Sara Mitchell, a cognitive neurologist at Sunnybrook Health Sciences Centre in Toronto, said the absence of a recommendation from CDA on lecanemab coverage would “mean a lot of despair for a lot of people.”Laura Proctor/The Globe and Mail
Canada’s public drug plans should not pay for a new medication that slows cognitive decline in Alzheimer’s patients because it’s not clear the expensive therapy provides clinically meaningful benefits, according to a report released Thursday by Canada’s Drug Agency.
The agency advises provincial and territorial governments on which drugs to cover. The draft recommendation means it’s unlikely that anyone other than the wealthiest Canadians will be able to obtain lecanemab, the first disease-modifying drug for Alzheimer’s to be approved by Health Canada.
Lecanemab, which is sold under the brand name Leqembi, costs nearly $30,000 a year for the average patient. Health Canada approved the drug in October.
A committee at the drug agency acknowledged there is a major unmet need for medications that treat the root cause of Alzheimer’s disease, rather than just mitigating its symptoms, as other available drugs do.
But the panel found that some of the evidence in favour of lecanemab was imprecise and unclear, making it “challenging to conclusively determine a clinically meaningful benefit of lecanemab in reducing cognitive or functional decline in the intended patients.”
It also noted that rare side effects of the drug include serious microbleeds and swelling in the brain. Those risks, however remote, mean patients must be monitored with frequent MRI scans, which the committee flagged as a concern given the country’s resource-constrained public health system.
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An estimated 772,000 Canadians have dementia, the catch-all term for loss of memory and thinking skills. Alzheimer’s is its most common cause.
Tokyo-based Eisai Co., Ltd., which developed lecanemab in partnership with the American pharmaceutical company Biogen Inc., disagreed with the recommendation and said it would immediately file for reconsideration.
“We just believe they got the decision really wrong, but there is time for them to get the decision right,” said Laveena Kamboj, senior director, value access and policy at Eisai Canada.
The agency’s draft recommendation will disappoint many of the Canadian patients and caregivers who were eagerly awaiting public funding of lecanemab.
The drug, which is delivered by IV infusion twice a month, is recommended for patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease. Once patients decline beyond those early stages, they no longer meet Health Canada’s qualifications for the drug.
An executive with Eisai Ltd. says Canada’s Drug Agency should be recommending the drug it has developed for coverage by public plans.Leon Neal/Getty Images
Sara Mitchell, a cognitive neurologist at Sunnybrook Health Sciences Centre in Toronto, said she watched some of her patients deteriorate past the point of eligibility while Health Canada spent two-and-a-half years reviewing lecanemab – an unusually long time by the regulator’s standards.
Sunnybrook is treating three patients with lecanemab, Dr. Mitchell said.
Eisai confirmed that nine Canadian patients are taking the drug – seven in Ontario and two in British Columbia. They are all paying out-of-pocket.
Now that lecanemab is available in Canada to those who can afford it, Dr. Mitchell, who is also deputy chief of the Hurvitz Brain Sciences Program at Sunnybrook, worries the negative recommendation from the drug agency could lead to inequity between rich and poor patients.
“That is my biggest concern. Not having public reimbursement is going to create a huge divide in terms of ability to access this therapy.” (Dr. Mitchell has received funding from pharmaceutical companies, including from Eisai, the maker of lecanemab.)
Christina Scicluna, chief executive officer of the Alzheimer Society of Canada, said the drug agency’s recommendation amounted to “hard news” for patients and their families.
Lecanemab is not a cure for Alzheimer’s; it only slows progression of the disease in early stage patients. The drug targets and clears beta-amyloid, a protein that congeals into sticky clumps in the brain, triggering a cascade of events that lead to brain cell death.
The clinical trial that led to the drug’s approval in more than 50 countries found it slowed the rate of cognitive and functional decline by 27 per cent compared with a placebo over 18 months.
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In practical terms, the trial showed that lecanemab users remained in milder stages of the disease for about five months longer on average than would have been the case if they hadn’t been treated.
Longer follow-up studies show that benefits persist beyond 18 months.
Jennifer Watt, a geriatrician at St. Michael’s Hospital, part of Unity Health Toronto, said she wasn’t surprised by the Canadian agency’s verdict because it was in keeping with the views of some other international evaluators.
Britain’s National Institute for Health and Care Excellence, for instance, ruled against funding lecanemab and a similar drug last summer, saying the benefits were too small to justify the costs.
“There’s a lot of uncertainty, but the best evidence that we have suggests that the cost and the challenges to the health care system will be too much right now, based on the calculations of the CDA,” Dr. Watt said.
The agency estimated it would cost Canadian public drug plans collectively more than $66-million in the first year to cover lecanemab for qualifying patients, a figure that could rise to as much as $728-million by the third year.
The Canadian agency’s funding recommendations are not binding, but provincial, territorial and federal drug plans rarely stray from them.
Its counterpart in Quebec, which goes by the French acronym INESSS, rejected lecanemab in December. The Quebec government confirmed it won’t reimburse the drug.
The lecanemab draft recommendation will be open for public feedback until at least March 5.