Dementia patients have been given fresh hope of accessing two blockbuster drugs on the NHS after the spending watchdog was ordered to review its previous ban.
Donanemab and lecanemab have been shown to delay progression from mild to moderate Alzheimer’s by up to six months and were licensed for use in the UK in 2024.
But they were not made available on the NHS after the National Institute for Health and Care Excellence (NICE) deemed their benefits ‘too small’ to justify the cost.
However, an independent panel has told NICE to look again at its final draft guidance following appeals by Eli Lilly, which makes donanemab, and Eisai, which makes lecanemab.
Issues that will be revisited for both drugs include their impact on the quality of life of those caring for Alzheimer’s patients, as well as evidence provided by NHS England estimating the cost of giving the treatments by infusion.
The companies claimed the document on infusion costs was only provided four days before a crunch committee meeting, leaving insufficient time for proper scrutiny.
According to Lilly, Nice will also revisit evidence relating to unpaid carer costs and the long-term data on donanemab, which shows additional benefits beyond that seen in early trials.
The drugs represent a major leap forward in the treatment of the disease as they target the underlying cause rather than the symptoms.
Dementia patients have been given fresh hope of accessing two blockbuster drugs on the NHS after the spending watchdog was ordered to review its previous ban
Donanemab and lecanemab are targeted antibody drugs that bind to amyloid, a protein which builds up in the brains of people living with Alzheimer’s.
This helps clear the build-up and slows down cognitive decline.
NICE published its final draft guidance on donanemab and lecanemab in June last year.
It concluded the treatments do delay progression of disease but were not good value for taxpayers as they ‘only provide modest benefits at best’.
The treatments were estimated to cost five to six times more than the threshold NICE can normally recommend.
They remain available privately for £60,000 to £80,000 a year.
The ruling comes as the Daily Mail and Alzheimer’s Society have partnered in a drive to beat dementia, which claims 76,000 lives each year and is the UK’s biggest killer.
The Defeating Dementia campaign aims to raise awareness of the disease, in an effort to increase early diagnosis, boost research and improve care.
Reacting to the outcome of the appeal, Chris Stokes, general manager of the northern European hub at Lilly, said: ‘This is a big moment in the battle against Alzheimer’s disease.
‘Nice was right to look again at the evidence in front of them and it’s welcome that our appeal has been upheld.
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‘For people living with Alzheimer’s disease, and for the families and carers who support them, this matters, perhaps now more than ever.’
An Eisai spokesperson added: ‘This news offers a welcome glimmer of hope for the Alzheimer’s disease community in England.
‘We are keen to work quickly with Nice to assess this treatment effectively, because while we wait, Alzheimer’s disease does not.’
Helen Knight, director of medicines evaluation at Nice, said: ‘The independent appeal panel has ruled that some elements the committee used to inform its decision-making in relation to the cost effectiveness of donanemab and lecanemab need further consideration.
‘So today we have announced we will give stakeholders an opportunity to provide more information for the committee to help it address the areas of continuing uncertainty highlighted by the appeal panel.
‘Throughout our assessment of donanemab and lecanemab we have done everything we possibly can to try and achieve a positive outcome, including providing an additional opportunity for evidence to be submitted.
‘Today’s decision underlines our commitment to continuing that process.’
A public consultation on the guidance is expected to reopen next week and NICE appraisers will meet in June to consider responses.
Michelle Dyson, chief executive of Alzheimer’s Society, said: ‘We welcome NICE’s decision to look again at the case for lecanemab and donanemab, particularly at the significant impact of dementia on unpaid carers.
‘We know that carers are too often pushed to breaking point and this needs to be properly recognised.
‘People living with dementia are desperate for new treatments that delay the progression of symptoms and help them stay independent for longer.
‘The science is moving fast and globally more people are starting to access these drugs, but the UK is falling behind.
‘With over 30 Alzheimer’s disease drugs in late-stage clinical trials, there are likely to be more treatments submitted for approval soon.’
