EU HTA “Gap Years“

Mind the gap

Tue, 2023 / 04 / 11
With the EUnetHTA 21 service contract expiring in September 2023, the so-called EU HTA "gap years" begin – until the EU HTA regulation comes into force in January 2025 for oncology drugs and advanced therapy medicinal products (ATMPs). During this transition period, there is no officially responsible authority for tasks arising within the EU HTA process, such as conducting Joint Scientific Consultations (JSCs). This is problematic for manufacturers whose products are subject to an EU HTA assessment at the beginning of the period of validity of the regulation because, for them, the urgently needed consultation within the framework of a JSC is not available in advance. The German Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) may now offer a solution to this problem.

Until the start of the period of validity of the EU HTA regulation for oncologics and ATMPs on January 12, 2025, EUnetHTA 21, a consortium of national HTA bodies, has been appointed to ensure the implementation of the contents of the regulation. Its main tasks include the development of specific guidance documents (deliverables) on the methodological and procedural details of the EU HTA process and the conduction of trial runs for Joint Clinical Assessments (JCA) and Joint Scientific Consultations (JSC). However, the service contract of EUnetHTA 21 with its ordering party, the European Health and Digital Executive Agency (HaDEA), expires on September 16, 2023. For the resulting transitional phase until January 2025, the coordination group of the European Commission will partially take over responsibility for the EU HTA process, but no further preliminary JCA or JSC procedures are planned for this period.

For health technology developers whose product will have to undergo an EU HTA assessment as early as 2025, this poses a significant problem: for them, there is no possibility during the gap years to consult with European HTA authorities via a JSC on the evidence and PICO schemes required for their product. In addition, no further consultations are currently offered under EUnetHTA 21 responsibility, as all scheduled JSC procedures are already ongoing. These circumstances significantly reduce the prospects of affected manufacturers for a successful EU HTA process for their new medicinal product.

The G-BA has recognized this problem and has now announced that there will be a few additional consultations for this transitional phase, which will be carried out with the participation of other European HTA authorities, in order to give manufacturers the opportunity to prepare for the EU HTA procedure of their product by 2025. The consultation appointments will be assigned to the manufacturers on an ad hoc basis, depending on the availability of the involved national HTA partners. According to the G-BA, there will also be no consolidation of the positions of the individual HTA authorities with regard to the required evidence. Discussions between the HTA authorities concerning the details of the design of this transition model are still ongoing – an official announcement by the G-BA is currently planned for June 2023.

SKC will continue to keep you informed about these and all other relevant developments regarding the EU HTA process. If you are interested in accessing European advice during the gap years via the G-BA or if you are looking for a strategic partner to achieve the highest possible planning security for the EU HTA process of your product in view of the current situation, please feel free to contact us. We are the market access special forces.


About the author

Ihr Ansprechpartner  Sebastian  Vinzens
Sebastian Vinzens
M.Sc. Drug Research and Development
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18
2nd to 4th of Oct 2023
Prof. Matthias P. Schönermark, M.D., Ph.D.

Excellence for Market & Patient Access, Pricing and Reimbursement


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