Presentation (CTI)

OBJECTIVES: The core health technology assessment (HTA) questions of interest are focused on the value of the health technology relative to other relevant comparators, and long-term value. Real-world evidence (RWE) is often included in manufacturer drug submissions when clinical trials do not address all HTA evidence needs. Clear, concise, and practical guidance is essential for those submitting evidence to CDA-AMC to ensure that RW study methodologies and findings are reported transparently and comprehensively. This will, in turn, facilitate appraisal.
METHODS: CDA-AMC previously published the Guidance for Reporting Real-World Evidence (April 2023). The methodology to develop this Guidance, and the extensive engagement and feedback that helped shape this work are described within that document. The Guidance outlines 12 sections: Study design and research questions; Setting and context; Data specifications; Data sources; Participants; Comparators and Exposure definitions; Outcomes; Bias and Confounding; Statistical Methods; Study findings; Interpretation and Generalizability; Limitations. Based on user feedback, CDA-AMC developed a checklist to facilitate practical application of the RWE reporting guidelines. This checklist simplifies key concepts and describes required elements that would be most important and relevant to include in a submission containing RWE to address the core HTA questions of interest.
RESULTS: The RWE Reporting Checklist will be available as of May 2025 to those who submit evidence to CDA-AMC, and to those who review and appraise the evidence submission. Based on additional user feedback, this document may be modified over time.
CONCLUSIONS: As use of RWE to address core HTA questions continues to increase, there is a need for tools such as the CDA-AMC RWE Reporting Checklist to guide the reporting of RWE and facilitate the clinical evidence appraisal, ultimately to support decision-making.