The NHS is ‘a long way’ from being able to provide a new class of Alzheimer’s drugs to patients should they get approval, research suggests.
The UK is on the cusp of deciding whether the first treatments found to slow down the early signs of disease are safe and effective.
Regulators are expected to rule on lecanemab in the coming weeks and donanemab later this year, with both treatments now given the go-ahead in the US.
Approval would mark a major change in treatment because they target one of the known causes of Alzheimer’s, rather than just helping to relieve symptoms.
But experts have warned the lack of proper testing means the NHS faces being swamped with patients wrongly assumed to have the disease.
UK is on the cusp of deciding whether the first treatments found to slow down the early signs of disease are safe and effective
Regulators are expected to rule on the Alzheimer’s drug lecanemab (pictured) in the coming weeks and another donanemab later this year
They said there is a ‘clear and urgent’ need to improve NHS screening to work out who may benefit from new Alzheimer’s drugs.
Researchers including from University College London (UCL) and Queen Mary University, London, examined clinical notes from 1,017 NHS patients in five areas of London, including 517 patients assessed in memory services and 500 in a specialist cognitive service.
Almost a third (32 per cent) of patients in memory services were likely to be referred as potential candidates for the drugs.
Nearly all had undergone brain scans but only two patients were given lumbar punctures- which confirm if a patient had amyloid and tau proteins, associated with Alzheimer’s.
This proportion increased in specialist clinics where more tests are available, with nearly two thirds (62 per cent) getting the necessary fluid biomarker tests.
Once those who would not be eligible for the treatments because of frailty and other issues, they found four in ten were potentially eligible for treatment with the new drugs.
Writing in the Journal of Neurology, Neurosurgery and Psychiatry, researchers said this is equivalent to just 14 per cent of all the cases reviewed at the specialist cognitive clinics.
Meanwhile, the lack of biomarker testing using lumbar punctures for patients seen in community memory clinics, means almost a third (30 per cent) of suspected cases are not Alzheimer’s.
Researchers said the NHS systems ‘need to be set up to deal with this potential large mismatch between referral and ultimate eligibility in order to avoid overwhelming services’.
Alzheimer’s disease is the most common cause of dementia, accounting for up to 80 per cent of the 944,000 people living with dementia in the UK.
Alzheimer’s disease is the most common cause of dementia, accounting for up to 80 per cent of the 944,000 people living with dementia in the UK
Currently, the only available drugs for Alzheimer’s are to treat symptoms but recent clinical trials show that new therapies – which use monoclonal antibodies to remove amyloid plaques that form on the brain – may slow down disease progression.
Two ‘disease-modifying therapies’ (DMTs) have been granted ‘breakthrough therapy’ designation in the UK and are could become available to patients by the end of the year, pending approval by the MHRA and then NICE.
David Thomas, head of policy and public affairs at Alzheimer’s Research UK, said cheaper, more scalable diagnostics such as blood tests, were urgently needed.
He said: ‘New Alzheimer’s drugs are finally on the horizon, but for their full potential to be realised, health systems need to be able to offer people with symptoms of dementia an accurate and early diagnosis to find out whether these treatments could benefit them.
‘As this research demonstrates, the NHS is a long way from being able to do this testing routinely.
“Whoever forms the next government must invest in the NHS urgently, to ensure we have the right diagnostics and workforce in place to help identify people who could benefit from new treatments should they be deemed safe and effective by the regulators.’
A report published earlier this year by NHS England said ‘timely diagnosis of dementia is vital’, adding new blood tests could soon replace lumbar punctures in diagnosing the disease.
It predicts the number of patients who might be eligible for the drugs ranges from 50,000 to 280,000, at an estimated cost of £500 million and £1 billion per year.
However, actual costs will depend on the drugs prices agreed for England.
The document said: ‘To be eligible for treatment, patients will need to have a baseline MRI scan and then either a PET-CT scan or lumbar puncture that confirms the presence of beta-amyloid proteins in the brain, which are associated with the Alzheimer’s disease process.’
Dr Alex Osborne, policy manager at the Alzheimer’s Society, said: ‘These drugs are only available to people in the early stages of Alzheimer’s disease – and more than a third of the 982,000 people living with dementia in the UK don’t have a diagnosis at all.
‘That’s why Alzheimer’s Society is calling on the NHS to publish plans on how it will deliver groundbreaking new treatments to the people who need them, with a specific focus on diagnosis and investment in the tools and workforce needed to identify eligible patients.’
