REYVOW (lasmiditan)

REYVOW (lasmiditan) 

Self-Administration – Oral

Indication for Prior Authorization:

• Acute Treatment of Migraine - Indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use:

•  Not indicated for the preventive treatment of migraine.

Coverage Criteria:

Acute Treatment of Migraine

• Dose does not exceed 200 mg per day (limit of 4 tablets per month); AND
• Patient is 18 years of age or older; AND
• Documented trial and failure or intolerance to TWO triptan medications, or a contraindication to all triptan drugs (i.e., sumatriptan, rizatriptan, almotriptan, eletriptan, frovatriptan, naratriptan, zolmitriptan); AND
• Average number of migraine headaches experienced per month is confirmed by medical records; AND
  • If patient experiences 4 or more migraine headaches days per month: Patient has experienced an inadequate response (minimum two-month trial) to at least TWO prophylactic medications used for migraine headaches, each from a different pharmacologic class supported by the American Academy of Neurology, American Headache Society (AAN/AHS), or a contraindication to all medications listed for migraine headache prophylaxis, or is currently being treated with one of the following:
    • Antiepileptic drugs (i.e., divalproex sodium, sodium valproate, topiramate, carbamazepine)
    • Beta-blockers (i.e., metoprolol, propranolol, timolol, atenolol, nadolol, nebivolol, pindolol)
    • Antidepressants (i.e., amitriptyline, venlafaxine)
    • Blood pressure drugs (i.e., lisinopril, candesartan)
    • Alpha-agonists (i.e., clonidine, guanfacine)
    • Antihistamines (i.e., cyproheptadine); AND
• Will not be used in combination with another oral CGRP inhibitor or 5-HT-1F agent; AND
• Patient has a documented trial and failure or intolerance to Ubrelvy® AND Nurtec™ ODT.

Reauthorization Criteria:

Acute Treatment of Migraine

• Dose does not exceed 200 mg per day (limit of 4 tablets per month); AND
• Documentation of positive clinical response to therapy; AND
• Not being used in combination with another oral CGRP inhibitor or 5-HT-1F agent.

Coverage Duration:

• Initial: 3 months
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Reyvow® may cause central nervous system (CNS) depression, including dizziness and sedation. Because of the potential for Reyvow® to cause sedation, other cognitive and/or neuropsychiatric adverse reactions, and driving impairment, Reyvow® should be used with caution if used in combination with alcohol or other CNS depressants.  Patients should be warned against driving and other activities requiring complete mental alertness for at least 8 hours after Reyvow® is taken.
• Other clinically significant adverse reactions include serotonin syndrome and medication overuse headache.
• The recommended dose is 50 mg, 100 mg or 200 mg taken orally 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).
• The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established.
• Avoid concomitant use with P-gp or BCRP substrates.
• Use caution in patients taking concomitant medications that lower heart rate if this magnitude of heart rate decrease may pose a concern.

Policy Updates:

• 08/18/2020 – New policy approved by P&T.
• 10/19/2021– Prophylactic pharmacologic therapy trial and failure criteria updated; combination CGRP inhibitor criteria updated; reauthorization criteria created; coverage duration updated to initial 3 months

References:

• American Headache Society. The American Headache Society position statement on integrating new migraine treatments into clinical practice. Headache. 2019;59(1):1-18.
• Goadsby PJ, Wietecha LA, Dennehy EB, et al. Phase 3 randomized, placebo-controlled, double-blind study of lasmiditan for acute treatment of migraine. Brain. 2019 Jul 1;142(7):1894-1904. 
• Gronseth GS, Woodroffe LM, Getchius TS, et al; for the American Academy of Neurology. Clinical Practice Guideline Process Manual, 11th edition. 2011. Available at: http://tools.aan.com/globals/axon/assets/9023.pdf. Accessed June 28, 2021.
• International Headache Society (IHS); Headache Classification Committee. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013; 33: 629-808.
• Lipton RB, Silberstein SD. Episodic and chronic migraine headache: breaking down barriers to optimal treatment and prevention. Headache. 2015 Mar;55 Suppl 2:103-22.
• Nurtec ODT Prescribing Information. Biohaven Pharmaceuticals, Inc. New Haven, CT. May 2021.
• Reyvow Prescribing Information. Lilly USA, LLC Indianapolis, IN. August 2021.
• Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016 May 10;86(19):1818-26.
• The International Classification of Headache Disorders 3rd edition. Trigeminal autonomic cephalgias (TACs). Available at: https://ichd-3.org/3-trigeminal-autonomic-cephalalgias/3-1-cluster-headache/3-1-1-episodic-cluster-headache/. Accessed on June 14, 2021.
• Ubrelvy Prescribing Information. Allergan USA, Inc. Madison, NJ. March 2021.
• United Council for Neurologic Subspecialties website. www.ucns.org. Accessed June 14, 2021.