Lasmiditan (Reyvow) Form

Lasmiditan (Reyvow™) is a serotonin (5-HT) 1F agonist. FDA Approved Indication(s) Reyvow is indicated for the acute treatment of migraine with or without aura in adults. Limitation(s) of use: Reyvow is not indicated for the preventive treatment of migraine.
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 Reyvow is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Migraines (must meet all):

1. Diagnosis of migraine headaches;
   2. Age ≥ 18 years;
   3. Failure of at least TWO formulary generic 5HT1B/1D-agonist migraine medications (e.g., sumatriptan, rizatriptan, zolmitriptan) at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated;
      *Prior authorization may be required.
2. For requests for quantities greater than two doses per month, member meets one of the following (a or b): a. Failure of TWO prophylactic migraine medications, unless clinically significant adverse effects are experienced or all are contraindicated (see Appendix B); b. Member is being treated by or in consultation with a neurologist, headache, or pain specialist;

3. Dose does not exceed all the following (a, b, and c): a. 200 mg per day; b. 2 tablets per day; c. 4 days per month. Approval duration:
   Medicaid/HIM – 12 months
   Commercial – 12 months or duration of request, whichever is less Page 1 of 7

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

4. 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.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and 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.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
5. 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.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. II. Continued Therapy A. Migraines (must meet all):
6. 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);
   2. Member is responding positively to therapy;
   3. For dose increase requests for quantities greater than two doses per month, member meets one of the following (a or b): a. Failure of TWO prophylactic migraine medications, unless clinically significant adverse effects are experienced or all are contraindicated (see Appendix B); b. Member is being treated by or in consultation with a neurologist, headache, or pain specialist;
7. If request is for a dose increase, new dose does not exceed all the following (a, b, and c): a. 200 mg per day; b. 2 tablets per day; c. 4 days per month. Approval duration:
   Medicaid/HIM – 12 months
   Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):

8. 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): Page 2 of 7

   CLINICAL POLICY Lasmiditan 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.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and 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.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

9. 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.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and 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.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key 5-HT: serotonin AAN: American Academy of Neurology
   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 naratriptan (Amerge®)
   almotriptan (Axert®) frovatriptan (Frova®) sumatriptan (Imitrex® nasal spray)
   sumatriptan (Imitrex®)
   rizatriptan (Maxalt® /Maxalt MLT®) eletriptan (Relpax®) One tablet (1 or 2.5 mg) PO at onset; can be repeated in 4 hours 6.25 to 12.5 mg PO QD May repeat dose in 2 hours 2.5 mg PO QD May repeat dose in 2 hours One spray (5 – 20mg) at onset into one nostril; can be repeated in 2 hours One tablet (25 -100mg) PO at onset; can be repeated in two hours One tablet (5 or 10 mg) PO at onset of migraine headache; can be repeated in two hours 20 or 40 mg PO QD Page 3 of 7 Dose Limit/
   Maximum Dose 5 mg/day 25 mg/day 7.5 mg/day 40 mg/day 200 mg/day 30 mg/day 40 mg/dose

   CLINICAL POLICY Lasmiditan Drug Name
   Dosing Regimen Dose Limit/
   Maximum Dose 80 mg/day 5 mg/dose 10 mg/day May repeat dose in 2 hours 1.25 or 2.5 mg PO QD May repeat dose in 2 hours Refer to prescribing information or Micromedex Migraine Prophylaxis Refer to prescribing information or Micromedex Migraine Prophylaxis Refer to prescribing information or Micromedex zolmitriptan (Zomig®/Zomig® ZMT) Anticonvulsants such as: divalproex (Depakote®), topiramate (Topamax®), valproate sodium
   Beta-blockers such as: propranolol (Inderal®), metoprolol (Lopressor®), timolol, atenolol (Tenormin®), nadolol (Corgard®)
   Antidepressants/tricy clic 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 Migraine Prophylaxis Refer to prescribing information or Micromedex Refer to prescribing information or Micromedex Refer to prescribing information or Micromedex Appendix C: Contraindications/Boxed Warnings None reported
   Appendix D: General Information
   • The AAN recommends that prophylactic migraine medications should be considered if the patient experiences 2 or more attacks per month that produce aggregate disability of 3 or more days/month. • The AAN and the National Headache Foundation recommend that prophylactic migraine medications should be considered if one or more of the following are present: greater than 2 migraine headaches per week; migraines cause significant impairment in daily routine even with abortive treatment; contraindication to, adverse effects, overuse or failure of abortive migraine medications, presence of uncommon migraine condition (e.g., basilar migraine); or patient requesting prophylactic therapy. Page 4 of 7

   CLINICAL POLICY Lasmiditan V. Dosage and Administration
   Indication Migraines Dosing Regimen 50 mg, 100 mg, or 200 mg PO, as needed. No more than one dose should be taken in 24 hours. A second dose has not been shown to be effective for the same migraine attack. Maximum Dose 200 mg/dose/24 hours VI. Product Availability
   Tablets: 50 mg, 100 mg VII.