Lecanemab: German Quality institute not convinced by new Alzheimer's drug

The Institute for Quality and Efficiency in Healthcare (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) has not certified any additional benefit for the new drug Lecanemab for people suffering from Alzheimer's dementia in its early benefit assessment. This assessment is a significant basis for the upcoming price negotiations between the manufacturer and the GKV-Spitzenverband. Lecanemab is a monoclonal antibody that attacks pathological amyloid deposits in the brain, as they occur in nerve cells of Alzheimer's patients. The goal of the treatment is to slow down the decline in cognitive and functional abilities and to give affected individuals more time for a life as independent as possible.

The IQWiG justifies its decision (PDF) by stating that no statistically significant advantage of Lecanemab over standard therapy could be proven in the patient groups relevant to everyday German care. To this end, the institute analyzed the data from the approval study "Clarity AD" in two specific subgroups: patients with mild cognitive impairment (MCI) and patients with mild Alzheimer's dementia. According to Dr. Daniela Preukschat from IQWiG, there were no significant differences in these groups, which were decisive for the assessment, which is why the verdict is "additional benefit not proven".

In the MCI subgroup, Lecanemab patients were only compared to observation without active ingredient, whereas for mild Alzheimer's dementia, the drug was tested against treatment with conventional symptomatic medications (acetylcholinesterase inhibitors). Due to this procedure, significantly fewer patients were included in the IQWiG analysis than in the complete approval study, which included further patient groups. According to Dr. Daniela Preukschat from IQWiG, there were no significant differences in these groups, which were decisive for the assessment, which is why the verdict is "additional benefit not proven".

IQWiG did not consider data from the USA, as these originate from clinical application after approval there and therefore do not represent randomized, comparative study data as required by the German benefit assessment procedure. Although real-world data are generally of interest, they do not meet the methodological requirements of the early benefit assessment according to § 35a SGB V, Preukschat emphasized; at the same time, IQWiG only focused on study participants who were treated according to German therapy standards. The positive effects of Lecanemab observed in the overall population, on the other hand, occurred predominantly in patients who had not been treated according to this standard, she explained.

Leading neurologists immediately expressed sharp criticism of IQWiG's methodology. Prof. Dr. Jörg Schulz from RWTH Aachen University Hospital and Prof. Dr. Lutz Fröhlich from the Central Institute of Mental Health in Mannheim criticized that IQWiG had used a statistical procedure that deviated from the approval study. The analysis of small, subsequently formed subgroups is not statistically significant. They also criticized the assessment criteria used by IQWiG, such as a blanket 15 percent deterioration threshold, as unsuitable for the gradual progression of Alzheimer's disease.

Next steps

The experts urgently warned of the consequences of the negative assessment. If no agreement is reached in the price negotiations as a result, the manufacturer could withdraw the drug from the German market. This would, according to Prof. Schulz, lead to "two-class medicine" in which only self-payers could afford the therapy.

The process is not yet concluded. In the next step, the manufacturer and the professional societies can react to the assessment within the framework of a statement procedure before the Gemeinsamer Bundesausschuss (G-BA) makes a final decision on the additional benefit in mid-February 2026.

In the USA, Lecanemab is regularly approved by the FDA for the treatment of early Alzheimer's disease, i.e., in individuals with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. When elevated beta-amyloid levels in the brain are detected.

(mack)