Take a closer look at how erenumab, the first CGRP inhibitor to win FDA-approval for migraine prevention, earned that spot.
Erenumab: First-in-Class Approved for Migraine Prevention. Erenumab is the first of 4 calcitonin gene related peptide inhibitors to receive FDA approval for the prevention of migraines in adults. Erenumab, a fully humanized monoclonal antibody, works by targeting and blocking the CGRP receptor. Scroll through the slideshow above for highlights of the ARISE trial, which supported the FDA decision for erenumab approval, plus a modeling study on cost.
First CGRP Inhibitor Approved for Migraine Prevention. Erenumab is the first FDA-approved CGRP inhibitor for the prevention of adult migraine and is given as a once-monthly injection. FDA approval was supported by the phase III results of the ARISE trial.
ARISE Trial: Erenumab in Episodic Migraine. The ARISE trial was a double-blind, placebo-controlled phase III study conducted at 69 sites throughout North America and Europe over one year; 577 adults with episodic migraine were randomized to either placebo or 70 mg of erenumab with follow-up at 3 months.
Reduction in Migraine Days with Erenumab vs Placebo. Erenumab vs placebo showed 1 fewer migraine day per month with significantly more participants reporting a greater than 50% decrease from baseline in migraine days per month. Also, participants had fewer days a month requiring migraine-specific medication, experienced improved physical function and quality of life, and reported reduction in clinically meaningful disability.
Will Erenumab be Cost-Effective? At the time of approval, list price for erenumab had not been determined. A separate statistical modeling study estimated a value-based price range (VBP), which was the maximum price at which erenumab was considered cost effective vs comparator. The study compared erenumab 140 mg subQ monthly to supportive care.
Potential Savings: >$8000 Erenumab vs Supportive Care. The modeling study estimated that over 10 years, participants who received erenumab vs supportive care had 144 fewer migraine days; that $8482 is saved per patient due to decreased MMDs, and the estimated VBP was between $14 238 and $23 998 a year.
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References:1. FDA.Â FDA approves novel preventive treatment for migraine. May 2018. Accessed May 31 2018 at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608120.htmÂ 2.Â 2. Dodick DW, Ashina M, Brandes JL, et al. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018;38:1026-1037.Â 3.Â 3. Lipton RB, Brennan A, Palmer S, et al. Estimating the clinical effectiveness and value-based price range of erenumab for the prevention of migraine in patients with prior treatment failures: a US societal perspective. J Med Econ. 2018;3:1-10Â Â