Early Alzheimer’s Treatment LEQEMBI Approved by Health Canada

Health Canada has granted conditional approval for Leqembi (lecanemab), marking the first treatment in Canada that tackles the root cause of early Alzheimer’s disease. The therapy has been approved for adults with mild memory or thinking problems due to Alzheimer’s disease (early AD) who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes and who have confirmed abnormal protein buildup.

Unlike older treatments that only manage symptoms, Leqembi works by reducing harmful proteins in the brain that are linked to Alzheimer’s. Clinical studies show it can slow down the loss of memory and daily functioning.

Dr. Sharon Cohen, neurologist at the Toronto Memory Program, adds: “This is a major step forward—finally, there’s a treatment that slows the relentless decline of Alzheimer’s, giving patients more time to enjoy life with their loved ones.”

Slowing the Progression of Early Alzheimer’s

The approval is based on large global studies where Leqembi was shown to slow the progression of early Alzheimer’s. Health Canada has granted a conditional approval, which means the treatment will continue to be studied to confirm its benefits.

“We share the hope and excitement of hundreds of thousands of Canadians impacted by Alzheimer’s disease,” said Cathy Barrick, CEO of Alzheimer Society of Ontario. “This announcement brings Canada one step closer to our first-ever approved disease-modifying treatment for Alzheimer’s disease. Leqembi, and similar treatments, may offer time to people at the earlier stages of Alzheimer’s disease–time to continue to make and enjoy memories with those closest to them. We urge all provinces to recognize that disease-modifying treatments are a catalyst to help improve Alzheimer’s care and ensure that they act now so that Alzheimer’s disease is treated with urgency, compassion, and comprehensive care.”

Is Leqembi Covered by Public Health Insurance?

While Health Canada approvalis a critical first step, it is separate from provincial funding decisions. After federal approval, drugs are reviewed by Canada’s Drug Agency. Provinces then individually negotiate with the manufacturer, Eisai, regarding pricing and public coverage. This process is now underway for Leqembi and according to Canada’s Alzheimer Society, lecanemab could still take over a year to become accessible through private drug plans and more than two years through public plans. 

Even when approved, accessing the drug may be difficult in Ontario due the complex nature of how the drug is administered (IV infusion) and ongoing monitoring needs along with an existing shortage of neurologists and geriatricians who are needed to conduct assessments.

Leqembi costs around US$26,000 annually in the U.S.. Without public coverage, the anticipated cost in Canada would be a major barrier for most people. Many drug companies introducing new, impactful drugs establish patient support programs to help as many people as possible get access to important treatments in a timely manner. At the time of this publishing, the manufacturer Eisai appears to be establishing a patient support program in Canada for Leqembi called Eisai Cares.

According to the Alzheimer Society of Ontario, there are over 771,000 Canadians living with dementia, with approximately two thirds of those women. This number is expected to rise to over 1 million by 2030. Family care for those with dementia currently equates to 290,000 full-time jobs, expected to reach 690,000 by 2050.

“Alzheimer’s disease has a profound impact on those living with the condition, their families, care partners and the health system at large,” said Pat Forsythe, Vice President & General Manager, Eisai Limited. “Eisai is proud that the culmination of our 40 years of Alzheimer’s research can bring hope to Canadians living with this debilitating disease with a new treatment option. We will continue to work with all stakeholders to ensure timely access to LEQEMBI for patients across Canada, and to support diagnosis and treatment for early AD.”

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