Alzheimer’s Drug Approval Faces Scrutiny in Germany

The University Hospital Schleswig-Holstein (UKSH) in Kiel has begun treating the first patients with new antibody drugs aimed at slowing the progression of Alzheimer’s disease, following European Commission approval of two active ingredients in September 2025. However, the rollout coincides with a contentious decision by the German Federal Joint Committee (G-BA) regarding one of these drugs, lecanemab.

G-BA Questions Lecanemab’s Additional Benefit

The G-BA has determined that lecanemab, an antibody drug designed to combat protein deposits in the brain, demonstrates no proven additional benefit compared to existing Alzheimer’s treatments. According to the G-BA, the drug did not demonstrate improvement in symptoms or quality of life over current approaches. This decision significantly impacts potential pricing and market access for lecanemab in Germany.

Strong Criticism from Medical Societies

The G-BA’s decision has drawn sharp criticism from leading medical societies. Prof. Dr. Frank Jessen, a member of the board and lead co-author of the S3 dementia guidelines, emphasizes that lecanemab represents the first opportunity for causal intervention in the course of Alzheimer’s disease. Studies showed the disease progressed around 30 percent less in treated patients after 18 months compared to a placebo group, which he considers a clinically meaningful benefit. [1]

The German Society for Neurology (DGN) also views the decision as a setback, stating that lecanemab is the first disease-modifying drug for Alzheimer’s. Prof. Jörg B. Schulz, spokesman for the DGN Dementia Commission, notes that the positive effects of lecanemab persist even after symptom-oriented drugs are discontinued.

Methodological Concerns Raised

The DGPPN criticized the analyses conducted by the Institute for Quality and Efficiency in Health Care (IQWiG), which informed the G-BA’s decision, as conceptually and methodologically flawed. Jessen argues that comparing lecanemab to acetylcholinesterase inhibitors is an inappropriate comparison, akin to comparing chemotherapy to a painkiller.

Potential Market Withdrawal

The G-BA’s decision heavily influences price negotiations between Eisai, the manufacturer of lecanemab, and the GKV umbrella association. Without a proven additional benefit, the price of the new drug cannot significantly exceed that of existing treatments. Lecanemab currently costs around €25,000 per year, whereas comparison medications cost around €250. Peter Berlit, Secretary General of the German Society for Neurology, fears that Eisai may withdraw the drug from the German market if a suitable price cannot be reached.

How Lecanemab Works

Alzheimer’s disease is characterized by the buildup of amyloid plaques in the brain. Lecanemab targets and eliminates these plaques. Studies suggest that the drug reduces the likelihood of progression to the next stage of Alzheimer’s disease. Treatment involves infusions every two or four weeks, with a duration ranging from 18 months to long-term therapy.

The therapy is currently indicated for individuals with mild cognitive impairment or in the early stages of Alzheimer’s disease. Extensive testing and evidence of amyloid changes in the brain are prerequisites. Patients carrying two copies of the Alzheimer’s risk gene APOE-ε4 are excluded from treatment. An estimated 10,000 to 20,000 patients in Germany could be eligible, but currently, only a few hundred are receiving treatment.

Impact on Research

The DGN also expresses concern that the G-BA’s decision will hinder research efforts, making it more difficult to collect real-world data on lecanemab and identify which patient groups benefit most. The manufacturer may lack the incentive to conduct further studies to address existing data gaps.

Donanemab Decision Pending

The G-BA is scheduled to decide on the second approved Alzheimer’s drug, donanemab, in mid-April. IQWiG has also indicated no additional benefit for donanemab, a finding contested by specialist societies.

Updated Guidelines Support Antibody Treatment

The current S3 dementia guidelines support the use of both lecanemab and donanemab in the early stages of Alzheimer’s disease. The second update of the Living Guideline, published in March 2026, specifically recommends these antibodies. This recommendation is based on consensus from a large majority of experts from 37 specialist societies, associations, and organizations representing those affected and their families. Prof. Dr. Richard Dodel, coordinator of the guidelines for the DGN, criticizes the IQWiG methodology, stating that the institute only analyzed 44 percent of the study patients, potentially leading to unreliable results due to reduced sample size.