New migraine drugs approved by FDA

Migraine headaches are an intrusive part of life for many. They affect approximately 18% of women and 6% of men, who experience about one or two per month on average.1 In addition to pain, migraines can be associated with nausea, vomiting, and/or sensitivity to light or sound. Sufferers have reason for encouragement though. The United States Food and Drug Administration (FDA) recently approved three new drugs (Nurtec™ ODT, Reyvow™, and Ubrelvy™) for the acute treatment of migraine headaches and one new drug for the prevention of migraine headaches (Vyepti™).  

Reyvow is the first drug in a new class called “ditans” and is a controlled substance schedule V.  Nurtec and Ubrelvy are the first oral calcitonin gene-related peptide (CGRP) inhibitors. Vyepti is the fourth CGRP inhibitor for prevention, but it is the first administered intravenously.

The average wholesale price (AWP) for a dose of Reyvow equals $96, while Nurtec ODT equals $127.50, and Ubrelvy equals $102.2 The FDA recommends treating no more than four migraines per month with Reyvow, 15 migraines per month with Nurtec ODT, and eight migraines per month with Ubrelvy. For Vyepti, The AWP for each infusion given quarterly is $1,794 to $5,328, depending on the dose administered or an annual AWP of $7,176 to $21,528.2

Vyepti is a specialty treatment, covered under the medical benefit with prior authorization. Reyvow, Nurtec ODT and Ubrelvy are all currently excluded from formulary coverage. If medical necessity criteria are met, coverage will be available under the pharmacy benefit as a non-preferred brand. Ubrelvy and Nurtec ODT will be added to the formulary as preferred brands on July 1, 2020. Both will be subject to prior authorization and quantity limits. Effective August 1, 2020, Reyvow will be non-formulary or non-preferred brand, depending on the prescription drug list selected with prior authorization and quantity limits.

  1. The Migraine Research Foundation (MRF). About Migraine. <https://migraineresearchfoundation.org/about-migraine/migraine-facts/>. Accessed June 2020.
  2. Cigna national book of business financial analysis. June 2020.

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