When Should the Conduct of RWE Studies Be Prioritized for Reimbursement: Insights from Canadian and Global Stakeholders

OBJECTIVES: Given the ongoing importance of RWE both in international and Canadian healthcare decision-making (such as influencing HTA reimbursement decisions), we set out to collect insights from stakeholders on when generating RWE should be prioritized. This builds on previous work where we identified CADTH reimbursement reviews from 2017-2021 that demonstrated the influence of RWE on recommendations.

METHODS: To better understand the process for deciding when a RWE study should be prioritized, educational workshops were held providing examples of how RWE has previously been used in reimbursement decision-making. Stakeholders included industry partners, HTA decision-makers, payers, and patient advocates. As a subsequent step, qualitative data are being collected from stakeholders in 1:1 or small-group sessions to obtain insights on RWE experiences both in Canada and other global markets. Analyses of RWE in CADTH reimbursement reviews were also updated with 2022 data.

RESULTS: Background information on the RWE environment and previous findings of our research were shared with stakeholders. Perspectives are being obtained on the following topics: (1) what factors have influenced decisions to conduct RWE studies in the past, (2) when does RWE generated in other countries influence this decision, (3) when does including a RWE study optimize impact on reimbursement. Approximately 28% of initial CADTH submissions included RWE in 2022; similar trends were observed as in previous work for top therapeutic areas and use in rare diseases.

CONCLUSIONS: Given the recent publication of frameworks by global HTA/regulatory agencies that focus on RWE methodology, there is a need to further support practical implementation of RWE. A framework that prioritizes when to generate RWE and that could influence decision-making would provide value and could be tailored to different countries’ RWE environment.