The CHS urges provinces to accept CBS recommendation to introduce Altuviiio

Montréal, December 12, 2025 – In a letter dated December 10, the Canadian Hemophilia Society (CHS) urged the Provincial/Territorial Blood Liaison Committee (P/TBLC) to accept the Canadian Blood Services (CBS) recommendation to add efanesoctocog alfa (Altuviiio), an ultra-half-life extended factor VIII, to the CBS formulary for the treatment of hemophilia A.

The P/TBLC, representing provincial/territorial ministries of health (except Québec) is responsible for decisions on adding new products to CBS’ Plasma Protein and Related Products Formulary.

In November, CBS issued this recommendation:

Canadian Blood Services recommends that Altuviiio be listed without restrictions for use in adults, adolescents, and children with hemophilia A (congenital factor VIII deficiency) for:

• routine prophylaxis to prevent or reduce the frequency of bleeding episodes
• treatment and control of bleeding episodes
• perioperative management of bleeding (surgical prophylaxis).

This follows Health Canada regulatory approval of Altuviiio in March 2025, a positive Health Technology Assessment by Canada’s Drug Agency in September 2025 and multiple submissions by the CHS and the Association of Hemophilia Clinic Directors of Canada (AHCDC) in favour of rapid introduction.

Phase 3 clinical studies in adults and children concluded that in patients with severe hemophilia A, once-weekly efanesoctocog alfa provided superior bleeding prevention to pre-study prophylaxis, normal to near-normal factor VIII activity, and improvements in physical health, pain, and joint health.

In its submissions, the CHS and AHCDC identified these populations with hemophilia A as potentially benefitting from Altuviiio:

• People engaged in activities that put them at higher risk of traumatic injuries;
• People who have frequent breakthrough bleeding with other FVIII concentrates or emicizumab;
• People with higher risk physical activities or occupations;
• People with chronic joint disease, leading to more frequent spontaneous bleeds, and chronic pain who may benefit from higher peak and trough levels;
• People being considered for antithrombotic therapy and who consequently need higher trough levels;
• People who develop anti-drug antibodies to emicizumab;
• Pediatric patients treated with factor concentrates to obviate the need for central venous catheter placement required by multiple weekly infusions;
• People with mild and moderate hemophilia A on on-demand treatment. Treating these bleeds with efanesoctocog alfa, with its threefold longer half-life, would likely reduce the episodes for which multiple infusions and hospital visits over several days are required.

A decision by the P/TBLC is expected at any time. If positive, access to Altuviiio would start later this spring or early this summer.

QUÉBEC
The decision to add Altuviiio to the Héma-Québec formulary will be made separately. If considered “innovative” by Québec health authorities, Altuviiio could be made available later in 2026. If not, it would need to compete with other factor VIII concentrates in the next Request for Proposals (appel d’offres) which would take effect in spring 2027.

For more information on Altuviiio, see past articles here in CHS CONTACT.