Health chiefs were today urged to reconsider approving a breakthrough Alzheimer’s drug proven to tackle the devastating disease on the NHS.
Lecanemab and donanemab were hailed as ‘the beginning of the end’ of dementia last year, after studies showed they slowed the progression of memory-robbing illness in its early stages by up to 35 per cent.
They were approved by medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
But draft guidance by the NHS spending watchdog last year ruled the benefits of both drugs were ‘too small’ to justify the estimated £1bn a year roll-out cost.
It means lecanemab and donanemab are currently only available to patients who can afford to pay about £60,000 privately every year at select clinics.
Yet, the National Institute for Health and Care Excellence (NICE), today revealed it would now convene a third committee meeting in May to evaluate of the drugs’ effectiveness before issuing final guidance.
It has also launched a second public consultation inviting the public to comment on the committee’s decision to reject the drug, which will conclude at the end of this month.
The provisional decision to block both drugs last year saw campaigners and charities slam NICE, labelling it ‘incredibly disappointing’ and ‘a frustrating setback’.
Lecanemab (pictured) and donanemab are currently only available to Brits who can afford to pay around £60,000 privately every year at select clinics
Experts have long believed donanemab could herald a new era of dementia treatment, after studies showed it slowed the memory-robbing illness in its early stages
Alzheimer’s disease is the most common cause of dementia. The disease can cause anxiety, confusion and short-term memory loss
It is estimated around 70,000 adults in England could eligible for the treatment if approved for use on the health service.
The drugs, which patients receive through a drip in their arm every month, work by stimulating the body’s immune system to remove the build up of the harmful protein amyloid in the brains of people with early-stage Alzheimer’s.
Lecanemab has been proven to slow progression of the disease by as much as 27 per cent in trials and has already been given the green light in the EU, US, China, Japan, Hong Kong, South Korea and Israel.
Donanemab, meanwhile, has been shown to slow progression by up to 35 per cent.
However, the EU medicines regulator the European Medicines Authority has raised concerns over the drug’s rare side effects such as ‘swelling’ and ‘potential bleedings in the brain’.
Experts have also repeatedly voiced concerns over the potential of such serious complications, warning there has been a handful of deaths linked to the drug in trials.
Such fatalities are caused by amyloid-related imaging abnormalities (ARIA) where the drugs trigger changes in the brain can cause headaches, confusion, dizziness, vision changes, nausea, difficulty walking, and seizures.
Professor Rob Howard, an expert in old age psychiatry at University College London, told MailOnline: ‘About 40 per cent of patients who are treated with this class of drugs develop brain swelling and bleeding.
Around 900,000 Brits are currently thought to have the memory-robbing disorder. But University College London scientists estimate this will rise to 1.7million within two decades as people live longer. It marks a 40 per cent uptick on the previous forecast in 2017
‘In most people, this isn’t too serious. But in about 1 per cent of cases, this complication can lead to severe life-changing side effects including strokes and death.’
Responding to today’s decision by NICE to convene a third committee meeting, Eisai who leads lecanemab’s regulatory submissions, said it was ‘encouraging’.
Eisai’s European-area president Nick Burgin, added: ‘It enables further evaluation of lecanemab and how it could be introduced to the NHS.’
‘However, today’s decision means that eligible early Alzheimer’s disease patients in England and Wales still cannot access the medicine through the NHS.
‘We recognise that introducing a new class of medicine is not always straightforward, substantial changes are needed to improve Alzheimer’s disease management and lecanemab is just one part of the bigger picture.’
Alzheimer’s is the most common cause of dementia in the UK.
Recent analysis by the Alzheimer’s Society estimates the overall annual cost of the dementia to the UK is £42billion a year, with families bearing the brunt.
An ageing population means these costs — which include lost earnings of unpaid carers — are set to soar to £90billion in the next 15 years.
No price for the drug has been publicly announced in the UK. In the US the treatment costs £20,000 a year. But it was rejected by EU medicines regulator the European Medicines Authority last month, due to concerns over side effects such as ‘swelling’ and ‘potential bleedings in the brain’
Around 944,000 in the UK are thought to be living with dementia, while the figure is thought to be around 7million in the US.
It is thought to be caused by a build-up of amyloid and tau in the brain, which clump together and from plaques and tangles that make it harder for the brain to work properly.
Eventually, the brain struggles to cope with this damage and dementia symptoms develop.
Memory problems, thinking and reasoning difficulties and language problems are common early symptoms of the condition, which then worsen over time.
Alzheimer’s Research UK analysis found 74,261 people died from dementia in 2022 compared with 69,178 a year earlier, making it the country’s biggest killer.
