Although we will not be issuing a
formal press release, we wanted to let you know that today (6
March 2025) NICE has published further draft guidance for public
consultation that continues to not recommend Alzheimer's
treatments donanemab and
lecanemab.
The NICE 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Today's draft guidance will allow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, NICE is
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 NICE 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
facilitate NHS patients using 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 the draft
NICE 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 in
May before producing its final draft
recommendations.
Ends
- The draft guidance on donenamab is available here: https://www.nice.org.uk/guidance/indevelopment/gid-ta11221/consultation/html-content-9
- The draft guidance on lecanemab is available here: https://www.nice.org.uk/guidance/indevelopment/gid-ta11220/consultation/html-content-8
