproex (Depakote®), topiramate (Topamax®),valproate sodium Beta-blockers such as: propranolol (Inderal®), metoprolol (Lopressor®), timolol, atenolol (Tenormin®), nadolol (Corgard®) Antidepressants/tricyclic antidepressants such as: Migraine Prophylaxis Refer to prescribing information or Micromedex Refer to prescribing information or Micromedex Migraine Prophylaxis
    70 mg SC once monthly Refer to prescribing information or Micromedex Page 3 of 7

    CLINICAL POLICY Eptinezumab-jjmr Drug Name Dosing Regimen amitriptyline (Elavil®), venlafaxine (Effexor®) Aimovig® (erenumab- aaoe) Some patients may benefit from a dosage of 140 mg injected subcutaneously once monthly Migraine Prophylaxis
    70 mg SC once monthly Dose Limit/ Maximum Dose 140 mg/month Emgality® (galcanezumab-gnlm) Some patients may benefit from a dosage of 140 mg injected subcutaneously once monthly Migraine Prophylaxis
    Loading dose: 240 mg SC once Maintenance dose: 120 mg SC once monthly 120 mg/month Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): serious hypersensitivity to eptinezumab-jjmr or to any of the excipients
    • Boxed warning(s): none reported Appendix D: General Information
    • In the PROMISE-I clinical trial, a migraine was classified by the following characteristics: lasted 4–72 hours; with at least two of the following: unilateral location, pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; and had one or more of the following: nausea and/or vomiting and photophobia and phonophobia. A probable migraine was a qualifying headache with two of the three preceding criteria. Appendix E: Appropriate Experimental Design Methods • Randomized, prospective controlled trials are generally considered the gold standard; however:
    o In some clinical studies, it may be unnecessary or not feasible to use randomization, double-blind trials, placebos, or crossover. o Non-randomized prospective clinical trials with a significant number of subjects may be a basis for supportive clinical evidence for determining accepted uses of drugs. • Case reports and chart reviews are generally considered uncontrolled and anecdotal information and do not provide adequate supportive clinical evidence for determining accepted uses of drugs.
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    CLINICAL POLICY Eptinezumab-jjmr V. Dosage and Administration
    Indication Migraine prophylaxis Dosing Regimen The recommended dosage is 100 mg IV every 3 months.
    Maximum Dose 300 mg every 3 months Some patients may benefit from a dosage of 300 mg IV every 3 months. VI. Product Availability
    Single-dose vial: 100 mg/mL VII.