Lecanemab approved in UK but deemed too costly for NHS
The Alzheimer’s drug lecanemab has been licensed by the UK medicines regulator but is considered too costly for use in the NHS.
After being approved for use by the US FDA back in January 2023, lecanemab has been granted Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA; London, UK) for use in the early stages of Alzheimer’s disease [1]. Lecanemab, a monoclonal antibody developed by Eisai (Tokyo, Japan), is the first drug that shows some evidence of slowing the progression of Alzheimer’s to be licensed in the UK.
The drug has been approved to treat individuals in the early stages of Alzheimer’s disease with one or no copies of the apolipoprotein E4 gene (ApoE4), not for individuals with two copies. This is because having two copies of the ApoE4 gene placed individuals receiving the drug during its clinical trial at a higher risk of developing amyloid-related imaging abnormalities (ARIAs). ARIAs are abnormal differences seen in MRI images of the brain that can result in mild to severe bleeding or swelling in the brain. They have therefore advised that ApoE4 testing should be carried out before treatment.
“As with all medical products, we will keep its safety under close review, and with a controlled post-authorization safety study to be undertaken, we will ensure that the benefit risk of lecanemab in clinical use is closely followed up,” commented Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access.
The costs outweigh the benefits
However, the moment is bittersweet, as the National Institute for Health and Care Excellence (NICE; London, UK) has published draft guidance for the NHS that the benefits of lecanemab are too small to justify the costs [2].
Lecanemab is administered intravenously in a healthcare setting every 2 weeks, with each infusion lasting approximately 1 hour, and treatment continues until a patient progresses beyond mild Alzheimer’s disease to moderate disease. Treatment also requires intensive monitoring for side effects.
The price of providing the treatment and the cost of the drug – approximately US$26,000 per patient per year – along with the relatively small benefits it offers, means it is not considered good value for the taxpayer. After the independent NICE committee examined the available research trial evidence, real-world data and heard from patient representatives and their carers, NICE issued draft guidance for consultation not recommending lecanemab for use on the NHS because it is not a cost-effective use of limited NHS funding.
“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,” commented Helen Knight, Director of Medicines Evaluation at NICE. “Lecanemab provides on average 4 to 6 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.”
It is estimated that around 70,000 people in England would have been eligible for lecanemab treatment. Making the drug not available on the NHS means that only those who use private healthcare, around 22% of the population, would have access to the drug.
The public consultation on the draft NICE guidance will close on 20 September 2024. The independent committee will then review all responses before making its final recommendations.
“Today’s approval of lecanemab by MHRA marks a significant milestone in Alzheimer’s research, demonstrating for the first time that we can modify the disease course and slow cognitive decline,” commented Siddharthan Chandran, Director of the UK Dementia Research Institute (London, UK) to the Science Media Center. “However, NICE’s initial recommendation that the benefits are too small to justify NHS use highlights the challenges we face in making these breakthrough treatments better and more widely accessible.”
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