Lecanemab is approved by MHRA in Great Britain, and restricted in NHS
Published on 22nd August 2024 by Scottish Brain Sciences
Following today’s announcements from the MHRA and NICE about a new drug, lecanemab – which approve its use in Great Britain, but block its adoption in the NHS – our CEO and Founder, Prof Craig Ritchie, said the following:
“Today’s announcements mark an important step forward in the ongoing effort to deliver better treatments for Alzheimer’s disease, but they will no doubt leave patients and their families with uncertainty about what it means for them.
“Today’s announcements mark an important step forward in the ongoing effort to deliver better treatments for Alzheimer’s disease, but they will no doubt leave patients and their families with uncertainty about what it means for them.
“We should not lose sight of how encouraging it is to be exploring the possibility of prescribing treatments that can slow the decline of Alzheimer’s disease. This is a turning point in the history of this condition, and gives hope to all those affected that improved treatments are coming.
“However, these drugs are not easy to deliver safely, which means great care must be taken and costs are necessarily high in their safe use; they require a high degree of clinical expertise and access to brain imaging, complex diagnostic work up and treatment centres in order to make sure the right patients get the treatment and we can monitor potential side effects. Our current healthcare systems are not adequately set up to do this right now.
“At Scottish Brain Sciences, we are committed to increasing patient access to early detection and treatments for Alzheimer’s and other types of neurodegenerative disease and we continue to develop our research programme to provide opportunities for patients to access better treatments. This announcement proves how vital it is that we continue to advance our work and once again we thank all of our participants for joining us on this mission, as we could not achieve it without them.”
FAQs
1. What is lecanemab?
Lecanemab is a treatment designed for individuals in the early stages of Alzheimer’s disease. It is a monoclonal antibody that targets and reduces amyloid plaques in the brain, which are believed to contribute to the progression of Alzheimer’s. While lecanemab does not cure Alzheimer’s, it aims to slow the rate of cognitive decline.
2. Is lecanemab licensed for use in Great Britain?
Yes, lecanemab was licensed for use in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA) on August 22, 2024. This means that it has been approved as safe and effective for treating adults with early-stage Alzheimer’s disease.
3. Is it available on the NHS?
No, lecanemab is not currently available on the NHS. Although the drug has been licensed by the MHRA, the National Institute for Health and Care Excellence (NICE) has released draft guidance indicating that it does not recommend lecanemab for use in the NHS. This decision is based on the assessment that the drug’s benefits — an average delay of 4 to 6 months in cognitive decline — do not justify the high costs involved in its administration, which includes bi-weekly infusions and intensive monitoring for potential side effects like ARIA (Amyloid-Related Imaging Abnormalities).
4. Is it safe?
Lecanemab has shown some effectiveness in slowing the progression of Alzheimer’s, but it also carries risks. Clinical trials revealed that some patients experienced side effects like Amyloid-Related Imaging Abnormalities (ARIA), which can cause brain swelling or small brain bleeds. Although these effects were generally manageable, the long-term safety of lecanemab is still being evaluated, and it remains a concern for ongoing monitoring.
5. What’s the situation in Scotland?
In Scotland, lecanemab is also licensed for use following the MHRA’s decision. However, its availability in the NHS in Scotland will depend on the decision of the Scottish Medicines Consortium (SMC).
The SMC will conduct its own assessment of the drug’s cost-effectiveness and overall benefits before determining whether it should be made available to patients through the NHS in Scotland. This decision is expected later this year, and the outcome will influence whether lecanemab can be prescribed by doctors in Scotland.