A review of market access for acute migraine treatments shows that under the pharmacy benefit, almost 46% of the lives under commercial formularies are covered with utilization management restrictions. Around 35% of the lives under health exchange formularies are not covered for at least one of the drugs.
For about 53% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, 65% require multiple steps. Around 47% of payer-controlled pharmacy benefit covered lives require prior authorization, with 30% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
In February 2020, the FDA approved Biohaven Pharmaceuticals’ Nurtec ODT (rimegepant) for the acute treatment of migraine in adults. The medication is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet, according to the company’s news release.
In December 2019, the FDA approved Allergan USA, Inc.’s Ubrelvy (ubrogepant) tablet for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. The drug is not indicated for the preventive treatment of migraine. It was the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine, according to the FDA.
New oral medications for acute migraine — Eli Lilly and Co.’s Reyvow (lasmiditan), Allergan’s ubrogepant and Biohaven Pharmaceuticals’ CGRP antagonist rimegepant — likely won’t shake up formulary coverage for a condition that’s largely treated by generic triptan medications, pharmacy benefit experts say.
Market Events Drive Changes
There are a variety of multisource branded and generic triptans on the market. The ergotamine agents have been in the market for quite some time but are not considered first-line for acute migraine treatment for the majority of patients. In February 2020, the FDA approved Biohaven Pharmaceutical Holding Company Ltd.’s Nurtec ODT (rimegepant) tablet for the acute treatment of migraine in adults. In December 2019, the agency approved Allergan USA, Inc.’s Ubrelvy (ubrogepant) tablet for the acute (immediate) treatment of migraine with or without aura in adults. In October 2019, Eli Lilly and Co.’s Reyvow (lasmiditan) tablet was approved for the acute (active but short-term) treatment of migraine with or without aura in adults.
Competitive Market Landscape
There is a lot of competition due to this being a mature class with generics available, as well as newer branded products with different mechanisms of action.
Pharmacy Benefit Implications
Most policies require diagnosis and use of generic triptans before ergotamine, mainly due to the black box warning on ergotamine agents. Most policies require use of generic ergotamine prior to brand name products. Quantity limits are more common than PA for the class.
Key Players in Market: