Health Canada Approves Donanemab
Find information about how donanemab works for people living with mild cognitive impairment or early Alzheimer’s disease, eligibility and access.
Read frequently asked questions here.
Donanemab in Canada
Health Canada announced that they have approved donanemab (brand name: Kisunla™), the second disease-modifying Alzheimer’s treatment approved for use in Canada.
The announcement follows Health Canada’s recent conditional approval of lecanemab, the first new treatment for Alzheimer’s disease in more than a decade.
It’s important to note that this is not a cure — it’s a treatment. Donanemab can slow the progression of Alzheimer’s disease, but doesn’t stop it.
Only people with mild cognitive impairment or early-stage Alzheimer’s disease will be eligible for treatment. This drug is only to be used for dementia related to Alzheimer’s disease — no other form of dementia.
In order to introduce new Alzheimer’s disease therapies, the health-care system must be ready to support them. Donanemab is given through an IV and requires ongoing monitoring through MRI imaging. Canadians will benefit most when they have timely access to diagnosis, appropriate imaging and properly trained health-care teams to manage these treatments.
While Health Canada has approved donanemab, it doesn’t mean it’s available to Manitobans yet. Health Canada’s approval only means the drug can be marketed. The next step is for Canada’s Drug Agency to review the drug for cost-effectiveness and decide if it should be paid for by the government. After that, each province and territory will decide on pricing and coverage. Access through public drug plans typically takes at least two years from the date of the Health Canada announcement, while access through private drug plans typically occurs within a year. You can read more about this process here.
Even with these barriers, it is our hope that as new treatments are approved, they will be available to anyone in need.
Frequently asked questions
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. It is designed to slow the progression of Alzheimer’s disease.
The drug is only approved to be used in people with mild cognitive impairment or mild (early-stage) Alzheimer’s disease. This drug is only supposed to be used for dementia related Alzheimer’s disease — no other form of dementia.
Health Canada allows the medication to be marketed and sold within the guidelines set out by Health Canada and the manufacturer.
It is still unclear how much donanemab will cost in Canada. It 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.
A timely dementia diagnosis 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.
Similar to lecanemab, donanemab is administered via intravenous infusions. It targets amyloid plaques that contribute to cognitive decline and allows a person’s immune system to clear them from the brain. Unlike lecanemab, however, people are able to stop taking donanemab once their amyloid levels drop below a certain threshold.