The first drug proven to slow Alzheimer’s disease is not being given to dementia patients unless they pay to have it treated on a private market.
Regulators made two key decisions yesterday: they licensed lecanemab in the UK but then refused to supply it to NHS patients because of the cost.
That means eligible people in England will only be able to access the drug, which has been shown to slow cognitive decline by up to six months, if they can afford to pay tens of thousands of pounds a year for private treatment.
Last night, charities warned that the conflicting statements will cause “uncertainty and confusion” for around a million dementia patients and their families, who are desperate for treatment.
David Thomas of Alzheimer’s Research UK said the decisions mean the “groundbreaking” drug is likely to be accessible only to “the very rich”.
Lecanemab (pictured) has been shown to slow the progression of the memory-destroying disease in its early stages. It was approved today by the 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 loss of short-term memory.
He said: ‘There are people who could benefit from this drug at the moment through the NHS.
‘If there is an approved medicine that is safe and effective, assessed by the regulator, then that should be available to NHS patients, not just those who can afford it.’
He added: ‘This drug is not a silver bullet, but we need to think about how the UK can build on this rather than not allowing access at all and letting other countries do the work. That doesn’t feel right.’
‘We can give drugs through infusions via the NHS, as is done for cancer and other diseases, and we now have the right diagnostics available.’
The annual cost of dementia to the economy is estimated at £42 billion, with the loss of income and unpaid costs for carers exceeding the cost of treatment. Earlier this year, the Alzheimer’s Society predicted that this cost would reach £90 billion over the next 15 years, with families bearing the brunt of providing unpaid care.
But these external costs are not taken into account by regulators, who must assess value for money compared to other NHS treatments.
Research has shown that lecanemab slows cognitive decline by about a quarter in patients with early-stage Alzheimer’s, leading many to see it as a ‘turning point’ in the fight against the disease.
It was given the green light by the Medicines and Healthcare products Regulatory Agency, the body that decides whether a medicine is effective and safe.
But the National Institute for Health and Care Excellence (Nice) announced at the same time that the benefits of lecanemab were ‘too small to justify the significant cost to the NHS’.
Around 70,000 NHS patients in England would be eligible, with the cost of purchasing and administering it estimated at around £30,000 per year per patient.
However, Nice said the cost of twice-weekly infusions in hospital, intensive monitoring for rare but serious side effects and the “relatively small benefits it brings to patients” do not provide good value for taxpayers.
Vanessa Raymont, an honorary consultant psychiatrist at the University of Oxford, said the MHRA’s approval of lecanemab was “groundbreaking”.
She said it was the first drug approved in the UK with “the potential to… have a real impact on the progression of memory loss”.
It is used in the US and Japan, but has been rejected by the EU regulator because of the risk of serious side effects. In their submission to the regulator, the manufacturers have given estimates for the ‘non-medical’ costs of care.
It is currently thought that around 900,000 Britons suffer from the memory-robbing disorder. But scientists from University College London estimate that this number will rise to 1.7 million within two decades as people live longer. It is a 40 per cent increase on the previous forecast in 2017.
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No price for the drug has been made public in the UK. In the US, the treatment costs £20,000 a year. But it was rejected last month by the European Medicines Agency, amid concerns about side effects including “swelling” and “possible bleeding in the brain”.
But the Telegraph said the Nice commission excluded the evidence because most of the care was paid for by the families or provided unpaid by them.
Mr Thomas from Alzheimer’s Research said: ‘Not including the cost of care in the model is fundamentally unfair. The way these assessments are being done is simply not fit for purpose.’
Nearly a million people in the UK are living with dementia. Experts said that despite yesterday’s setback, it was ‘a question of when, not if, new treatments become available’ with more than 160 global trials underway.
A Department of Health spokesman said: ‘It is right that these decisions are made independently. The government is committed to expanding research and innovation in this area.’