France’s health authority, the Haute Autorité de santé (HAS), has rejected a request for early access to donanemab for the treatment of early Alzheimer’s disease (AD), developed by Eli Lilly.
Donanemab received EU-wide marketing authorisation in September 2025 following a positive opinion from the European Medicines Agency (EMA), and has also been authorised in several countries, including the United States.
In its decision of 12 March, the HAS refused early access to donanemab for people with early symptomatic AD with confirmed amyloid pathology who are either heterozygous or non carriers of the ApoE ε4 allele. In its assessment, the HAS concluded that the available evidence does not demonstrate sufficient clinical benefit to justify early access in France. According to the authority, the treatment’s effects remain modest and are not yet considered clinically meaningful. It also emphasised that reductions in amyloid plaques observed through imaging do not necessarily translate into tangible improvements in cognition or functioning. Safety concerns were another key factor in the decision. As with other anti-amyloid therapies, donanemab is associated with risks of amyloid-related imaging abnormalities (ARIA), including brain swelling and microbleeds, which require close monitoring. Overall, the HAS concluded that donanemab does not meet the criteria required for early access in France, despite recognising that AD is a serious and progressive condition for which there are currently no appropriate pharmacological treatments.
The decision has been met with disappointment by France Alzheimer, which argues that, in a context of severe and progressive disease with few therapeutic options, the arrival of new therapies naturally raises strong expectations. They stressed that patients in other countries already have access to these drugs and expressed concern that the voices and hopes of people affected by AD were not sufficiently taken into account in the debate.
Read the statement from France Alzheimer here: https://www.francealzheimer.org/kisunla-la-haute-autorite-de-sante-refuse-son-acces-precoce-en-france/
Read the HAS decision here: https://www.has-sante.fr/jcms/p_3894165/fr/kisunla-donanemab-maladie-d-alzheimer
