The UK’s healthcare regulator has approved the first drug proven to slow down Alzheimer’s disease in its early stages.
While lecanemab has been given a product licence by the Medicines and Healthcare products Regulatory Agency (MHRA), the drug will not be available on the NHS because the National Institute for Health and Care Excellence (NICE) has said its benefits are “too small to justify the cost” to the health service.
This means the drug, which has been shown to slow down progression of the disease by between four and six months, will only be available to those who can pay.
Alzheimer's Research UK has said that costs in the private sector are likely "unaffordable for the vast majority of people".
Lecanemab is the first treatment for Alzheimer’s disease licensed for use in Great Britain that shows some evidence of efficacy in slowing progression of the disease.
NICE, an executive non-departmental public body for the Department of Health and Social Care, said that the costs of providing the treatment, including fortnightly infusions in hospital and intensive monitoring for side effects, combined with the "relatively small benefits" it provides to patients means it "cannot be considered good value for the taxpayer".
"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," said Dr Samantha Roberts, chief executive, NICE. "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."
UK Alzheimer's charities have described the MHRA's approval as bittersweet.
Alzheimer's Research UK's chief executive Hilary Evans-Newton said: "It's a remarkable achievement that science is now delivering licensed treatments that can slow down the devastating effects of Alzheimer's, rather than just alleviating its symptoms. However, it's clear our health system isn't ready to embrace this new wave of Alzheimer's drugs."
Fiona Carragher, chief policy and research officer at the Alzheimer's Society, said that MHRA's approval of the first safe and effective Alzheimer’s disease treatment is a "defining moment" for people with early-stage Alzheimer’s disease in the UK.
“While we welcome the MHRA approval, it is disappointing that NICE has not recommended approving lecanemab for use on the NHS at this stage,” said Fiona Carragher, chief policy and research officer, Alzheimer’s Society. “The news that lecanemab will be restricted to certain groups of patients will also lead to uncertainty for many people with Alzheimer’s disease and their loved ones.”






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