Alzheimer’s patients could lose out on two groundbreaking new drugs because the NHS is unprepared, says leading charity, Alzheimers Research UK.
Drugs such as lecanemab and donanemab slow down the early stages of Alzheimer’s. These medications represent a step forward because they target one of the causes of Alzheimer’s, rather than treating the symptoms. In global trials involving hundreds of early-stage Alzheimer’s patients, the drugs were shown to slow cognitive decline by between about a quarter and a third over 18 months. They could both be licensed this year but will be subject to an assessment of costs and benefits prior to this.
The UK medicines regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) – is assessing the drugs and is expected to approve lecanemab within the next few months, with the licence for donanemab – made by Eli Lilly – following slightly later.
One negative is that the effectiveness of the drugs depends on early diagnosis, and very few people have the specialist scans or investigations which would be needed. Questions also remain over potentially harmful side-effects of the drugs and whether the benefit they offer represents value for NHS money.
Both drugs come with potentially serious side effects, most notably swelling and bleeding in the brain. Three of the 853 people who took donanemab during the clinical trial, died as a result of the treatment. As a result, patients need very careful monitoring via MRI brain scans. The side effects of the drugs and their limited effectiveness has led some critics to dismiss them as a dead end.
But even if the drugs are licensed in the UK, it does not mean they will be immediately available on the NHS. The National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium will assess the effectiveness of lecanemab and donanemab, and whether they represent value for money.
A briefing paper for NHS England estimates that between 50,000 and 280,000 patients might be eligible for the new treatments if NICE recommends that the drugs are used by the health service. The cost of the drugs – and administering the treatment – would be between £500m and £1bn per year.
To be eligible for either drug, patients would have to be in the early stages of Alzheimer’s and have had a PET scan or lumbar puncture to confirm high levels of amyloid in their brain. Currently, only 2% of dementia patients receive either of these “gold standard” methods of diagnosis, according to Alzheimer’s Research UK.
It is hoped that a blood test to detect amyloid levels may be available within five years. However, Dr Susan Kohlhaas, director of research at Alzheimer’s Research UK, says that, currently, fewer than two thirds of sufferers receive any dementia diagnosis at all. “Would we accept that for any other disease area, much less than for the biggest killer in the UK?” she asks. “This is a major issue that we need to start addressing now.”
NHS England says that the pandemic had a “significant impact” on dementia diagnosis rates, but (as of November 2023) they are the highest they have been in three years. It adds that a dedicated programme team has been established “to accelerate NHS preparations for the rollout of any future Alzheimer’s treatment”.
Curia’s Dementia Commission
In response to the dementia crisis, through Curia’s Dementia Commission healthcare professionals, policymakers, and stakeholders are advocating for the implementation of new pathways for dementia diagnosis and care. These pathways, anchored in the principles of ICSs, aim to address the diagnostic deficit head-on, ensuring a comprehensive and integrated approach to dementia care.
“Beyond the statistics, there lies an opportunity to reshape our healthcare landscape. We envision a future where data is not just a tool but the foundation of effective, accountable, and patient-centric care,” emphasises former Deputy National Medical Director at NHS England and Co-Chair of the NHS Innovation and Life Sciences Commission, Professor Mike Bewick.
The charts and data available in the 2023 Dementia Commission report reveal a pressing need for immediate intervention. The new models of care proposed are not only a response to the current crisis but a forward-looking strategy to build a resilient and responsive healthcare system.
Commissioners have recommended that the journey towards improved dementia diagnosis rates is a collective effort, requiring collaboration between healthcare professionals, policymakers, and the community. As England confronts this challenge, the rallying cry is clear: new pathways, accountable ICSs, and better data are the keystones to unlocking a future where no dementia case goes undiagnosed.
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