NHS watchdog will re-evaluate lecanemab and donanemab under new cost-effectiveness thresholds linked to the US trade deal.
The National Institute for Health and Care Excellence (NICE) will reconsider its decision to reject two breakthrough Alzheimer’s treatments from NHS funding following appeals by the drugs’ manufacturers. The development offers fresh hope to thousands of patients with early-stage disease, though significant hurdles remain before the medications become widely available on the health service.
The two drugs at the centre of the reassessment are lecanemab and donanemab, both licensed by the UK medicines regulator as safe and effective treatments for mild cognitive impairment and mild dementia caused by Alzheimer’s disease. Clinical trials have demonstrated that both medications can slow disease progression in people at the earliest stages of the condition.
NICE’s initial rejection came in June 2025, when the watchdog determined that neither drug represented a cost-effective use of NHS resources. The treatments were estimated to cost five to six times more than the threshold NICE can normally recommend for NHS funding. Beyond the cost of the drugs themselves, the expense of rolling out the treatments proved prohibitive: patients require regular intravenous infusions and close medical monitoring to watch for serious side effects, including brain swelling and microhaemorrhages.
The reassessment represents a significant shift. NICE has confirmed that the re-evaluation will take place under new, and controversial, cost-effectiveness thresholds that were agreed as part of a trade deal with the United States. These revised thresholds potentially lower the bar for what NICE considers acceptable value for money, creating space for previously rejected treatments to be reconsidered.
The decision reflects growing momentum for these treatments. Alzheimer’s Research UK and other patient advocacy groups have mounted compelling campaigns, highlighting real-world evidence from countries where the drugs are already in use. Early data suggests that the benefits of lecanemab and donanemab may last longer than initial clinical trials indicated, and that serious adverse effects are occurring less frequently than first feared. For patients and families facing the devastating cognitive decline of Alzheimer’s, even a modest delay in disease progression can mean months or years of preserved independence and quality of life.
Despite the optimism, significant practical barriers stand between regulatory approval and widespread NHS availability. The health service is not currently equipped to deliver these treatments at scale. Diagnostic infrastructure capable of identifying suitable candidates at sufficiently early stages of disease remains inadequate across most regions. There is also a critical shortage of trained healthcare staff who understand how to administer the treatments safely and manage potential complications.
Baroness Casey of Blackstock has joined the calls for action, urging the Government to establish NHS pilot trials for the two drugs. This approach, long standard in oncology and cardiology, would allow the health service to develop the systems needed to identify eligible patients safely and fairly, determine optimal staffing models, and organise safety monitoring protocols. Pilot trials would also generate valuable real-world evidence about how the treatments perform within the NHS context, potentially addressing NICE’s earlier cost-effectiveness concerns.
Alzheimer’s Research UK has emphasised that the current situation—where access to potentially life-changing treatment depends on personal wealth—is untenable. The charity argues that even with today’s reassessment, fundamental changes are needed to how dementia drugs are evaluated. Current assessment methods, it contends, fail to capture the full societal value of slowing cognitive decline in an ageing population.
The prospect of NHS funding for these drugs comes as the number of people with dementia in the UK continues to rise. Approximately 920,000 people live with dementia in the UK, and this figure is projected to grow significantly over coming decades. Early intervention with disease-modifying treatments could have substantial implications for patients, carers, and the wider healthcare system.
For the NHS to successfully integrate lecanemab and donanemab, if approved, workforce development must become a priority. Neurologists, geriatricians, memory clinic staff, and imaging specialists will all need training in patient identification, treatment administration, and adverse event management. Additionally, diagnostic capacity—particularly amyloid positron emission tomography (PET) imaging—must be expanded to identify the patients most likely to benefit.
The timeline for NICE’s reassessment remains unclear, though the decision to reopen the evaluation signals that both manufacturers believe the new cost thresholds create a realistic pathway to approval. The outcome will be closely watched not only by patient groups and industry, but by healthcare systems across Europe facing similar decisions about these emerging Alzheimer’s treatments.
Source: @bmj_latest
Key Takeaways
- NICE will re-evaluate lecanemab and donanemab for NHS funding under new cost-effectiveness thresholds negotiated in the US trade deal
- The drugs can slow early-stage Alzheimer’s disease progression; initial trials showed benefits can last longer than expected
- Previous rejection centred on cost (five to six times NICE’s normal threshold) and logistical challenges around infusions and safety monitoring
- Alzheimer’s Research UK is calling for NHS pilot trials to develop diagnostic and treatment delivery infrastructure before full rollout
- Significant workforce training and diagnostic capacity expansion will be needed if the drugs are approved for NHS use
What This Means for Kent Residents
For Kent residents living with early-stage Alzheimer’s disease and their families, the reassessment offers genuine hope. NHS Kent and Medway Integrated Care Board (ICB) will play a central role should NICE approve funding, working with local hospital trusts including Maidstone and Tunbridge Wells NHS Trust and East Kent Hospitals University NHS Foundation Trust to establish diagnostic pathways and treatment services. In the meantime, patients and carers can discuss early-stage symptoms with their GP, who can arrange appropriate cognitive assessment and referral to local memory clinics. Organisations such as the Alzheimer’s Society continue to provide free support and information to Kent residents affected by dementia.
