NICE Rejects Alzheimer’s Drug Leqembi in the U.K

The U.K.'s Medicines and Healthcare products Regulatory Agency approved lecanemab, marketed as Leqembi, for early-stage Alzheimer's disease in August 2024. However, the National Institute for Health and Care Excellence (NICE) has recommended against its reimbursement by the National Health Service (NHS), citing insufficient benefits relative to its costs. Lecanemab is reported to slow the progression of Alzheimer's by four to six months, which NICE deems inadequate for the financial burden it would impose on the NHS. The draft guidance from NICE is currently open for consultation until September 20, 2024, before a final decision is made. There is potential for further negotiations between NICE, the drug's manufacturer Eisai, and the NHS, as suggested by advocates from Alzheimer’s Research UK. This situation mirrors a previous assessment by the U.S. Institute for Clinical and Economic Review, which found the evidence for lecanemab's health benefits lacking compared to standard supportive care. Despite a growing demand for the drug, its market performance in the U.S. has not met initial expectations, partly due to neurologists' divided opinions on its recommendation. Clinical trials have raised concerns, with about 12% of participants experiencing amyloid-related imaging abnormalities, and two deaths possibly linked to the drug's use. These factors contribute to a cautious approach towards lecanemab's adoption in clinical practice. The ongoing discussions and evaluations highlight the complexities of introducing new treatments for Alzheimer's disease, balancing potential benefits against financial implications and safety concerns. The outcome of NICE's consultation could significantly impact the future availability of Leqembi in the U.K. healthcare system.