The national health spending watchdog is set to re-evaluate its decision on two pioneering Alzheimer’s drugs following successful appeals from their manufacturers.
Donanemab and lecanemab, licensed for use in the UK in 2024, were initially deemed too expensive for NHS provision by the National Institute for Health and Care Excellence (Nice).
The watchdog had concluded their benefits were “too small” to justify a cost estimated to be five to six times higher than its usual recommendation threshold.
However, Nice must now revisit its draft guidance after appeals by Eli Lilly, makers of donanemab, and Eisai, which produces lecanemab.
Key areas for reconsideration include the impact on the quality of life for carers of Alzheimer’s patients, alongside evidence from NHS England regarding the estimated costs of administering the treatments via infusion.
The companies claimed the document on infusion costs was only provided four days before the third committee meeting, leaving insufficient time for proper scrutiny.
According to Lilly, Nice will also revisit evidence relating to unpaid carer costs and the long-term data on donanemab.
Donanemab and lecanemab are targeted antibody drugs that bind to amyloid, a protein which builds up in the brains of people living with Alzheimer’s.
This helps clear the build-up and slows down cognitive decline.
The drugs represent a huge step forward as they target the known cause of the disease rather than symptoms.
Nice published its final draft guidance on donanemab and lecanemab in June last year.
It said the treatments have been shown to delay progression from mild to moderate Alzheimer’s by four to six months, but the medicines cannot be provided on the NHS because they are not good value for money and “only provide modest benefits at best”.
Reacting to the outcome of the appeal, Chris Stokes, general manager of the northern European hub at Lilly, said: “This is a big moment in the battle against Alzheimer’s disease.
“Nice was right to look again at the evidence in front of them and it’s welcome that our appeal has been upheld. For people living with Alzheimer’s disease, and for the families and carers who support them, this matters, perhaps now more than ever.”
An Eisai spokesperson added: “This news offers a welcome glimmer of hope for the Alzheimer’s disease community in England.
“We are keen to work quickly with Nice to assess this treatment effectively, because while we wait, Alzheimer’s disease does not.”
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.”
Michelle Dyson, chief executive 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.”
