Galcanezumab-gnlm (Emgality®)

SELF ADMINISTRATION

Indications for Prior Authorization:
  • Indicated for the preventive treatment of migraine in adults
  • Indicated for the treatment of episodic cluster headache in adults
Patients must meet the following criteria for the indication(s) above:

Preventive treatment of migraine:

  • 18 years of age or older, AND
  • Patient has 4 or more migraine headache days per month (prior to initiating a migraine-preventative medication) as confirmed by chart note documentation, AND
  • Patient has tried and failed at least 2 standard prophylactic pharmacologic therapies, each from a different pharmacologic class (e.g. angiotensin receptor blocker, angiotensin converting enzyme inhibitor, anticonvulsant, ß-blocker, calcium channel blocker, tricyclic antidepressant, other antidepressant), and meets one of the following:
    • Patient has had inadequate efficacy to both of those standard prophylactic pharmacologic therapies, according to the prescribing physician, OR
    • Patient has experienced adverse event(s) severe enough to warrant discontinuation of both of those standard prophylactic pharmacologic therapies, according to the prescribing physician, OR
    • Patient has had inadequate efficacy to one standard prophylactic pharmacologic therapy and has experienced adverse event(s) severe enough to warrant discontinuation to another standard prophylactic pharmacologic therapy, according to the prescribing physician, AND
  • For patients previously on Botox®: patient has not received a Botox® injection in the past 8 weeks, AND
  • Patient will not be initiating Botox® injection therapy, AND
  • Patient will not use Emgality® in combination with another CGRP receptor antagonist (e.g. Aimovig® or Ajovy®)

Episodic cluster headache:

  • 18 years of age or older, AND
  • Patient has between one headache every other day and eight headaches per day, AND
  • Patient has tried at least two standard prophylactic pharmacologic therapies, each from a different pharmacologic class, for cluster headache (examples of standard prophylactic pharmacologic therapies for cluster headache include lithium, verapamil, melatonin, frovatriptan, prednisone, subocciptal steroid injection, topiramate, and valproate), AND
  • Patient meets ONE of the following criteria:
    • The patient has had inadequate efficacy to both of those standard prophylactic pharmacologic therapies, according to the prescribing physician, OR
    • Patient has experienced adverse event(s) severe enough to warrant discontinuation of both of those standard prophylactic pharmacologic therapies, according to the prescribing physician, OR
    • Patient has had inadequate efficacy to one standard prophylactic pharmacologic therapy and has experienced adverse event(s) severe enough to warrant discontinuation to another standard prophylactic pharmacologic therapy, according to the prescribing physician
The following conditions do not meet the criteria for use as established by WHA P&T committee:
  • Acute treatment of migraine
  • Not approvable for concomitant use with Botox®
Dosing:

Migraine headache:

  • Loading dose: 240mg (administered as 2 consecutive injections of 120mg each)
  • Maintenance dose: 120mg every month

Cluster headache:

  • 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
Approval:
  • Initial: 3 months
  • Renewal: 1 year if chart note documentation denotes a positive clinical response documenting a decrease in the number and frequency of migraine headaches

Last review date: July 15, 2020

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