Comparison of the Joint Clinical Assessment (JCA) Dossier With the German Medicines Market Reorganization Act (AMNOG) Dossier: What Content Remains to Be Presented AMNOG Dossier After the Implementation of JCA?

OBJECTIVES: Commencing 2025, new oncology medicines and advanced therapy medicinal products will be assessed at EU level. We aimed to examine whether a distinct comprehensive German AMNOG dossier as currently mandated will still be required after the implementation of the JCA process and what additional content still needs to be presented for Health Technology Assessment (HTA) in Germany.

METHODS: We evaluated the content of the JCA dossier template included in the JCA Implementing Regulation Annex (as of 23/05/2024) and the EUnetHTA21 submission dossier template with the latest German AMNOG dossier templates. First, the dossier templates were compared and screened for major differences. Subsequently, the derived differences were used to conclude what content is not covered by the JCA dossier and therefore remains to be presented in an as yet unspecified German dossier adapted to the JCA.

RESULTS: The content of the dossiers to be submitted in terms of JCA and AMNOG is highly similar. However, there are relevant differences concerning statistical methods, endpoints, and the presentation of study results, particularly regarding certain effect measures and subpopulations.

CONCLUSIONS: The great similarity between the templates reflects how much the German HTA authorities (Federal Joint Committee [G-BA], Institute for Quality and Efficiency in Health Care [IQWiG]) have shaped the JCA. Nevertheless, a distinct German AMNOG dossier still needs to be submitted, as some relevant information required in the German AMNOG dossier is not covered by the JCA dossier. Additionally, it is possible that Germany will require additional PICOs not addressed within JCA, especially for specific subpopulations. How the German dossier will develop remains to be seen.