OBJECTIVES: To compare the PICO (Population, Intervention, Comparator, Outcomes) criteria applied in Joint Action 3 (JA3) assessment reports and respective national health technology assessments (HTA) for oncology drugs and to explore potential implications for the Joint Clinical Assessment (JCA) which will become mandatory for oncology drugs in 2025.

METHODS: JA3 reports of oncology drugs published between 2019 and 2021 were compared to the national HTA reports in Denmark, France, Germany, and Sweden.

RESULTS: Between 2019 and 2021 three oncology drugs venetoclax, glasdegib and polatuzumab were assessed in the JA3 framework. National HTA bodies in Denmark, France, and Sweden assessed venetoclax and polatuzumab, while all the drugs were assessed in Germany. JA3 and national reports aligned particularly well regarding the populations and interventions, although Germany requested a subpopulation analysis for venetoclax. While the JA3 reports overall covered national requirements in terms of comparators and outcomes, there were differences seen between the four national assessments for venetoclax and polatuzumab. Overall, Germany was less restrictive than other countries for the comparator in case of orphan drugs, but more restrictive regarding outcomes and study types considered. Denmark and France included data from studies other than randomized controlled trials for polatuzumab. Despite slight differences in PICOs, overall conclusions on the additional benefit of the drugs vs comparators were similar between countries.

CONCLUSIONS: Based on our findings, we conclude that national differences in European health care systems and treatment guidelines may lead to extensive PICO criteria in the JCA. To accelerate the overall HTA process in European Union (EU) countries, it will be crucial that PICOs consolidated during the JCA scoping process are streamlined, while adequately addressing national requirements from all EU countries. From this analysis, additional data requirements from individual countries are to be expected, which could delay entry of affected drugs in these countries.