G-BA rules Leqembi provides no added benefit for Alzheimer's treatment
The German Federal Joint Committee (G-BA) has concluded that the Alzheimer’s drug Leqembi shows no proven added value over standard therapy, sparking debate over assessment methodologies.
The Federal Joint Committee (G-BA) in Germany has ruled that the Alzheimer's drug Leqembi (lecanemab) offers no demonstrated added benefit compared to existing standard treatments. The decision, based on a December 2025 assessment by the Institute for Quality and Efficiency in Health Care (IQWiG), now serves as the basis for upcoming price negotiations between the manufacturer and statutory health insurance funds.
The Alzheimer Forschung Initiative (AFI) has criticized the decision, arguing that the assessment methodology is ill-suited for early-stage Alzheimer's treatments. AFI representatives contend that IQWiG's criteria are too rigid, failing to account for subtle but clinically significant improvements in cognitive function and patient independence.
Professor Stefan Teipel, a researcher and member of AFI’s scientific advisory board, noted that standard assessment methods often fail to reflect the real-world utility of dementia medications. While Leqembi targets a specific, limited patient demographic, AFI maintains that the therapy can play a crucial role in maintaining quality of life for those in the early stages of the disease.
The G-BA ruling does not currently impact the prescriber's ability to issue the drug, but it will significantly influence future reimbursement terms. Meanwhile, a similar benefit assessment for the drug Kisunla is still pending, highlighting a broader ongoing debate regarding the valuation of new Alzheimer's therapies.