NICE Set to Review Evidence on Two Pioneering Alzheimer’s Drugs
The UK’s medicines cost watchdog is to take a fresh look at two high-profile Alzheimer’s treatments after successful appeals from their manufacturers.
National Institute for Health and Care Excellence (NICE) confirmed it will revisit its draft guidance on donanemab and lecanemab, both of which were approved for use in the UK in 2024 but have yet to be made available on the NHS.
The drugs were previously rejected for routine NHS use after NICE concluded they did not represent value for money. Its initial assessment found that, while the treatments offered some clinical benefit, their cost was estimated to be several times higher than the threshold typically considered acceptable.
The reassessment follows formal appeals lodged by manufacturers Eli Lilly and Eisai, who argued that key elements of the evaluation process required further scrutiny.
Among the issues now set for reconsideration are the wider impact of Alzheimer’s on unpaid carers and updated evidence around the cost of delivering the treatments within the NHS. Both medicines are administered via infusion, and the companies raised concerns that data relating to these costs was provided too late in the process for full evaluation.
Donanemab and lecanemab are part of a new generation of antibody-based therapies designed to target amyloid, a protein that accumulates in the brains of people with Alzheimer’s disease. By reducing this build-up, the drugs aim to slow the progression of cognitive decline rather than simply manage symptoms.
Clinical evidence reviewed by NICE previously suggested the treatments could delay the worsening of early-stage Alzheimer’s by several months. However, the watchdog concluded that the overall benefit was limited when weighed against the projected cost to the health service.
Helen Knight, director of medicines evaluation at Nice, said: “The independent appeal panel has ruled that some elements the committee used to inform its decision-making in relation to the cost effectiveness of donanemab and lecanemab need further consideration.
“So today we have announced we will give stakeholders an opportunity to provide more information for the committee to help it address the areas of continuing uncertainty highlighted by the appeal panel.
“Throughout our assessment of donanemab and lecanemab we have done everything we possibly can to try and achieve a positive outcome, including providing an additional opportunity for evidence to be submitted.
“Today’s decision underlines our commitment to continuing that process.”
A revised recommendation timeline has not yet been confirmed, but the move signals that access to these treatments could still be reconsidered pending the outcome of the updated review.
Michelle Dyson CB, Chief Executive Officer at Alzheimer’s Society, said: ‘We welcome NICE’s decision to look again at the case for lecanemab and donanemab, particularly at the significant impact of dementia on unpaid carers. We know that carers are too often pushed to breaking point and this needs to be properly recognised.
“People living with dementia are desperate for new treatments that delay the progression of symptoms and help them stay independent for longer.
‘The science is moving fast and globally more people are starting to access these drugs, but the UK is falling behind. With over 30 Alzheimer’s disease drugs in late-stage clinical trials, there are likely to be more treatments submitted for approval soon.
‘The Government must be ambitious about preparing for new treatments in their upcoming dementia plan. Time is ticking and it’s important that people with dementia in the UK don’t miss out.’
