British health authority rejects Lecanemab as Alzheimer's treatment | Alzheimer's

The British health authority has rejected a drug that can slow the progression of Alzheimer's disease. The reason: its benefits are too small to justify the cost of the therapy and the close monitoring of patients for signs of “serious side effects”.

Lecanemab is administered twice a month and removes sticky clumps of the protein amyloid-beta from the brain, which are considered a hallmark of the disease. The drug is not a cure. But in clinical trials, the therapy slowed cognitive decline in early-stage Alzheimer's patients by 27 percent compared to a placebo.

The Medicines and Healthcare products Regulatory Agency (MHRA), the British drug authority, gave the drug the green light on Thursday. At the same time, however, the health authority National Institute for Health and Care Excellence (Nice) ruled out making the drug available via the NHS.

This came a few weeks after the EU's drug regulator also rejected the drug, saying the risk of severe brain swelling did not outweigh the drug's small effect in slowing cognitive decline. It also said the drug's effect in delaying cognitive decline was small.

The decision in Nice is a further blow to the companies behind the drug, Eisai and Biogen, as the treatment has been slow to take off in the US, where it costs around £20,000 per patient per year. It also exposes the complexities involved in a new class of drugs that have helped early-stage patients but can cause serious side effects.

The therapy, also known as Leqembi, is approved in the US, China, Hong Kong, Israel, Japan and South Korea. The MHRA approval makes the UK the first country in Europe to approve the drug, which can treat the neurodegenerative disease rather than its symptoms.

Because Nice opposes the use of the drug in the British health system, it is likely to benefit only a small number of patients in the UK, who will have to obtain the drug privately.

Hilary Evans-Newton, chief executive of Alzheimer's Research UK, said: “Today's news is bittersweet for people affected by Alzheimer's.

“It is a remarkable achievement that science is now providing approved treatments that can slow the devastating effects of Alzheimer's rather than just relieve symptoms. However, it is clear that our health care system is not ready to embrace this new wave of Alzheimer's drugs.

“This means that, as things stand, people in the early stages of the disease are denied access to lecanemab through the NHS and it is only available to those who can pay for it privately.”

Dr Samantha Roberts, CEO of Nice, said: “This is a new and emerging field of medicine that will undoubtedly develop rapidly.

“The reality, however, is that the benefit of this initial treatment is simply too small to justify the significant cost to the NHS.

“The treatment is very intensive and requires hospitalization every two weeks. Specialists must monitor patients for signs of serious side effects. Added to this is the cost of purchasing the drug.”

“Our independent committee has carefully reviewed the available evidence, including the benefits to caregivers, but Nice can only recommend treatments that offer good value for the taxpayer.”

Nice said clinical trials have shown that lecanemab can slow cognitive decline by four to six months, but there is little evidence of its long-term effects. It is estimated that around 70,000 adults in England would have been eligible for treatment.

A public consultation on the draft Nice guidelines ends on 20 September.

Julian Beach, interim executive director for healthcare quality and access at the MHRA, said: “Authorising medicines that meet acceptable standards of safety, quality and efficacy is a key priority for us.”

“We are convinced that in addition to the conditions of approval, the relevant regulatory standards for this medicinal product have been met.

“As with all medical products, we will closely monitor safety and conduct a controlled post-approval safety study to ensure that the benefit-risk profile of lecanemab is closely monitored in clinical use.”

Tara Spires-Jones, a professor at the UK Dementia Research Institute at the University of Edinburgh, said the drug's introduction marked “a turning point” but warned it could bring “dangerous side effects”.

Speaking on Radio 4's Today programme, she said: “It's the first time we've been able to slow down the progression of the disease at all. So from that point of view it's amazing.”

“However, the treatment is not perfect. It only moderately slows the progression of the disease and has dangerous side effects. Patients really need to be monitored very carefully and only certain people can use the drug. So overall, this is great news, but we need to temper our enthusiasm.”

When asked about the dangerous side effects, Spires-Jones said: “Some people who take this drug experience brain swelling and bleeding, and some people have died from these side effects.”