By Angela Maas

When the FDA approved BioCryst Pharmaceuticals, Inc.’s Orladeyo (berotralstat) last month, 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.

The FDA approved the first drug to treat HAE, Shire plc’s Cinryze (C1 esterase inhibitor [human]), on Oct. 10, 2008. Since then, the FDA has approved eight drugs to treat HAE: half for acute attacks and half for prophylaxis.

Orladeyo will compete against Cinryze, Haegarda (C1 esterase inhibitor [human]) and Takhzyro (lanadelumab-flyo) to prevent HAE attacks.

For the Managed Care Biologics and Injectables Index: Q1 2020, between Feb. 25, 2020, and April 1, 2020, Zitter surveyed 51 commercial payers with 138.1 million covered lives about their anticipated management of Orladeyo. Payers covering 93% of lives said they likely would manage it to label and not allow off-label use.

Among 46 commercial payers with 130.3 million covered lives surveyed during the same time period, payers with 74% of covered lives said they were likely to manage Orladeyo at parity to the prophylactic therapies. And even though it is the only oral HAE drug, payers with 80% of lives said they were unlikely to manage it separately from the other drugs based on route of administration.

Among providers who would transition current patients to Orladeyo, the most likely prophylactic agent to transfer from was Cinryze, cited by 42%; followed by Haegarda, at 25%; and Takhzyro at 8%.

BioCryst has priced Orladeyo at $485,000 per person per year, which is slightly more than the $450,000 PPPY that Evercore ISI expected, according to analyst Liisa Bayko in a Dec. 4 research note. That price, though, is lower than Haegarda’s $510,000 PPPY and Takhzyro’s $566,000, she pointed out.

“As an oral, once-daily option, Orladeyo provides significant attack reduction without the burden associated with injectables — the hallmark of treatment options,” wrote Bayko. “Our market research showed that patients and physicians were eagerly awaiting an oral option, with anticipated use of Orladeyo reaching 34% of prophylaxis HAE market by [year-end] 2021 — driven by switching and growth of the market with use of prophylaxis rising from 60% to 80% over time.”