Reimbursement of Altuviiio recommended, but…
MONTRÉAL, July 3, 2025 – In June, both Canada’s Drug Agency (CDA) and Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS) released their final recommendations on Altuviiio, an ultra-extended-half-life factor VIII concentrate. They recommended that Altuviiio be reimbursed for adults and children with hemophilia A for …
- routine prophylaxis to prevent or reduce the frequency of bleeding episodes;
- treatment and control of bleeding episodes; and
- perioperative management of bleeding (surgery).
Their recommendations, however, come with conditions regarding pricing. Moreover, the steps required before Altuviiio is available vary between Québec and the rest of the country.
The Provinces/Territories (with the exception of Québec)
While the CDA report is a major milestone, several steps remain before patients have access to this novel therapy. These include:
- successful price negotiations between Canadian Blood Services (CBS) and the manufacturer, Sanofi. The CDA stipulated that the introduction of Altuviiio should not result in an increase in the annual drug costs for hemophilia A prophylaxis;
- a decision, following price negotiations, by the Provinces/Territories to add Altuviiio to the CBS National Formulary;
- a formal procurement contract;
- preparations for blood banks to handle the new product.
CBS announced at the May annual meeting of the Association of Hemophilia Clinic Directors of Canada that these steps would take at least one year, meaning that Altuviiio would not be available until the second or third quarter of 2026. In its written response to the recommendation, the Canadian Hemophilia Society challenged CBS and the Provinces/Territories to fast-track these steps and target a start date of January 1, 2026.
“Altuviiio has significant benefits,” said CHS President Emil Wijnker. “Its long half-life means that a person can infuse just once a week, with a high peak FVIII level and a high trough. This results in better protection. We’ve come this far; it should not take a whole year for the final steps.”
Québec
In discussions with the Québec Chapter of the CHS, Héma-Québec stated that it would not immediately negotiate a contract for Altuviiio, as CBS is doing. Instead, once Altuviiio is added to the Héma-Québec formulary, it will be eligible to compete for a share of the market in the next appel d’offres, or product tender, for factor VIII and IX concentrates. This tender is expected to be announced in autumn 2025, but contracts will not take effect until April 1, 2027.
For more information on Altuviiio, please click on the title of our most recent CHS publication:
All About Novel Therapies.