NICE's cautious stance on new Alzheimer's treatments: A reasoned approach

The National Institute for Health and Care Excellence (NICE) in the UK has recently decided not to recommend two newly developed Alzheimer's drugs for routine use within the NHS. This decision, while disappointing to some families affected by dementia, underscores a careful, evidence-based approach aimed at safeguarding patients and responsible resource allocation.

The drugs in question—lecanemab, produced by Eisai, and donanemab, by Eli Lilly—have garnered significant media attention, with headlines heralding them as potential breakthroughs or even miracles in Alzheimer's care. Despite the excitement, NICE has historically scrutinized such treatments stringently. Their latest assessment highlighted that, although these drugs may delay disease progression by approximately four to six months in early-stage patients, the overall benefit remains modest.

It is essential to differentiate between clinical trial results and real-world efficacy. Trials often occur under ideal, controlled conditions, which do not fully represent the broader patient population treated by the NHS, where variability increases.

Furthermore, these drugs carry risks including brain swelling and bleeding, and involve invasive procedures like lumbar punctures and continuous brain scans before and during treatment. The infusions require hospital visits over many months, which may impose significant burdens on patients—burdens that may outweigh the limited benefits.

Another critical factor is the uncertainty about whether the benefits persist beyond the trial period of 18 months. NICE relies on long-term projections, utilizing tools like quality-adjusted life year (QALY) estimations, to balance potential health gains against costs. Given the high price points—up to £25,000 per patient annually—cost-effectiveness remains a concern, especially since these expenses could divert resources from other essential services.

Experts, including Professor Tom Dening from the University of Nottingham, describe the benefits as minimal and caution that focusing on these drugs could divert attention from improving care and support for current dementia patients.

The debate has intensified, with some drug companies arguing that the UK's approval process is flawed and suggesting that offering free drugs wouldn't influence NICE’s decision. Nonetheless, NICE’s approach involves assessing the comprehensive costs—including scans, infusions, and monitoring—making it a responsible decision aligned with public health priorities.

Historically, attempts by companies to pressure NICE politically or legally have largely failed. In 2007, Eisai took NICE to court over similar decisions and was unsuccessful. Both current drug manufacturers have the opportunity to appeal the decision before finalization.

Overall, NICE’s decision reflects a careful weighing of extensive evidence and ethical considerations, aiming to ensure that NHS resources support treatments offering meaningful and sustained benefits. Understanding these principles highlights the agency’s commitment to fairness and responsible healthcare policymaking.

Source: https://medicalxpress.com/news/2025-06-nice-alzheimer-drugs.html