WHA

EMGALITY (galcanezumab-gnlm)

Self-Administration – injectable

Indications for Prior Authorization:
  • Preventive Treatment of Migraine - Indicated for the preventive treatment of migraine in adults
  • Episodic Cluster Headache - Indicated for the treatment of episodic cluster headache in adults
Coverage Criteria:

Preventive Treatment of Migraine

  • Dose does not exceed 240 mg given subcutaneously (SC) for the first month, then 120 mg SC once per month thereafter; 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

Episodic Cluster Headache

  • Dose does not exceed 300 mg given subcutaneously (SC) once monthly; AND
  • Patient is 18 years of age or older; AND
  • Prescribed by or in consultation with a neurologist, pain specialist or headache specialist, OR medical records document the patient has experienced at least 2 cluster periods lasting from 7 days to 365 days, separated by pain-free periods lasting at least three months; AND
  • Documented inadequate response or intolerable side effects to at least TWO prophylactic medications used for cluster headaches as supported by the American Academy of Neurology, American Headache Society (AAN/AHS), or a contraindication to all medications listed for cluster headache prophylaxis:
    • suboccipital steroid injections
    • verapamil
    • melatonin
    • lithium
    • warfarin; AND
  • Will not be used in combination with another injectable CGRP inhibitor
Reauthorization Criteria:

Preventive Treatment of Migraine

  • Dose does not exceed 120 mg 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

Episodic Cluster Headache

  • Dose does not exceed 300 mg given subcutaneously (SC) once monthly; AND
  • Documentation of positive clinical response to therapy (e.g., decrease in number of cluster headaches experienced 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:

Dosing:

  • Preventive Treatment of Migraine - The recommended dosage of Emgality is 240 mg (two consecutive subcutaneous injections of 120 mg each) once as a loading dose, followed by monthly doses of 120 mg injected subcutaneously.
  • Episodic Cluster Headache - The recommended dosage of Emgality is 300 mg (three consecutive subcutaneous injections of 100 mg each) at the onset of the cluster period, and then monthly until the end of the cluster period.
Policy Updates:
  • 10/15/2019 – New policy approved by P&T.
  • 07/15/2020 – Criteria updated for not used in combination with another CGRP
  • 10/19/2021– Prophylactic pharmacologic therapy trial and failure criteria updated; reauthorization criteria modified; modified criteria point under episodic cluster headache to being prescribed by a specialist or having chart notes confirming episodic migraine definition (at least 2 cluster periods lasting from 7 days to 365 days, separated by pain-free periods lasting at least three); 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