WHA

VYEPTI (epitinexumab-jjmr)

Office-Administered – IV

Indications for Prior Authorization:
  •  Preventive Treatment of Migraine - Indicated for the preventive treatment of migraine in adults
Coverage Criteria:

Preventive Treatment of Migraine

  • Dose does not exceed 100 or 300 mg given intravenously (IV) once every 3 months; AND
  • Patient is 18 years of age or older; AND
  • Patient has 4 or more migraine headaches per month as confirmed by medical records; AND
  • Documented 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:
    • 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 injectable CGRP inhibitor
Reauthorization Criteria:

Preventive Treatment of Migraine

  • Dose does not exceed 100 or 300 mg given intravenously (IV) once every 3 months; AND
  • Documentation of positive clinical response to therapy (e.g., decrease in number of migraine headaches experienced per month compared to baseline); AND
  • Not being used in combination with another injectable CGRP inhibitor
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:
  • Vyepti™ must be administered by a healthcare professional in a healthcare setting.
Policy Updates:
  • 10/19/2021– New policy approved by P&T.
References:
  • American Headache Society Consensus Statement. The American Headache Society position statement on integrating new migraine treatments into clinical practice. Headache. 2019;59:1-18.
  • Aimovig Prescribing Information. Amgen Inc. Thousand Oaks, CA. May 2021.
  • Ajovy Prescribing Information. Teva Pharmaceuticals USA, Inc. North Wales, PA. May 2021.
  • Amgen press release. When Others Fail, New Migraine Treatment May Work. April 17, 2018. Accessed June 14, 2021.
  • ClinicalTrials.gov. A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies (LIBERTY). NCT03096834. Website. https://clinicaltrials.gov/ct2/show/NCT03096834?term=NCT03096834&rank=1. Accessed June 14, 2021.
  • ClinicalTrials.gov. Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine. NCT02629861. Website. https://clinicaltrials.gov/ct2/show/NCT02629861?term=NCT02629861&rank=1. Accessed June 14, 2021.
  • ClinicalTrials.gov. Evaluation of LY2951742 in the Prevention of Chronic Migraine (REGAIN). NCT02614261. Website. https://clinicaltrials.gov/ct2/show/NCT02614261?term=NCT02614261&rank=1. Accessed June 14, 2021.
  • ClinicalTrials.gov. Evaluation of LY2951742 in the Prevention of Episodic Migraine- the EVOLVE-1 Study (EVOLVE-1). NCT02614183. Website. https://clinicaltrials.gov/ct2/show/NCT02614183?term=NCT02614183&rank=1. Accessed June 14, 2021.
  • ClinicalTrials.gov. Evaluation of LY2951742 in the Prevention of Episodic Migraine- the EVOLVE-2 Study (EVOLVE-2). NCT02614196. Website. https://clinicaltrials.gov/ct2/show/NCT02614196?term=NCT02614196&rank=1. Accessed June 14, 2021.
  • ClinicalTrials.gov. Study to Evaluate the Efficacy and Safety of AMG 334 Compared to Placebo in Migraine Prevention (ARISE). NCT02483585. Website. https://clinicaltrials.gov/ct2/show/NCT02483585?term=NCT02483585&rank=1. Accessed June 14, 2021.
  • Croop R, Lipton RB, Kudrow D, et al.Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021 Jan 2;397(10268):51-60.
  • Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the Treatment of Migraine. N Engl J Med. 2019 Dec 5;381(23):2230-2241.
  • Emgality Prescribing Information. Eli Lilly and Company. Indianapolis, IN. December 2019.
  • Goadsby PJ, Reuter U, Hallström Y, et al. A Controlled Trial of Erenumab for Episodic Migraine (STRIVE). N Engl J Med. 2017 Nov 30;377(22):2123-2132.
  • 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
  • Institute for Clinical and Economic Review Draft Evidence Report. Calcitonin Gene-Related Peptide (CGRP) Inhibitors as Preventive Treatments for Patients with Episodic or Chronic Migraine: Effectiveness and Value. April 2018. Available here: https://icer-review.org/wp-content/uploads/2017/11/ICER_Migraine_Draft_Report_041118.pdf. Accessed June 14, 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.
  • National Institute for Health and Care Excellence. Management of migraine (with or without aura). April 17th, 2018. Available at: https://pathways.nice.org.uk/pathways/headaches/management-of-migraine-with-or-without-aura#path=view%3A/pathways/headaches/management-of-migraine-with-or-without-aura.xml&content=view-node%3Anodes-prophylactic-treatment. Accessed June 14, 2021.
  • Nurtec ODT Prescribing Information. Biohaven Pharmaceuticals, Inc. New Haven, CT. May 2021.
  • Per Clinical Consultation with a Neurologist. January 24, 2018.
  • Qulipta Prescribing Information. AbbVie Inc. North Chicago, IL. October 2021.
  • Reyvow Prescribing Information. Lilly USA, LLC Indianapolis, IN. August 2021. 
  • Silberstein SD, Holland S, Freitag F, et al. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012 Apr 24;78(17):1337-45.
  • 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.
  • Vyepti Prescribing Information. Lundbeck Seattle BioPharmaceuticals, Inc. Bothell, WA. February 2020.

Last review date: October 19, 2021