Presentation (CTI)

OBJECTIVES: To characterize comparator selection patterns across European HTA bodies under Joint Clinical Assessment (JCA) and assess their implications for PICO scoping and evidence generation strategies.
METHODS: A targeted review of EU‑level JCA guidance and national HTA methodological documents (Germany, France, Italy, Spain, Sweden, Poland, and England) was conducted alongside analysis of recent assessment practices. Explicit and implicit comparator requirements were extracted and synthesized into a tiered “comparator pyramid” reflecting relative priority and cross‑country relevance. As an additional step, structured validation and elicitation sessions were conducted with country‑level market access and HTA experts to test the relevance, feasibility, and sufficiency of proposed comparator tiers. Expert input was used to refine comparator categorization, identify nationally critical add‑ons beyond EU‑level cores, and assess implications for JCA PICO scoping, ITC feasibility, and JCA dossier positioning.
RESULTS: Findings were synthesized into a tiered “comparator pyramid” reflecting decreasing cross‑country relevance under JCA. All assessed EU countries converged on the local standard of care most likely to be replaced in routine clinical practice as the primary “must‑have” comparator. A second tier comprised centralized or mandated “appropriate” comparators, notably in Germany and France, where comparator choice is prescriptive. National formulary or public funding status represented a further tier, particularly relevant in Italy, Spain, and Poland. Economic efficiency considerations were applied in selected countries, while trial‑based comparators and indirect evidence were consistently positioned as secondary or last‑resort options, subject to strict justification. Country market access expert elicitation validated this structure and emphasized that JCA PICO scoping should prioritize lower‑tier EU‑core comparators, with higher‑tier options anticipated as national extensions to preserve JCA dossier usability.
CONCLUSIONS: Comparator selection under JCA is a strategic, policy‑relevant decision that shapes evidence usability. A structured comparator pyramid can support early differentiation between EU‑level core comparators and national extensions, enabling more efficient PICO scoping and evidence development strategy.