First drug to slow Alzheimer’s costs NHS too much

The first drug to slow the progression of early-stage Alzheimer’s disease will not be available on the UK NHS because health assessment body NICE says the benefits “are too small to justify the costs”.

Lecanemab has been authorised for use in Britain by the medicines regulator, the MHRA, meaning it can be prescribed privately.

On trialThe drug has been shown to slow cognitive decline by about a quarter in patients with early stages of Alzheimer’s disease over an 18-month period.

But in the orientation projectNICE said the treatment involved significant costs, including intensive monitoring for side effects and fortnightly hospital visits for patients.

Alzheimer’s Research UK said it was a “bittersweet moment”.

“The approval of lecanemab is an important milestone, but NICE’s decision not to approve it for the NHS is deeply disappointing,” said head of policy David Thomas.

Dr Samantha Roberts, NICE’s chief executive, said the body had rigorously assessed the available evidence, including the benefits for carers, but could only recommend treatments that “provide good value for money for the taxpayer”.

“Lecanemab slows the rate of progression of mild to moderate Alzheimer’s disease by an average of four to six months, but this is simply not enough of a benefit to justify the extra cost to the NHS,” said Helen Knight, director of medicines assessment at NICE.

A final decision from NICE will be made towards the end of the year following a public consultation.

Around 70,000 adults in England would have been eligible for treatment with lecanemab.

Wales and Northern Ireland often follow medical advice in England.

The body that assesses newly authorised medicines in Scotland has not yet made a decision on the drug’s value.

NHS England said a dedicated team was studying 27 other Alzheimer’s drugs currently in late-stage trials that could be approved in the coming years.

Lecanemab works by removing an unwanted protein called amyloid, which builds up in the brains of patients with Alzheimer’s disease. It is given as an intravenous infusion every two weeks.

Alzheimer’s researchers hailed the trial results as historic, because no previous drug had convincingly shown that the underlying mechanism of the disease could be slowed.

However, concerns have been raised about the common occurrence of so-called amyloid-related imaging abnormalities (ARIAs), which show up on MRI scans as small brain hemorrhages and temporary swellings.

Although most symptoms observed during the trials were mild or asymptomatic, in some cases participants required hospitalization.

No price for the drug has been publicly announced in the UK, but in the US it costs around £20,000 per patient per year.

Fiona Carragher, from the Alzheimer’s Society, told BBC News the move would “lead to uncertainty and confusion for almost a million people living with dementia”.

Although the MHRA has approved the drug in the UK, it has placed some restrictions on who can receive it because of the risk of side effects.

People who carry two copies of the apolipoprotein E4 (ApoE4) gene, about 15% of the population, will not be eligible, nor will those taking blood thinners.

Lecanemab, whose trade name is Leqembi, has already been approved in the United States, Japan and China.

But last month, the European Medicines Agency (EMA) rejected a license, saying the benefits were minimal and did not outweigh the risk of serious side effects, including bleeding and swelling in the brain.

To assess a patient’s eligibility for lecanemab, amyloid levels in the patient’s brain must be measured. This measurement is performed either by brain positron emission tomography (PET) scan or by lumbar puncture.

None of these methods are standard diagnostic tools for patients with suspected dementia and are used only in research settings. It is estimated that only 2% of Alzheimer’s patients have access to one of these “gold standard” diagnostic methods.

Mavis Guinn, 90, is one of a few dozen people in the UK to receive lecanemab as part of a clinical trial.

Her husband Rodney says it has allowed Mavis to retain her personality.

“We’ve had wonderful years since you started taking this medicine and good times,” he told her.

“And I’m grateful for that too, God, because it makes a difference in your life, doesn’t it,” Mavis said.

She receives the drug every two weeks through an IV, but her short-term memory remains severely affected.

The benefits of lecanemab are modest – some say they are barely noticeable. Added to this are the potential side effects.

Yet many experts see this as a key moment, showing that Alzheimer’s is not inevitable. Alzheimer’s is the most common form of dementia, and is the leading cause of death in the UK.

The BBC’s Panorama programme followed patients taking lecanemab and another new drug, donanemab.

In the program, Speaking earlier this year, Professor Cath Mummery, consultant neurologist and clinical trials lead at the Dementia Research Centre at University College London, said that while the benefits of these drugs were modest, they represented a turning point.

“For the first time, we have drugs that show that it is possible to modify the course of Alzheimer’s disease, and that is an extraordinary thing.”