AIMOVIG, Erenumab-aooe Form

Erenumab-aooe (Aimovig™) is a calcitonin gene-related peptide (CGRP) receptor antagonist. FDA Approved Indication(s) Aimovig is indicated for the preventive treatment of migraine in adults. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Aimovig 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. Member experiences ≥ 4 migraine days per month for at least 3 months;
   3. Prescribed by or in consultation with a neurologist, headache, or pain specialist;
   4. Age ≥ 18 years;
   5. 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. If currently receiving treatment with Botox® for migraine prophylaxis and request is for concurrent use of Botox and Aimovig (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; Page 1 of 7

   CLINICAL POLICY Erenumab-aooe iv. Appropriate experimental design and method to address research questions (see Appendix E for additional information); 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;

3. Aimovig is not prescribed concurrently with other injectable or oral CGRP inhibitors (e.g., Ajovy®, Emgality®, Vyepti™, Nurtec®, Qulipta™, Ubrelvy™);
4. Dose does not exceed one of the following (a or b): a. 70 mg (1 injection) once monthly; b. 140 mg (1 injection) once monthly if medical justification is provided. Approval duration: 3 months
   B. Other diagnoses/indications (must meet 1 or 2):
5. 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: CP.PMN.255 for Medicaid; 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: CP.PMN.16 for Medicaid; or
6. 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: CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Migraine Prophylaxis (must meet all):
7. 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);
8. Member has experienced and maintained positive response to therapy as evidenced by a reduction in migraine days per month from baseline;
9. Aimovig is not prescribed concurrently with other injectable or oral CGRP inhibitors (e.g., Ajovy, Emgality, Vyepti, Nurtec, Qulipta, Ubrelvy);This requirement does not apply to CA if member was previously approved via Centene benefit and is currently stable on therapy with both oral and injectable CGRP inhibitors

10. If request is for a dose increase, new dose does not exceed one of the following (a or b): a. 70 mg (1 injection) once monthly; Page 2 of 7

    CLINICAL POLICY Erenumab-aooe b. 140 mg (1 injection) once monthly if medical justification is provided. Approval duration: 6 months 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: CP.PMN.255 for Medicaid; 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: CP.PMN.16 for Medicaid; 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: CP.PMN.53 for Medicaid.
    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 – CP.PMN.53 for Medicaid or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration CGRP: calcitonin gene-related peptide
    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 Anticonvulsants such as: divalproex (Depakote®), topiramate (Topamax®), valproate sodium Beta-blockers such as: propranolol (Inderal®), metoprolol (Lopressor®), timolol, atenolol (Tenormin®), nadolol (Corgard®)*
    Migraine Prophylaxis Refer to prescribing information or Micromedex Dose Limit/ Maximum Dose Refer to prescribing information or Micromedex Migraine Prophylaxis Refer to prescribing information or Micromedex Refer to prescribing information or Micromedex Page 3 of 7

    CLINICAL POLICY Erenumab-aooe Drug Name Dosing Regimen Migraine Prophylaxis Refer to prescribing information or Micromedex Antidepressants/tricyclic antidepressants such as: amitriptyline (Elavil®), venlafaxine (Effexor®) 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. Off-label use Dose Limit/ Maximum Dose Refer to prescribing information or Micromedex Appendix C: Contraindications • Contraindication(s): serious hypersensitivity to erenumab-aooe or to any of the excipients • Boxed warning(s): none reported Appendix D: General Information
    • In clinical trials, a migraine day was defined as any calendar day in which the patient experiences a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache is defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria (a and/or b): a) ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity; b) ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia, and phonophobia. 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.
    V. Dosage and Administration
    Indication Migraine prophylaxis Dosing Regimen 70 mg SC once monthly Maximum Dose 140 mg/month Some patients may benefit from a dosage of 140 mg injected subcutaneously once monthly VI. Product Availability
    Single-dose prefilled SureClick® autoinjector or prefilled syringe: 70 mg/mL, 140 mg/mL Page 4 of 7

    CLINICAL POLICY Erenumab-aooe VII.