The Joint Federal Committee (G-BA) has found no proven added benefit for the Alzheimer's drug Leqembi (Lecanemab) compared to the previous standard therapy. The decision of February 2026 is based on the benefit assessment by the Institute for Quality and Efficiency in Health Care (IQWiG) from December 2025. It forms the basis for the upcoming price negotiations between statutory health insurance funds and the manufacturer Eisai, which are intended to lead to a nationwide reimbursement amount within six months.
Leqembi is the first monoclonal antibody preparation approved in the EU for early Alzheimer's disease. It is exclusively for patients with confirmed amyloid pathology in the stage of mild cognitive impairment (MCI) or early dementia. Approval was granted based on the Phase 3 CLARITY AD study, which showed a moderate slowing of cognitive decline by about 27 percent. The drug does not cure the disease but aims to slow mental deterioration and maintain independence longer. In Germany, an estimated around 400 people are currently being treated; the annual therapy costs are about 40,000 euros per patient.
The IQWiG assessment and the G-BA decision are met with criticism in the professional community. The non-profit Alzheimer's Research Initiative (AFI) points to three central methodological issues: Firstly, the approval study was primarily designed for an overall evaluation, while IQWiG performed a fine subgroup analysis – a post-hoc division for which the study was not statistically designed and which limits the validity of the results. Secondly, the chosen comparison arm did not fully correspond to real-world care practice, as patients already taking Alzheimer's medications were excluded, even though such combinations are common in the early stages. Thirdly, IQWiG sets a high threshold for demonstrating added benefit in very early stages of the disease, where even clinically relevant but naturally small effects are often not considered sufficient.
Prof. Dr. Stefan Teipel, dementia researcher and member of the AFI's Scientific Advisory Board, emphasizes: "The critical examination of study data is essential, but IQWiG's standard methodology only incompletely reflects the efficacy of Alzheimer's drugs in early stages." AFI Managing Director Dr. Anne Pfitzer-Bilsing adds that Leqembi can be relevant for a small, clearly defined patient group and can enable a noticeable difference in quality of life and independence. The G-BA decision has direct implications for price negotiations and thus for future availability.
Objectively, the decision reflects the strict requirements of the German AMNOG procedure, which demands a clear added benefit compared to the appropriate comparator therapy. The moderate clinical efficacy of Leqembi – with simultaneously relevant risks such as amyloid-related imaging abnormalities (ARIA) – and the very limited target group justify the classification "no added benefit" from the perspective of IQWiG and G-BA. At the same time, there is increasing discussion in the professional community as to whether the established evaluation criteria for novel, disease-modifying therapies in early stages of dementia should be adapted to appropriately appreciate small, but significant effects for those affected.
The decision does not currently affect the prescribing ability of Leqembi. The IQWiG assessment for the second approved antibody preparation, Kisunla (Donanemab), was similar; the G-BA decision is still pending here. The debate about Leqembi and Kisunla shows the tension between strict evidence-based evaluation and the need for options for early Alzheimer's stages – a conflict that continues to be intensely waged in Germany and Europe.
