NHS lacks capacity for Alzheimer’s diagnostics, warn experts

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Many thousands of patients in the U.K. could miss out on new treatments for Alzheimer’s disease because its National Health Service (NHS) lacks capacity for diagnostic tests, warn experts.

Scientists and leading Alzheimer’s disease charities have urged authorities to ramp up diagnostic resources and staffing so patients can access drugs when they are licensed.

Two drugs which slow down the early stages of Alzheimer’s disease (AD), lecanemab and donanemab, could be approved this year by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA).

To be eligible for either drug, people 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 the hallmark protein amyloid in their brain. However, only 2% of people with dementia in the U.K. currently receive either of these “gold standard” methods of diagnosis, Alzheimer’s Research UK said.

Experts fear tens of thousands of patients could miss out on treatments and be “locked out of care” and support because the NHS isn’t ready to deliver them.

“We have to move quickly,” John Hardy, a professor of neurodegenerative disease at University College London (UCL) who leads the U.K. Dementia Research Institute, told BBC radio on February 12.

“The trouble is, most people who go into clinical services at the moment really don’t get a diagnosis of Alzheimer’s disease, they get a diagnosis of dementia, and that’s really not adequate for the giving of these drugs.”

“We need to use biomarkers or PET scans – and we don’t have many PET scanners in the country – to sharpen the diagnosis. And this is quite a difficult task. It is possible in a research setting, but it is not yet possible within the general NHS,” Hardy added. â€śI think this is a wake-up call for the NHS that we need to improve and sharpen our dementia services.”

The BBC also broadcast a TV documentary highlighting the experiences of clinical trial patients who have been taking donanemab and lecanemab and the views of doctors and charities about the drugs’ likely clinical and policy impacts.

The drugs target the build-up of toxic clumped proteins in and around the brain and can slow cognitive decline (by around a quarter to a third of patients in trials) but come with potentially serious side effects, most notably swelling and bleeding in the brain.

According to NHS England estimates, 50,000 to 280,000 patients could be eligible for the disease modifying drugs if they were to be approved for use by the National Institute for Health and Care Excellence (NICE). This could cost the NHS between ÂŁ500 million and ÂŁ1 billion (approximately $628 million to 1.2 billion) per year.

NHS England has said it is possible that biomarker-based blood tests will be available in the future to be used in the pathway as potential screening, diagnostic or monitoring tests. 

The agency has expressed caution about driving a big expansion in amyloid PET-CT capacity, saying that this could “become redundant” in the longer term, according to an organization briefing paper.

NHS England says in the paper that further blood-based biomarker research, and specifically achieving test validation for clinical use, is a key focus of the government’s Dementia Mission and recent NIHR (National Institute for Health and Care Research) calls.

Dr. Susan Kohlhaas, Alzheimer’s Research UK's executive director of research and partnerships, called for “a clear plan from the NHS about how they’re going to scale up services,” and for sustained investment in the dementia diagnosis pathway.

“We need to rapidly upscale both the infrastructure and the workforce capability to be able to deliver on these diagnostic tests,” Jennifer Keen, head of policy at the Alzheimer Society, told BBC Radio.

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