Two drugs – donanemab and lecanemab – have been rejected for NHS use because their benefits are “too small” to justify their cost
Drugs to treat Alzheimer’s disease have been rejected for use on the NHS by the health spending watchdog.
The National Institute for Health and Care Excellence (NICE) has said the benefits of donanemab and lecanemab are “too small” to justify their cost, based on new information submitted by manufacturers.
Alzheimer’s disease is the most common form of dementia, accounting for 60-70 per cent of 944,000 dementia cases in the UK. It currently has no cure.
Charities have described the move as “disappointing” and a “painful setback” for patients, as the targeted antibody drugs have shown to slow down the early stages of Alzheimer’s.
Donanemab and lecanemab had previously been hailed “game-changing” as the drugs target a known cause of the disease – a protein called amyloid which builds up in the brain – rather than just treating symptoms.
The firms Lilly, which makes donanemab, and Eisai, which makes lecanemab, said they would appeal the decision by NICE.
Professor Fiona Carragher, Alzheimer’s Society’s chief policy and research Officer, said the decision was “disappointing”.
She said: “There is no doubt that today’s decision is a setback for people with Alzheimer’s disease. It is highly disappointing that we are in a situation where treatments that slow the progression of the condition are not available on the NHS.
“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.
“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.”
Publishing its final draft guidance, NICE said the treatments have been shown to delay progression from mild to moderate Alzheimer’s by four to six months, but said the medicines cannot be provided on the NHS because they are not good value for money and “only provide modest benefits at best”.
The NHS published a paper last year that suggested the cost of bringing the drugs to the health service could be £500 million to £1 billion per year.
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.”
She added: “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.
“We have done everything we possibly can to try and achieve a positive outcome in our assessments of these treatments, including providing an additional opportunity for evidence to be submitted.
“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.”
In clinical trials, donanemab has shown to slow the rate at which memory and thinking get worse by more than 20 per cent, and a 40 per cent slowing in the decline of everyday activities such as driving, enjoying hobbies and managing money.
Lecanemab has been shown to successfully remove protein build-up from the brains of people living with early Alzheimer’s disease and slowed decline in thinking and memory skills was slowed down by 27 per cent, while slowing the decline in quality of life by up to 56 per cent.
However, side-effects of the drugs can be serious, including brain bleeds and risk of death.
Hilary Evans-Newton, chief executive of Alzheimer’s Research UK, said: “This rejection is a painful setback for people affected by Alzheimer’s – but sadly not a surprising one.”
She added: “This decision sends a troubling signal to the life sciences sector – undermining confidence in the UK as a home for research, innovation and clinical trials. That risks lasting damage to both patients and the economy.
“Nice’s decision should ring alarm bells for a Government that, only a year ago, pledged to make the UK a global leader in dementia treatments.
“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.”
Drug firms and registered patient groups now have until July 8 to appeal against the NICE decision. Lilly said it would appeal on the grounds it was unreasonable based on the evidence submitted.