The Joint Federal Committee's (G-BA) decision of April 16, 2026, to classify the additional benefit of donanemab as „not proven“ does not surprise the digiDEM project management. The G-BA had already reached this conclusion for lecanemab in February 2026 of this year. Now it turns out that the second drug with a similar mechanism of action also cannot prove any clinically relevant benefit that would be noticeable in everyday life for those affected. To make matters worse, for one of the two approved patient groups, despite supplementary evaluation attempts by the manufacturer, there was no suitable data basis to assess the additional benefit at all.
With estimated treatment costs of around 25,000 euros per year, pricing in the upcoming negotiations with the GKV-Spitzenverband must be consistently aligned with the proven evidence – just as digiDEM has already demanded in the case of Lecanemab. Innovation must not be a blanket excuse for demands that are not reasonably proportionate to the proven benefit.
