The German Center for Neurodegenerative Diseases (DZNE) has criticized the benefit assessment of the Federal Joint Committee (G-BA) on the Alzheimer’s drug donanemab (Kisunla) as inappropriate. Prof. Gabor Petzold, Director of Clinical Research at the DZNE, described the evaluation criteria as inappropriate. He also expressed considerable doubts about a new review of amyloid antibodies by the Cochrane Collaboration:

“For Alzheimer’s research in Germany, the G-BA’s assessment sends an unfortunate signal. We will only be able to further develop and improve this therapeutic approach if we gain practical experience with it. And this – at least from a German perspective – under the framework conditions of the German health system and the conditions of the local population. Such “real-world data” is essential for medical progress. We cannot be satisfied with the fact that such data is only collected abroad – under conditions that do not reflect the situation in Germany, or only insufficiently. If the decision of the G-BA now leads to the drug becoming only available to a limited extent in this country, this would be a very unfortunate development. Unfortunate for patients in this country. And for clinical research in this country, it would not only be a hurdle – it would be a real step backwards on the way to a better therapy for Alzheimer’s.”

On April 16, 2026, the G-BA had determined that no proven additional benefit could be demonstrated for donanemab compared to the previous standard of care in Germany. The monoclonal antibody has been administered by infusion since November 2025 and breaks down beta-amyloid proteins in the brain. As justification, the committee pointed out that the study data submitted did not allow a sufficient separation between patients with mild cognitive disorders (MCI) in amyloid pathology and those with mild Alzheimer’s dementia.

Petzold regretted this assessment. The strict division into subgroups does not do justice to the current scientific view of Alzheimer’s disease as a continuum, he said. The transitions between MCI with amyloid pathology and mild dementia are fluid. This historically conditioned classification is based on clinical symptoms and only incompletely reflects the course of the disease – especially against the background of today’s biomarkers.

The drug remains approved in the EU and has been certified by the European authorities as having a positive benefit-risk ratio. The G-BA decision does not change this, but concerns the question of reimbursement and thus potentially practical availability in Germany. Petzold hoped that the upcoming price negotiations between health insurance companies and manufacturers would keep the therapy option open for suitable patients.

In addition, the DZNE researcher warned of negative signals for research in this country. Real-world data from everyday care in Germany is essential to further develop the approach. Limited availability would not only disadvantage patients, but would also mean a step backwards for clinical research in Germany.

Petzold also criticized the Cochrane Review, which was published on April 16, 2026. The review concludes that amyloid antibodies do not show any clinically relevant benefit overall. The analysis includes seven active ingredients – including several that have failed in studies and have not been approved. It is methodologically questionable to lump all substances together without sufficient differentiation, Petzold explained. The conclusions of the review are therefore doubtful. Donanemab and lecanemab are the only representatives of this class currently approved in the EU.

The DZNE is one of the world’s leading research centers for neurodegenerative diseases such as Alzheimer’s, Parkinson’s and ALS. With ten locations nationwide, it makes a significant contribution to the development of new strategies in prevention, diagnosis, treatment and care. It is a member of the Helmholtz Association.

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Editor: X-Press Journalistenbüro GbR

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