A review of market access for acute migraine treatments shows that under the pharmacy benefit, about 47% of the lives under commercial formularies are covered with utilization management restrictions. Around 49% of the lives under health exchange formularies are not covered for at least one of the drugs.
For about 43% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, only 62% of the lives require multiple steps. Around 53% of payer-controlled pharmacy benefit covered lives require prior authorization, with 44% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
In September 2021, the FDA approved Impel NeuroPharma, Inc.’s Trudhesa (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. According to the company, the medication is the first and only therapeutic to use Precision Olfactory Delivery (POD) technology to deliver dihydroergotamine mesylate (DHE) to the vascular-rich upper nasal space.
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.
Despite a slew of new branded therapies for acute migraine treatment and migraine prevention, many of which target calcitonin gene-related peptide (CGRP) receptors, health plans and PBMs continue to rely mainly on generic triptans for acute migraine treatment and generic beta-blockers, antiepileptics and tricyclic antidepressants for migraine prevention, drug benefits 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 September 2021, the FDA approved Impel NeuroPharma, Inc.’s Trudhesa (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. In May 2021, the FDA gave Biohaven Pharmaceutical Holding Company Ltd.’s Nurtec ODT (rimegepant) an additional approval for the preventive treatment of migraine, making it the only migraine medication approved for both acute and preventive treatment. In February 2020, the agency approved the tablet for the acute treatment of migraine 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 Implication
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: