MMIT Reality Check on Hemophilia A or B With Inhibitors (July 2022)

Payer Coverage:

A review of market access for hemophilia A or B with inhibitors treatments shows that under the pharmacy benefit, about 42% of the lives under commercial formularies are covered with utilization management restrictions. Around 16% of the lives under health exchange 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 75% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

For about 89% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 7% of the lives require multiple steps. Around 59% of payer-controlled pharmacy benefit covered lives require prior authorization, with 21% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

2022 Outlook: Notable FDA Approvals, Payer Strategies Are Specialty Trends

The specialty pharmacy industry will continue its growth in 2022, experts tell AIS Health, a division of MMIT. According to Dea Belazi, Pharm.D., M.P.H., president and CEO of AscellaHealth, “the focus on the specialty pipeline is on new and emerging therapies for disease states that have not had prior therapeutic options or new advances in treatment options, particularly for rare and orphan diseases, hemophilia, hereditary angioedema (HAE) and emerging gene/cell therapies….[Sanofi’s] fitusiran, a first-in-class RNAi targeting antithrombin, is being investigated for the treatment of all hemophilia A and B patients with or without inhibitors.”

Fitusiran Prophylaxis Safe, Effective for Patients With Hemophilia A or B With Inhibitors

A once-monthly subcutaneous prophylaxis dose of fitusiran cut bleeding for people with hemophilia A or B with inhibitors compared with patients who had on-demand bypassing agents, according to results of the randomized Phase III ATLAS-INH study presented at the American Society of Hematology annual meeting in December 2021.

FDA Approves Sevenfact

In April 2020, the FDA approved Laboratoire Francais du Fractionnement et des Biotechnologies S.A.’s Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding episodes in people at least 12 years old with hemophilia A or B with inhibitors. The weight-based dosing and administration of product are based on whether bleeds are mild, moderate or severe.

Key Findings:

Market Events Drive Changes

In April 2020, the FDA approved Laboratoire Francais du Fractionnement et des Biotechnologies S.A.’s Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding episodes in people at least 12 years old with hemophilia A or B with inhibitors. HEMA Biologics, LLC commercializes and distributes the product in the U.S. and Canada. In November 2017, the FDA approved Roche Group unit Genentech USA, Inc.’s Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have factor VIII inhibitors.

Competitive Market Landscape

Health plans are not differentiating hemophilia A or B with inhibitor products. There is minimal contracting for this class. Competition is expected to grow with longer-acting products entering the market.

Pharmacy, Medical Benefit Implications

While there are very limited instances where products aren’t covered under either the medical and/or pharmacy benefits, there is minimal management of specific products. More pharmacy coverage is seen as products are listed as self-administered specialty drugs. For managed Medicaid, few MCOs will carve out hemophilia products to the state Medicaid fee-for-service program. Coverage is prevalent under Medicare Part B. The majority of the time where prior authorization is defined, diagnosis will be required.

Key Players in Market:

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