Groundbreaking Alzheimer's drug rejected for NHS use 'as it doesn't demonstrate value for money'
23 October 2024, 10:18
An Alzheimer's drug deemed the "best ever" has been rejected for use on the NHS due to its high cost.
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Donanemab, manufactured by pharmaceutical giant Eli Lilly, is a targeted antibody drug which slows down the early stages of Alzheimer's.
It was approved by the medicines regulator on Wednesday, but rejected by the NHS spending watchdog as it "does not currently demonstrate value" for the health service.
Donanemab is the second new Alzheimer's drug to be rejected by the National Institute for Health and Care Excellence (Nice) in a matter of months.
Scientists have said that donanemab could give Alzheimer's patients another two years of living at home, with the drug slowing the progress of the disease by 35%, with some advocates branding it the "best ever" medicine for the disease.
Alzheimer's Research UK said the announcement was a "frustrating setback" that "risks signalling that the UK is no longer a good place to launch new dementia treatments".
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Nice's director of medicines evaluation, Helen Knight, said: "For Nice to be able to approve a medicine for use in the NHS it must provide additional benefits to patients, and it must also represent a good use of NHS resources and taxpayers' money.
"Our independent committee looked at all the available evidence, including the benefits for carers. This shows donanemab could slow down cognitive decline by four to seven months, but this is just not enough benefit to justify the additional cost to the NHS.
"The cost-effectiveness estimate for donanemab is five to six times above what Nice normally considers an acceptable use of NHS resources.
"I know this will be disappointing news, but this is an emerging field of medicine and there are other treatments being developed."
The drug, and another new drug for Alzheimer's called lecanemab, have been billed as a huge step forward in research because they target a known cause of the disease, rather than just treating the symptoms.
But Nice also blocked lecanemab earlier this year, despite the regulators saying that the drug was efficient at slowing Alzheimer's, making it the first drug of its kind to be licensed for use in Great Britain.
The NHS spending watchdog said the benefits of lecanemab were "just too small to justify the significant cost to the NHS".
One charity said that it is "deeply disappointing" that patients with early stage Alzheimer's will not have access to the drug on the health service "and it will only be available to those who can pay privately".
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Hilary Evans-Newton, chief executive at Alzheimer's Research UK, said: "Today's announcement marks another frustrating setback for people affected by Alzheimer's disease.
"We finally have two new treatments licensed in Britain for Alzheimer's, but it's incredibly disappointing that NHS patients in England and Wales won't receive them.
"While these drugs are not cures and come with risk of side-effects, trials show they are the first treatments to slow the decline in memory and thinking skills linked to Alzheimer's, rather than just alleviating symptoms.
"We've written to the Health Secretary again, calling for his leadership to bring together Nice, NHS England and industry so that people with dementia in the UK aren't left behind.
"Today's decision also risks signalling that the UK is no longer a good place to launch new dementia treatments."
Meanwhile one prominent dementia researcher said that Nice was "on the wrong side of the argument".
Professor Sir John Hardy, from the UK Dementia Research Institute at UCL, told the Telegraph: “These drugs can give people an extra two years at home, rather than in a nursing home. That is time enjoying their lives, having holidays, this is important stuff. These are finely balanced arguments, but I do think they’ve come down on the wrong side of it.
“I also think that the benefit of approval would be that it would kick NHS dementia care into shape — which really needs to happen. These drugs will come down the line at some point, and I don’t think the NHS is ready for them.”
Both donanemab and lecanemab bind to amyloid, a protein which builds up in the brains of people living with Alzheimer's disease.
By binding to amyloid, the drugs are designed to help clear the build-up and slow down cognitive decline.
Evidence suggests that people get the most benefit if they are given the treatment earlier in the disease.
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Clinical trials testing the safety and efficacy of donanemab, also known as Kisunla, found that it could slow the rate at which memory and thinking get worse by more than 20%.
Results also suggest the drug leads to a 40% reduction in the decline of everyday activities such as driving, enjoying hobbies and managing money.
The drug, which is given to patients via an intravenous drip once every four weeks, does carry a risk of side effects - some of them serious, including brain swelling and micro brain bleeds.
Some researchers have argued that the benefits of donanemab and lecanemab may not be so great as to outweigh the possible side-effects.
Sebastian Walsh of Cambridge Public Health said: "If approved, the drugs are likely to be relevant only for a relatively small cohort of Alzheimer’s patients, so potential recipients will need a range of assessments before being given access to the drugs.
“Plus, effect sizes seen in the trials are very small and the drugs will need to be administered as early in the disease process as possible, when symptoms are mild — and people in these phases can be hard to identify."
