Presentation (CTI)

OBJECTIVES: This study aims to explore how real-world evidence (RWE) can address critical gaps in the incorporation of new health technologies into Brazil’s public healthcare system.
METHODS: A narrative review was conducted to analyze the role of RWE in HTA processes, with a focus on its applicability to Brazil’s public healthcare system. Insights were drawn from case studies and existing literature on RWE utilization in low- and middle-income countries.
RESULTS: RWE significantly supports HTA by providing real-world data on resource utilization, treatment patterns, and health outcomes, which are essential for cost-effectiveness analyses and budget impact assessments. In Brazil, RWE addresses epidemiological gaps by providing data on disease prevalence and treatment outcomes in underrepresented populations, especially in regions with limited clinical trial coverage. Additionally, RWE enhances post-market surveillance by evaluating long-term safety and effectiveness, supporting adaptive reimbursement strategies, and informing evidence-based policy adjustments. However, challenges persist, including issues with data quality, lack of standardization, limited data integration, and the scarce availability of outcome data within DATASUS, Brazil's public healthcare database. Additionally, biases inherent in observational data further complicate the integration of RWE into HTA in Brazil as an official data source of information. A framework describing the RWE flow for insights generation in HTA will be presented in the poster.
CONCLUSIONS: RWE has the potential to fill critical gaps in Brazil’s HTA processes, complementing clinical trial data to support CONITEC's decision-making. Addressing challenges related to data quality, standardization, and methodological rigor is essential to realize RWE’s full potential. When effectively integrated, RWE can improve the accuracy of economic evaluations, enhance epidemiological insights, and support dynamic policy-making, ultimately strengthening Brazil’s public healthcare system.