OBJECTIVES: According to Regulation (EU) 2021/2282, the joint clinical assessment (JCA) will initially be implemented for oncology drugs and ATMPs applying for EMA marketing authorization from January 2025. Orphan drugs will subsequently follow in January 2028, and in January 2030, all centrally approved drugs will be subject to joint European clinical evaluation. Due to the staggered entry into the mandatory EU HTA process, the question arises as to how many procedures are completed within the first years. EU HTA is expected to be a learning system. But how many procedures will we be able to learn from?

METHODS: The vast majority of EMA-approved medicines will eventually enter the German market and undergo the German benefit assessment “AMNOG”. Thus, we extrapolated the procedural volume for JCAs per indication area in the first years of EU HTA implementation from the respective German HTA procedures. Various aspects of EU HTA obligation must be taken into account, such as the specific conditions for indication extension procedures.

RESULTS: For initially submitted oncology drugs and ATMPs, approximately 20 procedures per year are expected. From January 2028, orphan drugs will then increase the number of estimated JCA procedures by a dozen per year. Indication extensions were counted separately and represent only a few additional procedures.

CONCLUSIONS: There is a high degree of uncertainty in the EU HTA process as it is still taking shape. In the first years, there will be few orienting precedents that could be used as learning cases – for both the authorities and the manufacturers. In addition, in the gap years between late 2023 and early 2025, only 14 consultations are planned at the European level, which could not prepare numerically for the estimated EU HTA procedures. Capacity bottlenecks are to be expected and should be addressed proactively.