OBJECTIVES: The use of RWE as a component of Health Technology Assessment (HTA) submission has seen a marked increase in recent years. This study aims to understand this increasing trend of RWE submission to NICE and CADTH in the last 3 years as well as the impact of recent RWE guidance published by these HTA agencies.

METHODS: A search was conducted on NICE and CADTH websites for HTAs published between January 2021 and December 2023. After excluding non-relevant HTAs, selected appraisals with RWE were further analysed for study type, data sources, and their type of use in the submission e.g. utility cost, and efficacy.

RESULTS: A total of 539 and 256 appraisals, were identified on NICE and CADTH websites, respectively. Among included appraisals, around 60% in the UK and 37% in Canada included RWE. Most RWE studies in both countries were observational, primarily utilizing retrospective cohorts, and the predominant sources of data were patient & disease registries, or electronic health records. Overall, the most common use of RWE included in the submissions was related to efficacy, patient characteristics and healthcare resource utilization. Of all the CADTH and NICE appraisals incorporating RWE, around 50% were in oncology. A trend of increasing RWE submissions was observed in both countries, rising from 51% in 2021 to 66% in 2023 in the UK and from 24% to 47% in Canada.

CONCLUSIONS: NICE and CADTH lean towards increased importance and thoroughness given to RWE in the context of the HTA processes as shown by this analysis and recent guidelines. Nonetheless, HTA in general still lacks clarity about which type of RWE study and data sources can be used and when. There is great potential to drive mutual understanding of RWE’s impact further, establish acceptance thresholds, and ensure transparency in decision-making related to RWE