Alzheimer's sufferer Jacqueline Kretschmann receives an infusion of new antibody drug donanemab from doctor Joseph Kuchling at Charite.Jens Kalaene/Reuters
Health Canada has approved a second drug that targets the underlying cause of Alzheimer’s disease, a development that could give Canadian patients more options to slow the course of the pernicious brain illness.
But access to the expensive treatment will depend on whether government drug plans opt to cover it, something they have so far declined to do for a similar medication that was greenlit by the federal regulator last year.
Eli Lilly Canada Inc. received notice from Health Canada on Friday for the approval of donanemab, a once-monthly intravenous therapy for people with mild cognitive impairment or mild dementia due to Alzheimer’s disease.
The approval came more than two years after Health Canada began reviewing the drug in February, 2024.
Donanemab, sold under the brand name Kisunla, is part of a new class of disease-modifying drugs for Alzheimer’s. Unlike older drugs, which only address symptoms, the new options target and clear beta-amyloid, a hallmark of the disease. Beta-amyloid is a protein that congeals into sticky clumps in the brain, triggering a cascade of events that lead to brain-cell death.
Health Canada approves lecanemab, a drug that slows progression of Alzheimer’s disease
However, neither donanemab nor lecanemab, the Alzheimer’s treatment approved in Canada last October, are cures. They only slow cognitive decline, allowing some patients to remain longer in mild stages of the disease.
Alzheimer’s is the most common cause of dementia, a condition that is thought to affect about 770,000 Canadians.
The approval of a second disease-modifying treatment, “really cements the change that we see in our field,” said Sharon Cohen, a behavioural neurologist and medical director of the Toronto Memory Program.
“Treating earlier is possible. Slowing disease, preventing people from becoming more disabled from the disease – these are very, very important and highly valued milestones.”
The question now is whether the federal, provincial and territorial drug plans that cover senior citizens will pay for the drug. Donanemab has a Canadian sticker price of $47,250 a year, according to Ethan Pigott, a spokesman for Eli Lilly, higher than the average annual price of nearly $30,000 for Eisai Ltd.’s lecanemab.
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Public drug plans negotiate confidential discounts before listing new drugs, so the true prices are usually lower.
In February, Canada’s Drug Agency released a draft recommendation that advised public plans not to reimburse lecanemab.
An expert committee at the agency said it was unclear that lecanemab provided clinically meaningful benefits. The committee also flagged concerns about the number of MRI scans required to monitor for rare but serious side effects, namely swelling and microbleeds in the brain.
The agency’s advice means that, for now at least, lecanemab is only available to Canadian patients with deep pockets or generous private insurance plans.
Donanemab is approved in 48 other countries, but publicly funded in only a handful, including the United States, China and Japan.
Other countries have taken the same tack as Canada’s Drug Agency and Britain’s National Institute for Health and Care Excellence, which ruled against funding lecanemab and donanemab last year, saying the benefits were too small to justify the costs.
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A key difference between the drugs is that donanemab is a limited-time treatment, which patients can stop taking after 18 months, unlike lecanemab, which patients can continue to take.
In the pivotal randomized control trial that led to donanemab’s approval, patients in the treatment arm were moved to the placebo group without benefits diminishing after a PET scan confirmed their brains were clear of visible amyloid plaques.
“That may appeal to payers because there’s a limited duration for which they are paying for the drugs,” Dr. Cohen said.
Christina Scicluna, chief executive officer of the Alzheimer Society of Canada, said it is important to make clear that the new drugs aren’t cures, nor are they for patients who’ve progressed beyond the early stages of the disease.
“But it’s not our moment to be quiet either,” she said. “We actually have options that are disease modifying, options that did not exist before. So, this is about changing the conversation.”
Neither the Alzheimer Society of Canada, nor Dr. Cohen personally, receive funding from companies that make Alzheimer’s treatments, although Dr. Cohen’s Toronto clinic does for conducting clinical trials. However, Eli Lilly helped make both available for media interviews.