A reorganisation of NHS dementia care is needed to ensure UK patients can receive a groundbreaking drug that slows the progression of Alzheimer’s disease, doctors say.
Detailed results from a clinical trial of lecanemab have confirmed that the drug reduces cognitive decline in patients with early-stage Alzheimer’s, in a hard-won breakthrough hailed as a historic moment for the field.
The drug, created by Biogen in the US and Eisai in Japan, is the first to demonstrate that it can change the trajectory of the disease. While the benefit is modest – the drug slowed cognitive decline by 27% over 18 months – doctors believe it has the potential to give patients months more independent living.
The US Food and Drug Administration is expected to approve lecanemab in January, paving the way for US hospitals to start prescribing the drug next year. But the NHS faces an enormous challenge in preparing for the introduction of the drug, doctors say, with patients unlikely to receive it before 2026.
Writing in the Guardian, Jonathan Schott, a professor of neurology at UCL’s Queen Square Institute of Neurology and the chief medical officer at Alzheimer’s Research UK, says the NHS is “nowhere near ready” to deliver lecanemab.
“While some specialist centres have the capabilities required, the wider NHS simply does not have the infrastructure and staff to diagnose potentially eligible patients, nor to deliver the drug, which is given by infusion every two weeks, nor to perform and read multiple MRI safety scans,” he writes.
Other senior doctors share the view. “We are not prepared,” said Dr Liz Coulthard, an assistant professor in dementia neurology at the University of Bristol. “We need a massive change in workforce service delivery.”
Lecanemab is an antibody therapy that targets clumps of protein called beta-amyloid, which build up in patients’ brains. Scientists still debate amyloid’s role in Alzheimer’s, but clearing it from the brain may prevent other pathological processes from taking hold, such as the formation of protein tangles inside brain cells.
Patients who are diagnosed early with mild cognitive impairment due to Alzheimer’s typically have about six years of independent living before they need support at home. If the benefits of lecanemab are sustained over six years, a patient might have 19 more months of independent living, Coulthard said.
“The problem is, we don’t see patients at the mild cognitive impairment stage,” she said. “We don’t have the services. In Bristol, which is not atypical, there is no clinical pathway for mild cognitive impairment. If you get diagnosed with it, you are discharged, and there is hardly ever any follow-up.”
Part of the problem is that most dementia patients in the UK are cared for in memory clinics run by psychiatric or gerontology services, which do not have routine access to Alzheimer’s tests. While blood tests for Alzheimer’s are on the horizon, the disease is currently confirmed by lumbar puncture, which looks for amyloid in spinal fluid, or positron emission tomography (PET) scan, which detects the protein in the brain. Alzheimer’s Research UK estimates that only 2% of patients eligible for lecanemab would have access to the drug under existing testing.
“We’ll need to have new services, either within psychiatry, perhaps referring to neurology for lumbar puncture or scans, or within neurology that can deliver the large numbers of new diagnostic tests that we’ll need to do,” Coulthard said.
Nearly 1 million people in the UK live with dementia, the leading cause of death in the country. Two-thirds of cases are due to Alzheimer’s. The condition causes the relentless destruction of neurons in the brain, driving memory loss, problems with decision-making, and ultimately difficulties with eating, speaking and movement.
Lecanemab would have to be approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute of Health and Care Excellence (Nice) before it could be given by the NHS. MHRA approval could come as early as 2024, with the Nice review taking another year.
“Even if those things were to happen overnight, we would just not be able to deliver this, because of the scale of what is needed,” said Masud Husain, a professor of neurology and cognitive neuroscience at the University of Oxford.
Besides swift and accurate diagnoses to identify those likely to benefit, hospitals would need specialist staff and equipment to provide regular drug infusions and MRI scans to check for side-effects, which include brain swelling. One hope is that the drug can be used in bursts, with patients taking it until their amyloid levels fall, then being monitored to watch for it rising back up.
Prof Paul Matthews, the head of the UK Dementia Research Institute at Imperial College London, said he did not expect the UK to be a “rapid adopter” of lecanemab. This would give time for health officials to assess how effective the drug was in real-world settings and prepare the NHS to deliver it.
Dr Richard Oakley, of the Alzheimer’s Society, said: “We’re on the cusp of exciting new treatments for Alzheimer’s disease, but we need to improve dementia diagnosis in the UK to ensure the right people are getting these drugs when they are most effective. This will involve better access to PET scanners and tests to make sure everyone gets a quick, accurate diagnosis.
“We estimate that at least 106,000 people could benefit from lecanemab if and when it becomes available in the UK. But currently one in six people wait over a year to see a specialist after GP referral, and one in 10 wait over six months for a brain scan.”
