Montreal, December 16, 2021 – The rollout of emicizumab (Hemlibra) in the provinces and territories served by Canadian Blood Services (CBS) is well underway.
Emicizumab access was expanded to severe hemophilia A patients (baseline factor VIII level less than 1%) without inhibitors, effective October 18, 2021. Over the past eight weeks, CBS has received 133 new requests for emicizumab. As of mid-December, CBS has made emicizumab available to 74 new patients, in addition to the approximately 80 inhibitor patients on therapy since 2019. There are just over 1,000 people with severe hemophilia A in Canada.
The rate of new requests for emicizumab has been higher than CBS anticipated. It continues to work with the manufacturer, Roche, to increase inventory, and is monitoring volumes closely to ensure that supply for all patients currently on the therapy does not fall short.
At this time, the available inventory can only support the currently approved patients, as well as additional 41 patients whose applications were received prior to December 10 and who were approved to start treatment in January and February 2022. CBS has asked prescribing physicians to continue to submit new requests in advance, but not to plan for starts prior to March 1, 2022. For new patients, treatment centres are being asked to order only a one-month supply (the loading dose) to start. This will help to mitigate supply challenges while still supporting new starts until inventory increases.
CBS has written to physicians, “We appreciate your support with staggering patient starts based on clinical priority. This is helping us to ensure that patients requiring therapy have been prioritized. We are committed to ensuring all eligible patients are provided access and are working as quickly as we can to increase our inventories.”
Meanwhile in Quebec, the situation is less clear. Children four years of age or less as of August 2021 requiring prophylaxis are eligible to receive emicizumab and a number of patients have started treatment. Those with inhibitors to factor VIII are also eligible; however, a final decision on access for those five years and older without inhibitors remains to be taken. News is expected very early in 2022.