UK health authority rejects lecanemab as treatment for Alzheimer’s
Britain’s health regulator has rejected a drug that can slow the progression of Alzheimer’s disease, saying the benefits are too small to justify the cost of the therapy and the close monitoring of patients for signs of “serious side effects”.
Lecanemab, given twice a month, removes sticky clumps of the protein amyloid beta from the brain that are believed to be a hallmark of the disease. The drug is not a cure. But in clinical trials, the therapy slowed cognitive decline by 27% in patients with early Alzheimer’s, compared with a placebo.
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s drug regulator, gave the green light for the drug on Thursday. However, the National Institute for Health and Care Excellence (Nice), the health regulator, simultaneously ruled out the drug being offered via the NHS.
The development comes weeks after the European Union’s drug regulator also rejected the drug, saying the risk of serious brain swelling did not outweigh its limited impact on slowing cognitive decline. It also said the drug’s effects on slowing cognitive decline were small.
The Nice decision is a fresh blow to the companies behind the drug, Eisai and Biogen, as the treatment has been slow to gain traction in the US, where it costs around £20,000 per patient per year. It also highlights the complexities of a new class of drugs that helped patients early on but can cause serious side effects.
The therapy, also known as Leqembi, has been approved in the US, China, Hong Kong, Israel, Japan and South Korea. The green light from the MHRA means the UK is the first country in Europe to license the drug, which can treat the neurodegenerative condition rather than its symptoms.
However, the fact that Nice has rejected the use of the drug in the NHS means that only a small number of patients in the UK are likely to benefit from it and they will have to obtain the drug privately.
Hilary Evans-Newton, chief executive of Alzheimer’s Research UK, said: “Today’s news is twofold for people affected by Alzheimer’s disease.
“It is a remarkable achievement that science is now delivering approved treatments that can slow the devastating effects of Alzheimer’s, rather than just alleviate symptoms. But 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 will no longer be able to access lecanemab through the NHS, and it will only be 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 benefits provided by this initial treatment are too small to justify the significant cost to the NHS.
“It is an intensive treatment that patients have to undergo, where they have to go to the hospital every two weeks and where they need skilled personnel to monitor them for signs of serious side effects. On top of that, there is the cost of purchasing the drug.
“Our independent committee has thoroughly evaluated the available evidence, including the benefits to carers, but Nice should only recommend treatments that offer good value to the taxpayer.”
Nice said clinical trials showed lecanemab can slow cognitive decline by four to six months, but there was little evidence of long-term effects. It is estimated that around 70,000 adults in England would be eligible for treatment.
The public consultation on the draft Nice guidelines closes on 20 September.
Julian Beach, MHRA interim director for quality and access to healthcare, said: “Licening medicines that meet acceptable standards of safety, quality and efficacy is a top priority for us.
“We are confident that, in addition to the conditions for licensing, the applicable regulatory standards for this medicine have been met.
“As with all medical products, we will closely monitor its safety and with a controlled post-approval safety study we will ensure that the risk-benefit balance of lecanemab in clinical use is closely monitored.”
Tara Spiers-Jones, professor at the UK Dementia Research Institute at the University of Edinburgh, said the drug’s arrival marked “a turning point” but warned it could come with “dangerous side effects”.
Speaking on Radio 4’s Today programme, she said: “It’s the first time we’ve actually been able to slow the progression of the disease at all. So from that point of view it’s amazing.
“The treatment is not perfect, though. It only moderately slows the progression of the disease, and it comes with dangerous side effects, and people really need to be monitored very closely, and only certain people will be able to use the drug. So, all in all, it’s great news, but we need to temper our enthusiasm.”
When asked about the dangerous side effects, Spiers-Jones said: “Some people who take this drug get swelling and bleeding in the brain and a few people have died from those side effects.”