New drug approved for Alzheimer’s disease may not be available to NHS patients?

Lecanemab is the first treatment for Alzheimer’s disease licensed for use in Great Britain

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved lecanemab (Leqembi) for use in the early stages of Alzheimer’s disease, following a thorough review of the drug’s benefits and risks.

Developed by Japanese pharmaceutical company Eisai, lecanemab is the first treatment for Alzheimer’s disease licensed for use in Great Britain, with evidence indicating its potential to slow the disease’s progression.

Although the MHRA has granted a product license for the medicine, there are concerns about its cost and the potential delay before it becomes accessible to NHS patients.

Pharmacist Thorrun Govind told Talk TV that the National Institute for Health and Care Excellence (NICE) is expected to make a final decision on its cost and availability by the end of the year.

She highlighted that the drug is currently approved for private use, and that NICE will next evaluate it, weighing patient care against the value for taxpayers, with a final decision expected later this year.

Govind also voiced concerns that NHS patients may face delays in accessing the treatment.

Professor Sir Stephen Powis, NHS National Medical Director, commented that the health service is now waiting for a final decision from NICE that will "look at the clinical benefits and cost-effectiveness of lecanemab and determine if it should be routinely offered by the NHS in England."

He noted that lecanemab is the first disease modifying treatment for Alzheimer’s disease with a market approval in the UK.

Furthermore, he revealed that 27 other drugs are currently in advanced clinical trials, which could potentially be approved by 2030.

He added that a dedicated NHS team is reviewing these drugs to ensure the health system is prepared for future advances in treatments.

Know more about lecanemab 

According to MHRA, lecanemab is approved for treating adults in the early stages of Alzheimer’s disease who have one or no copies of the apolipoprotein E4 gene (ApoE4).

About 15 per cent of those diagnosed with Alzheimer’s are estimated to have two copies of the gene, known as homozygous patients, who face a higher risk of developing the disease.

The MHRA noted that individuals with one copy of the gene also have an increased risk.

A clinical trial involving 1,795 participants with early-stage Alzheimer’s found that ApoE4 homozygous patients treated with lecanemab had a higher risk of developing Amyloid Related Imaging Abnormalities (ARIAs) compared to those with one or no copies of the gene—45%, 19%, and 13%, respectively.

ARIAs commonly occur as temporary brain swelling in one or more areas of the brain (ARIA-E) or small spots of bleeding in or on the surface of the brain (ARIA-H).

The MHRA said that while most ARIA events did not cause any symptoms and were only detected through brain scans, a small number of patients developed serious symptoms.

Additionally, the level of benefit in patients with two copies of the ApoE4 gene was uncertain when compared to those with one copy or none.

The Commission on Human Medicines (CHM), the government's independent advisory body, therefore recommended that the risk-benefit ratio of lecanemab was favourable for ApoE4 non-carriers or heterozygous patients, but not for those who are homozygous. They advised that patients should be tested for the APOE4 gene before starting treatment.

Use of lecanemab is also restricted for patients on anticoagulants (blood thinners, including warfarin) or those diagnosed with cerebral amyloid angiopathy (CAA) via MRI, as the risks in these patients are considered to outweigh the benefits.

How the drug works

Lecanemab is a monoclonal antibody that targets amyloid beta protein, which forms plaques in the brain of Alzheimer’s patients.

“Lecanemab works by binding to these clumps and reducing them, therefore slowing the progression of the disease,” the MHRA explained.

In the clinical trial, participants received either lecanemab (10 mg/kg every two weeks) or a placebo. After 18 months, lecanemab demonstrated a statistically significant reduction in both clinical decline and amyloid beta plaque levels compared to the placebo group.

The MHRA revealed that a controlled post-authorisation safety study will be conducted to investigate the safety and benefit-risk profile of lecanemab in routine clinical practice.