Presentation (CTI)

OBJECTIVES: To identify and operationalize key considerations for the transparent justification, feasibility assessment, and reporting of ITCs within EU JCAs, and to develop a practical framework for transparent ITC documentation.
METHODS: Guidance documents adopted by the Health Technology Assessment Coordination Group (HTA CG) were reviewed to identify relevant recommendations relating to ITC justification, feasibility assessment, method selection and reporting. Recommendations were extracted, consolidated, and translated into a structured framework. The framework was subsequently applied to the first published EU JCA dossier (tovorafenib) and assessor report to evaluate the extent to which these considerations were documented and to identify opportunities to improve transparency in future JCA submissions.
RESULTS: Application of the framework demonstrated that reporting was generally strongest for the decision problem, study identification, network construction, and similarity assessments. Partially met or unmet criteria were most frequently identified in the documentation and justification of treatment effect modifier selection, completeness of prognostic and effect-modifying variables, exchangeability assessments, target estimand specification, and method selection. EU JCA assessor criticisms were most frequently driven by insufficient justification and transparency of assumptions and methodological decisions. Notable gaps included incomplete documentation of the process used to identify and prioritize treatment effect modifiers and the absence of an explicitly defined target estimand. Most partially met or unmet recommendations corresponded with issues identified by the EU JCA assessors.
CONCLUSIONS: We describe a structured framework that can be applied to operationalize EU JCA expectations for ITC documentation. Application to the first published EU JCA dossier demonstrated close alignment between the framework and assessor critiques, suggesting it captures many of the methodological considerations underpinning ITC assessment. Explicit justification of methodological assumptions and decisions should accompany key reporting elements to enable assessors to evaluate the appropriateness of the proposed ITC approach.