Orladeyo may soon be available through Canada’s healthcare system

Orladeyo (berotralstat), an approved oral treatment to prevent attacks in hereditary angioedema (HAE) patients 12 years and older, is one step closer to being eligible for reimbursement under public drug plans in Canada, according to its developer, Biocryst Pharmaceuticals.

Biocryst has successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA), a government partnership that negotiates medication prices for the country’s provinces and territories, which manage their own public health programs.

“Today’s announcement marks an important step in making Orladeyo accessible through our publicly funded healthcare system for many people across Canada living with HAE,” Michelle Cooper, president of HAE Canada, said in a press release. “We appreciate the collaboration between BioCryst and the pCPA to reach this agreement to help improve the quality of life for HAE patients.”

While some HAE patients in Canada can be reimbursed for the therapy via private insurance plans, Biocryst will work with provincial and territorial drug plans to ensure Orladeyo is added to the public list of medications, the company said.

Orladeyo was approved in Canada in 2022

Orladeyo was approved by Health Canada in 2022 for the routine prevention of HAE attacks in patients 12 and older. Negotiations with the pCPA, which began earlier this year, come on the heels of a positive clinical recommendation for Orladeyo from Canada’s Drug Agency, formerly the Canadian Agency for Drugs and Technologies in Health.

The move was also supported by L’Institut national d’excellence en santé et en services sociaux (INESSS), Quebec’s regulatory review agency.

“In a relatively short amount of time, we have made significant progress, including securing approval of Orladeyo from Health Canada and receiving positive recommendations from Canada’s Drug Agency and INESSS,” said Anand Janack, vice president and general manager of Biocryst Canada.

Given as an oral capsule once a day, Orladeyo is designed to prevent HAE attacks by blocking kallikrein, a precursor of bradykinin. This pro-inflammatory molecule is overproduced in HAE patients and triggers sudden swelling and pain attacks.

Orladeyo’s approvals for HAE in various countries, including Canada, were mainly supported by data from the Phase 3 APeX-2 study (NCT03485911). Data showed Orladeyo outperformed a placebo in lowering rates of swelling attacks.

In a real-world claims analysis, the therapy also significantly reduced the number of disease-related or all-cause hospitalizations and emergency room visits among HAE patients in the U.S.

“The completion of the negotiations with pCPA mark a critical step in bringing Orladeyo to patients with HAE through the public health system in Canada,” Janack said. “These achievements fuel our mission to bring our oral, once-daily prophylactic [preventive] therapy to as many people living with HAE as possible around the world.”