Presentation (CTI)

OBJECTIVES: This study aimed to develop a structured framework for systematic prioritization and optimization of PICO scenarios to support early HTA evidence planning.
METHODS: The framework was developed through synthesis of evidence from published JCA scoping documents, six official HTACG PICO scoping exercises, over 30 published studies, and ISPOR MCDA guidelines. An initial framework was constructed and iteratively refined through three consensus-based internal review cycles involving four HEOR and market access experts, to ensure operational relevance, usability, and alignment with real-world HTA expectations.
RESULTS: The proposed framework establishes a four-phase integrated workflow. Phase 1 (Evidence Mapping) involves targeted landscape searches and clinical guideline reviews to extract and standardize PICO-relevant parameters. Phase 2 (Structured Scoring and Prioritization) generates PICO scenarios through systematic combination of elements, which are evaluated using a weighted multi-criteria scoring system (1-5 scale) across five domains: evidence frequency, clinical relevance, HTA alignment, country-specific factors, and future market dynamics. Element-level scores are aggregated to derive composite scenario scores, enabling ranking into high, moderate, and low priority tiers. Phase 3 (Expert validation) refines prioritized scenarios through stakeholder input and alignment. Phase 4 (Decision Optimization) applies a 2×2 matrix assessing likelihood of HTA request against feasibility of evidence generation to identify decision-critical scenarios.
CONCLUSIONS: This framework provides a transparent and reproducible approach to early PICO planning in the evolving JCA landscape. By integrating likelihood of HTA request with evidence feasibility, it supports more structured evidence planning, enables early identification of data gaps, and helps mitigate potential risks during HTA submissions.