A drug that can slow the debilitating symptoms of Alzheimer’s has been approved by the UK’s medicines regulator.
In an unusual double-header assessment by UK authorities, the Medicines and Healthcare products Regulatory Agency (MHRA) has said the drug lecanemab is safe and effective enough for doctors to prescribe, but a separate NHS watchdog has ruled that it’s not cost-effective and won’t be available.
The decision by the National Institute for Health and Care Excellence (NICE) means that the first drug to show an effect in Alzheimer’s will only be available privately.
In the US the treatment costs £20,000 a year.
A key clinical trial has shown lecanemab can slow the decline in memory and mental agility by 27% in patients with mild Alzheimer’s.
But it can also cause swelling and bleeding in the brain of some patients.
NICE heard evidence it slows down progression of the disease by between four and six months but concluded 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.
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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.”
While US authorities have approved the drug, the EU’s medical regulator rejected a licence because it considered the benefits too small to justify the risks.
According to results of the clinical trial published two years ago, the drug cleared clumps of a protein called amyloid – thought to be a key cause of the most common form of dementia – from patients’ brains.
It removed so much of the amyloid protein that the patients wouldn’t have had enough evidence of Alzheimer’s disease on their brain scans to actually qualify for entry to the trial.
The study strongly suggests the drug only starts to have a clinical effect once amyloid is reduced to low levels in the brain.
Results after 12 months of treatment suggested it was ineffective – but after 18 months, the effect was significant.
Doctors were optimistic at the time that continued treatment would lead to even better results.
