A Covid-style effort is needed to ensure NHS patients are first in line for a new wave of dementia drugs, according to the former head of the UK’s vaccine taskforce.
Kate Bingham is calling for the immediate recruitment of large numbers of patients to ensure that, as with Covid vaccines, the UK is a leading player in testing and launching drugs.
While two drugs have now been shown to slow cognitive decline in early Alzheimer’s, it remains unclear whether either is effective enough to be made widely available on the NHS, meaning a race is on to achieve this goal.
“We need to have tens of thousands of patients consented and available to go into clinical trials,” said Bingham. “If you have 50,000 patients at high risk of Alzheimer’s pre-consented we could make that an easy shortcut for companies, which is exactly what we did with vaccines. The government has to embrace working with industry rather than thinking they’re out to nick your wallet.”
Experts have expressed frustration that, almost two years after a breakthrough trial, the first Alzheimer’s drugs shown to slow the rate of cognitive decline are yet to be approved in the UK.
Bingham, who is a managing partner at SV Health Investors and spearheaded the launch of the Dementia Discovery Fund, said trials of drugs and diagnosis tools needed to be a priority for the new Labour government, given the devastating health consequences and cost of care.
“We’re in an ageing society, where medicine is keeping people alive in good health for longer,” she said. “Cancer is no longer a death sentence. You can manage cancer and have good quality of life for years. For dementia we’re not doing that. You’re basically having to pay for 10 years plus of patient [care]. The cost to the families or state is very expensive. I think it’s an economic imperative to invest in this whole area.”
The Medicines and Healthcare products Regulatory Agency (MHRA) is considering applications for Eisai and Biogen’s drug lecanemab and Eli Lilly’s donanemab, both of which have been approved for the treatment of early Alzheimer’s in the US. The drugs work by reducing amyloid levels in the brain.
Sir Prof John Hardy, of University College London (UCL), who was the first to identify the role of misfolded amyloid in Alzheimer’s 30 years ago, said: “We now have finally got something that started here in the UK, it would be nice to see it actually helping patients. There is frustration, yes.”
Hardy, who is vice-president of Alzheimer’s Research UK, said patients were already travelling abroad to access the drugs, which are administered by infusion and require patients to be monitored via MRI scans. “I’ve just had two patients phone me up who are flying to New York privately to get the treatment,” he said. “That’s not a good outcome.”
However, others warned against the MHRA and the National Institute for Health and Care Excellence (Nice), which rules on cost-effectiveness, coming under undue political pressure to rush through the approval of novel drugs, which can have complex risk-benefit profiles.
The cognition of Alzheimer’s patients given lecanemab declined by 27% less than those on a placebo treatment after 18 months, an improvement that some argue falls short of being clinically meaningful for an individual patient. This has to be weighed against side-effects that include accelerated brain shrinkage, with those taking the drug losing the equivalent of an extra teaspoon of brain matter over 18 months.
Rob Howard, a professor of old age psychiatry at UCL, said: “My own view is that these drugs can’t possibly be cost-effective for the NHS – the benefits of treatment are so tiny and the costs of giving them and ensuring patient safety will be high. We’ve been told that there will be no new money for the NHS to pay for these drugs and so we’ll have to cut other services to people with dementia if we are to supply them.”
He added: “Nobody has explained the worrying accelerated brain volume loss seen with these drugs. Generally brain volume loss is regarded as a bad thing in people with dementia and I am concerned about the potential medium to long-term impact of this.”
The case for the drugs could become clearer if patients are found to have maintained a better trajectory beyond the first 18 months in trial results expected to be unveiled at the Alzheimer’s Association conference later this month.