OBJECTIVES: The European Union’s (EU) Health Technology Assessment (HTA) Regulation 2021/2282 will be fully implemented in January 2025 for oncology drugs and advanced therapeutic medicinal products (ATMPs). The regulation aims to improve patient access to drugs by streamlining evaluations through a Joint Clinical Assessment (JCA). Central to this is the need for harmonisation of population, intervention, comparator, and outcome (PICO) criteria across EU member states. This study assessed variations in PICO criteria within HTA assessments for oncology drugs in England, France, Germany, Ireland, and the Netherlands.

METHODS: A systematic review examined 45 HTA reports for nine oncology drugs, drawing from publicly available documentation from national HTA bodies: NICE (England), HAS (France), G-BA (Germany), NCPE (Ireland), and ZIN (Netherlands). PICO information was extracted to identify variations among these countries.

RESULTS: The analysis revealed noteworthy variations in PICO criteria for several oncology drugs, with treatment line and relevant comparators being the two main drivers of these differences, impacting five treatments each. Examples of variations included trastuzumab deruxtecan for HER2-positive unresectable or metastatic breast cancer after 1 or more anti-HER2 treatments, with three variations in the PICO criteria; and olaparib for advanced (FIGO III or IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube, or peritoneal carcinoma, with four variations between countries.

CONCLUSIONS: The differences in PICO criteria highlight the difficulties of consolidating the PICO phase of JCA scoping. While this analysis concentrated on five nations with current HTA reports, it is expected that the number of PICOs will increase as more EU HTA member states are included. Therefore, a thorough examination of clinical and contextual information is required as national PICOs converge into a single framework.