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Calcitonin Gene-Related Peptide (CGRP) agentsBlue Cross Blue Shield of Montana

off-label indication with evidence from two peer-reviewed studies

Initial criteria

  • One of the following:
  • • The patient has another FDA labeled indication for the requested agent and route of administration OR
  • • The patient has another indication supported in compendia for the requested agent and route of administration OR
  • • The prescriber has submitted TWO articles from major peer-reviewed professional medical journals (e.g., JAMA, NEJM, Lancet) supporting the proposed use as generally safe and effective (case studies not acceptable)

Reauthorization criteria

  • ALL of the following:
  • 1. The patient has been approved for the requested agent previously through the plan’s Prior Authorization process AND
  • 2. ONE of the following:
  • A. BOTH of the following:
  • 1. ONE of the following:
  • A. The requested agent is used for migraine prophylaxis AND ALL of the following:
  • • The patient has had clinical benefit with the requested agent AND
  • • The patient will NOT use the requested agent in combination with another prophylactic use CGRP AND
  • • ONE of the following:
  • A. BOTH of the following:
  • • The patient has a diagnosis of chronic migraine (≥15 headache days per month for ≥3 months prior to prevention therapy) AND
  • • The requested agent/strength are FDA labeled for chronic migraine OR
  • B. BOTH of the following:
  • • The patient has a diagnosis of episodic migraine (4–14 monthly migraine days prior to prevention therapy) AND
  • • The requested agent/strength are FDA labeled for episodic migraine OR
  • B. The requested agent is used for episodic cluster headache AND BOTH of the following:
  • • The patient has had clinical benefit with the requested agent AND
  • • The requested agent/strength are FDA labeled for episodic cluster headache OR
  • C. The requested agent is used for acute migraine AND ALL of the following:
  • • The patient has had clinical benefit with the requested agent AND
  • • The patient will NOT use the requested agent in combination with another acute migraine therapy (5HT-1F, acute-use CGRP, or ergotamine) for this indication AND
  • • The requested agent/strength are FDA labeled for acute migraine treatment AND
  • 2. Medication overuse headache has been ruled out OR
  • B. The patient has a diagnosis other than migraine prophylaxis, episodic cluster headache treatment, or acute migraine treatment AND has had clinical benefit with the requested agent.
  • 3. The patient does not have any FDA labeled contraindications to the requested agent.

Approval duration

12 months