The recent approval of lecanemab, a drug that slows the progression of Alzheimer’s disease, by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has sparked controversy and concerns among experts and charities about its effectiveness and cost-effectiveness. The National Institute for Health and Care Excellence (Nice), which reviews the cost-effectiveness of new treatments, has declined to recommend lecanemab for use on the National Health Service (NHS) due to its high cost, approximately £20,000 per patient per year, and the lack of evidence on its long-term effects.
The MHRA approved lecanemab as the first treatment for Alzheimer’s licensed for use in the UK, citing its ability to slow disease progression by 27% in patients with early-stage Alzheimer’s. The drug works by binding to a protein called amyloid, which builds up in the brains of people living with Alzheimer’s. In clinical trials, lecanemab successfully removed amyloid build-up from the brains of patients with early-stage Alzheimer’s, slowing down the decline in thinking and memory skills by 27% and quality of life by up to 56%. However, during trials, some patients experienced side effects, including reactions to infusion, fever, rash, chills, and body aches, as well as swelling or microbleeds in the brain.
The debate surrounding lecanemab’s approval has raised questions about the drug’s potential benefits and drawbacks. Dr. Sebastian Walsh, a University of Cambridge researcher, explained that the MHRA’s role is to ensure the drug is safe and effective, while Nice’s role is to consider whether the drug offers good value for money for the NHS. Dr. Walsh noted that the majority of people with Alzheimer’s would not be eligible for lecanemab due to the need for genetic testing and brain scans, making it unlikely that the drug would be cost-effective for the NHS.
Experts Disagree on Alzheimer’s Treatment Efficacy (Image via Getty)
Charities have also weighed in on the issue. Fiona Carragher, chief policy and research officer at Alzheimer’s Society, described the Nice decision as “disappointing,” while Hilary Evans-Newton, chief executive at Alzheimer’s Research UK, called the news a “bittersweet moment.” However, both charities acknowledged that further negotiations between Nice, Eisai, and the NHS may offer a way forward.
The approval of lecanemab in the UK marks a significant milestone in the development of treatments for Alzheimer’s disease. However, the disagreement between the MHRA and Nice highlights the complexities involved in determining the cost-effectiveness of new treatments, particularly in a publicly-funded healthcare system like the NHS. The debate surrounding lecanemab’s approval serves as a reminder of the need for a nuanced approach to evaluating the benefits and drawbacks of new treatments, and the importance of considering the needs and priorities of patients, families, and healthcare systems.
