Presentation (CTI)

OBJECTIVES: Under the EU Health Technology Assessment Regulation, health technology developers (HTDs) have 100 days to submit a Joint Clinical Assessment (JCA) dossier covering all 27 EU member states (MS). These requests reflect heterogeneous national comparator frameworks and evidence standards, creating a risk that evidence gaps are identified too late to address. This study aimed to develop a structured framework for predictive PICO (population, intervention, comparator, outcomes) scoping through tiered country prioritization.
METHODS: A tiered country prioritization framework was developed through structured evidence mapping of national HTA guidelines, assessment reports, and targeted literature review. Countries were evaluated across three domains: (1) HTA documentation availability and transparency; (2) comparator requirements, identifying five distinct national definitions; and (3) geographic coverage. Domain application was hierarchical: evidence availability determined eligibility, comparator requirements drove prioritization, and geographic coverage ensured complete representation.
RESULTS: Five distinct national comparator definitions were identified (current clinical practice, most likely replaced treatment, most cost-effective treatment, reimbursed standard of care, and best standard treatment), with meaningful within-definition variation. Countries were ranked into three tiers as an ordered inclusion sequence. Tier 1 (France, Germany, Italy, Spain, and the Netherlands) is the mandatory minimum scope, covering three comparator definitions. Tier 2 (Denmark, Belgium, Poland, Bulgaria) should be added, completing all five definitions. Tier 3 comprises four conditional clusters (Austria + Ireland, Finland + Sweden, Portugal, Slovakia + Estonia), activated by indication-specific triggers. Eleven MS are represented through regional proxies.
CONCLUSIONS: This proposed framework offers HTDs a structured approach to anticipating JCA PICO heterogeneity before formal scope release, supporting early evidence gap identification and evidence planning. Its tiered design provides a prioritized country ranking, while preserving coverage of key PICO variation drivers. Prospective application to live JCA submissions is needed to validate framework performance.