Alzheimer’s drug approved by UK regulator but too costly for NHS

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A drug that can slow decline in patients with early stage Alzheimer’s disease will not be available to NHS patients in England, the healthcare spending watchdog has ruled, despite the UK medicines regulator approving it.

The National Institute for Health and Care Excellence on Thursday said lecanemab would not be prescribed by the health service because its benefits were “just too small to justify the significant cost to the NHS”.

The announcement by Nice came as the Medicines and Healthcare products Regulatory Agency, which assesses the safety of drugs, approved lecanemab, making it the first dementia treatment to be licensed in more than 20 years.

During clinical trials, lecanemab slowed the progression of Alzheimer’s disease by four to six months in people in the early stages of the condition by targeting the protein beta-amyloid in the brain. 

In people with Alzheimer’s, the most common cause of dementia, abnormal levels of the protein clump together to form plaques that disrupt brain function. At present almost 1mn people in the UK are living with dementia, which is the country’s leading cause of death.

But the treatment has proved contentious, both because of a significant risk of side effects and the cost and complexity of administering it. The drug is given through fortnightly infusions in hospital and patients must be intensively monitored for possible adverse effects. 

To be effective, it must be given early in the course of the disease. But only about 2 per cent of UK patients have access to diagnostics such as a PET brain scan or lumbar puncture needed to be judged eligible to receive the drug.

Hilary Evans-Newton, chief executive of Alzheimer’s Research UK, said Nice’s decision meant lecanemab would only be available to those who could pay privately, which was “deeply disappointing”.

She said she hoped further talks between Nice, the manufacturer Eisai and the NHS might offer a way forward, and that the charity had written to health secretary Wes Streeting “urging him to act”.

Professor Jonathan Benger, Nice chief medical officer, told journalists that in addition to the cost of the drug, priced at more than £20,000 a year in the US, the NHS faced over £500 in costs for each patient visit to receive an infusion. Patients received the drug every two weeks for 18 months in clinical trials.

But at a briefing on Thursday, David Thomas, head of policy at Alzheimer’s Research, said the NHS needed investment in diagnostics and staff to be ready to deliver new treatments.

Donanemab, a separate Alzheimer’s treatment in development by US pharmaceuticals group Eli Lilly which, like lecanemab, targets amyloid plaque in the brain, would likely face the “same hurdles”, he added. 

Professor Sir Stephen Powis, NHS England national medical director, said lecanemab was the first disease-modifying treatment for Alzheimer’s to be approved for UK use.

He added that health service staff were “looking ahead to 27 other drugs which are currently in advanced clinical trials that could be potentially approved by 2030”.

Announcing regulatory approval of the drug, Julian Beach, MHRA interim executive director for healthcare quality and access, said “a controlled post-authorisation safety study” would be carried out to continue to assess its risks and benefits.

Last year lecanemab was approved by the Food and Drug Administration, the US regulator. But in July the European Medicines Agency declined to approve it on the grounds that the benefits were small and the drug was associated with adverse side effects such as brain swelling.

Eisai and Biogen, the two companies marketing lecanemab, welcomed the MHRA approval.

Eisai said it was “working collaboratively” with Nice, the Scottish Medicines Consortium — which judges value for money north of the border and has not yet made a decision — and the NHS “to make this medicine available to eligible people living with early AD in Great Britain as soon as possible”.

Nice’s rulings apply to England but are generally followed in Wales and Northern Ireland.