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The benefits of Alzheimer’s treatment lecanemab are too small to justify the cost to the NHS, the National Institute for Health and Care Excellence (NICE) has decided in draft guidelines.
In a statement published on 22 August 2024, NICE said that “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”.
Lecanemab is a monoclonal antibody that is administered intravenously once a fortnight in a clinical setting, with evidence suggesting that it can slow down the progression of cognitive decline by 4–6 months.
Experts told The Pharmaceutical Journal in July 2023 that many UK hospitals do not yet have the infrastructure to deliver the drug.
The decision from NICE was announced on the same day as the Medicines and Healthcare products Regulatory Agency (MHRA) approved lecanemab for patients who are in the early stages of Alzheimer’s disease.
The licence excludes those who are carrying two copies of the apolipoprotein E4 gene (ApoE4), known as homozygous patients, who comprise around 15% of people with the disease.
Homozygous patients were at comparatively greater risk of developing amyloid related imaging abnormalities (ARIAs) — temporary swelling or bleeding on the brain — when taking the medicine in trials, the MHRA said.
The Commission on Human Medicines (CHM) said that testing for the ApoE4 gene should be carried out before treatment and that people with one copy, or no copies, of the gene would be eligible for the treatment.
Lecanemab is also not suitable for people taking anticoagulants, or who have been diagnosed with cerebral amyloid angiopathy (CAA) by MRI before starting treatment, the MHRA said.
Sebastian Walsh, National Institute for Health Research doctoral fellow at the University of Cambridge, said: “It may seem confusing that the MHRA have granted a licence but NICE have rejected lecanemab. But this is consistent with their roles in the system.”
“Lecanemab is expensive… and requires fortnightly infusions in specialist centres with trained staff. Moreover, working out who is and isn’t eligible requires a lot of testing, including genetic testing and brain scans.
“The majority of people with Alzheimer’s wouldn’t be eligible for these treatments. So it is unsurprising that NICE does not consider these drugs cost-effective and recommends against use in the NHS.”
Hilary Evans-Newton, chief executive at Alzheimer’s Research UK, said the news was “bittersweet 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,” she said.
“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.”
Sir Stephen Powis, NHS national medical director, said: “Lecanemab is the first disease modifying treatment for Alzheimer’s disease with a market approval in the UK, and to ensure the health system is prepared for future advances in treatments, a dedicated NHS team is also looking ahead to 27 other drugs which are currently in advanced clinical trials that could be potentially approved by 2030.”
The draft NICE guidance is currently open for consultation, and the deadline for responses is 20 September 2024.
