Presentation (CTI)

OBJECTIVES: The EU Joint Clinical Assessment (JCA) introduces a harmonized framework for evaluating clinical evidence across member states. Although economic evaluations remain nationally governed, early economic models must increasingly align with JCA expectations to ensure clinical consistency and policy relevance. This study aimed to: (1) develop a structured checklist to guide early economic modelling in alignment with JCA principles, and (2) apply it in a case study of lifileucel, a novel therapy for advanced melanoma.
METHODS: A targeted review of the EU HTA Regulation (EU 2021/2282), EUnetHTA guidance, and recent JCA scoping templates informed checklist development. Key domains included PICO alignment, evidence synthesis, comparator relevance, outcome mapping, model flexibility, transferability, and transparency. The checklist was applied to a published Dutch Markov model evaluating lifileucel versus ipilimumab in post-PD-1 advanced melanoma. The model was benchmarked against JCA PICO elements derived from national HTA bodies (e.g., HAS, AOTMiT) and EMA-labelled clinical populations. Expert feedback from HTA economists and stakeholders is currently being gathered to inform ongoing refinement.
RESULTS: The checklist includes nine domains and over 40 criteria. Application to the lifileucel model revealed strong alignment on population and intervention. However, gaps were identified in comparator inclusion with JCA frameworks recommending broader alternatives such as PD-1 inhibitors. Although the model focused on QALYs and ICERs, incorporating JCA-relevant clinical endpoints like ORR, PFS, and DoR may improve alignment with the assessment’s clinical focus.
CONCLUSIONS: This checklist offers a practical tool to align early economic models with evolving JCA expectations and improve EU HTA submission readiness. The case study highlights the importance of early alignment on comparators and outcomes. Broader validation and expert input are ongoing to ensure applicability across therapeutic areas.