OBJECTIVES: The European Regulation on Health Technology Assessment (2021/2282) that defines the scope for Joint Clinical Assessments (JCA) will become mandatory for oncology drugs starting in 2025. This study aimed to assess to what extent the drivers for decision-making proposed in EUnetHTA21 guidelines are currently employed in the development of therapeutic positioning reports (IPTs) in Spain and understand the potential impact of JCA on IPT development moving forward.

METHODS: IPTs published in Spain between July-2023 and May-2024 were screened. To align with JCA’s 2025 implementation staging, only IPTs for oncology drugs with new European marketing authorizations were included (n=16). JCA methodological guidelines were reviewed and the drivers for decision-making were compared against those drivers for decision-making included in the IPTs. Each JCA driver for decision-making was classified as “exhibiting similarity”, “lesser stringency” or “greater stringency” when compared to those in the IPTs.

RESULTS: Ten domains within EUnetHTA21 guidelines were identified. Overall, the drivers for decision-making of the IPTs was considered similar to the JCA for four domains (4/10); “PICO mismatch “, “utilization of real-world evidence”, “safety reporting requirements” and “trial methodologies”. Similarly, four domains (4/10) were found to be less stringent in the IPTs compared to the JCA: “risk of bias assessment”, “quality of life data”, “requirements for subgroup reporting” and “sensitivity analysis of outcomes”. In contrast, the IPTs showed to the more stringent for only one domain (1/10): “indirect treatment comparisons”. It was not possible to conclude on the domain “specifications for network meta-analyses”.

CONCLUSIONS: The drivers for decision-making for the clinical assessments of drugs when developing IPTs are overall aligned with those when conducting JCAs. Consequently, JCA will likely provide a valuable framework for IPT development with little expectations for additional data requirements, potentially reducing time for IPTs development and time to initiate price and access negotiations.