European dossier in a German guise

The long awaited JCA dossier template is finally public

Tue, 2023 / 09 / 26
In deliverable D5.1 Submission Dossier Template, EUnetHTA 21 published the template for the preparation of a European benefit dossier for medicinal products yesterday. As of January 12, 2025, this template will be used in the corresponding Implementing Acts of Regulation (EU) 2021/2282 for the submission of Joint Clinical Assessment (JCA) dossiers by pharmaceutical entrepreneurs. Further, the JCA dossier template partly shows great similarity to the template of the German AMNOG dossier.

Compared to the dossiers for the national HTA procedures of other member states, both the layout (for example with explanatory comments on the following section in gray boxes) of the JCA dossier template and the general structure as well as the content compilation of the requirements for the pharmaceutical entrepreneur largely correspond to the templates for the German AMNOG dossier in modules 1 to 5. An adaptation of the JCA dossier template in the Implementing Acts is possible but seems unlikely at this time. Thus, the design of the dossier template also shows the alignment of the JCA with the established AMNOG process, after the G-BA and IQWiG have already significantly shaped the methodological framework of the process.

The general structure of the JCA dossier template includes the following sections:

  1. Overview with executive summary
  2. Background information on the disease and the drug
  3. Research question and assessment scope
  4. Methods of content presented in the dossier
  5. Results
  6. References and appendices

In the future, the different PICOs, which are disclosed to the pharmaceutical entrepreneur after the scoping process, will be addressed separately from each other both methodologically (section 4.) and in terms of content (section 5.) (PICO 1 followed by PICO 2, etc.).

With the publication of the JCA dossier template, it is once again clear that the German AMNOG process serves as a model for the JCA process. Knowledge of the process, requirements and strategic hurdles of the German HTA process is thus indispensable for future success at the European level.

SKC will continue to provide you with detailed information on all relevant developments in this crucial phase of the EU HTA implementation process. If you are interested in a detailed analysis of the JCA dossier template and its implications, or if you are looking for a strategic partner to make your company EU HTA ready, please feel free to contact us. We are the Market Access Special Forces.


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