Impact of EMA's Conditional Marketing Authorizations on the Benefit Assessment Validity Period in Germany: Insights From 2017-2023

OBJECTIVES: To understand the implications of conditional marketing authorizations (CMAs) by the European Medicines Agency (EMA) on the benefits assessments’ resolution validity period in Germany.

METHODS: Products granted a CMA between 2017 and 2023 were identified using the annual reports published by the EMA. For the identified products, the date of the benefit assessment by the Federal Joint Committee (G-BA) and the resolution’s validity period were analyzed.

RESULTS: From 2017 to 2023, 55 products were conditionally approved by the EMA. Out of these 55 products, most products (n=32; 58%) had an indication in oncology, followed by products with an indication in viral infections (n=8; 15%) and hematology (n=6; 11%). In total, 40 of these products were assessed by the G-BA, 12 were not assessed and 3 are currently pending.

Of the 40 products evaluated by G-BA, 14 (35%) were subject to a time limit on the benefit assessment resolution. This is about 3 times higher than the ratio of time-limited procedures in the total pool of G-BA assessments (n=142; 15%). The average time difference between the date of the initial resolution and the time limit for reassessment was 42 months (range: 5 months – 82 months). The main reason for a time limit was awaited data on efficacy and safety, with most cases (12/14) referencing the obligated data delivery required by the EMA as part of the CMA conditions.

CONCLUSIONS: Obtaining a CMA from the EMA triples the chances of a decision to impose a time limit on the benefit assessment by the G-BA. Manufacturers need to carefully consider whether the benefits of earlier market access outweigh the risk of a time limited resolution and therefore reassessment and subsequent price renegotiation. One mitigation strategy might be conducting additional data analyses to supplement the data package submitted for CMA before seeking market access in Germany.