MMIT Reality Check on Migraine Prevention (4Q2022)

Payer Coverage:

A review of market access for preventive migraine treatments shows that under the pharmacy benefit, about 50% of the lives under commercial formularies are covered with utilization management restrictions. Around 15% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 65% of the lives under commercial policies are covered with utilization management restrictions. Almost 47% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.

For about 41% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 74% require multiple steps. Around 70% of payer-controlled pharmacy benefit covered lives require prior authorization, with 10% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Approves Eprontia

In November 2021, the FDA approved Azurity Pharmaceuticals, Inc.’s Eprontia (topiramate) oral solution for the preventive treatment of migraine in patients 12 years of age and older. The medication is the first and only liquid formulation of topiramate to be approved as a monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; an adjunctive therapy for treatment of partial-onset seizures, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older; and, as a preventive treatment of migraine in patients 12 years of age and older.

FDA Approves AbbVie’s Qulipta in Migraine Prevention

In September 2021, the FDA approved AbbVie Inc.’s CGRP inhibitor Qulipta (atogepant) for the prevention of episodic migraine in adults, with analysts already calling the drug a blockbuster-to-be. Qulipta will have to face off against Biohaven’s Nurtec ODT (rimegepant), the first oral CGRP inhibitor approved in the migraine space. For migraine prevention, Nurtec holds covered or better status for 77% of all insured lives under the pharmacy benefit and is not covered for 19.2% of lives, as of October 2021.

FDA Gives Additional Approval to Nurtec ODT

In May 2021, the FDA approved Biohaven Pharmaceutical Holding Company Ltd.’s Nurtec ODT (rimegepant) for the preventive treatment of episodic migraine in adults. It was the first oral CGRP antagonist approved for the preventive treatment of migraine and the only migraine medication approved as a dual therapy for both preventive and acute treatment, with the agent first gaining approval for the latter indication in February 2020.

Key Findings:

Market Events Drive Changes

In November 2021, the FDA approved Azurity Pharmaceuticals, Inc.’s Eprontia (topiramate) oral solution for the preventive treatment of migraine in patients 12 years of age and older. In September 2021, the agency approved AbbVie’s CGRP inhibitor Qulipta (atogepant) for the prevention of episodic migraine in adults. In May 2021, the agency approved Biohaven’s Nurtec ODT (rimegepant for the preventive treatment of episodic migraine in adults. It was the first oral CGRP antagonist approved for the preventive treatment of migraine and the only migraine medication approved as a dual therapy for both acute and preventive treatment.

Competitive Market Landscape

Payers have equal amount of power and position when it comes to coverage of prophylactic treatments of migraine. More than 90% require patients to fall under certain criteria for coverage eligibility.

Pharmacy, Medical Benefit Implications

Coverage of drugs in this class is under both the pharmacy and medical benefits. Payers cover the medications for migraine prevention with prior authorization. Patients must be 18 or older and have the medication prescribed by a neurologist or a headache specialist. Patients must also have three to four headache days per month and tried other prophylactic options. Finally, in order to get a re-authorization after six months, the prescriber needs to present documentation showing a 50% reduction in headache days since initiation of therapy.

Key Players in Market:

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