Donanemab, marketed as Kisunla, has received regulatory approval in the UK for treating early-stage Alzheimer's disease. The drug, developed by Eli Lilly, targets and removes amyloid plaques, a hallmark of Alzheimer's pathology, offering a potential disease-modifying approach. However, the National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending against its funding by the National Health Service (NHS), citing concerns over cost-effectiveness.
Efficacy and Mechanism of Action
Donanemab is a monoclonal antibody designed to clear amyloid plaques from the brain. Clinical trials have demonstrated that it can slow cognitive decline in patients with early Alzheimer's disease. The regulatory agency noted that Kisunla "showed some evidence of efficacy in slowing (Alzheimer’s) progression." The treatment involves regular intravenous infusions and requires careful monitoring for potential side effects, including brain swelling or bleeding.
Cost-Effectiveness Concerns
Eli Lilly has priced a year's course of donanemab at $32,000 (approximately €28,700). NICE has stated that the cost of administering Kisunla, coupled with the need for rigorous monitoring, "means it cannot currently be considered good value for the taxpayer." The agency has requested additional information from Eli Lilly and the NHS to address uncertainties in the evidence regarding its long-term benefits and cost implications.
Expert Reactions and Future Prospects
Experts in the field have expressed disappointment with NICE's decision. Tara Spires-Jones, director of the Centre for Discovery Brain Sciences at the University of Edinburgh, noted that "People living with dementia and their loved ones will undoubtedly be disappointed by the decision not to fund this new treatment." She also highlighted the positive aspect that new treatments can slow the disease, even if by a small amount, and emphasized the importance of continued research to develop safer and more effective therapies.
Fiona Carragher, chief policy and research officer at the Alzheimer’s Society, called NICE's decision "disheartening" but pointed out that there are approximately 20 Alzheimer’s drugs currently in advanced stages of testing, suggesting that more treatments may become available in the coming years. She drew parallels with cancer treatments, where therapies have become more effective, safer, and cheaper over time, expressing hope for similar progress in dementia care.
