Overview

• The Haute Autorité de santé rejected an early-access request for Leqembi, halting rapid rollout in France.
• This is not the reimbursement decision, with a separate opinion expected by November according to the HAS.
• HAS experts cited a non‑clinically significant effect, noting a 0.45‑point difference on an 18‑point scale over 18 months.
• Safety concerns included higher rates of brain edema and micro‑hemorrhages in treated patients compared with placebo.
• Implementation burdens such as biweekly infusions and regular MRI monitoring weighed against approval, despite EU authorization that was narrowly and controversially granted.