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AMNOG-Monitor
Information · Analysis · Research
(2 MB)
Dear readers of the AMNOG-Monitor,
Since 1 October 2025, all healthcare providers (doctors, pharmacists, hospitals) have been required to use electronic patient records (ePA) and to document certain data such as doctor's letters, findings and medications in them. The ePA is intended to facilitate the day-to-day care of patients, avoid duplicate examinations and make drug therapy more transparent. The aim is to improve the quality of treatment and at the same time reduce costs through digitalisation.
The GKV Estimation Group (GKV-Schätzerkreis) expects the average additional contribution for statutory health insurance (GKV) to remain at 2.9 per cent in the coming year. Each health insurance fund sets its own additional contribution, which is paid proportionally by employers and employees in addition to the general contribution rate of 14.6 per cent. This year, numerous health insurance funds increased their additional contributions in order to replenish their reserves, resulting in an increase from 2.5 to 2.94 per cent in 2025. With an austerity package, particularly in the hospital segment, Minister Nina Warken (CDU) wants to keep health insurance contributions stable for 2026. Next year, structural reforms for both health and long-term care insurance are expected to ensure medium to long-term stability.
The German Federal Council (Bundesrat) has issued a resolution calling for a strengthening of the pharmaceutical industry by reducing bureaucracy and for reforming the AMNOG process, taking into account the special features of advanced therapies (ATMPs) and personalized medicine, and defining the pharmaceutical industry as a key industry for Germany. https://www.bundesrat.de/SharedDocs/drucksachen/2025/0401-0500/463-25(B).pdf
In October, there were 14 new resolutions on early benefit assessment (see table) and 12 new procedures were initiated. The G-BA discontinued the Elosulfase alfa (3, reassessment ≥€30m) procedure because the pharmaceutical manufacturer withdrew the orphan drug designation in October 2025. The current EU HTA procedures are listed at the following link: https://health.ec.europa.eu/document/download/d947533e-7e4e-4e82-a9c6-e06830d708f8_en?filename=hta_ongoing-jca_en.xlsx
The AMNOG Monitor once again formed the basis for a scientific publication – this time in the renowned journal PharmacoEconomics (2025) 43:1223-133. The authors Jörg Tomeczkowski (EGDE, formerly Janssen-Cilag), Tanja Heidbrede (UCB), Birte Eichinger (Novartis), Ulrike Osowski (Merck), Friedhelm Leverkus (EGDE, formerly Pfizer), Sarah Schmitter (Pfizer) and Charalabos-Markos Dintsios (Bayer) evaluated all assessments of single-arm studies by IQWiG and G-BA and identified the success criteria.
https://www.researchgate.net/publication/394028198_Challenges_and_Criteria_for_Single-Arm_Trials_Leading_to_an_Added_Benefit_in_German_Health_Technology_Assessments
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Kind regards,
Dr Johannes Hankowitz and Christian Rieke