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27 June 2025

Industry News

NICE Issues Final Draft Recommendation Against Lecanemab and Donanemab

The National Institute for Health and Care Excellence (NICE ) has issued a final draft recommendation against approving the Alzheimer’s drugs Leqembi (lecanemab) and Kisunla (donanemab) for treating mild cognitive impairment or mild dementia due to Alzheimer’s.

The decision cites high treatment costs, limited clinical benefits, and insufficient long-term evidence. NICE also noted the significant burden on NHS resources and potential displacement of more effective treatments. Expert comments included concerns that the modest benefits observed in trials were unlikely to be noticeable to patients, especially given the risks and substantial monitoring required. Stakeholders can appeal NICE’s decision by 8 July 2025. The draft recommendation contrasts with recent European approval of lecanemab.

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