France's National Authority for Health (Haute Autorite de Sante, HAS) has formally refused early-access reimbursement for both of the two anti-amyloid drugs approved for early Alzheimer's disease in the European Union, according to a World Dementia Council update published in Alzheimer's & Dementia. The update, drawn from a June 24, 2026 roundtable of European advocacy leaders, states that between September 2025 and May 2026 the HAS denied early access to lecanemab and donanemab, concluding that neither offered sufficient clinical benefit to justify the burden their delivery would place on the health system. HAS records show the lecanemab refusal was issued September 4, 2025, citing what it called modest efficacy alongside safety concerns over brain swelling or bleeding known as ARIA, and was made final on November 7, 2025 when the agency rated the drug's overall medical benefit insufficient for reimbursement. The donanemab refusal followed on March 12, 2026, covering patients with confirmed amyloid pathology who are not carriers, or are only single-copy carriers, of the ApoE4 gene variant linked to higher treatment risk.
Both drugs, monoclonal antibodies that clear amyloid protein from the brain, had already cleared regulatory review: lecanemab received European Commission marketing authorization in 2025 after an earlier rejection, and donanemab was authorized EU-wide in September 2025. Marketing authorization establishes that a regulator judges a drug safe and effective enough to be sold; it does not obligate a national health system to pay for it, and HAS reimbursement decisions in France rest on a separate assessment of what is called the Service Medical Rendu, or medical benefit rendered, weighed against the resources needed to deliver monitoring such as genetic testing and repeat brain scans.
Lorene Gilly, head of public affairs at France Alzheimer, told the roundtable that patient representatives were given only five minutes to present their views during the HAS hearings, and noted that France has not reimbursed any Alzheimer's treatment since it dropped coverage of older symptomatic drugs in 2018. She said the window for patients who might benefit from the newer drugs narrows daily, and that the decisions risk discouraging clinical trial activity in the country. France is not acting alone: Italy's medicines agency AIFA has separately declined to reimburse both drugs, and Britain's National Health Service has not funded either one, though the UK's cost-effectiveness body agreed in March 2026 to reconsider both following manufacturer appeals.