NICE has launched a second consultation on its decision not to recommend new Alzheimer’s disease treatments on the NHS after considering additional evidence.
Last year, NICE ruled that both lecanemab and donanemab should not be available on the NHS because they showed too little benefit to justify the significant additional cost to the NHS of providing and administering them.
Trials have shown they slow the rate of cognitive decline in people with Alzheimer’s disease but debate remains about how clinically meaningful the treatments are as well as long-term effects.
NICE said the committee had asked for additional evidence to be provided which it had now considered but its conclusion remained the same.
The new evidence confirmed that the medicines are not currently cost-effective and should not be provided on the NHS at this time, it concluded.
Among the new evidence considered by the committee were proposals for a managed access scheme as well as details of ongoing studies looking at longer-term data.
But the committee said several uncertainties would only be partly addressed by longer-term follow up.
In addition, the committee heard the drugs do not meet the criteria for a managed access scheme which is designed to provide NHS access to medicines at a reduced cost while more data is collected on how they work outside clinical trials.
Last month, the Scottish Medicines Consortium also rejected lecanemab for use on the NHS in Scotland.
In publishing its decision, it said there were uncertainties about the health benefits of lecanemab set against its costs, including monthly infusions and regular monitoring for side effects.
It also said it would welcome further submissions from the company addressing the uncertainties.
Both lecanamab and donanemab are designed to treat Alzheimer’s disease in the early stages and are given via monthly infusions that require intensive monitoring.
They had received marketing authorisation from the Medicines and Healthcare Regulatory Agency last year.
NHS England had advised NICE that introducing treatments such as donanemab ‘would substantially increase demand on primary care and memory clinics because of increased awareness of mild cognitive impairment and availability of treatment options’.
NICE said the new draft guidance would allow stakeholders to comment on new conclusions reached by the committee at its second meeting.
It would also give stakeholders the opportunity to submit new evidence or commercial proposals that might address the barriers to the use of the treatments on the NHS.
‘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,’ NICE said.
There are currently over 160 trials worldwide testing more than 125 experimental Alzheimer’s treatments. Of these, 30 are in late-stage trials that NHS England has identified as potential treatments available by 2030.
The public consultation on the draft NICE guidance on donanemab and lecanemab will close on 27 March 2025 with a final draft expected in the summer.
This article was first published by our sister title Pulse
