Senior man looking pensive

This means the medicines should not be provided on the NHS as they are not good value for money.

Last month the appraisal committee met to consider new information submitted as part of its additional consultation on negative draft recommendations for donanemab and lecanemab.

The committee’s conclusion in final draft guidance published today remains that neither drug can be recommended for treating mild cognitive impairment or mild dementia caused by Alzheimer’s disease.

This is because, based on all the evidence submitted, they still do not demonstrate sufficient benefit for their high cost, including the cost of administering them. The treatments have been shown to delay progression from mild to moderate Alzheimer’s by 4-6 months but the overall costs of purchasing and administering the drug remain high and the benefits too small.

For us to be able to approve a medicine for use in the NHS it must not only represent a step forward in treatment, but it must also represent a good use of NHS resources and taxpayers’ money. These treatments do not do that.

We have done everything we possibly can to try and achieve a positive outcome in our assessments of these treatments, including providing an additional opportunity for new evidence to be submitted.  

Helen continued: “The committee accepted that any slowing of the disease getting worse would be meaningful for people with mild cognitive impairment or mild dementia caused by Alzheimer’s disease and their carers because it could mean more time socialising, driving and being independent, so needing less help day-to-day from family members.

“However, the committee concluded the small benefits of donanemab and lecanemab shown in the clinical trials and the lack of long-term evidence of effectiveness, together with the substantial resources the NHS would need to commit to the treatments means if they were approved they could displace other essential treatments and services that deliver significant benefits to patients.”

Registered stakeholders including the companies and patient groups now have until 3 July to appeal against the final draft recommendations.

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