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.
Joint Clinical Assessment: What the First Four JCA Reports Reveal About Evidence Assessment
The first four published Joint Clinical Assessment (JCA) reports reveal recurring methodological challenges in European evidence assessment. Key issues include PICO scoping and comparators, indirect treatment comparisons, the selection of prognostic factors and effect modifiers, and the handling of non-randomised evidence and post-hoc analyses. For manufacturers, the critical question is therefore whether the evidence for each PICO can be planned, generated and presented in a methodologically robust and transparent way.
Inside the black box: individualised treatment comparators in JCA
Some JCA scoping questions cannot be reduced to a single comparator. The relevant decision context may be a bundle of patient-individual treatment options, while clinical trials cover only part of that bundle.
JCA discontinued: Why EU-HTA assessments are stopped and what this means for Germany
JCAs can be discontinued if the underlying EMA marketing authorisation application is withdrawn, if the central authorisation procedure is not continued, or if the JCA dossier fails to meet key requirements for completeness, methodology, transparency and documentation. For Germany, a discontinued JCA mainly means one thing: there is no final European JCA report that can serve as a clinical reference point for the national AMNOG procedure.
Mapping methods gaps between EU joint clinical assessments and local health technology assessment decision-making
Curated publication page on the peer-reviewed article and its relevance for JCA, national HTA decision logic and Delta-Dossiers.
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.
Mapping the use of real-world evidence across the EU Health Technology Assessment Regulation
Curated publication page on the role of real-world evidence across JSC, JCA, national HTA and Delta-Dossiers.