NICE says another no to Alzheimer’s drugs in final draft guidance
NICE has once again rejected new drugs for early Alzheimer’s disease because the costs are too great to justify the small benefits.
An independent committee had reviewed new evidence submitted as part of an ongoing consultation process but said it did not change their position on whether donanemab and lecanemab should be made available on the NHS.
It is the third draft document published since the start of the NICE consultation process last year and which is now closing on 8 July.
Both drugs are licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) for adult patients in the early stages of Alzheimer’s disease who have one or no copies of the ApoE4 gene.
Clinical trials have shown they slow the rate of cognitive decline in people with Alzheimer’s disease by around four to six months, but debate is ongoing about how clinically meaningful the treatments are as well as long-term effects.
NICE said the cost of administering the drugs in the NHS in England and Wales, as well as intensive monitoring for side effects is too high when weighed against the small benefits seen.
Earlier this year the Scottish Medicines Consortium also rejected lecanemab for use on the NHS in Scotland.
NICE’s decision was not unexpected but it has raised concerns about two-tier access where those who can afford to pay privately can have them.
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.’
If they were approved, they could displace other essential treatments and services that deliver significant benefits to patients, she added.
‘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.
‘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 evaluation.’
Professor Rob Howard, professor of old age psychiatry, at UCL, said: ‘Well-conducted clinical trials demonstrated that the actual size of benefits experienced by patients were too small to be noticeable, treatment carries risks of side-effects, and the annual cost of the drugs and safety monitoring required would have been close to the cost of a nurse’s salary for each treated patient.
‘We need better treatments that can make an appreciable difference to the lives of people with dementia and these can only come from further research and study.’
Hilary Evans-Newton, chief executive at Alzheimer’s Research UK, said the decision was a ‘painful setback’ but not surprising.
‘The drugs’ modest benefits, combined with the significant costs of delivering them in the NHS, meant they faced insurmountable challenges.
‘While these drugs are not a cure and do come with potentially serious side effects, they represent an important first step in changing the course of Alzheimer’s.
‘With over 30 Alzheimer’s drugs now in late-stage trials globally, momentum is building – and more will enter regulatory systems in the years ahead. Without intervention from government, people with Alzheimer’s will continue to miss out — not because science is failing, but because the system is.’
Early and accurate diagnosis is one major barrier that will continue to prevent patient’s accessing treatment unless addressed, she added.
Professor Fiona Carragher, Alzheimer’s Society’s chief policy and research officer, said: ‘The reality we’re faced with is that these treatments remain out of reach of both the NHS and most eligible people with Alzheimer’s disease.
‘In other diseases like cancer, treatments have become more effective, safer and cheaper over time. It’s essential we see similar progress in dementia.’
She added: ‘The fact is, even if donanemab and lecanemab were made available on the NHS tomorrow, too many patients wouldn’t be able to access them because the health system isn’t ready to deliver them.’
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