OBJECTIVES: To identify how PICOs were determined by EUnetHTA reviewers during the JA3 project (2016-2021), for medicines, in order to anticipate how PICO selection might be done for the forthcoming EU Joint Clinical Assessment.

METHODS: Examination of the lists of PICOs in the REA reports published by EUnetHTA during the JA3 project (2016-2021): 14 medicines were selected from the 18 published, excluding 4 Covid-19 treatments.

RESULTS: The 14 REAs were authored by 9 countries. Six products were Oncology drugs. Most medicines were appraised on the population stated in their label. Only 2 medicines had 2 sets of populations in their REA report: Polatuzumab (JA6) and Ustekinumab (JA07), one corresponding to their label, the other being on a restricted population. The authors of the reports were different, as were the therapeutic areas. The existing comparators (on average, 4 comparators per product) were chosen from EU clinical guidelines. The Outcomes lists were of different structures and lengths (average of 6 for efficacy, average of 9 for safety) some differentiating critical outcomes, others not. Only four of the efficacy outcomes were common for all Oncology drugs (OS, PFS, CR, Progression/relapse free survival). HRQoL requirement was a standard. Safety outcomes were different, some using a grade classification, others not.

CONCLUSIONS: In this analysis, we see that the PICOs reviewed for the 14 medicines selected from the JA3 EUnetHTA project were different in their presentations and content/wording, even for drugs in the same therapeutic area (Oncology). Safety outcomes were not standardized. A minority of drugs were appraised for 2 different populations. EU JCA co-ordinators should consider improving standardization and predictability.