OBJECTIVES: With the increasing use of real-world evidence (RWE) in health technology assessments (HTAs), robust reporting tools for RWE data are crucial for ensuring suitability, transparency, and building trust. We analyzed the suitability and transparency of RWE for indirect treatment comparison in recent National Institute for Health and Care Excellence (NICE) oncology appraisals to inform the need for optimizing the provenance, quality, and relevance of the RWE for future HTA submissions.

METHODS: A search of NICE Technology appraisals was conducted to identify oncology medicines appraisals referencing RWE published in 2023. The data Suitability Assessment Tool (DataSAT) developed by NICE was used for assessment of provenance, quality, and relevance of RWE to the research question.

RESULTS: Four oncology assessments were considered out of 18 HTAs, primarily using RWE for indirect treatment comparison to support clinical trial results for Olaparib, Dabrafenib + Trametinib, Pembrolizumab + Lenvatinib, and Regorafenib. The RWE sources identified in the appraisal documents satisfied the quality requirement by 71.4%, relevance requirement by 50-75%, and provenance requirement by 33.3–80%. The usage of DataSAT identified uncertainties in the reporting of data linkage and pooling, data specification, availability of key elements, and care-setting. Thus, the assessment of RWE studies using DataSAT serves the purpose of providing consistent and structured information on data suitability during decision-making.

CONCLUSIONS: When incorporating RWE into the clinical evidence base, suitability of evidence, through use of quality assessment tools, in line with the NICE RWE framework should be considered to increase trust and acceptability of such evidence. Further steps for improving the acceptability in HTA through greater quality, provenance, relevance, and accessibility of RWE data is warranted.