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The spending watchdog has recommended that a drug shown to slow the progression of Alzheimer’s disease should not be rolled out on the NHS.
This is despite the UK medicines regulator saying it is safe and effective for use.
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”.
A charity said it is “deeply disappointing” that patients with early stage Alzheimer’s will not have access to the drug on the health service “and it will only be available to those who can pay privately”.
The Medicines and Healthcare products Regulatory Agency (MHRA) has deemed lecanemab, developed by pharmaceutical company Eisai and sold under the brand name Leqembi, efficient at slowing Alzheimer’s disease.
The targeted antibody treatment binds to amyloid, a protein which builds up in the brains of people living with the condition.
It is designed to help clear the build-up and slow down cognitive decline and is given to patients through an intravenous drip fortnightly.
The drug 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However, Nice has recommended lecanemab is not rolled out on the NHS in England in draft guidance due to the cost to the taxpayer.
Dr Samantha Roberts, chief executive of Nice, 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.”
Reacting to the announcements, the chief executive of Alzheimer’s Research UK, Hilary Evans-Newton, said the charity has urged Mr Streeting to “act”.
She said: “Further negotiations between Nice, Eisai and the NHS may offer a way forward. But the heartbreaking reality is that those who could benefit from drugs like lecanemab don’t have time to wait.
“We’ve written to the Health Secretary, Wes Streeting, urging him to act, and to find a solution so that people with dementia in the UK don’t continue to miss out on innovative treatments.
“As well as considering how to make drugs like lecanemab available, there also needs to be a real focus on improving the way dementia is diagnosed within the NHS.
“The shocking reality is that one in three people in England with dementia never get a formal diagnosis, leaving them unable to access the care and support they need.”
Ms Evans-Newton said it is “deeply disappointing” that people in the early stages of the disease “will be denied access to lecanemab through the NHS, and it will only be available to those who can pay privately”.
According to Nice, clinical trials showed lecanemab can slow cognitive decline by four to six months, however there is little evidence on its long-term effects.
It estimates about 70,000 adults in England would have been eligible for treatment.
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.”
Lecanemab is already licensed in the US, where it costs about £20,000 per patient per year, although it was rejected by the European Medicines Agency (EMA) in late July.
The EMA said the benefits of lecanemab did not counterbalance the risk of people suffering serious side-effects such as bleeding and swelling in the brain.
It also said the effects of the drug on delaying cognitive decline were small.
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.
