NHS rejects Alzheimer’s drugs over cost concerns

Two new Alzheimer’s drugs have been rejected for NHS use after health officials said the benefits were too limited to justify potential costs of up to £1bn a year.

Donanemab and lecanemab are antibody-based treatments that target the underlying cause of Alzheimer’s disease, rather than only managing symptoms. They work by binding to amyloid – a protein that builds up in the brain – helping to clear these deposits and slow cognitive decline.

The National Institute for Health and Care Excellence (Nice) confirmed its earlier decision to reject both drugs after considering new evidence submitted by the manufacturers, Lilly and Eisai, who say they will appeal.

Publishing its final draft guidance, Nice said the treatments delay progression from mild to moderate Alzheimer’s by four to six months but offer “only modest benefits at best” and would require substantial NHS resources.

NHS England previously estimated annual costs could reach between £500m and £1bn.

Charities described the decision as “disappointing” and a “painful setback” for patients. They also warned that the drugs may now be out of reach for all but those who can afford private care.

“There is no doubt that today’s decision is a setback for people with Alzheimer’s disease,” said professor Fiona Carragher, chief policy and research officer at Alzheimer’s Society. “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.”

She called on the Government to commit to long-term investment in earlier diagnosis and access to specialist testing, so the NHS can prepare for future disease-slowing treatments.

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.

“The drugs’ modest benefits, combined with the significant costs of delivering them in the NHS, meant they faced insurmountable challenges.

“People with early Alzheimer’s in England and Wales now face a long wait for innovative new treatments as they won’t be able to access lecanemab or donanemab unless they can afford to pay privately.

“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.”

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.

“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, which is given via intravenous drip, was shown to slow the decline in memory and thinking by over 20 per cent, and slow deterioration in daily tasks – such as managing money or hobbies – by 40 per cent.

Lecanemab, also administered by drip, successfully reduced amyloid build-up in the brain and slowed cognitive decline by 27 per cent. It was also linked to up to a 56 per cent reduction in decline in quality of life.

However, both treatments carry significant risks, including brain swelling, bleeds and in rare cases, death.

A reformulated version of lecanemab, which can be injected under the skin rather than delivered by drip, is in development and may be assessed separately by Nice.

Chris Stokes, president and general manager for 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.”

Dr Jeremy Isaacs, national clinical director for dementia at NHS England, said: “NHS England has a dedicated team preparing for the rollout of new Alzheimer’s treatments.

“There are several other Alzheimer’s treatments in development, and the NHS stands ready to offer patients access to new treatments as soon as they are deemed by regulators to be clinically and cost effective.”

Patient groups and manufacturers have until 8 July to appeal the decision.