EU HTA authorities are still building the foundation for their work

Key takeaways from the last events of the coordination group and the German HTA institutions

Wed, 2023 / 11 / 29
In the period between the end of the EUnetHTA 21 service contract on 16 September 2023 and the entry into force of the EU HTA Regulation on 12 January 2025 ("gap years"), the methodological and organizational framework for the EU HTA process is set to be defined in detail. The so-called Implementing Acts will be an integral part of this process, which are intended to anchor the details of the EU HTA procedure in a legally secure manner. These Implementing Acts will be adopted by the European Commission on the recommendation of the Member State Coordination Group on HTA. The first Implementing Act on Joint Clinical Assessment (JCA) is expected to be published before the end of this year.

Meeting of the Coordination Group

The sixth meeting of the Coordination Group took place on November 16, 2023. However, discussions on the first Implementing Acts were not primarily on the agenda; instead, the focus was still set on the general framework for collaboration within the Coordination Group in the form of establishing Standard Operating Procedures (SOPs) and setting priorities for voluntary joint cooperation between the HTA institutions of the Member States, which were not announced in further detail.

Information event with German HTA institutions

The G-BA, IQWiG and the German Federal Ministry of Health also discussed the impact of the EU HTA process on the German HTA process with clinicians, patients and industry representatives at an information event on November 10, 2023. A seamless alignment of the processes was clearly defined as the goal here, but the German authorities explained that it could take another one to two years to fully clarify how the AMNOG timetables will be coordinated and what impact the JCA report will have on the German system. The reason given was that the legal implications of the Implementing Acts cannot yet be adequately foreseen. However, it is already clear that the national systems must be fully adapted by 2026 at the latest, i.e., when the first JCA reports are available.

The reaction of the German authorities and the current work status of the HTA coordination group make it painstakingly clear how much uncertainty still surrounds the establishment of the EU HTA process and the associated impact on the national HTA systems. This makes it all the more important for the industry to initiate strategic preparations now on the basis of existing information. SKC will keep you informed about all relevant developments and effects of the implementation process. If you are interested in a detailed analysis of the JCA dossier template and its implications for the AMNOG process or are looking for a strategic partner to make your company EU-HTA-ready, please contact us. We are the Market Access Special Forces.


About the author

Ihr Ansprechpartner  Joey Rehkopf
Joey Rehkopf
M. Sc. Molecular Microbiology
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18

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