NICE rejects Donanemab for NHS use despite MHRA approval
A new Alzheimer's treatment, donanemab, has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA), but a draft decision by the National Institute for Health and Care Excellence (NICE) has rejected the drug for use on the NHS. Manufactured by Eli Lilly, donanemab, also known as Kisunla, is designed to slow cognitive decline in patients with early-stage Alzheimer’s disease by targeting beta-amyloid plaques in the brain, a known cause of the condition.
The decision from NICE, published today (23 October 2024), has sparked frustration within the Alzheimer’s community, especially following NICE's similar rejection of another Alzheimer’s drug, lecanemab, just months earlier. While both treatments represent a breakthrough in addressing the disease's underlying cause rather than just managing symptoms, NICE determined that donanemab does not currently demonstrate sufficient value for NHS use due to its high costs and limited benefits.
According to NICE's independent committee, clinical evidence showed that donanemab could slow the progression of Alzheimer’s disease by 4 to 7 months. However, the cost-effectiveness estimate for the drug was found to be five to six times higher than what NICE typically considers acceptable. Helen Knight, director of medicines evaluation at NICE, stated, “While the drug offers some benefit, this is just not enough to justify the significant cost to the NHS.” She emphasized that the draft decision could be revisited pending further evidence from Eli Lilly and NHS England.
Despite the MHRA’s approval, NICE raised concerns over the drug’s safety profile, as 33% of trial participants experienced amyloid-related imaging abnormalities (ARIA), including brain swelling and bleeding. The treatment also requires monthly hospital infusions and intensive monitoring, adding to the costs. With an estimated 70,000 patients in England eligible for the treatment, the financial strain on the NHS was a critical factor in NICE’s rejection.
Alzheimer's Society - mixed emotions
The UK’s leading dementia charity, Alzheimer’s Society, responded to the news with mixed emotions. While celebrating the MHRA’s approval, the charity expressed disappointment with NICE’s draft guidance. Professor Fiona Carragher, Chief Policy and Research Officer at Alzheimer’s Society, remarked, “Disease-modifying therapies like donanemab and lecanemab offer a new horizon of hope in the fight against dementia. However, we respect NICE's decision and hope to see improvements in the affordability and efficacy of treatments over time, as we have seen in other diseases like cancer.”
Alzheimer’s Society funded the research that identified the role of amyloid plaques 30 years ago, laying the groundwork for today’s treatment developments. The charity continues to advocate for better access to treatments and early diagnosis, highlighting that more than a million people live with dementia in the UK, many without a diagnosis. Professor Carragher emphasized, “New treatments are only one part of the solution. We must ensure that people with dementia have access to timely and accurate diagnosis so they can benefit from the treatments available now and in the future.”
As the landscape for Alzheimer’s disease treatment evolves, NICE has announced that it is monitoring around 27 new products in the pipeline. The organization also plans to revisit its suite of guidance on Alzheimer’s care and diagnostics, including researching blood biomarkers for earlier and more accurate detection.
The consultation period for NICE’s draft guidance on donanemab will run until 20 November 2024, during which further evidence and responses will be reviewed. A final decision on donanemab’s NHS availability is expected in the coming months. Meanwhile, the Alzheimer’s community continues to await the final recommendations for lecanemab, with its second committee meeting scheduled for November 2024.
