Health spending watchdog rules Alzheimer's drug should not be rolled out on NHS

ITV News Science Correspondent Martin Stew explains why the drug has been rejected as too expensive for use by the health spending watchdog

A new drug which has been shown to slow the progression of Alzheimer's disease should not be rolled out on the NHS, the health service spending watchdog has recommended.

The National Institute for Health and Care Excellence (Nice) said the benefits of lecanemab are "just too small to justify the significant cost to the NHS".

It comes despite the UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), saying the drug is safe and effective to use.

Lecanemab, developed by pharmaceutical company Eisai, is a targeted antibody treatment that binds to amyloid, a protein which builds up in the brains of people living with Alzheimer's disease.

The drug is designed to help clear the build-up and slow down cognitive decline in people with the condition and is given to patients via an intravenous drip fortnightly.

It is the first treatment of its kind to be licensed for use in Great Britain.

However, Nice has recommended lecanemab is not rolled out on the NHS in England in draft guidance due to the cost to the taxpayer.

Nice Chief Executive Dr Samantha Roberts said: "This is a new and emerging field of medicine which will no doubt develop rapidly.

"However, the reality is that the benefits this first treatment provides are just too small to justify the significant cost to the NHS.

"It is an intensive treatment to give to patients involving a hospital visit every two weeks with skilled staff needed to monitor them for signs of serious side-effects, plus the cost of purchasing the drug.

"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."

Clinical trials showed lecanemab can slow cognitive decline by four to six months, however there is little evidence on its long-term effects, according to Nice.

The watchdog estimates about 70,000 adults in England would have been eligible for treatment.

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A public consultation on Nice's draft guidance will close on September 20.

Julian Beach, interim executive director for healthcare quality and access at MHRA, said: "Licensing medicines which meet acceptable standards of safety, quality and efficacy is a key priority for us.

"We're assured that, together with the conditions of the licence approval, the appropriate regulatory standards for this medicine have been met.

"As with all medical products, we will keep its safety under close review, and with a controlled post-authorisation safety study to be undertaken, we will ensure that the benefit risk of lecanemab in clinical use is closely followed up."

David Essam has lived with Alzheimer's for the past eight years, four of which have been spent trialling lecanemab.

Cheryl Essam told ITV News that she and her husband, David - who lives with Alzheimer's - hope further trials of lecanemab will improve knowledge and awareness of the drug

Speaking to ITV News, alongside his wife, Cheryl, they explained how David had suffered no side effects while undergoing treatment, which required hundreds of transfusions, MRI scans and lumbar puncture tests.

Ms Essam said the couple "do believe" the drug has helped to slow the progression of David's condition, explaining their hope that further trials could eventually see the drug given the green light by Nice.

"When we volunteered four years ago there was no hope. We never expected there to be any success," Ms Essam added.

"So, for anybody now if you're at that very early stage I'd just really say please try to get involved in the trial.

"And it won't be your salvation, but for the next generation it will make such a difference."

Lecanemab is already licensed in the United States, where it costs about £20,000 per patient per year, although it was rejected by the European Medicines Agency (EMA) in late July.

A similar drug called donanemab, which is developed by Eli Lilly, is also being assessed for approval in the UK by medicine regulators.

NHS England estimates between 50,000 and 280,000 patients might be eligible for the new treatments.

Prior to being given the drugs, they will need to have a baseline MRI scan and then either a Pet-CT scan or lumbar puncture to confirm Alzheimer's.

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