Access to emicizumab expanded

Montreal, May 24, 2024 – Canadian Blood Services (CBS) announced this week that the provinces and territories have agreed to expand access to emicizumab (Hemlibra) for people with moderate hemophilia A and a severe bleeding phenotype requiring prophylaxis.

Until now, use of emicizumab had been restricted to those with severe hemophilia defined as a factor level of less than 1% or a history of an inhibitor to factor VIII. Analysis conducted by the Canadian Bleeding Disorder Registry estimate that up to 100 additional people may become eligible.

In its announcement, CBS wrote that “Exceptional access requests will now be considered for hemophilia A patients with a FVIII level of 1% or greater with a severe bleeding phenotype. To be considered, patients must be on prophylactic therapy with FVIII or demonstrate a requirement for prophylactic therapy.”

This change means that access criteria are now the same as in Quebec where those with a severe bleeding phenotype requiring prophylaxis have been eligible for emicizumab since 2022.

In addition, emicizumab can now be prescribed for those with acquired hemophilia A, a very rare condition that affects about 1 in 1 million people every year, usually later in life.

“This is incredible news,” said Wendy Quinn, CHS President, “and many thanks to all who advocated so solidly and stayed the course.”

The advance comes after two and a half years of efforts by the Canadian Hemophilia Society to convince the provinces and territories of the need for a change to the access criteria. Emicizumab was first introduced for non-inhibitor patients in October 2021.

People who think they may qualify should contact their treatment centre. Prescribing physicians must complete an Exceptional Access form and provide detailed clinical information to support the request.