Canada's Drug Agency reversed its do-not-reimburse draft, and pCPA negotiations decide what plans pay next
Canada's Drug Agency will back public reimbursement of the Alzheimer's treatment LEQEMBI (lecanemab) only if its price falls.
Canada's Drug Agency (CDA-AMC) limited coverage to adults aged 50 or older with early Alzheimer's disease (AD) and confirmed amyloid pathology.
The August 31 recommendation in the Canadian Journal of Health Technologies also excludes APOE4 homozygotes.
Further conditions set by CDA-AMC require prescribing by clinicians with expertise in diagnosing and managing AD, in settings with timely access to magnetic resonance imaging (MRI).
CDA-AMC states that treatment should not begin, and should stop, in patients unable or unwilling to undergo the recommended MRI monitoring for amyloid-related imaging abnormalities.
The agency also rules out reimbursement alongside other monoclonal antibody therapies for AD or once disease progresses to moderate dementia.
An earlier draft went the other way.
The Canadian Drug Expert Committee recommended that lecanemab not be reimbursed for patients with mild cognitive impairment (MCI) or mild dementia due to AD, according to CDA-AMC's draft recommendation document.
CDA-AMC's reconsideration record shows the committee then reviewed the sponsor's argument that its initial finding of uncertain clinical meaningfulness rested on a misapplication of the minimal important difference threshold, and moved to reimburse with conditions.
Eisai Limited and Biogen Canada Inc. said in a joint August 27 release that the recommendation follows a review of clinical data including new 48-month evidence on continuous treatment, along with input from clinical experts, patients, and stakeholders.
Pat Forsythe, vice president and general manager at Eisai Limited, said in the companies' release that the recommendation brings eligible Canadians with early AD "closer to equitable access to LEQEMBI."
Forsythe urged those in the reimbursement process to move as efficiently as possible.
Per the August 31, 2026 announcement from Eisai Co., Ltd. and Biogen Inc., next in the process are negotiations through the pan-Canadian Pharmaceutical Alliance, followed by individual reimbursement decisions by public drug plans across the provinces and territories.
Clarity AD, the global placebo-controlled, double-blind, randomized phase 3 trial behind the drug's approvals, enrolled 1,795 patients, with 898 in the treatment group and 897 on placebo, Eisai and Biogen said.
The companies reported that the drug slowed disease progression by 27 percent versus placebo at 18 months, with a mean change from baseline of -0.45 (P=0.00005) on the Clinical Dementia Rating Sum of Boxes primary endpoint, and that 478 patients were still receiving treatment at four years.
Starting treatment early preserves independence and quality of life, said Sharon Cohen, neurologist and medical director of Toronto Memory Program.
Delays cost patients and families opportunities that cannot be recovered, Cohen said in the Eisai and Biogen release.
BioArctic AB, Eisai's research partner on the molecule, put the Canadian dementia population at more than 770,000 people in 2025 in its September 1 release, projecting a rise to 1.7m by 2050.
The Swedish company said lecanemab is approved in 53 countries and under regulatory review in six.
