Calcitonin Gene-Related Peptide (CGRP) agents — Blue Cross Blue Shield of Illinois
off-label indication with peer-reviewed literature support
Initial criteria
- 1. The patient has another FDA labeled indication for the requested agent and route of administration OR
- 2. The patient has another indication that is supported in compendia (non-oncology compendia: DrugDex level 1, 2A, or 2B; AHFS-DI supportive; oncology compendia: NCCN 1 or 2A, AHFS-DI supportive, DrugDex level 1, 2A, or 2B, Clinical Pharmacology supportive, LexiDrugs evidence level A, peer-reviewed medical literature) OR
- 3. The prescriber has submitted TWO articles from major peer-reviewed professional medical journals (e.g., JAMA, NEJM, Lancet) supporting the proposed use(s) as generally safe and effective (randomized, double-blind, placebo-controlled trials acceptable; case studies not acceptable)
Reauthorization criteria
- 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 (migraine prophylaxis): 1. ONE of the following: A. Chronic migraine – diagnosis of chronic migraine (≥15 headache days/month of migraine-like or tension-like headache for ≥3 months before prevention therapy) AND the requested agent/strength are FDA labeled for chronic migraine OR B. Episodic migraine – diagnosis of episodic migraine (4–14 monthly migraine days before prevention therapy) AND the requested agent/strength are FDA labeled for episodic migraine; AND the patient has had clinical benefit with the requested agent; AND the agent not used in combination with another prophylactic use CGRP. OR B. Episodic cluster headache treatment – patient has had clinical benefit with the requested agent AND agent/strength FDA labeled for episodic cluster headache treatment. OR C. Acute migraine treatment – patient has had clinical benefit with the requested agent AND agent not used with another acute migraine therapy (5HT‑1F, acute use CGRP, ergotamine) for same indication AND agent/strength FDA labeled for acute migraine treatment; medication overuse headache ruled out. OR D. Non‑migraine indications – patient has 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