NICE's Rejection of Alzheimer’s Treatments Sparks Debate on Cost-Effectiveness

The National Institute for Health and Care Excellence (NICE) has officially recommended against the approval of two Alzheimer’s treatments, Leqembi (lecanemab) and Kisunla (donanemab), citing high costs and limited benefits as primary factors in its decision. This conclusion, outlined in the final draft guidance released on June 19, 2025, raises significant questions about the future of Alzheimer’s treatment options in the UK.

NICE's guidance comes after a thorough review of the new evidence submitted during an additional consultation phase. Helen Knight, Director of Medicines Evaluation at NICE, emphasized the committee's exhaustive efforts to assess the treatments. "We have done everything we possibly can to try and achieve a positive outcome in our assessments of these treatments," Knight stated. However, the costs associated with purchasing and administering these drugs are prohibitively high, compounded by insufficient long-term efficacy evidence.

The decision follows the European Commission's earlier approval of lecanemab for specific Alzheimer’s patients. Professor Rob Howard, a leading expert in Old Age Psychiatry at University College London, criticized the effectiveness of these treatments, remarking, "Well-conducted clinical trials demonstrated that the actual size of benefits experienced by Alzheimer’s patients were too small to be noticeable. Treatment carries risks of side effects, and the annual cost of the drugs and required safety monitoring would have been prohibitively expensive for the NHS."

Despite the negative appraisal, the landscape of Alzheimer’s research is rapidly evolving. With over 30 drugs in late-stage trials globally, the momentum for potential breakthroughs continues to build. Hilary Evans-Newton, Chief Executive at Alzheimer’s Research UK, expressed concern regarding NICE's decision. She stated, "This should ring alarm bells for a government that, only a year ago, pledged to make the UK a leader in dementia treatments. While these drugs are not a cure, they represent an important first step in changing the course of Alzheimer’s disease."

In contrast, Professor Atticus Hainsworth from St George’s, University of London, pointed out that the benefits observed in clinical trials for these antibody treatments were comparable to those seen in past trials of intensive blood pressure control. He noted the ongoing need for the NHS to adapt and prepare for future treatments as more data emerges.

NICE's decision has significant implications for healthcare policy and patient care within the UK. Stakeholders have until July 8, 2025, to appeal the recommendations, potentially leading to further discussions around the role of cost-effectiveness in the approval of new Alzheimer’s therapeutics. As the debate unfolds, the focus will remain on balancing financial constraints with the urgent need for effective treatments in the face of a growing Alzheimer’s epidemic.

In summary, while the rejection of Leqembi and Kisunla highlights the challenges of high-cost treatments in the NHS, it also underscores the need for ongoing research and investment in dementia therapies. The future of Alzheimer’s treatment in the UK hangs in the balance, as healthcare authorities, researchers, and patient advocates continue to seek the most effective pathways forward.