U.S. Food and Drug Administration approves Aimovig™

On May 17, 2018, the U.S. Food and Drug Administration (FDA) approved Aimovig™ (erenumab-aooe) for the preventive treatment of migraines in adults. Aimovig (erenumab-aooe) is the first FDA approved drug in a new class of drugs that are classified as calcitonin gene-related peptide receptor blockers. The calcitonin gene related peptide receptor (CGRP-R) is associated with migraine headache. This new agent aids in reducing the number of headache days a month.

Aimovig was approved for the preventative treatment of migraines in adults based on evidence of three placebo controlled clinical trials. More than 3,000 patients participated in the efficacy and safety tests. Between the three studies, patients experienced one to two and one-half fewer migraines per month as compared to placebo. The most common side effects reported in clinical trials were injection site reactions and constipation. The discontinuation rate is listed at two percent. Ongoing open label extension studies will continue for up to five years.

Aimovig, developed in partnership by Novartis Pharmaceuticals and Amgen, Inc., is expected on the market in a week. Aimovig is administered once monthly by self-injection in either a 70 mg or a 140 mg dose. The U.S. list price according to Novartis is $575.00 for a once monthly 70 mg or 140 mg self-administered injection ($6,900 annually). The Redbook average wholesale price (AWP) pricing is not yet published. The pricing of Aimovig is comparable to the cost of botulinum toxin (Botox) 200 units every three months with an annual cost of $5,768. This cost does not include the in-office Botox administration provider fee. Botox is FDA approved for chronic migraine prophylaxis.

With the commonality of migraine headaches in workers’ compensation and liability claims, adjusters are likely to see the use of this medication in the near future. We expect that, similar to the criteria of botulinum toxin for prevention of chronic migraine, Aimovig users will have failed more conservative first line therapy (amitriptyline, beta-blockers, topiramate and valproic acid derivatives). At this time, there is no evidence for the use of botulinum toxin and Aimovig for chronic migraine prevention.

Optum will provide updates as new medications enter the marketplace as well as details on their impact on settlements.

View highlights of prescribing information here.

Additional sources:

  1. FDA approves new drug for preventive treatment of migraine in adults- Drug Information Update Available at: Aimovig Accessed May 18, 2018.
  2. Novartis and Amgen announce FDA approval of Aimovig™ (erenumab-aooe), a novel treatment developed specifically for migraine prevention. Available at: https://www.prnewswire.com/news-releases/novartis-and-amgen-announce-fda-approval-of-aimovig-erenumab-aooe-a-novel-treatment-developed-specifically-for-migraine-prevention-300650779.html. Accessed May 18, 2018.
  3. The Workloss Data Institute. The Official Disability Guidelines (ODG). http://www.disabilitydurations.com/. Accessed May 2018.
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About Evelio Prieto, PharmD., RPh., CPh.

Evelio Prieto is a pharmacist and consultant pharmacist registered in the state of Florida. He is a graduate of the University of Florida College of Pharmacy where he earned a Doctor of Pharmacy degree in 1994. Evelio has worked as a pharmacist at Optum Settlement Solutions for four years. Prior to Optum, Evelio managed two local hospital outpatient and ambulatory infusion pharmacies (Tampa General Hospital and All Children’s Hospital John’s Hopkins Medicine). Prior to this, Evelio spent 15 years managing a Walgreens pharmacy. Throughout his career, he has worked with worker’s compensation and managed care Pharmacy Benefit Managers (PBMs) as well as Medicare Part B and D billing to ensure care for claimants in the community. Evelio served on the Florida Medicaid Drug Utilization Review Board from 2010 to 2015 and is part Optum’s Clinical Center of Excellence.

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