OBJECTIVES: The Regulation (EU) 2021/2282 on health technology assessment (HTA), that will start to apply in 2025, foresees a joint clinical assessment (JCA) that will collect the PICO (Population, Intervention, Comparator(s), Outcomes) from each European Country in order to have harmonized PICO/PICOs. The objective of this analysis was to evaluate the overlaps and differences in the PICOs across Australia, EU4 and UK.

METHODS: HTA and P&R assessments for Australia, France, Germany, Italy, Spain, and the UK were obtained for: Fetcroja, a new generation antibiotic (not yet approved in Australia), and Kimmtrak, an orphan medicine approved in all countries analyzed. From published HTA documents, the information for define the PICO have been recorded.

RESULTS: For Kimmtrak, authorized for the treatment of an oncology rare disease, all the countries defined a similar PICO: no restriction on the eligible population, same comparators and same outcomes. Differently, the PICOs of Fetcroja, an antibiotic with an improved efficacy against resistant and difficult to treat pathogens, was significantly discordant: while Australia, Germany, Spain and UK approved the use of the drug only in case of limited treatment options (with some differences), France and Italy further restrict the indication detailing pathogens and their resistant mechanisms. Same for the comparators: only the new generation antibiotics have been considered in Spain, while other Countries included all the (different) options available.

CONCLUSIONS: JCA subgroups, responsible for delivering JCA reports, should try to limit PICOs to 2-3. However, our research showed how if for an orphan drug it is possible to observe a harmonized approach, in case of other treatments, significant discrepancies can arise. The potential lack of alignment between the different PICOs across European Countries could lead to several challenges for the JCA, impacting the time of evaluation and making difficult to respect each national need.