NICE draft guidance opposes NHS coverage for the Alzheimer’s drug lecanemab

The MHRA has approved lecanemab for early-stage Alzheimer’s, but NICE’s draft recommendation blocks NHS access.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved lecanemab, the first drug designed to slow the progression of early-stage Alzheimer’s disease. However, the National Institute for Health and Care Excellence (NICE) has decided against making it available through NHS England, citing that its benefits do not justify the costs.

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Clinical efficacy and concerns

Lecanemab, marketed as Leqembi, was shown to slow cognitive decline by about a quarter in patients during the early stages of Alzheimer’s over 18 months in clinical trials. The drug works by clearing amyloid, a protein that accumulates in the brains of patients with Alzheimer’s disease.

Despite the promising trial results, concerns remain about lecanemab’s real-world effectiveness and potential side effects. The approval was based on a trial involving 1,795 volunteers with early-stage Alzheimer’s, who were generally healthier and younger than the typical patient seen in clinical practice. This has led to questions about the drug’s efficacy in older, frailer individuals, particularly those with multiple health conditions or “mixed” dementia, which combines Alzheimer’s with other forms of the disease.

Lecanemab is associated with the risk of amyloid-related imaging abnormalities (ARIA), which can result in brain swelling and bleeding. While most cases observed in clinical trials were mild, some participants required hospitalization. These safety concerns contributed to the European Medicines Agency’s (EMA) recent decision to reject lecanemab’s license application, as the agency determined that the benefits did not outweigh the risks of serious side effects.

Helen Knight, director of medicines evaluation at NICE, emphasized that while lecanemab does offer some benefit, providing “on average 4 to 6 months’ slowing in the rate of progression from mild to moderate Alzheimer’s disease”, this effect is “just not enough benefit to justify the additional cost to the NHS”.

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Cost and NHS implications

The cost of lecanemab in the UK remains undisclosed, but it is estimated at £20,000 per patient annually in the USA. Additional expenses include diagnostic procedures such as PET scans or lumbar punctures, and ongoing monitoring for side effects.

NICE’s decision highlights the challenge of balancing innovation with financial sustainability in the NHS. Dr Samantha Roberts, CEO of NICE, explained,

“Our independent committee has rigorously evaluated the available evidence, including the benefit for carers, but NICE must only recommend treatments that offer good value to the taxpayer.”

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Mixed reactions and outlook

The decision has sparked mixed reactions. David Thomas of Alzheimer’s Research UK acknowledged the milestone of having the drug approved but stated that “the decision by NICE not to approve it for the NHS is deeply disappointing”. Fiona Carragher of the Alzheimer’s Society echoed these sentiments, stating the decision would lead to “uncertainty and confusion” for the nearly 1 million people living with dementia in the UK.

Dr Tomas Welsh of ReMind UK Research & Medical viewed it more positively, stating, “This still represents a long-awaited day in the field of Alzheimer’s disease research”, as the “advent of disease-modifying treatment is upon us.”

NICE’s decision is not final, with a public consultation open until September 20, 2024. Meanwhile, NHS England is preparing for potential future treatments, noting that “a dedicated NHS team is also looking ahead to 27 other drugs which are currently in advanced clinical trials that could be potentially approved by 2030”.