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CGRP Antagonists

Preferred Drug - Emgality™ 120 mg/mL prefilled pen and prefilled syringe (galcanezumab-gnlm) [Eli Lilly and Company]
                             Aimovig™ (erenumab-aooe) [Amgen Inc.] 
                             Ajovy™ (fremanezumab-vfrm) [Teva Pharmaceuticals USA, Inc.]
                             Emgality™ 100 mg/mL prefilled syringe (galcanezumab-gnlm) [Eli Lilly and Company

February 2020

Therapeutic area - Antimigraine Preparations, CGRP Antagonists

Initial approval criteria for Emgality 120mg/mL prefilled pen, Emgality 120mg/mL prefilled syringe (Preferred)

  • Preferred drug is prescribed by, or in consultation with a specialist (including neurologist or pain specialist) AND
  • Patient has a diagnosis of migraine with or without aura based on International Classification of Headache Disorders (ICHD-III) diagnostic criteria AND
  • Medication overuse headache has been ruled out by trial and failure of titrating off acute migraine treatments in the past AND
  • Patient has ≥ 4 migraine days per month for at least 3 months AND
  • Patient has tried and failed a ≥ 1 month trial of any 2 of the following oral medications:  
    • Antidepressants (e.g., amitriptyline, venlafaxine)
    • Beta blockers (e.g., propranolol, metoprolol, timolol, atenolol)
    • Anti-epileptics (e.g., valproate, topiramate)
    • Angiotensin converting enzyme inhibitors/angiotensin II receptor blockers (e.g., lisinopril, candesartan)
  • Initial approval is for 3 months

Initial approval criteria for Aimovig, Ajovy (Nonpreferred)

  • Patient must meet all initial approval criteria for preferred drug AND
  • Patient has tried and failed a 3-month trial of the preferred drug, unless contraindicated
  • Initial approval is for 3 months

Initial approval criteria for Emgality 100mg/mL prefilled syringe

  • Patient must be at least 18 years of age; AND
  • Emgality 100mg/mL prefilled syringe is prescribed by, or in consultation with a specialist (including neurologist or pain specialist); AND 
  • Patient has a diagnosis of episodic cluster headaches based on International Classification of Headache Disorders (ICHD-III) diagnostic criteria as documented in patient chart notes; AND
  • Patient has at least 5 attacks occurring in bouts (cluster periods) that meet the following criteria:
    • Severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes when untreated; during part (but less than half) of the active time course of cluster headache, attacks may be less severe and/or of shorter or longer duration AND
    • Either or both of the following:
      • At least one of the following symptoms or signs ipsilateral to the headache
        • Conjunctival injection and/or lacrimation OR
        • Nasal congestion and/or rhinorrhea OR
        • Eyelid edema OR
        • Forehead and facial swelling OR
        • Miosis and/or ptosis OR
      • A sense of restlessness or agitation AND
    • Attacks have a frequency between 1 every other day to 8 every day; during part (but less than half) of the active time-course of cluster headache, attacks may be less frequent; AND
  • Patient has experienced at least two cluster periods lasting from 7 days to 365 days, separated by pain-free periods lasting at least 3 months; AND
  • Medication overuse has been ruled out by trial and failure of titrating off treatments in the past AND
  • Patient has tried and failed a ≥ 1 month trial of the following oral medications:
    • Verapamil (maximum total daily dose of 480mg to 960mg, unless contraindicated or maximum daily dose cannot be reached due to intolerance) AND
    • Topiramate (maximum total daily dose of 100mg, unless contraindicated or maximum daily dose cannot be reached due to intolerance)
  • Initial approval is for 3 months

Renewal criteria for all CGRP antagonists

  • Patient demonstrated significant decrease in the number, frequency, and/or intensity of headaches AND
  • Patient has an overall improvement in function with therapy AND
  • Has not reached the end of the cluster period, if for cluster headaches AND
  • Absence of unacceptable toxicity (e.g., intolerable injection site pain)
  • Renewal approval is for 12 months

Quantity limits

  • Ajovy: 1 prefilled syringe per 30 days
  • Aimovig: 2 syringes or autoinjectors per 30 days
  • Emgality:
    • 120mg/mL prefilled syringe or prefilled pen: 2 prefilled pens or syringes for the first 30 days; 1 prefilled pen or syringe per 30 days thereafter
    • 100mg/mL prefilled syringe: 3 prefilled syringes every 30 days

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411

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