Presentation (CTI)

OBJECTIVES: To compare patient involvement in drug reimbursement processes across countries, and to assess discrepancies between formal procedures and real-world practice.
METHODS: A mixed-methods study was conducted combining a structured narrative review, documentary analysis of HTA agency procedures, and semi-structured interviews. An analytical framework assessed four domains: collection of patient evidence, procedural involvement, governance structures, and communication practices. Eight countries were included (Australia, Belgium, Canada, Czechia, England, Finland, France, and the Netherlands). Findings were triangulated and validated through interviews with national patient organisations and, where possible, HTA or reimbursement agency representatives.
RESULTS: Patient involvement was observed across multiple stages of the reimbursement process, including early scoping, evidence assessment, appraisal meetings, and feedback on draft recommendations. However, substantial cross-country variation exists in timing, format, and intensity of engagement. Key barriers identified include limited preparation time, insufficient guidance and training, inadequate remuneration, and limited transparency regarding the integration of patient evidence into reimbursement decisions. Promising practices include structured early notification, opportunities for oral participation in appraisal meetings, publication of meeting outputs, and provision of feedback on the use of patient input.
CONCLUSIONS: Although patient involvement is increasingly recognized as an essential component of reimbursement decision-making, its implementation remains inconsistent across countries. Strengthening early engagement, providing tailored support and fair compensation, and improving transparency and feedback may improve consistency, legitimacy, and impact of patient contributions in reimbursement decisions.