MMIT Reality Check on Acute Migraine (3Q2023)

Payer Coverage:

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 41% of the lives under Medicare 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, 61% of the lives require multiple steps. Around 57% of payer-controlled pharmacy benefit covered lives require prior authorization (PA), with 30% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Approves Rizafilm VersaFilm

In April 2023, the FDA approved IntelGenx Corp.’s Rizafilm VersaFilm 505(b)(2) new drug application for the treatment of acute migraine. Rizafilm (the U.S. market name for Rizaport) is a proprietary oral thin film formulation of rizatriptan benzoate, the active ingredient in Merck & Co., Inc.’s Maxalt.

FDA Approves Zavzpret

In March 2023, the FDA approved Pfizer Inc.’s Zavzpret (zavegepant), making it the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults.

FDA Approves Trudhesa

In September 2021, the FDA approved Impel NeuroPharma, Inc.’s Trudhesa (dihydroergotamine mesylate, or DHE) nasal 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 DHE to the vascular-rich upper nasal space.

Key Findings:

Market Events Drive Changes

There are a variety of multisource branded and generic triptans on the market. In April 2023, the FDA approved IntelGenx Corp.’s Rizafilm VersaFilm for the treatment of acute migraine. In March 2023, the agency approved Pfizer Inc.’s Zavzpret (zavegepant) for the acute treatment of migraine with or without aura in adults. In September 2021, the FDA approved Impel NeuroPharma, Inc.’s Trudhesa (dihydroergotamine mesylate) nasal spray for the acute 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. Market access is the biggest differentiator among migraine products, especially for the CGRPs. The CGRPs have similar efficacy, meaning physicians typically choose brands based on insurance coverage or convenience of formulation.

Pharmacy Benefit Implication

Most policies require diagnosis and use of generic triptans prior to brand name products. CGRPs provide a good option for those who have contraindications, who have intolerable side effects or whose migraine is not well controlled by triptans. Quantity limits are more common than PA for the class.

Key Players in Market:

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