Real-World Evidence in Healthcare Decision Making : Global trends and case studies from Latin America

Objectives: Real-world evidence (RWE) is increasingly used to inform health technology assessments (HTAs) for resource allocation, which are valuable tools for emerging economies such as in America. However, the characteristics and uses in South America are unknown. This study aims to identify sources, characteristics and uses of RWE in Argentina, Brazil, Colombia and Chile, and evaluate the context-specific challenges. The implications for future regulation and responsible management of RWE in the region are also considered. Methods: A systematic literature review, database mapping, and targeted grey literature search were conducted to identify the sources and characteristics of RWE. Findings were validated by key opinion leaders attending workshops in four South American countries. Results: A database mapping exercise revealed 407 unique databases. Geographic scope, database type, population and outcomes captured were reported. Characteristics of National Health Information Systems show efforts to collect interoperable data from service providers, insurers and government agencies, but that initiatives are hampered by fragmentation, lack of stewardship and resources. RWE is mainly used in South America for pharmacovigilance and as pure academic research, but less so for HTA decision-making or pricing negotiations and not at all to inform early access schemes. Conclusions: The quality of data collected in real-world in the case-study countries varies and RWE is not consistently used in healthcare decision-making. Authors recommend that future studies monitor the impact of digitalisation, and the potential effects of access to RWE on the quality of patient care.