OBJECTIVES: The Canadian Agency for Drugs and Technologies in Health (CADTH) is Canada’s health technology assessment (HTA) agency, responsible for providing public reimbursement recommendations for drugs entering the Canadian market. The agency has had a recent focus on real-world evidence (RWE), with publications and working groups providing guidance on RWE use. This research aims to explore trends among RWE usage and appraisal in reimbursement reviews.

METHODS: All CADTH reimbursement reviews with recommendations issued from 2022-2023 were gathered. Reviews were assessed for inclusion of RWE in clinical and/or economic evidence sections. RWE was categorized by data source, evidence category (effectiveness/safety/economic), and role (pivotal/supplementary). Data analysis examined positive recommendation rates, review duration, and therapeutic areas. Comments from CADTH regarding critical appraisal of RWE were gathered and categorized.

RESULTS: 149 reimbursement reviews were assessed. 31/149 (21%) included RWE. RWE categorization was mostly effectiveness (24/31) [77%], followed by safety (12/31) [39%], and economic (11/31) [35%]. A positive recommendation was issued in 123/149 (83%) reviews, and in reviews with RWE 23/31 (74%) recommendations were positive (p=0.1683). It took an average of 266 days for reviews containing RWE to receive a recommendation, compared to 254 days for reviews not containing RWE. CADTH discussed limitations of RWE in 26/31 (84%) reviews.

CONCLUSIONS: This research suggests that RWE is incorporated in approximately one in five reimbursement reviews, with effectiveness data being most common. However, CADTH often commented on limitations. Reviews including RWE had a lower positive recommendation rate, although it is uncertain how RWE contributed to the recommendations. Research limitations include the 2-year scope of this review and the reliance on report summaries only for data. As RWE use in HTA submissions grows, uncertainty remains regarding its use in decision-making, suggesting further guidance and research on RWE critical appraisal is needed.