Health Canada Approves Donanemab

Alzheimer Society of Canada responds to the final recommendation on donanemab reimbursement

On November 3, 2026 Canada's Drug Agency (CDA-AMC) issued a positive final recommendation to reimburse Kisunla® (donanemab) on public drug plans for eligible Canadians. This treatment is intended for Canadians living with mild cognitive impairment or mild dementia due to Alzheimer’s disease (early-stage Alzheimer’s disease). Donanemab is not a cure, but access to disease-modifying treatments may offer people living with Alzheimer's disease and care partners a new option, supporting efforts to maintain independence and quality of life for as long as possible.

"Treatments that can slow progression of Alzheimer's disease are incredibly meaningful as they preserve time and independence," said Christina Scicluna, CEO, Alzheimer Society of Canada. "Today's recommendation brings new treatment options one step closer to Canadians, creating hope for those who are affected by Alzheimer's disease while also underscoring the importance of all Canadians having access to a timely diagnosis."

This recommendation alone does not guarantee access, but it is a critical step in the process. It is important to know that people must be able to receive timely diagnosis, monitoring and care for new therapies such as donanemab to have meaningful impact. At the same time, sustained investment in navigation, community programs and care partner support is equally important to ensure Canadians affected by dementia receive the care they need regardless of their eligibility for pharmacological treatment. Currently, accessing lecanemab requires specialized diagnostic tools, such as an amyloid PET scan or cerebrospinal fluid analysis, along with genetic testing, to confirm eligibility. The medication is administered through intravenous infusion, and ongoing monitoring—typically via PET scans or MRI scans—is necessary to ensure safety and effectiveness.

Meeting these demands will require substantial investments in human resources, infrastructure, training and the creation of new healthcare pathways to deliver such treatments effectively and equitably. Across Canada, access to specialists, diagnostic tools and infusion services varies significantly. Ensuring equitable implementation across provinces and territories will be essential so that eligible Canadians who choose this treatment can benefit regardless of geography or financial circumstance. The Alzheimer Society of Canada will continue to advocate for equitable access, informed decision-making and health-system readiness so that scientific progress translates into real-world benefit for people living with dementia and care partners.

We will also continue to advocate with Alzheimer Societies across Canada for increased investment in public education on risk reduction, system navigation and all the community supports that are essential components of the dementia care continuum across Canada.

Health Canada approves donanemab

On May 1, 2026, Health Canada approved donanemab (Kisunla®) to treat people with a clinical diagnosis of mild cognitive impairment or early-stage Alzheimer's disease (mild dementia due to Alzheimer's disease). This is the second disease-modifying Alzheimer's treatment approved for use in Canada. 

The Alzheimer Society of Canada supports Health Canada's decision to authorize donanemab as a treatment for people diagnosed with mild cognitive impairment or early-stage Alzheimer's disease. We respect the careful and thorough process used by Health Canada to assess the safety, efficacy and tolerability data for donanemab.

This marks a historic moment in Alzheimer's disease treatment, but it's important to understand that this drug is not a cure. Donanemab targets the underlying cause of the disease by removing amyloid plaques (often connected to Alzheimer’s disease) but it cannot reverse it.

Despite this approval, donanemab could still take over a year to become accessible through private drug plans and more than two years through public plans. This underscores the critical importance of receiving a timely diagnosis, as the medication is effective only for those in the earliest stages of the disease. According to the World Alzheimer Report 2024 by Alzheimer's Disease International, over 90 per cent of respondents said they would pursue a dementia diagnosis if they knew a disease-modifying treatment was available. The Alzheimer Society of Canada hopes that as treatments become available, people will be encouraged to seek a diagnosis of dementia earlier.

With other promising treatments on the horizon, the Alzheimer Society of Canada has hope that donanemab can serve as a baseline to which we compare future treatments. The Alzheimer Society of Canada continues to advocate for increased research funding for dementia to develop, test and approve new treatment breakthroughs in the future. We also urge for broader and more equitable access to dementia risk reduction resources, diagnosis tools, symptom management, and care support. This ensures that all people living with dementia, and care partners, can maintain a good quality of life and access appropriate interventions in a timely manner.

