The UK’s National Institute for Health and Care Excellence (NICE) has announced that it will not approve the Alzheimer’s treatment donanemab for use in the National Health Service (NHS), despite the recent licensing of the drug by the UK’s medicines regulator. Manufactured by pharmaceutical giant Eli Lilly, donanemab, also known as Kisunla, is a targeted antibody drug that slows cognitive decline in the early stages of Alzheimer’s disease.
Helen Knight, director of the Medicines Evaluation at NICE, explained the reasoning behind the decision, stating that donanemab “does not currently demonstrate value for the NHS.” This marks the second time in just a few months that NICE has rejected a new Alzheimer’s treatment.
In its draft guidance, NICE indicated that while donanemab could slow cognitive decline by four to seven months, the benefit was not substantial enough to justify the drug’s high cost. Knight emphasized, “For NICE to be able to approve a medicine for use in the NHS, it must provide additional benefits to patients and represent a good use of NHS resources and taxpayers’ money.” She added that the cost-effectiveness estimate for donanemab is five to six times higher than what NICE typically considers acceptable.
The announcement has raised concerns among Alzheimer’s advocates. Hilary Evans-Newton, Chief Executive of Alzheimer’s Research UK, expressed disappointment, stating, “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 won’t receive them.”
Donanemab is part of a new wave of Alzheimer’s treatments aimed at targeting the underlying causes of the disease, rather than merely alleviating symptoms. Alongside another drug called lecanemab, donanemab has been hailed as a significant advancement in Alzheimer’s research. However, NICE previously rejected lecanemab for similar reasons, stating that the benefits did not justify the substantial costs.
Critics of NICE’s decision fear it could create a two-tier system for Alzheimer’s patients in the UK, where those who can afford private care may access these treatments, while those relying on the NHS remain without. The rejections have sparked a broader conversation about the future of Alzheimer’s treatments and the need for a balanced approach to resource allocation within the NHS.
As the search for effective Alzheimer’s therapies continues, stakeholders remain hopeful that ongoing research will yield treatments that not only gain regulatory approval but also meet the cost-effectiveness criteria set by NICE.