Doctors say a revamp of NHS dementia care is needed to ensure UK patients can receive a breakthrough drug that slows the progression of Alzheimer’s disease.
Detailed results from a clinical trial of lecanemab have confirmed that the drug reduces cognitive decline in patients with early-stage Alzheimer’s disease, in a hard-earned breakthrough hailed as a landmark moment for the field.
The drug, created by Biogen in the United States and Eisai in Japan, is the first to be shown that it can alter the trajectory of disease. Although the benefit was modest – the drug slowed cognitive decline by 27% over 18 months – doctors believe it has the potential to give patients months of more independent life.
The U.S. Food and Drug Administration is expected to approve lecanemab in January, paving the way for U.S. hospitals to begin prescribing the drug next year. But the NHS faces a huge challenge in preparing for the introduction of the drug, doctors say, with patients unlikely to receive it until 2026.
Writing in the Guardian, Jonathan Schott, professor of neurology at UCL’s Queen Square Institute of Neurology and chief medical officer at Alzheimer’s Research UK, says the NHS is “far from ready” to deliver lecanemab.
“While some specialist centers have the capacity, the wider NHS simply does not have the infrastructure and staff to diagnose potentially eligible patients, or to administer the drug, which is given by infusion every two weeks. , nor to perform and read multiple MRI safety scans,” he wrote.
Other senior doctors share the view. “We are not prepared,” said Dr Liz Coulthard, assistant professor of dementia neurology at the University of Bristol. “We need a massive change in the delivery of workforce services.”
Lecanemab is an antibody therapy that targets clumps of proteins called amyloid beta, which accumulate in patients’ brains. Scientists are still debating the role of amyloid in Alzheimer’s disease, but its removal from the brain may prevent other disease 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 disease typically have about six years of independent living before needing home support. If the benefits of lecanemab are sustained over six years, a patient could have an additional 19 months of independent living, Coulthard said.
“The problem is that we don’t see patients in 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 receive a diagnosis, you are fired and there is almost never a 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 testing. While blood tests for Alzheimer’s disease are on the horizon, the disease is currently confirmed by a lumbar puncture, which looks for amyloid in the cerebrospinal fluid, or a positron emission tomography (PET), 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 tests.
“We will need new services, either in psychiatry, perhaps referring to neurology for lumbar puncture or CT scans, or in neurology which can provide the large number of new diagnostic tests that we will need,” said Coulthard.
Almost a 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 disease. The disease causes the relentless destruction of neurons in the brain, leading to memory loss, problems with decision-making and, ultimately, difficulty eating, speaking and moving.
Lecanemab would need to be approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (Nice) before it can be administered by the NHS. MHRA approval could come as early as 2024, with the Nice review taking another year.
“Even if these things were to happen overnight, we simply wouldn’t be able to achieve this, due to the magnitude of what is needed,” said Masud Husain, professor of neurology and neuroscience. cognition at the University of Oxford.
Along with quick and accurate diagnoses to identify those who might benefit, hospitals would need specialized staff and equipment to provide regular infusions of drugs and MRI scans to check for side effects, including brain swelling. One hope is that the drug could be used in bursts, with patients taking it until their amyloid levels drop, then monitored to watch for it to rise again.
Professor Paul Matthews, director of the UK Institute for Dementia Research at Imperial College London, said he did not expect the UK to be an “early adopter” of lecanemab. This would give health officials time to assess the drug’s effectiveness in real-world conditions and prepare the NHS to deliver it.
Dr Richard Oakley, of the Alzheimer’s Society, said: “We are on the cusp of exciting new treatments for Alzheimer’s disease, but we need to improve the diagnosis of dementia in the UK to ensure that the right people receive these drugs when they are most effective. . This will involve greater access to CT scans and PET tests to ensure everyone gets a quick and 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 more than a year to see a specialist after being referred to a GP, and one in 10 wait more than six months for a brain scan.