Canada’s Drug Agency Recommends Reimbursement of Donanemab for Early Alzheimer’s Disease

Canada’s Drug Agency (CDA) has issued a positive recommendation for the public reimbursement of donanemab (Kisunla™), an Alzheimer’s disease treatment for people living with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease. The recommendation is an important step toward expanding access to disease-modifying treatment options for people in the early stages of Alzheimer’s disease.

Donanemab was approved by Health Canada in May 2026 for adults with a clinical diagnosis of MCI or mild dementia due to Alzheimer’s disease who have confirmed amyloid pathology and meet specific APOE ε4 criteria. It is designed to target and remove amyloid plaques in the brain, one of the biological features associated with Alzheimer’s disease.

The CDA recommendation follows its review of the available clinical and economic evidence, as well as input from patients, caregivers, clinicians, and other stakeholders. The recommendation supports reimbursement through provincial and territorial public drug plans, subject to the conditions outlined by CDA.

A second disease-modifying treatment option

Donanemab is the second disease-modifying therapy for early Alzheimer’s disease to receive Health Canada approval in Canada, following lecanemab (Leqembi®), which was approved in October 2025. Both treatments target amyloid in the brain and have demonstrated a slowing of cognitive and functional decline in people with early Alzheimer’s disease, although they differ in their treatment schedules and how they target amyloid.

In August 2026, CDA also issued a final recommendation supporting public reimbursement of lecanemab. Together, these recommendations represent an important development in the Canadian treatment landscape, giving eligible patients and their healthcare providers more than one disease-modifying treatment option to consider.

What this means for patients and families

A positive reimbursement recommendation does not mean that donanemab is immediately covered by every provincial or territorial drug plan. Following CDA’s recommendation, individual provinces and territories will determine public coverage through their respective drug programs.

Access to these treatments also depends on timely diagnosis and appropriate assessment. Donanemab is intended for people in the early stages of Alzheimer’s disease, and treatment requires confirmation of amyloid pathology and careful clinical assessment.

TDRA welcomes CDA’s recommendation as a step toward expanding access to disease-modifying therapies for people living with early Alzheimer’s disease. Having more than one treatment option can support discussions between patients, families, and healthcare providers about which treatment may be appropriate based on individual circumstances.

As implementation discussions continue across Canada, TDRA will continue to share updates on access to donanemab and other developments in Alzheimer’s disease diagnosis and treatment.