AIMOVIG (erenumab-aooe) injection, AJOVY* (fremanezumab-vfrm) injection, EMGALITY* (galcanezumab-gnim) *These medications are currently pending tier determination and may not be available at this time RATIONALE FOR INCLUSION IN PA PROGRAM Background Aimovig, Ajovy, and Emgality are human immunoglobulin G2 (IgG2) monoclonal antibodies that have high affinity for binding to the calcitonin gene-related peptide (CGRP) receptor and act by antagonizing this receptor. Aimovig, Ajovy, and Emgality are indicated for the preventive treatment of migraine in adults. Other migraine prophylaxis options include antiepileptic drugs, antidepressants, and antihypertensive agents (1-4). Regulatory Status FDA approved indication: Aimovig, Ajovy, and Emgality are calcitonin gene-related peptide receptor antagonists indicated for the preventive treatment of migraine in adults (1-3). The recommended dosage of Aimovig is 70 mg injected subcutaneously once monthly. Some patients may benefit from a dosage of 140 mg injected subcutaneously once monthly (1). Ajovy can be dosed as 225 mg once monthly, or 675 mg every 3 months (quarterly), which is administered as three consecutive subcutaneous injections of 225mg each (2). 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 (3). The safety and effectiveness of Aimovig, Ajovy, and Emgality in pediatric patients have not been established (1-3). Summary Aimovig, Ajovy, and Emgality are human immunoglobulin G2 (IgG2) monoclonal antibodies that have high affinity for binding to the calcitonin gene-related peptide receptor and acts by antagonizing this receptor. They are indicated for the preventive treatment of migraine in adults. The safety and effectiveness of Aimovig, Ajovy, and Emgality in pediatric patients have not been CGRP Antagonists FEP Clinical Rationale AIMOVIG (erenumab-aooe) injection, AJOVY* (fremanezumab-vfrm) injection, EMGALITY* (galcanezumab-gnim) *These medications are currently pending tier determination and may not be available at this time established (1-4). Prior approval is required to ensure the safe, clinically appropriate and cost effective use of Calcitonin gene-related peptide antagonists while maintaining optimal therapeutic outcomes. References 1. Aimovig [package insert]. Thousand Oaks, CA. Amgen Inc., March 2019. 2. Ajovy [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; September 2018. 3. Emgality [package insert]. Indianapolis, IN: Eli Lily and Company; September 2018. 4. Silberstein, S.D. 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 78.17 (2012): 1337–1345. CGRP Antagonists FEP Clinical Rationale .