OBJECTIVES : When authorizing new pharmaceuticals, the European Medicines Agency (EMA) can issue limitations on marketing authorizations. The Federal Joint Committee (G-BA) as the German Health Technology Assessment (HTA) institution decides on limitations within the early benefit assessment. This research aims to determine whether there is a correlation between the limitations of EMA and G-BA.

METHODS : A quantitative evaluation comparing EMA and G-BA decisions was conducted regarding the reasons and duration. As a data basis, the EMA’s published List of medicinal products under additional monitoring as of 22 February 2019 was used and all authorizations from the following categories were assessed: Conditional Marketing Authorization (CMA), Authorization Under Exceptional Circumstances (AUEC), Additional Monitoring (AM), Post-Authorization Safety Study (PASS). Information on six former CMAs was also used. Following this approach, all 436 early benefit assessment cases until 3 March 2019 have been assessed for G-BA limitations and linked with the respective EMA rationale.

RESULTS : The descriptive analysis shows that CMAs issued by the EMA also received a limitation with similar reasons by the G-BA with a probability of 88 %. In contrast, EMA authorizations with the status AUEC, PASS, or AM have only led to a limitation by the G-BA in 17 %. Limitations of the G-BA are on average 8.7 months shorter than the duration of CMAs from the EMA. Temporal limitations issued by the G-BA for cases without EMA limitations have mostly been justified by missing data to prove an additional benefit over the appropriate comparator but not with respect to safety or efficacy data.

CONCLUSIONS : This analysis illustrates that the national German HTA institution decides in a similar way like the international institution EMA. Though ultimately these findings do not suggest that having no restrictions after the authorization process of the EMA results in the same outcome with the G-BA.