EU HTA at national level - First concrete transition proposed

A new draft ordinance shows concrete intentions for the national implementation of the EU HTA Regulation in Germany

Fri, 2025 / 01 / 10
Just in time for the entry into force of the EU HTA Regulation on January 12, 2025: In the draft ordinance of December 17, 2024 to amend the German Drug Benefit Assessment Ordinance, the Federal Ministry of Health presents a detailed proposal for the transition of the European Joint Clinical Assessment (JCA) into the German AMNOG process. The aim is to “clearly regulate the relationship between the European and German dossiers and to organize the timelines in such a way that the European assessment reports are regularly incorporated into the German benefit assessment procedure”.  

Relationship between European and German dossiers

As set out in Regulation (EU) 2021/2282, a JCA dossier will have to be submitted for all new medicinal products at European level by 2030. To this end, a purely national dossier must still be submitted in order to meet the specific requirements for decision-making by the G-BA. The so-called “double request prohibition” (“Doppelanforderungsverbot”) applies: Information may neither be requested at both EU and national level nor be submitted twice on the initiative of the health technology developer (HTD).  

As already anticipated, this is to be implemented in Germany applying a “referencing solution” (“Verweislösung”), meaning the company indicates in the national dossier where in the JCA dossier the relevant content for the benefit assessment procedure can be retrieved from. This is particularly important for the PICOs as the core of the dossier. Therefore, the JCA dossier has to be either already published on the IT platform of the EU Commission or a company-approved version is to be made available to the G-BA for provisional publication. Interestingly, if the JCA is discontinued due to a late or incompletely submitted JCA dossier, the submission of a “regular” AMNOG dossier can be requested, as the prohibition on double requests would not apply in this case.  

For the AMNOG process, obviously meeting the Germany-specific requirements is still the decisive factor, which is why the company must check the appropriateness and recency of the contents of the JCA dossier for the German benefit assessment in any case. If the developer would even like to demonstrate an added benefit over an appropriate comparator therapy that is not part of the JCA dossier, he may still also do that.  

Contents of the German benefit assessment/ decision

The draft ordinance clarifies that the German benefit assessment should be based on the German and European dossier and the published European reports in future. The scientific content of the JCA report is not binding for the national authorities (a JCA report does not necessarily have to be available for the German assessment decision). However, it remains unclear to which specific contents of the European reports (e.g. PICOs classified as irrelevant by the company) the authorities can still refer to in the HTA procedure and the price negotiation in the future. However, it is specified that the company still has the option of submitting supplementary and detailed analyses as part of the national benefit assessment if these are necessary for the benefit assessment on the basis of current scientific knowledge.  

Time sequences

Principally, the German procedure for submitting dossiers to the G-BA, including the specified submission deadlines, will also remain in place for procedures preceded by a JCA. 

However, in order to be able to regularly consider the European reports for the national assessment, the G-BA is granted the authority to regularly suspend the procedure for up to 3 months after marketing authorization, as long as they have not yet been published. The reason for that is that even procedurally flawless JCA reports will usually only be published approx. 45 days after (first) authorization of a medicinal product and thus the earliest possible relevant date for dossier submission. As a result, although the company must submit the national dossier in accordance with the usual timelines, the procedure will not begin until up to 3 months later, which means that all downstream AMNOG milestones and the price negotiation will be postponed accordingly. The negotiated reimbursement amount, however, should continue to apply retroactively from the 7th month after launch.

Conclusion

The Federal Ministry of Health and the G-BA are now clearly aware of the challenges that are arising in the HTA transition from Europe to Germany. In particular, the handling of (regular) delays has led to much discussion, as the AMNOG procedure in the European context has so far led to rapid and broad availability of medicinal products - and can therefore basically only “lose” in the view of the upcoming changes from the perspective of many stakeholders. The now proposed implementation is intended to not change anything with regard to rapid availability, even though the pharmaceutical manufacturers will sometimes have to create larger clawbacks in the view of a potentially much later negotiated price. However, some specific questions have not yet been clarified, particularly with regard to the time at which the new clock stop is activated/deactivated, the corresponding notification to the developer and the consequences of an incomplete JCA dossier. We continue to keep our clients up to date and continuously informed about the strategic implications of the new findings as new updates continue to become publicly available.  

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