Canada’s Drug Agency Recommends Against Public Reimbursement of Leqembi for Early Alzheimer Disease
Canada’s Drug Agency (CDA-AMC) has recommended against the public reimbursement of Leqembi (lecanemab-irmb; Eisai, Tokyo, Japan; Biogen, Cambridge, MA) for early Alzheimer disease (AD), despite the drug’s prior conditional approval by Health Canada. The decision pertains to reimbursement under public drug plans and does not reverse Health Canada’s October 2025 Notice of Compliance with conditions (NOC/c) for the anti-amyloid monoclonal antibody (mAb).
Leqembi is indicated in Canada for adults with mild cognitive impairment or mild dementia due to AD who are apolipoprotein E ε4 (APOE ε4) noncarriers or heterozygotes and who have confirmed amyloid pathology. Health Canada’s authorization was based on results from the global phase 3 Clarity AD clinical trial (NCT03887455), a randomized, placebo-controlled study evaluating clinical efficacy and safety in early AD. In that study, Leqembi treatment demonstrated statistically significant slowing of cognitive and functional decline compared with placebo across primary and secondary end points, as previously reported. Specific efficacy estimates were not included in the current reimbursement announcement.
The CDA draft recommendation concluded that Leqembi should not be recommended for public reimbursement. If finalized, the decision would limit access to publicly funded Leqembi in Canada despite regulatory approval. The recommendation is open to stakeholder feedback through March 5, 2026.
In a press release from Eisai, the company stated that it disagrees with the CDA-AMC’s decision and will pursue public reimbursement in Canada.
Source: Eisai and Biogen Canada. Eisai maintains commitment to people living with early Alzheimer’s disease despite CDA-AMC draft recommendation: patients deserve access to effective treatment. Biospace. Published 19 February, 2026. Accessed 24 February, 2026. https://www.biospace.com/press-releases/eisai-maintains-commitment-to-people-living-with-early-alzheimers-disease-despite-cda-amc-draft-recommendation-patients-deserve-access-to-effective-treatment