NHS ‘nowhere near ready’ to supply new Alzheimer’s drug, doctors say

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An overhaul of NHS dementia care is needed to ensure UK patients can receive an innovative drug that slows the progression of Alzheimer’s disease, doctors say.

Detailed results from a clinical study of lecanemab 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 industry.

The drug, created by Biogen in the US and Eisai in Japan, is the first to show that it can change the trajectory of disease. While the benefit is modest — the drug slowed cognitive decline by 27 percent in 18 months — doctors believe it has the potential to give patients more independent months of life.

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 introduction of the drug, doctors say, with patients unlikely to receive it before 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 “nowhere near ready” to supply lecanemab.

“Although some specialist centers have the required capacity, the wider NHS simply lacks the infrastructure and staff to diagnose potentially suitable patients, nor to administer the drug, which is given by infusion every two weeks, nor to carry out and read more MRI safety scans,” he writes.

Other senior doctors share the view. ‘We are not prepared,’ said Dr Liz Coulthard, assistant professor of neurology of dementia at the University of Bristol. “We need a massive shift in the delivery of services to the workforce.”

Lecanemab is an antibody therapy that targets clumps of proteins called beta-amyloid, which build up in patients’ brains. Scientists still debate the role of amyloid in Alzheimer’s disease, but eliminating it from the brain could prevent other disease processes from taking hold, such as the formation of protein tangles within brain cells.

Patients diagnosed early with mild cognitive impairment due to Alzheimer’s typically have about six years of independent living before needing home support. If lecanemab’s benefits hold over six years, a patient could have another 19 months of independent living, Coulthard said.

“The problem is, we don’t see patients in the mild cognitive impairment stage,” he said. “We don’t have the services. In Bristol, which is not atypical, there is no clinical pathway for mild cognitive impairment. If you’re diagnosed, you’re discharged and there’s almost never any follow-up.

Part of the problem is that the majority of dementia patients in the UK are treated in memory clinics run by psychiatric or gerontological services, which lack 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 the spinal fluid, or positron emission tomography (PET), which detects the protein in the brain. Alzheimer’s Research UK estimates that only 2% of lecanemab-eligible patients would have access to the drug based on existing trials.

“We will need new services, both within psychiatry, perhaps referring neurology for lumbar punctures or scans, and within neurology that can provide the large number of new diagnostic tests that we will need to do,” he said Coulthard.

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. The condition causes the relentless destruction of neurons in the brain, causing memory loss, problems with decision making, and ultimately, difficulties eating, speaking and moving around.

Lecanemab would need to be approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute of Health and Care Excellence (Nice) before it can be administered by the NHS. MHRA approval could come as early as 2024, with Nice’s review taking another year.

“Even if these things were to happen overnight, we would not be able to provide this, due to the scale of what is needed,” said Masud Husain, professor of neurology and cognitive neuroscience at the University of Oxford.

Related: It’s just a first step, but this new Alzheimer’s drug could be a huge step forward | Jonathan Schott

In addition to fast and accurate diagnoses to identify those who could benefit, hospitals would need specialized staff and equipment to provide regular drug infusions 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 being monitored to watch it rise.

Professor Paul Matthews, head of the UK’s Dementia Research Institute at Imperial College London, said he did not expect the UK to be a ‘rapid adopter’ of lecanemab. This would give health officials time to assess the drug’s effectiveness in real-life settings and prepare the NHS to deliver it.

Dr Richard Oakley, from the Alzheimer’s Society, said: ‘We are on the cusp of exciting new treatments for Alzheimer’s, but we need to improve dementia diagnosis in the UK to ensure the right people get these medicines when they are most effective. This will mean better access to PET scanners and tests to ensure a quick and accurate diagnosis for all.

“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 a GP referral and one in 10 wait more than six months for a brain scan.

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