NHS Watchdog to Reassess Two Pioneering Alzheimer's Drugs After Appeals
The National Institute for Health and Care Excellence (Nice) is set to re-evaluate its decision on two pioneering Alzheimer's drugs following successful appeals from their manufacturers. Donanemab and lecanemab, which were licensed for use in the UK in 2024, were initially deemed too expensive for NHS provision by the health spending watchdog.
Initial Rejection and Cost Concerns
In its final draft guidance published in June last year, Nice concluded that the benefits of donanemab and lecanemab were "too small" to justify their cost. The watchdog estimated that the treatments would be five to six times higher than its usual recommendation threshold for cost-effectiveness. Nice stated that while the drugs have been shown to delay progression from mild to moderate Alzheimer's by four to six months, they "only provide modest benefits at best" and cannot be provided on the NHS because they are not good value for money.
Successful Appeals and New Considerations
However, Nice must now revisit its draft guidance after appeals by Eli Lilly, makers of donanemab, and Eisai, which produces lecanemab. The independent appeal panel has ruled that some elements the committee used to inform its decision-making need further consideration.
Key areas for reconsideration include:
- The impact on the quality of life for carers of Alzheimer's patients
- Evidence from NHS England regarding the estimated costs of administering the treatments via infusion
- Unpaid carer costs and long-term data on donanemab
The companies claimed that the document on infusion costs was only provided four days before the third committee meeting, leaving insufficient time for proper scrutiny.
Scientific Significance of the Treatments
Donanemab and lecanemab represent a significant advancement in Alzheimer's treatment as they are targeted antibody drugs that bind to amyloid, a protein which builds up in the brains of people living with Alzheimer's. This mechanism helps clear the amyloid build-up and slows down cognitive decline, targeting the known cause of the disease rather than just managing symptoms.
Industry and Advocacy Responses
Chris Stokes, general manager of the northern European hub at Lilly, welcomed the appeal outcome, stating: "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, emphasized the organization's commitment to the process: "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."
Broader Implications for Dementia Care
Michelle Dyson, chief executive at Alzheimer's Society, welcomed Nice's decision to reconsider the drugs, particularly highlighting 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," she said.
Dyson added: "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 reassessment process will now move forward with stakeholders providing additional information to address the areas of uncertainty identified by the appeal panel, potentially paving the way for these pioneering treatments to become available on the NHS in the future.
