The first drug proven to slow down Alzheimer’s disease is being denied to dementia patients – unless they pay to go private.
Regulators yesterday made two landmark decisions – granting a licence for lecanemab in the UK but then refusing to give it to NHS patients on cost grounds.
It means those eligible in England can only access the drug, found to slow cognitive decline by up to six months, if they can afford tens of thousands of pounds a year for private treatment.
Last night, charities warned that the conflicting rulings will cause ‘uncertainty and confusion’ for up to a million dementia patients and their families, desperate to access treatments.
David Thomas, of Alzheimer’s Research UK, said the decisions meant the ‘game-changing’ drug would probably be out of reach for ‘all but the very most wealthy of individuals’.
Lecanemab (pictured) has been proven to slow the progress of the memory-robbing illness in its early stages. It was today approved by medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA)
Alzheimer’s disease is the most common cause of dementia. The disease can cause anxiety, confusion and short-term memory loss
He said: ‘There are people who could benefit from this drug on the NHS right now.
It’s allowed me to live a full life
Larry Woelk, 77, with his wife Rita
Larry Woelk, 77, has been on a trial of lecanemab since 2020 after being diag – nosed with mild cognitive impairment, a condition that can increase the risk of developing dementia.
He has been having an IV infusion of the drug every two weeks at the Memory Assessment and Research Centre in Southampton.
‘When I first went on the trial my memory was getting worse,’ he said.
‘Not quickly, but I could tell. But the progression of my symptoms has pla – teaued.
‘My memory assessments have been unchanged since I started on it.’
An MRI scan in 2018 confirmed the retired business executive had MCI.
His wife, Rita, said: ‘There has been some decline, but it has been gradual. He is still able to live a full life. He is able to drive, go out on bike rides and socialise.
‘If there’s a licensed drug that is safe and effective, judged by the regulator, then that needs to be available to NHS patients, and not just those with the ability to pay.’
He added: ‘This drug isn’t a silver bullet but we should be thinking how the UK builds on this rather than not providing any access and letting other countries do the legwork – it doesn’t feel right.
‘We have the ability to provide drugs by infusion on the NHS – that’s done in cancer and other disease areas – and we do have the right diagnostics available now.’
The annual cost of dementia to the economy is estimated at £42billion with lost earnings and unpaid carer costs eclipsing treatment costs. Earlier this year, the Alzheimer’s Society predicted these costs are set to reach £90billion in the next 15 years, with families bearing the brunt by providing unpaid care.
But these external costs are not factored in by regulators, whose role is to assess the value for money against other NHS treatments.
Trials found lecanemab slowed cognitive decline by about a quarter in patients with early Alzheimer’s, leading many to hail it a ‘turning point’ in fighting the disease.
It was given the green light by the Medicines and Healthcare products Regulatory Agency, the body which decides whether a medicine works and is safe.
But the National Institute for Health and Care Excellence (Nice) simultaneously announced the benefits of lecanemab were ‘too small to justify the significant cost to the NHS’.
About 70,000 NHS patients in England would have been eligible for it, at an estimated cost of around £30,000 a year per patient to buy and administer.
But Nice said the cost of fortnightly infusions in hospital, intensive monitoring for rare but serious side-effects and the ‘relatively small benefits it provides to patients’ does not offer good value to the taxpayer.
Vanessa Raymont, honorary consultant psychiatrist at the University of Oxford, said the MHRA approval of lecanemab was ‘groundbreaking’.
It is being used in the US and Japan but has been rejected by the EU regulator over the risk of serious side-effects. In their submission to the regulator, the manufacturers set out estimates for the ‘non-medical’ costs of care.
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
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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’
But Nice’s committee, according to the Telegraph, reportedly excluded the evidence on the grounds that most of the care was either paid for by families or provided by them unpaid.
Mr Thomas at Alzheimer’s Research, said: ‘The failure to include the cost of caring in the model is fundamentally unjust. The way these assessments are being carried out is just not fit for purpose.’
Nearly one million people are living with dementia in the UK. Experts said that despite yesterday’s setback, it ‘is a matter of when, not if, new treatments become available’ with more than 160 global trials under way.
A health department spokesman said: ‘It is right that these decisions are taken independently. The Government is committed to expanding research and innovation in this area.’
