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Update on access to coagulation products for hemophilia A and B

| 17/02/2022

by David Page, CHS National Director of Health Policy

Access to a wide range of coagulation products is expanding in the provinces and territories served by Canadian Blood Services (CBS); however; many questions remain unanswered in Quebec.

Emicizumab (Hemlibra)
The introduction by CBS of emicizumab for those with severe hemophilia A (baseline factor VIII level of less than 1%) without inhibitors continues to proceed well.

Emicizumab was made available starting on October 18, 2021. As of mid-February, 143 people have transitioned from factor VIII prophylaxis to emicizumab. An additional 71 requests have been received by CBS for start dates later in February and March. Approximately 70 people with factor VIII inhibitors switched from bypassing therapies to emicizumab in 2019. There are 800 people with severe hemophilia A in provinces and territories served by CBS.

CBS is closely monitoring emicizumab inventory and the number of patients approved to ensure that all patients who switch to this therapy can continue without interruption. CBS has stated that supply is adequate to meet the current rate of new requests (13 per week) and it is able to respect the starting dates requested by physicians.

In Quebec, children four years of age or less as of August 2021 requiring prophylaxis are eligible to receive emicizumab and a small number of them have started treatment. Those with inhibitors to factor VIII have been eligible since 2019. However, a final decision on access for those five years and older without inhibitors remains to be taken. News is expected early in 2022. A negative decision would leave Quebec as one of the few jurisdictions in the developed world to deny access to emicizumab to those with severe hemophilia A.

Factor concentrates
New contracts between CBS and manufacturers of factor VIII and IX concentrates take effect April 1, 2022. People with hemophilia A and B will have access to the widest choice of concentrates ever.

CBS will supply seven recombinant FVIII products:

  • Adynovate (Takeda), extended half-life
  • Eloctate (Sanofi), extended half-life
  • Esperoct (NovoNordisk), extended half-life
  • Jivi (Bayer), extended half-life
  • Kovaltry (Bayer)
  • Xyntha (Pfizer)
  • Zonovate (Novo Nordisk)

All of these products will be supplied without any conditions. Physicians will not be required to use the Named Patient Contract form. Choice of product will be at the discretion of the patient and treating physician.

Among products currently on the market, only Nuviq (Octapharma) will not be renewed. Those currently using Nuviq will be required to change as of April 1, 2022.

CBS will supply three recombinant FIX products:

  • Alprolix (Sanofi), extended half-life
  • BeneFIX (Pfizer)
  • Rebinyn (Novo Nordisk), extended half-life

As in hemophilia A, all of these products will be supplied without restrictions. Physicians will not be required to use the Named Patient Contract form. No FIX products currently in use have been removed from the market.

Héma-Québec is currently holding, or about to begin, tenders to select factor VIII and IX concentrates for the 2022-2025 contract period. As with the recent CBS tender, the CHS is being consulted and will advocate for the widest selection possible, including extended half-life concentrates without special conditions for access, such as age. Results of these tenders should be known later in 2022.