Lecanemab receives conditional approval

Health Canada announced its conditional approval of lecanemab, the first new treatment for Alzheimer’s disease in more than a decade. While lecanemab is not a cure, and only for people in the early stages of Alzheimer’s disease (i.e., mild cognitive impairment or mild dementia due to Alzheimer’s disease), the Health Canada decision represents an important advancement in how we approach treatment and care.

“While lecanemab is not a cure, it moves the needle by opening a door for future treatments,” says Dr. Heather Cooke, Manager of Research and Knowledge Mobilization for the Alzheimer Society of B.C. “We're encouraged by the research into these new dementia treatments.”

Health Canada has decided to limit lecanemab access to people who have one or no copies of the APOE4 gene. This susceptibility gene potentially increases the risk of developing Alzheimer’s disease at a younger age. While only a small percentage of people have two copies of the APOE4 gene, research shows that this group faces a much higher risk of brain swelling and small brain bleeds when taking the medication. This decision aligns with those made in other countries, but it means more British Columbians and Yukoners will need genetic testing to find out if they’re eligible for treatment. The Alzheimer Society of B.C. supports expanding testing capacity and ensuring fair access so that eligibility can be determined quickly and equitably.

The tangible, immediate result of Health Canada’s approval is that the drug can be marketed. Provincial ministries and medical insurance companies will then make decisions about pricing and reimbursement. 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.

Clinical studies show that lecanemab can help slow decline in memory, thinking and daily activities for people with mild cognitive impairment or mild dementia due to Alzheimer’s disease. As the treatment is only approved for this group and requires careful monitoring for safety risks, access to a timely diagnosis, regular MRI scans and trained health-care professionals is essential if Canadians are to benefit fully from the treatment. Given current challenges accessing specialist care and MRIs, many British Columbians, particularly people in rural communities, could face significant barriers to access.

“This drug isn’t for everyone,” Cooke says. “To be effective, lecanemab requires early detection and ongoing monitoring – further underscoring the importance of addressing stigma, ensuring more British Columbians have access to health-care professionals for both a timely diagnosis and ongoing care.”