Donanemab (Kisunla)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Kisunla be reimbursed by public drug plans for the treatment of adult patients in the early stages of Alzheimer disease (AD) (i.e., mild cognitive impairment [MCI] or mild dementia) who have evidence of amyloid in the brain and who are APOE epsilon 4 (APOE4) noncarriers or heterozygotes, if certain conditions are met.
• The Canadian Drug Expert Committee (CDEC) determined that Kisunla demonstrates acceptable clinical value versus placebo in adult patients with a clinical diagnosis of MCI or mild dementia due to AD, who are APOE4 heterozygotes or noncarriers, and who have confirmed amyloid pathology. This determination was enough for CDEC to recommend that Kisunla be reimbursed. Given that Kisunla is expected to be an additive treatment to best supportive care (BSC), acceptable clinical value refers to added value versus BSC alone.
• Evidence from a clinical trial showed that, compared with placebo, treatment with Kisunla for up to 76 weeks provided a clinical benefit in slowing cognitive and functional decline in adults with MCI or mild dementia due to AD who were APOE4 heterozygotes or noncarriers and had confirmation of amyloid in the brain. CDEC determined that the evidence showed that Kisunla addresses a significant unmet clinical need in this patient population.