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Cost and evidence gaps remain barriers to approving funding in the NHS for donanemab and lecanemab.

Today we’ve published further draft guidance for public consultation that continues to not recommend Alzheimer’s treatments donanemab and lecanemab.

Our independent committee said last year that the medicines showed too little benefit to justify the significant additional cost to the NHS of providing and administering them. The committee asked for some additional evidence to be provided, which has now happened, and the committee has considered this. Unfortunately this has confirmed that the medicines are not currently cost effective and the committee’s recommendation remains that they should not be provided on the NHS at this time.

Today’s draft guidance will allow stakeholders to comment on the key new conclusions the independent appraisal committee reached at its second meeting.

Through this consultation, we’re providing the companies and other stakeholders the opportunity to submit new evidence or commercial proposals that might address the issues that have so far been a barrier to the use of these new treatments in the NHS.

The cost-effectiveness estimates for donanemab and lecanemab remain substantially higher than we can consider an acceptable use of taxpayers’ money and NHS resources. The evidence presented so far shows neither donanemab nor lecanemab provide enough benefit to justify the substantial resources the NHS would need to commit to implement access to them, even with a managed access arrangement.

Stakeholders are particularly encouraged to comment on the committee's latest conclusions regarding managed access arrangements and evidence requirements.

Managed access arrangements can allow NHS patients to use promising and potentially cost-effective medicines for a fixed period, at a discount to manage the uncertainty to the NHS, while further evidence is gathered on how those medicines can be provided and how well they work outside clinical trials.

The public consultation on our draft guidance on donanemab and lecanemab will close on 27 March 2025. The independent committee will consider all responses, including additional analyses, at a third committee meeting before producing its final draft recommendations.  

Associated guidance and resources

• Donanemab for treating mild cognitive impairment or mild dementia caused by Alzheimer's disease [ID6222]
• Lecanemab for treating mild cognitive impairment or mild dementia caused by Alzheimer’s disease [ID4043]