New medication approved for acute treatment of migraine ― Ubrelvy™ (ubrogepant) tablets
The U.S. Food and Drug Administration (FDA) has approved a new medication to treat acute (immediate) migraine with or without aura (often described as a visual disturbance such as flashing lights) in adults. This approval allows Allergan USA, Inc. to market Ubrelvy, which according to Allergan, is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist for acute migraine treatment. Ubrelvy will not be indicated to prevent migraine headaches like other injectable CGRP receptor antagonists on the market, such as Aimovig®, Emgality® and Ajovy®.
According to Allergan, Ubrelvy will be available in 50 mg and 100 mg oral tablets, packaged in unique On-the-Go single-dose packets so one dose can be taken as soon as a migraine attack starts. Each strength will be available in pre-packaged boxes containing 6, 8, 10, 12 and 30 packets. Ubrelvy is expected to be available in the first quarter of 2020. To date, the cost has not been published.
Prevention vs. acute treatment
As a reminder, medications used to treat an acute migraine attack are not the same as those medications used to prevent migraine headaches. For acute migraine, medications should be taken at the onset of a migraine and used as needed, at the lowest effective dose, for the shortest period of time to avoid a medication overuse headache.
Impact on workers’ compensation and auto no-fault
As mentioned in a previous blog for a different new medication for acute migraine, in our book of business, the top five most prescribed medications to treat acute migraine include sumatriptan tablets (Imitrex®), butalbital/acetaminophen/caffeine tablets (Fioricet®), butalbital/acetaminophen/caffeine capsules (Fioricet), rizatriptan tablets (Maxalt®) and eletriptan tablets (Relpax®).
Prior to a full review by the Optum Pharmacy and Therapeutics (P&T) Committee, Ubrelvy will be excluded or require prior authorization on our standard formularies. According to prescribing information, the safety of treating more than eight migraines in a 30-day period has not been established. Therefore, similar to other medications indicated to treat acute migraines, quantities should be limited.
To learn more about Ubrelvy, click here.
If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.
- U.S. Food and Drug Administration (FDA). News Release. FDA approves new treatment for patients with migraine. December 23, 2019. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-adults-migraine.
- Allergan. Press Release. Allergan Receives U.S. FDA Approval for Ubrelvy for the Acute Treatment for Migraine With or Without Aura in Adults. December 23, 2019. Available at: https://www.allergan.com/News/Details/2019/.
- Ubrelvy [package insert]. Madison, NJ: Allergan USA, Inc. December 2019. Available at: https://media.allergan.com/products/Ubrelvy_pi.pdf .