Abstract

Background: Real-world evidence (RWE) is increasingly used to inform health technology assessments for resource allocation, which are valuable tools for emerging economies such as in America. Nevertheless, the characteristics and uses in South America are unknown. Objectives: 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 gray literature search were conducted to identify the sources and characteristics of RWE. Findings were validated by key opinion leaders attending workshops in 4 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. In South America, RWE is mainly used for pharmacovigilance and as pure academic research, but less so for health technology assessment decision making or pricing negotiations and not at all to inform early access schemes. Conclusions: The quality of real-world data in the case study countries vary and RWE is not consistently used in healthcare decision making. Authors recommend that future studies monitor the impact of digitalization and the potential effects of access to RWE on the quality of patient care.