Quebec Rejects Public Funding for Alzheimer’s Drug Leqembi, Citing Efficacy Concerns
The National Institute of Excellence in Health and Social Services (INESSS) in Quebec has recommended against public reimbursement for Leqembi, a newly approved Alzheimer’s drug, raising concerns about its effectiveness and potential side effects. The decision, announced on Thursday, represents a significant setback for patients and advocates hoping for wider access to the costly treatment.
The recommendation comes despite Leqembi receiving approval from Health Canada this fall. INESSS concluded the drug presents “uncertainties in terms of effectiveness and side effects,” prompting the decision not to fund it through the province’s public healthcare system.
The Quebec Federation of Alzheimer Societies immediately decried the ruling, calling it “a setback for people living with the disease and their loved ones.” Approximately 90,000 Quebecers currently suffer from Alzheimer’s, with an additional 10,000 new cases diagnosed annually, according to the Alzheimer Society of Quebec and INESSS respectively.
Lecanemab, the active ingredient in Leqembi, is a monoclonal antibody designed to target and remove amyloid plaques – protein deposits in the brain associated with Alzheimer’s disease. Manufactured by Eisai, the drug is estimated to cost around $32,000 per year. It is administered via infusion, typically in specialized clinics, though a home injectable version has been approved in the United States for follow-up treatments after an initial 18-month period.
However, access to Leqembi is limited even with approval. Health Canada’s decision restricts its use to patients in the early stages of Alzheimer’s, and excludes those with two copies of the APOE4 gene. The drug is also not indicated for other forms of dementia where amyloid plaques are not a primary factor.
INESSS further determined that lecanemab demonstrates no “clinically significant” results or “demonstrated improvement in quality of life” for patients. This conclusion sharply contrasts with the assessments of Health Canada and regulatory bodies in other nations.
“INESSS has not said that they do not want to pay for it because it is too expensive,” noted a neuropsychiatrist at the McGill University Health Center. “They concluded radically that in their opinion the drug does not work, contrary to Health Canada and the English and European organizations.”
The decision highlights a global divergence in approaches to funding innovative, yet controversial, Alzheimer’s treatments. While the United States, Germany, and Japan currently reimburse Leqembi through their public healthcare plans, countries like France, England, and Australia do not, despite the drug being approved in over 50 countries worldwide.
A neurologist at Sherbrooke University Hospital expressed support for INESSS’s decision, pointing to the limited number of public plans globally that cover the drug. However, a neurologist at the University Hospital of Quebec, who previously published an open letter advocating for Leqembi, strongly condemned the ruling. “By ignoring very convincing data, INESSS deprives patients in the early stages of Alzheimer’s disease of a treatment that could slow progression and preserve their autonomy at a time when it is still possible to intervene,” the neurologist stated.
Estimates suggest that 5% to 10% of patients in US cognitive impairment clinics could potentially benefit from lecanemab. Currently, the primary treatment option for dementia focuses on increasing acetylcholine levels in the brain to support cognitive function, particularly memory.
The decision in Quebec does not necessarily dictate the outcome in other provinces. Reimbursement decisions elsewhere in Canada will depend on the assessment of the Canadian Medicines Agency, which is expected to deliver its opinion in the coming months. The debate surrounding Leqembi underscores the complex challenges of evaluating and funding treatments for neurodegenerative diseases, balancing hope for innovation with the need for demonstrable efficacy and responsible healthcare spending.
