New Alzheimer’s drug donanemab rejected for widespread use in NHS

A new Alzheimer’s drug has been rejected by the health spending watchdog for general use within NHS England, with the National Institute for Health and Care Excellence (Nice) stating the treatment "does not currently demonstrate value for the NHS".

Despite the UK’s medicines regulator hinting at a possible licence for donanemab's use in the country, it is the second time in just a few months that Nice has turned down a disease-modifying Alzheimer’s drug.

The charity Alzheimer’s Research UK voiced their disappointment, labelling it a "frustrating setback" for those suffering from Alzheimer’s. They further warned that such decisions could risk the UK being seen as less favourable for introducing new dementia treatments.

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Manufactured by Eli Lilly, donanemab is designed to slow down the progression of early Alzheimer's by targeting the causes of the disease rather than merely addressing symptoms. Another related drug called lecanemab had also faced rejection.

Explaining the position of Nice, Helen Knight, Director of Medicines Evaluation, explained: "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."

It's estimated that around 70,000 adults in England would have been eligible for treatment with donanemab.

Nice’s new draft guidance indicates that more evidence is needed on the clinical and cost-effectiveness of the drug. "The costs of providing donanemab, including the monthly infusions and intensive monitoring for serious side effects, balanced against the relatively small benefit it provides to patients, means it cannot currently be considered good value for the taxpayer," Nice stated.

Nice said did not recommend donanemab for use on the NHS "as the benefits it offers patients are too small to justify the additional costs". Nice further added that there are "significant uncertainties to how much benefit donanemab provides, and how long this lasts for after stopping treatment".

In August, the groundbreaking Alzheimer's drug lecanemab was given the green light by the Medicines and Healthcare products Regulatory Agency (MHRA), marking it as the first of its kind to be approved for use in the UK. However, the National Institute for Health and Care Excellence (Nice) has expressed reservations, stating in draft guidance that the benefits offered by lecanemab—marketed as Leqembi by pharmaceutical company Eisai—are "just too small to justify the significant cost to the NHS".

This stance has sparked fears of a potential two-tier system where only those who can afford private healthcare will have access to the drug, leaving NHS patients without this option.

Both donanemab and lecanemab target amyloid, a protein that accumulates in the brains of individuals with Alzheimer’s, aiming to clear these build-ups and slow cognitive deterioration. Research indicates that early-stage treatment maximises patient benefit.

Clinical trials for donanemab, also known as Kisunla, demonstrated its ability to decelerate memory and cognitive decline by over 20%, with additional data suggesting a 40% reduction in the deterioration of daily activities such as driving, engaging in hobbies, and managing finances.

The drug is administered to patients via an intravenous drip every four weeks but comes with the potential for serious side effects, including brain swelling and micro brain bleeds. While both donanemab and lecanemab have received approval for use in the United States, the European medicines authority turned down lecanemab earlier this year.

Julian Beach, from the MHRA, said the drug’s safety will be kept under “close review”, adding: “Licensing medicines which meet acceptable standards of safety, quality and efficacy is a key priority for us.

“We’re assured that, together with the conditions of the licence approval, the appropriate regulatory standards for this medicine have been met.”

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.”

Professor Fiona Carragher, chief policy and research officer at Alzheimer’s Society, said: “Disease-modifying therapies like donanemab and lecanemab offer a new horizon of hope in the fight against dementia.

“MHRA’s approval of donanemab marks another milestone in this journey, but it comes alongside a draft Nice decision not to recommend donanemab for use on the NHS. While this is disheartening, we respect the decision of the regulator.”

Manufacturer Lilly welcomed the news that the drug has been licensed in the UK and said it “remains confident in the clinical and cost-effectiveness of donanemab and the value that it can bring to patients and to the NHS”.

Chris Stokes, president and general manager of UK and northern Europe at Lilly, said: “After more than 35 years of commitment to scientific progress in Alzheimer’s disease, we’re delighted that donanemab has been authorised in Great Britain for eligible adults who need effective treatment options.

“Donanemab is part of a new class of medication and has demonstrated meaningful results for people with mild cognitive impairment and mild dementia due to Alzheimer’s disease.”

The MHRA licensed donanemab for the early stages of Alzheimer’s disease in adults who have “one or no copies of the apolipoprotein E4 gene (ApoE4)”.

Around 15% of people diagnosed with Alzheimer’s disease have two copies of this gene – and would therefore not be eligible.

The MHRA said those with two ApoE4 genes did not demonstrate a significant slowing in decline in clinical trials and they were also at higher risk of side effects.