Decision by NICE to Exclude New Alzheimer’s Drug from NHS Amidst Mixed Regulatory Responses
The UK’s health regulator has decided not to fund a new drug that slows the progression of Alzheimer’s disease, despite its approval by the Medicines and Healthcare products Regulatory Agency (MHRA). The drug, lecanemab, is designed to target and remove amyloid beta protein clumps in the brain, a hallmark of Alzheimer’s, and has been shown to slow cognitive decline by 27% in early-stage patients compared to a placebo. However, it is not a cure.
The MHRA approved lecanemab on Thursday, making the UK the first European country to license the drug. Yet, the National Institute for Health and Care Excellence (NICE) has ruled out its availability on the NHS, citing the drug’s modest benefits and high cost, along with the need for rigorous monitoring for serious side effects.
The decision mirrors that of the EU’s drug regulator, which rejected lecanemab, citing the risk of severe brain swelling and the drug’s limited impact on cognitive decline.
The rejection by NICE represents a setback for the drug’s manufacturers, Eisai and Biogen, and contrasts with its approval in the US, China, Hong Kong, Israel, Japan, and South Korea. In the US, where the drug costs about £20,000 per patient annually, uptake has been slow due to similar concerns.
Hilary Evans-Newton, Chief Executive of Alzheimer’s Research UK, commented: “It’s a bittersweet moment. While it’s a breakthrough to have licensed treatments that can slow Alzheimer’s, our health system isn’t yet equipped to integrate these new drugs. As it stands, only those who can afford to pay privately will have access to lecanemab.”
Dr. Samantha Roberts, Chief Executive of NICE, explained: “This treatment is still emerging and while it represents progress, the benefits are not sufficient to justify the substantial costs to the NHS. The treatment requires bi-weekly hospital visits and close monitoring for side effects, which adds to the expense.”
NICE’s review found that lecanemab could delay cognitive decline by four to six months but noted insufficient evidence on its long-term effects. The agency estimates that around 70,000 adults in England could have been eligible for treatment.
Julian Beach, Interim Executive Director for Healthcare Quality and Access at MHRA, stated: “Ensuring that medicines meet safety, quality, and efficacy standards is crucial. We will continue to monitor lecanemab’s safety closely through a controlled post-authorization study.”
Professor Tara Spires-Jones from the UK Dementia Research Institute at the University of Edinburgh described the drug as a “turning point” but warned of its potentially dangerous side effects, including brain swelling and bleeding. Speaking on Radio 4’s Today programme, she cautioned: “While it’s a significant development to slow disease progression, the drug’s moderate benefits and serious side effects require careful consideration and monitoring.”
The public consultation on NICE’s draft guidance will conclude on 20 September.
