Québec approves Hemlibra but …

August 20, 2021, Montréal – The Canadian Hemophilia Society – Quebec Chapter (CHSQ) has learned that the Québec Ministère de la Santé et des Services sociaux has added Hemlibra (emicizumab) to the Héma-Québec list of products for the treatment of patients with moderate and severe hemophilia A.

No restrictions are specified for access to those four years old and less; however, for older patients, the annual cost of treatment can be no more than the current cost of factor VIII.

Negotiations on the pricing of the medication remain to be undertaken between Héma-Québec and the manufacturer, Roche. “The CHSQ welcomes this decision, said CHSQ president, Mathieu Jackson. We urge Roche and Héma-Québec to reach a quick and successful agreement so that Hemlibra is priced to make it available to all those with severe hemophilia A in the coming weeks. Our members have been waiting for this treatment advance far too long already.”

Hemlibra is a bi-specific monoclonal antibody that mimics the function of factor VIII to prevent bleeding in hemophilia A. It is approved by Health Canada for all ages. Hemlibra is used for prophylaxis, but not to stop active bleeds.

Hemlibra has several important qualities:

• It is injected subcutaneously, not intravenously, once a week or less, making administration much easier, especially in small children. It removes the need for central venous access devices.
• It maintains a constant level of protection from bleeding, estimated to be equivalent to a factor VIII level of 10 to 20 percent, rather than the high peaks and low troughs that come with factor VIII prophylaxis.

Both the CHS and the CHSQ have advocated for access to Hemlibra, first for patients with inhibitors to factor VIII and, for the last two years, for patients without inhibitors. Hemlibra has been adopted as a standard of prophylactic care by patients in countries around the world since 2018.

In the rest of Canada, the provincial and territorial Ministries of Health have promised a decision on access “this summer.” Both Canadian Blood Services and the Canadian Agency for Drugs and Technologies in Health have made positive recommendations to the provincial/territorial Deputy Ministers. Price negotiations between Roche and Canadian Blood Services have successfully completed.

“I want to thank all those from the hemophilia community who took the time to write to their elected representatives and make sure the patient voice was heard,” said Mathieu Jackson.

The CHS-CHSQ will provide updates as they become available.