Presentation (CTI)

OBJECTIVES: The process of health technology assessment (HTA) has been widely adopted across the world to evaluate the clinical and economic value of interventions, inform pricing and reimbursement decisions, and ensure patient access to evidence-based care. Systematic reviews of published and unpublished literature play a vital role in the HTA process by establishing a robust evidence base for decision-making. This study aimed to provide a comprehensive overview of the commonalities and variations in clinical evidence and health economic (HE) modelling requirements across HTA bodies in North American, European, and Asia-Pacific countries.
METHODS: Nine HTA agency websites - NICE (England and Wales), NCPE (Ireland), JCA (Europe), JNHB (Denmark, Finland, Iceland, Norway, and Sweden), CDA (Canada), ICER (United States of America), MSAC (Australia), ACE (Singapore), and C2H (Japan) - were comprehensively searched to identify specific guidance for systematic literature reviews (SLRs) and HE modelling in HTA.
RESULTS: All assessed HTA agencies agreed on the need to identify, synthesise, and document clinical evidence in a systematic, reproducible way. Three also mandated similar criteria for economic and/or utility data (NICE, NCPE, C2H). NICE published the most prescriptive SLR guidelines. The CDA and C2H conduct SLRs of clinical evidence within the dossier review. Few agencies provided detailed guidance on search strategy development, information sources that should be used, and/or double reviewer screening. On HE modelling, most agencies preferred cost-utility analyses, generic utility instruments, uniform discounting, outcomes expressed in quality-adjusted life years, and exploration of uncertainty through sensitivity analyses.
CONCLUSIONS: Evidence requirements vary between agencies across the globe, but there are still relevant intersections to consider during the HTA process. Although accordance with the most stringent HTA guidelines (those of NICE) will guarantee high-quality SLRs, increased harmonisation of evidence requirements between jurisdictions is needed for more efficient use of resources.