Alzheimer’s wonder drug gets green light – but Britain’s state health service won’t offer it

Health watchdog says the benefits of lecanemab are too small to justify its costs

The first ever drug found to slow Alzheimer’s disease will not be funded by the NHS, the health service’s drugs watchdog has said.
On Thursday morning, safety regulators gave the drug lecanemab the green light, meaning that patients in the early stages of the disease will be eligible to purchase the medication.
The drug has been hailed as “the beginning of the end” after trials found it slowed cognitive decline by 27 per cent in sufferers.
But in draft guidance, the National Institute for Health and Care Excellence (Nice) said the benefits of lecanemab were too small to justify its costs.
Lecanemab was approved for use in the United States last year at an annual cost of $26,500 (£20,000).
Charities for Alzheimer’s disease said it was “deeply disappointing” that Nice had rejected the drug, just as the Medicines and Healthcare products Regulatory Agency (MHRA) gave it a licence for use.
Hilary Evans-Newton, the chief executive at Alzheimer’s Research UK, said: “Today’s news is bitter-sweet for people affected by Alzheimer’s disease. It’s a remarkable achievement that science is now delivering licensed treatments that can slow down the devastating effects of Alzheimer’s, rather than just alleviating its symptoms.
“However, it’s clear our health system isn’t ready to embrace this new wave of Alzheimer’s drugs. It means that, as things stand, people in the early stages of the disease will be denied access to lecanemab through the NHS, and it will only be available to those who can pay privately. This is deeply disappointing.”
Fiona Carragher, chief policy and research officer at Alzheimer’s Society, said the decision by the MHRA had been a “defining moment” followed by disappointment.
She said: “This does lead to uncertainty and confusion for nearly a million people out there with dementia and their loved ones.”
It is estimated that about 70,000 adults in England would have been eligible for treatment with lecanemab.
The decision is expected to cause fierce rows, and means the treatment will only be available for those who purchase the drugs privately.
David Thomas, head of policy at Alzheimer’s Research UK, said he believed the costs to obtain the drug privately would be “prohibitive for all but the most wealthy of individuals” because the price would include infusion and monitoring, on top of drug costs.
Charities criticised the failure of Nice to take into account the costs of the drugs to society, in reducing the burden on carers.
Nice said its independent committee found that lecanemab was the first medicine to be licensed in the UK that had been shown to slow down progression of the disease, by between four and six months.
But it said the costs of providing the treatment, including fortnightly infusions in hospital and intensive monitoring for side effects, combined with the relatively small benefits it provides to patients means it cannot be considered good value for the taxpayer.
The draft guidance will now go out to consultation until Sept 20, ahead of a final decision.
Helen Knight, director of medicines evaluation at Nice, said: “Lecanemab and other similar treatments for Alzheimer’s disease now coming on stream have prompted a great deal of debate about the prospects of being able for the first time to slow the effects of a condition that is progressive, life-limiting, complex and distressing.
“For Nice to be able to approve a medicine for use in the NHS it must not only provide benefits to patients, but it must also represent a good use of NHS resources and taxpayers’ money.
“Lecanemab provides on average four to six months slowing in the rate of progression from mild to moderate Alzheimer’s disease, but this is just not enough benefit to justify the additional cost to the NHS.”
The MHRA had on Thursday approved a product licence for the medicine lecanemab (sold under the brand name Leqembi) for use in the early stages of Alzheimer’s disease, saying this followed a thorough review of the benefits and risks.
It said the drug was the first treatment for Alzheimer’s disease licensed for use in Great Britain that shows some evidence of efficacy in slowing progression of the disease.
The decision was made with expert scientific advice on the benefit risk of lecanemab from the Commission on Human Medicines (CHM), the Government’s independent advisory body.
The drug is being licensed for patients who do not carry the ApoE4 gene. People with the gene, which increases the risk of Alzheimer’s disease, have been found to have a greater risk of suffering amyloid-related imaging abnormalities (Aria), which are characterised by swelling and bleeding of the brain.
Patients taking some types of blood-thinning medication will also be excluded, because of the increased risk of bleeds.
Julian Beach, MHRA interim executive director, healthcare quality and access, said: “Licensing medicines which meet acceptable standards of safety, quality and efficacy is a key priority for us.
“We’re assured that, together with the conditions of the licence approval, the appropriate regulatory standards for this medicine have been met.
“As with all medical products, we will keep its safety under close review, and with a controlled post-authorisation safety study to be undertaken, we will ensure that the benefit risk of lecanemab in clinical use is closely followed up.”
Ms Evans-Newton said further negotiations between Nice, drug manufacturer Eisai and the NHS might offer a way forward.
But she said: “The heartbreaking reality is that those who could benefit from drugs like lecanemab don’t have time to wait. We’ve written to the Health Secretary Wes Streeting urging him to act, and to find a solution so that people with dementia in the UK don’t continue to miss out on innovative treatments.
“As well as considering how to make drugs like lecanemab available, there also needs to be a real focus on improving the way dementia is diagnosed within the NHS. The shocking reality is that one in three people in England with dementia never get a formal diagnosis, leaving them unable to access the care and support they need.”