WHA

AIMOVIG (erenumab-aooe)

Self-Administration – injectable

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 70 mg or 140 mg given subcutaneously (SC) once per month; 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; AND
  • Patient has experienced an inadequate response or intolerable side effects to Emgality®
Reauthorization Criteria:

Preventive treatment of migraine

  • Dose does not exceed 70 mg or 140 mg given subcutaneously (SC) once per month; 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:
  • Constipation with serious complications has been reported following the use of Aimovig® in the postmarketing setting.  Patients should be monitored.
  • Development of hypertension and worsening of pre-existing hypertension have been reported following the use of Aimovig® in the postmarketing setting.  Patients should be monitored.
Policy Updates:
  • 07/23/2019 – New policy approved by P&T
  • 08/21/2020 – Criteria updated for not used in combination with another CGRP
  • 10/19/2021– Prophylactic pharmacologic therapy trial and failure criteria updated; reauthorization criteria modified; criteria not allowing combination with Botox removed; combination CGRP inhibitor criteria updated
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

Friday, July 19 Breaking News: A widespread computer software outage is impacting systems across the globe. Health care services in Northern California are reporting some disruption. WHA encourages members to call ahead to your provider if you have an appointment scheduled for today or this weekend.