MMIT Reality Check on Hereditary Angioedema (June 2022)

Payer Coverage:

A review of market access for hereditary angioedema treatments shows that under the pharmacy benefit, about 60% of the lives under commercial formularies are covered with utilization management restrictions. Around 29% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 64% of the lives under commercial policies are covered with utilization management restrictions. Almost 66% 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% require multiple steps. Around 81% of payer-controlled pharmacy benefit covered lives require prior authorization.

Trends:

Cycle Pharmaceuticals Launches Sajazir

In September 2021, Cycle Pharmaceuticals launched Sajazir (icatibant) for the treatment of acute hereditary angioedema attacks in people at least 18 years old. It is a generic version of Takeda Pharmaceuticals U.S.A., Inc.’s Firazyr.

FDA Approves First Oral Therapy For Prevention of HAE Attacks

When the FDA approved BioCryst Pharmaceuticals, Inc.’s Orladeyo (berotralstat), the drug became the first oral treatment for prophylaxis to prevent hereditary angioedema (HAE) attacks. According to Zitter Insights, payers with nearly three-quarters of covered lives plan to manage it at parity to other prophylactic treatments.

HAE is a rare but potentially fatal condition that causes swelling in various parts of the body, including the hands, feet, intestinal tract, face, larynx and trachea.

Prime Studies Show High Costs Among Asthma, HAE Biologics

Prime Therapeutics LLC released the results of two studies in 2020 focused on two classes of high-cost biologics, asthma and hereditary angioedema (HAE). Both conditions have seen new therapies recently and may be candidates for value-based contracts.

Therapies to treat HAE, a rare disease that causes episodes of subcutaneous or submucosal edema, consist of on-demand treatments for acute episodes and prophylactic drugs for long-term use to prevent attacks. The latter category has three treatments available: Cinryze (C1 esterase inhibitor), which the FDA approved in 2008; Haegarda (C1 esterase inhibitor), with a 2017 FDA approval; and Takhzyro (lanadelumab-flyo), approved in 2018.

Key Findings:

Market Events Drive Changes

There are currently multiple products approved by the FDA for preventing and treating hereditary angioedema (HAE) attacks, including numerous generic versions of Takeda Pharmaceuticals U.S.A., Inc.’s Firazyr. In December 2020, the FDA approved BioCryst Pharmaceuticals, Inc.’s Orladeyo (berotralstat) for prophylaxis to prevent HAE attacks in people at least 12 years old. It is the first oral treatment approved for this use. In August 2018, the FDA approved Shire plc’s (now a Takeda subsidiary) Takhzyro (lanadelumab-flyo) to prevent HAE attacks in people at least 12 years old, while in June of that same year, the agency expanded the label of Takeda’s Cinryze (C1 esterase inhibitor [human]) to include the prevention of HAE attacks in children at least six years old.

Competitive Market Landscape

Health plans don’t differentiate coverage among provider-administered products, and access to HAE products is not limited at the brand level. However, increased competition is expected as more prophylactic therapies enter the market. As contract negotiations continue to drive to preferred products, step therapy will become more prevalent.

Pharmacy, Medical Benefit Implications

Coverage is under both the pharmacy and medical benefits. Self-administered products are usually covered under the pharmacy benefit. Drugs for this indication are generally covered with prior authorization (PA). When PA is defined, diagnosis of HAE is confirmed by C4 and C1-INH levels below normal as defined by the laboratory performing the test. A history of HAE attacks is required. There is minimal step restriction with the exception of Cinryze, which most policies will require a step through a generic alternative prophylaxis.

Key Players in Market:

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