CDA-AMC reverses course, backs Leqembi’s first ruling contents still undisclosed
- Canada’s Drug Agency issued a final recommendation on 31 August 2026 supporting public reimbursement of Leqembi (lecanemab) for patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease. Eisai and Biogen state the recommendation follows a reconsideration by CDA-AMC.
- Reimbursement does not follow automatically. Negotiations run through the pan-Canadian Pharmaceutical Alliance first, then each province and territory decides separately whether to list the product on its public plan.
- Lecanemab is a humanised IgG1 antibody targeting aggregated soluble protofibril and insoluble amyloid-beta. It is approved in 53 countries and regions including Japan, the US, China, Europe and South Korea, and is under review in 6 more. Intravenous maintenance dosing every four weeks is approved in 8 countries, with filings in 12.
- More than 770,000 people in Canada were living with dementia in 2025, a figure projected to reach 1.7 million by 2050. Eisai leads development and regulatory submissions globally, co-commercialises with Biogen, and holds final decision-making authority.
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Four words carry the news: follows a reconsideration. CDA-AMC reached a different conclusion the first time and neither release says what it was. What comes next has a measurable track record in Canada.
- The agency changed its mind and the companies have not said why. Eisai Limited and Biogen Canada cite new 48-month data on continuous treatment among what CDA-AMC reviewed. The global release omits that detail entirely. The original recommendation appears in neither document.
- A positive recommendation is not coverage, and Canada has just supplied the benchmark. Roche’s Perjeta received a positive CDA-AMC recommendation on 6 October 2025 and cleared pCPA on 10 August 2026, roughly 10 months later. It still awaits provincial listing. Leqembi starts at the same point.
- Approval in 53 markets overstates how many fund it publicly. China’s NHSA added intravenous lecanemab to a Commercial Insurance Innovative Drug List in December 2025, not to basic medical insurance. CDA-AMC’s recommendation covers public reimbursement, a higher bar than much of that 53-country count reflects.
Read the original source (Eisai and Biogen) →
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