AMNOG Insights
Current analyses, case studies and expert perspectives on AMNOG and the German benefit assessment.
AMNOG Insights covers current developments and examines them through specific procedures and decisions. The focus is on their practical relevance for evidence strategy, dossier preparation and market access in Germany.
AMNOG analyses of German benefit assessment
Lurbinectedin and tarlatamab: What the G-BA benefit assessments reveal after the JCA
The German Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) published its benefit assessments of **lurbinectedin (Zepzelca) and tarlatamab (Imdylltra)** on 1 October 2026. They highlight differences between the European Joint Clinical Assessment (JCA) and Germany's early benefit assessment under AMNOG. Although randomised comparative evidence is available for both treatments, the assessments differ in their consideration of patient-reported outcomes, interpretation of safety findings and handling of methodological uncertainty.
Pembrolizumab (Keytruda) in AMNOG: What the G-BA assessments reveal
Germany's AMNOG benefit assessments of pembrolizumab (Keytruda) illustrate how challenging it can be to assess an established immune checkpoint inhibitor across different oncology indications. Key questions in proceedings before the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) concern the appropriate comparator therapy (zweckmäßige Vergleichstherapie, zVT), biomarker-defined populations, the applicability of clinical trial evidence and patient-relevant endpoints.
Evidence transfer in Germany’s AMNOG assessment: What Selumetinib and G-BA practice show for dossier strategy
Transferring evidence from one population to another may be scientifically plausible and accepted by the European Medicines Agency (EMA) for regulatory purposes. In Germany’s AMNOG early benefit assessment, however, this is not automatically sufficient. The practice of Germany’s Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) shows that the decisive question is whether the available evidence can also answer the specific German assessment question in the target population. An analysis of 52 AMNOG procedures involving evidence transfer shows recurring patterns. Particularly relevant are the comparability of the treatment setting, the suitability of endpoints and the question of which evidence actually supports the assessment of added benefit.
Germany’s 5% clinical trial threshold from 2027
What changes from 1 January 2027 for Germany’s 5% threshold, the BfArM application procedure and the manufacturer rebate.
Donidalorsen (Dawnzera): Why garadacimab was not included in the appropriate comparator therapy
In the German benefit assessment of donidalorsen (marketed as Dawnzera), Germany’s Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) found an indication of a minor added benefit versus berotralstat in its decision of 20 August 2026. For this hereditary angioedema (HAE) procedure, the G-BA determined routine prophylaxis with a C1 esterase inhibitor, lanadelumab or berotralstat as the appropriate comparator therapy (zweckmäßige Vergleichstherapie, ACT).
AMNOG 2.0: How Germany is debating the future of benefit assessment
AMNOG 2.0 is an ongoing debate about early access, evidence uncertainty, reassessment, EU HTA and the financial sustainability of innovative medicines in Germany.
Real-World Evidence in the AMNOG Dossier: Which Data Sources Can Robustly Define the Target Population?
Real-world evidence can support the German AMNOG dossier by informing epidemiological estimates, the statutory health insurance (GKV) target population, and the German healthcare context. Relevant sources include national registries, patient registries, epidemiological studies, and German claims data. The German Health Research Data Centre (Forschungsdatenzentrum Gesundheit, FDZ) adds a cross-insurer source of GKV routine data.
AMNOG analyses: How to manage thousands of GBA tables efficiently and reliably
AMNOG dossiers can require thousands of statistical tables. Reproducible analysis workflows help generate GBA outputs consistently, implement changes in a controlled manner, and produce German and English tables from a common analytical process.
EU HTA in Germany: What JCA means for AMNOG and the Delta-Dossier
Since January 2025, the EU HTA Regulation has become progressively relevant for the joint clinical assessment of new medicines. With the Joint Clinical Assessment, a common European evidence base is being established to support national HTA procedures and reduce duplication of work. For Germany, however, this does not mean that the AMNOG procedure will be replaced.
Tovorafenib after the JCA: What the first G-BA benefit assessment reveals about the EU-to-Germany evidence transfer
The first German benefit assessment of a medicinal product following a Joint Clinical Assessment shows concrete differences between the European and national evaluation of clinical evidence. In the case of tovorafenib, these differences primarily concern comparative evidence, the patient relevance of endpoints, the data cuts used, and the timing of the JCA report. The case therefore confirms a central point for the delta dossier: the delta dossier is not an official regulatory term, but a working term used in the German market access context for the national content and adaptations required between the JCA dossier and the AMNOG dossier.
Statutory Health Insurance Contribution Stabilization Act: Implications for AMNOG, Market Access and Dossier Strategy
Germany's Statutory Health Insurance Contribution Stabilization Act (GKV-Beitragssatzstabilisierungsgesetz), adopted in July 2026, expands the economic controls applied to innovative medicines. The Act introduces higher statutory manufacturer discounts, stronger price-volume arrangements and rebate contracts for patent-protected products. It does not abolish Germany's, the national and reimbursement process for newly authorised medicines. It changes how the result of that assessment is translated into realised commercial value.
Five theses on the Delta-Dossier: Why Germany needs more than cross-references
The term Delta-Dossier is not an official regulatory term. In the German market-access context, it describes the national adaptation required to use content from the European JCA dossier in the AMNOG process and to supplement it with Germany-specific content, analyses and evidence.