Presentation (CTI)

OBJECTIVES: In the new EU Joint Clinical Assessment (JCA) process, a PICO (Population, Intervention, Comparator, Outcome) survey will be conducted with member states to ensure that the scope of an assessment meets their needs. We aimed to assess the alignment between PICOs identified in EUnetHTA 21 scoping surveys for PLUVICTO®, EBVALLO® and POMBILITI™ published in 2023, versus PICOs considered in actual HTAs of these products.
METHODS: Published HTAs for PLUVICTO, EBVALLO and POMBILITI conducted to date (January 6, 2025) were identified and reviewed. PICOs covered in the HTAs were explored, consolidated, and then compared to the consolidated PICOs identified in the EUnetHTA 21 scoping exercise.
RESULTS: In total, 9 HTAs for PLUVICTO, 5 HTAs for EBVALLO, and 6 HTAs for POMBILITI were identified across twelve member states. After consolidation, 5 PICOs were included in actual HTAs for PLUVICTO compared to 6 identified in the EUnetHTA 21 scoping exercise. For EBVALLO, 3 PICOs were included in HTAs compared to 5 in the scoping exercise. For POMBILITI, 3 PICOs were included in HTAs compared to 9 in the scoping exercise. Generally, PICOs identified by EUnetHTA 21 covered the actual PICOs in HTAs; however, several PICOs in the scoping exercise were not assessed by HTAs, potentially resulting in over-scoping, particularly for orphan drugs with limited data available. Fewer PICOs may also have been identified due to the limited number of published HTAs and because PICOs were estimated post-HTA evaluation.
CONCLUSIONS: PICOs included in actual HTAs were predicted by the EUnetHTA 21 scoping exercise; however, there may be over-scoping of PICOs due to the scoping process and requirement to meet all member states' needs. This may place an unnecessary burden on manufacturers responding to irrelevant PICOs and manufacturer input into the scoping of EU JCAs could be beneficial