Two breakthrough drugs that slow the progression of Alzheimer’s disease have been refused for use on the NHS in a blow to thousands of patients.
Lecanemab and donanemab slow down the decline in Alzheimer’s patients' ability to carry out daily activities.
The drugs’ success in halting the progression of Alzheimer’s was heralded as a “new era” by campaigners and researchers.
However, the National Institute for Health and Care Excellence (Nice) has refused to recommend them on the NHS, saying they are not good value for money and “only provide modest benefits at best”.
Lilly, which makes donanemab, said it would appeal the decision.
Both drugs already have UK drug licences, making them available privately. It is estimated that around 70,000 adults in England would have been eligible for treatment if the drugs had been approved.
Lecanemab removes build-ups of the protein beta-amyloid from the brain. Donanemab, marketed as Kisunla in the UK, teaches the body’s immune cells to recognise and remove the amyloid protein, which builds up in the brains of people with Alzheimer’s disease.
The protein build-ups are thought to be toxic to brain cells, leading to the symptoms of Alzheimer’s, the Alzheimer’s Society has said.
Lecanemab can, however, cause swelling and bleeding in the brain. In trials for Donanemab, a third of recipients experienced abnormalities in their brain scans caused by brain swelling and bleeding, Nice said.
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 provide 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 to patients shown in the clinical trials and the lack of long-term evidence of effectiveness, balanced with the substantial resources the NHS would need to commit to the treatments, would be too great and could displace other essential treatments and services that deliver substantial benefits to patients.”
The drugs reportedly cost around £20,000 to £25,000, with the NHS being offered a lower price. Privately, the treatment costs between £60,000-80,000 per year, according to Alzheimer’s Research UK.
An NHS England briefing paper published last year suggested the cost of bringing the drugs to the NHS could be £500 million to £1 billion per year.
In a previous review by NICE in October 2024, director of medicines evaluation Helen Knight said: “Donanemab could slow down cognitive decline by 4-7 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”.
While the regulator said the decision would be disappointing for some, “there are other treatments being developed”.
Professor Fiona Carragher, Alzheimer’s Society’s chief policy and research officer, said the decision to turn down the drugs was “highly disappointing” and was a setback for patients.
“In other diseases like cancer, treatments have become more effective, safer and cheaper over time. It’s essential we see similar progress in dementia.
“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. The science is flying but the system is failing.”
Lilly said it would appeal the Nice decision on the grounds that it was unreasonable based on the evidence submitted.
Chris Stokes, president and general manager of UK and Northern Europe at Lilly, said: “If the system can’t deliver scientific firsts to NHS patients, it is broken.
“If the government is to deliver on its goals to reduce lives lost to the biggest killers and put Britain at the forefront of transforming treatment for dementia, it must keep pace with licensed medical breakthroughs.”
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