Eisai and Biogen have voiced strong opposition to a draft recommendation from Canada's Drug Agency (CDA-AMC) not to support public reimbursement of LEQEMBI (lecanemab-irmb) for early Alzheimer's disease in Canada.
The decision follows a separate recent setback for Eisai, after CDA-AMC also declined to recommend public reimbursement of its insomnia therapy DAYVIGO (lemborexant), despite the submission of additional real-world evidence and stakeholder input.
Background
LEQEMBI received a Notice of Compliance with conditions (NOC/c) from Health Canada in October 2025, becoming the first treatment approved in the country that targets an underlying cause of Alzheimer's disease.
The monoclonal antibody is indicated for adults with mild cognitive impairment or mild dementia due to Alzheimer's disease who are apolipoprotein E ε4 non-carriers or heterozygotes with confirmed amyloid pathology.
Approval was based on data from the global Phase III Clarity AD study, which demonstrated statistically significant slowing of cognitive and functional decline compared with placebo across primary and secondary endpoints.
More recently, four-year follow-up data presented at the 2025 Alzheimer's Association International Conference suggested continued treatment could delay progression by ten to 13 months while patients remain in the early stages of disease.
In a statement, Eisai said the draft reimbursement recommendation overlooks "compelling evidence" of LEQEMBI's benefit-risk profile and conflicts with Health Canada's regulatory assessment.
The company added that it remains committed to pursuing all available options to secure public coverage.
Patient advocacy groups have also raised concerns. Alzheimer Society of Canada said the decision highlights ongoing inequities in access to innovative therapies, particularly given the limited treatment options available for early Alzheimer's disease.
"People living with early Alzheimer's disease and their care partners have consistently told us that slowing disease progression and preserving autonomy matter deeply," said Christina Scicluna, CEO, Alzheimer's Society of Canada.
While evidence-based review processes are essential given the limited treatment options available, this decision reinforces the need for more equitable access to treatments for those who need it most.
For manufacturers, the development underscores the widening gap between regulatory approval and health technology assessment outcomes in Canada.
While Health Canada's conditional approval reflects acceptance of the clinical data package, reimbursement decisions remain contingent on cost-effectiveness and broader system impact—factors that are increasingly shaping market access strategies for high-cost biologics in neurology.
As Eisai continues to challenge the draft recommendation, the outcome could have significant implications for future Alzheimer's disease therapies seeking public funding in the Canadian market.