Presentation (CTI)

OBJECTIVES: The JCA is a newly-implemented process designed to streamline evaluation of clinical effectiveness for medicinal products across the EU. The evidence synthesis requirements for JCA slightly differ from those outlined in other widely used guidelines for HTA-compliant SLRs, such as Cochrane and NICE. Here we outline key methodological differences and discuss practical considerations for conducting JCA-compliant SLRs and ITCs.
METHODS: Search: In addition to standard databases, SLRs conducted for JCA must include EU-specific clinical trial registries and regulatory or HTA recommendations from individual EU/EEA member states. Reporting Requirements: The JCA template must be completed for each individual PICOS element specified in the JCA scope. Detailed safety data as well as exclusion reasons and justification are required. Effect Modifiers and Prognostic Factors:JCA requires reporting of subgroup, sensitivity, and post hoc analyses, based on a literature review, and evaluating potential effect modifiers, while NICE expects justification for such analyses but does not mandate them. ITC: Where feasible, ITCs must be conducted for each individual PICOS defined in the JCA scope.
RESULTS: It is critical that accurate PICO definitions are developed well in advance, to accommodate the 3 month cut-off required for the SLR searches. Changing PICO criteria during JCA submissions can lead to data fragmentation, repeated analyses, and reduced comparability. The resulting delays and resource demands may impact market access and reimbursement outcomes. To mitigate these effects, early alignment with HTA bodies, flexible methodologies, and transparent documentation are essential. These strategies help maintain the reliability and efficiency of the JCA process despite evolving requirements.
CONCLUSIONS: In conclusion, while JCA SLRs follow scientific principles consistent with other HTA-compliant reviews, the requirement to report results for each individual PICOS, combined with tight deadlines, often demands a large, well-coordinated review team. This is especially critical during final stages such as full-text screening, data extraction, and dossier preparation.