Early benefit assessment: Detailed analysis of all G-BA resolutions

The AMNOG monitor provides current, well-founded analyses of all early benefit assessments and an overview of the negotiated reimbursement prices in Germany. It is an indispensable tool for HTA, market access and pricing managers.
 

List of all G-BA Resolutions

The AMNOG monitor includes detailed analyses of every sinlge benefit assessment since 2011. more >>

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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 

Take advantage of our training courses or support for specific issues and feel free to contact us.

New reimbursement prices of AMNOG products are available here.
EMA Positive Opinions for new drugs are shown here.

Kind regards,
Dr Johannes Hankowitz and Christian Rieke

Ivacaftor / Tezacaftor / Elexacaftor (17) Kaftrio® Cystic fibrosis, combination treatment with ivacaftor, ≥ 2 years, non-class I mutation (no F508del mutation and no gating mutation) 64% Hint for major additional benefit Orphan (turnover limit)
Ivacaftor / Tezacaftor / Elexacaftor (16) Kaftrio® Cystic fibrosis, combination treatment with ivacaftor, ≥ 2 years, non-class I mutation (one gating mutation and no F508del mutation) 100% no additional benefit Orphan (turnover limit)
Trastuzumab deruxtecan (6) Enhertu® Breast cancer, HR+, HER2-low or -ultralow, after at least 1 endocrine therapy 100% Hint for minor additional benefit
Tiratricol Emcitate® Peripheral thyrotoxicosis in monocarboxylate transporter deficiency 8 100% Hint for non-quantifiable additional benefit Orphan
Serplulimab Hetronifly® Small cell lung carcinoma, in combination with carboplatin and etoposide, first-line 100% Hint for non-quantifiable additional benefit Orphan
Repotrectinib (2) Augtyro® Solid tumours, NTRK gene fusion, ≥ 12 years 100% no additional benefit
Repotrectinib Augtyro® Non-small cell lung cancer, ROS1-positive 100% no additional benefit
Pembrolizumab (40) Keytruda® Malignant pleural mesothelioma, non-epithelioid, first-line, combination with pemetrexed and platinum chemotherapy 100% no additional benefit
Eplontersen Wainzua® Hereditary transthyretin amyloidosis with polyneuropathy (stage 1 or 2) 100% no additional benefit
Concizumab (2) Alhemo® Haemophilia B, ≥ 12 years, with factor IX inhibitors 57% Hint for considerable additional benefit
Concizumab Alhemo® Haemophilia A, ≥ 12 years, with factor VIII inhibitors 100% no additional benefit
Bevacizumab Lytenava® Neovascular age-related macular degeneration 100% no additional benefit
Lisocabtagen maraleucel (3) Breyanzi® Follicular lymphoma, after ≥ 2 prior therapies 100% no additional benefit Orphan
Pirtobrutinib (2) Jaypirca® Chronic lymphocytic leukaemia (CLL), relapsed or refractory, monotherapy 10% Hint for minor additional benefit