Monoclonal antibodies (mAbs) lecanemab and donanemab have been approved for the treatment of early Alzheimer’s disease in the UK and USA respectively while lecanemab has been refused marketing authorisation in the EU in view of “unsatisfactory” safety and efficacy data from the clinical trials. NICE, the public body in the UK responsible for assessing evidence for new health technologies for ensuring value for the taxpayer, thinks that benefits of lecanemab are too small to justify the cost to the NHS. Given, Alzheimer’s disease is a common neurodegenerative disorder characterised by progressive decline in memory and about 4 % people aged 60+ years worldwide are affected (5.4 % in Western Europe and 6.4 % North America), approval of the two monoclonal antibodies for the treatment of early Alzheimer’s disease offers hope for improvement in quality of life (QoL) of the affected people.
On 22 August 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK approved lecanemab for use in the early stages of Alzheimer’s disease (AD). This is the first treatment for Alzheimer’s disease licensed for use in the United Kingdom.
Lecanemab is a monoclonal antibody (mAbs). It delays worsening of symptoms of Alzheimer’s disease by attaching to amyloid beta to reduce the plaques in the brain. It has shown some evidence of efficacy in slowing progression of the disease in clinical trials.
However, National Institute for Health and Care Excellence (NICE), the public body responsible for assessing evidence for new health technologies for ensuring value for the taxpayer, thinks that benefits of lecanemab are too small to justify the cost to the NHS.
National Health Service (NHS) is a universal system publicly funded out of general taxation. It provides health services to everyone, free at the point of delivery based on need of healthcare (and not based on ability to make payment). NICE performs cost effectiveness analysis (CEA) for a new treatment and provides clinical guidelines for the NHS. Benefits of a new treatment should be good enough to justify the cost before it is approved in the NHS. The draft recommendation of NICE regarding lecanemab (i.e., “benefits of new Alzheimer’s treatment lecanemab are too small to justify the cost to the NHS”) implies that lecanemab will not be available to the NHS patients. However, private patients can avail the lecanemab treatment upon making out of pocket payment for the care.
Earlier on 25 July 2024, the European Medicines Agency (EMA) refused the marketing authorisation for Leqembi (active substance: lecanemab) for the treatment of Alzheimer’s disease. EMA had concerns on both safety and effectiveness. Overall, the agency found that the benefits of treatment are not large enough to outweigh the risks hence refusal. As on 5 August 2024, the company for Leqembi has requested a re-examination of refusal opinion.
In the USA, Kisunla (donanemab-azbt; like lecanemab, donanemab too is a monoclonal antibody that binds to amyloid in the brain and reduce symptoms) was approved for the treatment of Alzheimer’s disease on 02 July 2024. It is indicated for patients with mild cognitive impairment or mild dementia stage of Alzheimer’s disease.
Alzheimer’s disease is a common neurodegenerative disorder characterised by progressive decline in memory. Cognitive functions such as thinking, learning and organizing abilities are affected. About 4 % people aged 60+ years worldwide are affected. The prevalence in Western Europe and North America is 5.4 % and 6.4 % respectively. Approval of the two monoclonal antibodies, Lecanemab in the UK and donanemab in the USA, for the treatment of early Alzheimer’s disease offers an option and hope for improvement in quality of life (QoL) for the affected people. Even “some” evidence of efficacy is a welcome beginning.
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References:
- van Dyck, C. H. et al. Lecanemab in Early Alzheimer’s Disease. N. Engl. J. Med. 388, 9–21 (2023). DOI: https://doi.org/10.1056/NEJMoa2212948
- MHRA. Press release – Lecanemab licensed for adult patients in the early stages of Alzheimer’s disease. Posted 22 August 2024. Available at https://www.gov.uk/government/news/lecanemab-licensed-for-adult-patients-in-the-early-stages-of-alzheimers-disease
- NICE. News – Benefits of new Alzheimer’s treatment lecanemab are too small to justify the cost to the NHS. Posted 22 August 2024. Available at https://www.nice.org.uk/news/articles/benefits-of-new-alzheimer-s-treatment-lecanemab-are-too-small-to-justify-the-cost-to-the-nhs
- European Medicines Agency. Leqembi. Update as of 5 August 2024. Available at https://www.ema.europa.eu/en/medicines/human/EPAR/leqembi
- FDA approves treatment for adults with Alzheimer’s disease https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease
- KISUNLA (donanemab-azbt) injection, for intravenous use Initial U.S. Approval: 2024 https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761248s000lbl.pdf
- Espay AJ, Kepp KP, Herrup K. Lecanemab and Donanemab as Therapies for Alzheimer’s Disease: An Illustrated Perspective on the Data. eNeuro. 2024 Jul 1;11(7):ENEURO.0319-23.2024. DOI: https://doi.org/10.1523/ENEURO.0319-23.2024
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