The benefits of Alzheimer’s treatments donanemab and lecanemab remain too small to justify the additional costs, says NICE in final draft guidance

The benefits from 2 new Alzheimer's treatments remain too small to justify the additional cost to the NHS, an independent NICE committee has concluded following consultation.  

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

Last month NICE's independent appraisal committee met to consider new information submitted as part of its additional consultation on negative draft recommendations for Alzheimer's treatments donanemab (also called Kisunla and made by Eli Lilly) and lecanemab (also called Leqembi and made by Eisai). 

The committee's conclusion in final draft guidance published today remains that neither donanemab nor lecanemab can be recommended for treating mild cognitive impairment or mild dementia caused by Alzheimer's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, these treatments 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 NICE 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. 

Helen Knight, director of medicines evaluation at NICE, said: “While we recognise the hope these treatments offer, the evidence shows they only provide modest benefits at best and substantial resources would be needed to enable access to them.  

“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.  

“But 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.

“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 evidence to be submitted. We realise today's news will be disappointing for many, but we now need to focus on the encouraging pipeline of new Alzheimer's drugs in development, a number of which are already earmarked for NICE evaluation1.” 

Registered stakeholders including the companies and patient groups now have until 8 July to appeal against the final draft recommendations.  

Ends  

1. The NICE final draft guidance on donanemab is available here (from 00:01, 19 June): https://www.nice.org.uk/guidance/indevelopment/gid-ta11221/documents  An embargoed copy is available here: https://dmscdn.vuelio.co.uk/publicitem/825ea42a-c052-41ed-a470-587d0446a777  

1. The NICE final draft guidance on lecanemab is available here (from 00:01, 19 June): https://www.nice.org.uk/guidance/indevelopment/gid-ta11220/documents. An embargoed copy is available here: https://dmscdn.vuelio.co.uk/publicitem/9cbded63-d790-4033-9ee2-98b27db973c4 

References 

1 Hydromethylthionine mesylate for treating mild cognitive impairment or mild or moderate dementia caused by Alzheimer's disease 

Blarcamesine for treating mild cognitive impairment or mild dementia caused by Alzheimer's disease 

NICE is aware that a reformulation of lecanemab is being developed so it can be administered subcutaneously. NICE will consider reviewing its guidance on lecanemab when data on the subcutaneous reformulation is available.