Download and read our full position statement (PDF).

Frequently asked questions

What is donanemab?

• Donanemab is an intravenous monoclonal antibody treatment that removes amyloid plaques (a protein often connected to Alzheimer’s disease) from the brain.
• This drug is not a cure. 

Who is donanemab intended for?

• The drug is only approved to treat people with a clinical diagnosis of mild cognitive impairment or early-stage Alzheimer's disease (mild dementia due to Alzheimer's disease) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes and who have confirmed amyloid pathology.
• This drug is also not supposed to be used for any other form of dementia–only for dementia related to Alzheimer’s disease.

How much does donanemab cost? Will the cost be covered by provincial/territorial health plans?

• Health Canada allows the medication to be marketed and sold within the guidelines set out by Health Canada and the manufacturer. 
• November 3, 2026 - Canada's Drug Agency released a positive recommendation to reimburse donanemab on public drug plans for the treatment of mild cognitive impairment and early-stage Alzheimer’s disease.
• It is still unclear how much donanemab will cost in Canada. Donanemab is approved for clinical use in Canada, however whether the cost of the drug is covered by private or public health plans will depend on the province or territory you live in. 
• After a drug is approved by Health Canada, it takes time to determine if or whether the drug will be covered by private and/or public drug plans.

How can I request donanemab ?

• A timely diagnosis of dementia offers many benefits, including better access to treatment options and support, ability to plan for the future, and more meaningful time with family and friends. Learn more about getting a diagnosis. 
• Ask your health-care provider if this drug is right for you, and for more information about donanemab assessment and testing procedures. Health-care providers can provide an accurate assessment of your symptoms to determine if you can be treated with donanemab.  

How can I, or someone I know, participate in dementia drug trials and research studies in Canada?

• You can find information about clinical trials internationally at clinicaltrials.gov. Some of these trials will have Canadian sites. 
• You can also find many Canadian dementia studies, and some clinical trials, to participate in at alzheimer.ca/find-studies. 

What else should I know about the field of dementia drug development right now?

• There are many dementia drugs in development internationally. A major push in the drug development field is to find drugs that treat underlying causes of dementia, not just dementia symptoms.
• You can read about medications that are approved to treat dementia in Canada 

Help is available

If you have any questions about dementia drugs and access to them, ask your health-care provider if this medication is right for you.

Contact your local Alzheimer Society for more information about programs, resources and support services in your area.

Including living/lived experience of dementia in donanemab reviews

During May-July 2024, the Alzheimer Society of Canada developed an online survey to gather the experiences of people living with Alzheimer's disease or mild cognitive impairment (MCI) due to Alzheimer's disease, and their caregivers, and those who were involved in clinical trials of Leqembi (lecanemab) and/or donanemab. The results of this survey (see links below), were submitted to Health Canada to ensure that the voices of people with living/lived experience are represented and considered during the review process.

Alzheimer Society of Canada submission - CADTH Reimbursement Review Patient and Clinician Group Input lecanemab (Leqembi)

Alzheimer Society of Canada submission - CDA-AMC Reimbursement Review Patient and Clinician Group Input donanemab

More information and resources

Medications approved for dementia in Canada.  Alzheimer Society of Canada. Get all the information you need on the current medications approved to treat the symptoms of dementia including their potential benefits and risks.

Use of new medications for Alzheimer's disease in the Canadian healthcare system by the Canadian Consortium on Neurodegeneration in Aging (CCNA). Frequently asked questions (and answers) about new medications for Alzheimer's disease that may be made available in Canada in the future.

National statements - donanemab. Alzheimer Society of Canada. Learn more about the Alzheimer Society of Canada’s position and perspective on a range of considerations relating to dementia, people living with dementia and caregivers.

Last updated: November 9, 2026