Milestone in Alzheimer’s drugs “bittersweet” for some patients

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the first Alzheimer's treatment in the UK that has shown some effectiveness in slowing the progression of the disease. Lecanemab is approved for the treatment of adults with early-stage Alzheimer's disease.

It is therefore suitable for people who have either one or no copies of the apolipoprotein E4 gene (ApoE4). You can have zero, one or two copies of this gene.

The Commission on Human Medicines (CHM), the UK government's independent advisory body, pointed out: “The risk-benefit balance of lecanemab was positive in patients who were not ApoE4 carriers or heterozygous, but not in the homozygous group, and testing for the APOE4 gene should be performed before treatment.”

The MHRA's decision is largely based on data from Phase III of the global Clarity AD clinical trial, which showed statistically significant results for participants with Alzheimer's disease.

“The MHRA’s decision to approve lecanemab is an important step forward for eligible patients in the UK who could now have access for the first time to a treatment that has been shown in studies to slow the progression of early Alzheimer’s disease,” commented Gunilla Osswald, CEO of BioArctic.

NICE decision on Lecanemab

However, a draft recommendation from the National Institute for Health and Care Excellence (NICE) states that the benefits of lecanemab are “too small” to justify making the drug available on the NHS.

This is because the anti-amyloid antibody drug “represents intensive treatment for patients, requiring hospital visits every two weeks and skilled staff to monitor them for signs of serious side effects, plus the cost of purchasing the drug,” said Dr Samantha Roberts, chief executive of NICE.

Because the clinical evidence only includes reports of patients taking lecanemab for 18 months, NICE said this meant there was “a lack of evidence of long-term effects.”

“Lecanemab slows the progression of the disease from mild to moderate Alzheimer's by an average of four to six months. However, this benefit is not sufficient to justify the additional cost to the NHS,” explains Helen Knight, head of drug evaluation at NICE.

The public consultation on the draft NICE guidelines will end on 20 September 2024, NICE confirmed.

More comments from the industry

“The combination of the drug's high cost, relatively small impact on disease and significant risk probably justifies the NICE guideline. It is possible that the balance will shift and the guideline will be changed as better methods of identifying those most likely to benefit emerge and the results of longer-term use in the US become known,” noted Professor Paul Morgan, interim director of the UK Dementia Research Institute Cardiff at Cardiff University.

“Whatever you think of the MHRA and NICE decision, the most important thing is that lecanemab has been approved. This is encouraging for the development of next-generation therapies that offer more benefit with less risk. There is reason to hope that these next-generation drugs will become available on the NHS, so it is vital that the UK remains fully focused on developing these treatments,” said Professor John Gallacher, Director of Dementia Research UK and the University of Oxford.

“NICE's statement does not represent a final decision but the start of a period of consultation and the provision of further information,” summarised Professor Robert Howard, Professor of Geriatric Psychiatry in the Department of Psychiatry at UCL.

Lecanemab is subject to additional monitoring.