A scientist looks at scans at the Memory Centre at the Department of Readaptation and Geriatrics of the University Hospital in Geneva, Switzerland. The Health Canada-approved drug, lecanemab, slows progression of Alzheimer’s disease by 27 per cent on average, according to the main clinical trial that led to regulatory approval.DENIS BALIBOUSE/Reuters
Quebec will not publicly fund the first Health Canada-approved treatment for the underlying cause of Alzheimer’s disease after an expert committee concluded its benefits are too modest to improve patients’ lives.
The negative recommendation from Quebec’s National Institute for Excellence in Health and Social Services, known by the French acronym INESSS, marks the first time a government advisory body in Canada has evaluated whether the medication, lecanemab, should be paid for out of the public purse.
The experts at INESSS rejected the drug without considering its price because they concluded lecanemab didn’t pass the first test of providing clear therapeutic value.
Lecanemab, which sells under the brand name Leqembi, will have a sticker price of about $32,000 a year in Canada, according to drugmaker Eisai Co. Ltd.
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According to INESSS’s notice to Quebec’s health minister, posted Thursday: “The gains observed with lecanemab on cognitive and functional decline (e.g., memory, self-care, judgment) in a clinical trial are limited and below what is generally considered clinically significant. Furthermore, there is no demonstrated improvement in quality of life.”
The notice said the government accepted INESSS’s advice and won’t reimburse the drug.
Lecanemab may yet be publicly funded elsewhere in the country. Canada’s Drug Agency, which advises provinces outside Quebec, is scheduled to release a draft recommendation for the drug in February.
INESSS’s negative ruling will come as a blow to Quebec patients, doctors and advocacy groups who hoped public coverage of lecanemab would help people in the early stages of Alzheimer’s stave off their inevitable decline for a time.
Health Canada approved the drug in October for patients with mild cognitive impairment or early Alzheimer’s disease who have confirmed buildup of a sticky substance called amyloid – which is linked to the disease – in the brain, and who do not carry two copies of a gene that raises the risk of rare but serious side effects, including brain swelling and bleeding.
Lecanemab does not cure or halt the decline in thinking and memory caused by Alzheimer’s. Rather, it slows progression of the disease by 27 per cent on average, allowing some patients to stay in the mild stage for longer, according to the main clinical trial that led to regulatory approval.
Howard Chertkow, a neurologist and senior scientist at the Baycrest Academy for Research and Education in Toronto, said he worried that INESSS is “using a bit of a sledgehammer,” by issuing a blanket rejection of the medication, which is given intravenously every two weeks.
Alzheimer’s is a heterogeneous disease, he added. That means some patients will respond well to lecanemab, while others won’t see any positive effects. Now, however, the only Quebec patients able to find out will be the wealthy, Dr. Chertkow added.
The costs for individuals, and for the public health care system if other provinces eventually cover lecanemab, go beyond the price of the drug itself.
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Patients would need a PET scan or spinal fluid test to confirm the presence of amyloid, as well as genetic testing and frequent MRIs in the first year to check for swelling and microbleeds in the brain.
Laveena Kamboj, senior director, value access and policy at Eisai Canada, said the pharmaceutical company was “profoundly disappointed” by the INESSS rejection.
“INESSS reached a fundamentally different conclusion on Leqembi’s benefit-risk profile when compared to Health Canada,” she said, emphasizing the federal regulator spent two and a half years reviewing the drug.
Nonetheless, Ms. Kamboj said lecanemab will be available in Canada starting next month for those who have private insurance coverage or the money to pay out of pocket.