A reorganization of National Health Service Dementia care is needed to ensure UK patients can receive a breakthrough drug that slows the progression of Alzheimer’s disease, doctors say.
Detailed results of a clinical trial of lecanemab have confirmed that the drug reduces cognitive decline in patients with early-stage Alzheimer’s, in a hard-earned breakthrough hailed as a landmark moment for the field.
The drug, created by Biogen in the US and Eisai in Japan, is the first to show that it can change the trajectory of the disease. While the benefit is modest—the drug reduced cognitive decline by 27% over 18 months—doctors believe it has the potential to give patients months of 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 a huge challenge preparing for the drug’s introduction, doctors say, and patients are unlikely to receive it before 2026.
writing in the guardianJonathan Schott, professor of neurology at UCL’s Queen Square Institute of Neurology and chief medical officer of Alzheimer’s Research UK, says the NHS is “nowhere near ready” to administer lecanemab.
“While some specialist centers have the required capabilities, the NHS in general simply does not have the infrastructure and staff to diagnose potentially eligible patients, or to administer the drug, which is infused every two weeks, or to perform and read multiple security MRIs. scans,” she writes.
Other high-level doctors share the opinion. “We are not ready,” said Dr. Liz Coulthard, an assistant professor of dementia neurology at the University of Bristol. “We need a massive change in workforce service delivery.”
Lecanemab is an antibody therapy that targets groups of proteins called beta-amyloid, which accumulate in the brain of patients. Scientists still debate the role of amyloid in Alzheimer’s, but removing it from the brain may prevent other disease processes from taking hold, such as the formation of protein tangles within brain cells.
Patients who are diagnosed early with mild cognitive impairment due to Alzheimer’s disease usually have about six years of independent living before they need support at home. If the benefits of lecanemab are sustained for six years, a patient could have 19 more months of independent living, Coulthard said.
“The problem is that we don’t see patients in the mild cognitive impairment stage,” he said. “We don’t have the services. In Bristol, which is not outlier, there is no clinical pathway for mild cognitive impairment. If you are diagnosed, you are discharged and there is almost never follow-up”.
Part of the problem is that most dementia patients in the UK are cared for in memory clinics run by gerontology or psychiatric services, which do not have routine access to Alzheimer’s tests. 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) scan, which detects the protein in brain. Alzheimer’s Research UK estimates that only 2% of patients eligible for lecanemab would have access to the drug based on existing evidence.
“We will have to have new services, either within psychiatry, perhaps referring to neurology for lumbar puncture or scans, or within neurology that can offer the myriad of new diagnostic tests that we will have to do.” Coulthard said.
Nearly 1 million people in the UK are living with dementia, the leading cause of death in the country. Two thirds of cases are due to Alzheimer’s disease. The condition causes relentless destruction of neurons in the brain, leading to memory loss, problems with decision making, and ultimately difficulties eating, speaking, and moving.
Lecanemab would have to be approved by the Medicines and Health Products Regulatory Agency (MHRA) and the National Institute of Health and Care Excellence (Nice) before it could be provided by the NHS. Approval of the MHRA could come as early as 2024, with the Nice review taking another year.
“Even if those things happened overnight, we just couldn’t 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.
In addition to quick and accurate diagnoses to identify those likely to benefit, hospitals would need specialized staff and equipment to provide drug infusions and regular MRIs 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 being monitored to see if it rises again.
Prof. Paul Matthews, UK Director Dementia Research Institute of Imperial College London, said it did not expect the UK to be a “rapid adopter” of lecanemab. This would give health officials time to assess how effective the drug was in real-world settings and prepare the NHS to administer it.
Dr Richard Oakley, from the Alzheimer’s Society, said: “We are 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 receive these. medications when they are most effective. . This will mean better access to PET scans and tests to ensure everyone gets a quick and accurate diagnosis.
“We estimate that at least 106,000 people could benefit from lecanemab when it becomes available in the UK. But currently, one in six people wait more than a year to see a specialist after a GP referral, and one in 10 wait more than six months to get a brain scan.