On 4 September 2025, the Haute Autorité de Santé (HAS) published a decision refusing to grant early access to lecanemab in France. The French early access programme allows medicines deemed to be innovative and clinically beneficial, for diseases where there is no satisfactory alternative treatment, to be reimbursed for patients before a full evaluation has been completed. Lecanemab, an anti-amyloid therapy for mild cognitive impairment or mild dementia due to Alzheimer’s disease, was approved by the European Medicines Agency in November 2024, with a marketing authorisation granted by the European Commission in April this year. In their decision, the HAS judged that the available clinical evidence did not demonstrate a clinically relevant benefit relative to risks, citing “modest” efficacy and concerns around safety, notably the incidence of amyloid-related imaging abnormalities that may be linked to small brain bleeds or swelling. The HAS also highlighted operational constraints around the processes required to ascertain eligibility (e.g. genetic tests) and for safety monitoring (e.g. brain MRIs). In a reaction published earlier this month, our colleagues at France Alzheimer expressed their deep disappointment with the decision, stating that people living with early Alzheimer’s disease cannot afford to wait. Lecanemab will now undergo a full evaluation by the Haute Autorité de Santé, which can take between 12-18 months to complete.
Read the HAS decision letter: https://www.has-sante.fr/jcms/p_3644193/fr/decision-n2025-0204/dc/sem-du-4-septembre-2025-du-college-de-la-haute-autorite-de-sante-portant-refus-d-acces-precoce-de-la-specialite-leqembi-lecanemab
Read France Alzheimer’s reaction: https://www.francealzheimer.org/la-haute-autorite-de-sante-refuse-daccorder-lacces-precoce-au-leqembi-en-france/