When should RWE studies be prioritized for reimbursement? Insights from the Canadian perspective

Abstract Given the increasing importance of real-world evidence (RWE) in health technology assessment (HTA) decision-making, we aimed to assess RWE use in Canadian HTA and collect stakeholder insights on when RWE generation should be prioritized in HTA. We found that RWE was included in one-third of Canadian Drug Agency–L’Agence des médicaments du Canada (CDA-AMC) reimbursement reviews (2017–2022). To further understand drivers of RWE generation for reimbursement, consultations were held with stakeholders (pharmaceutical industry representatives, payers, and patient advocates) to obtain insights in Canada and other global markets. Stakeholders highlighted the value of RWE to complement randomized controlled trials (RCT) data, as well as the need to consider feasibility and multiple stakeholder perspectives. Our findings indicate there is a need to further support the practical implementation of RWE in policy decision-making. A framework providing guidance on when to prioritize RWE studies for reimbursement would provide value and could be tailored by region.