From the Regions

Appendix 1 for “Real-World Data in Healthcare Technology Incorporation: A Strategic Opportunity for Latin America”

Beyond the volume of data available, the critical determinant for the production of useful real-world evidence (RWE) in Latin America is not only technical but institutional. The generation of valid, cumulative, and relevant evidence for decision-making depends on the ability to parse fragmented information systems.  

Brazil 

The Brazilian agency DGITS (Department of Management and Incorporation of Technologies and Innovation in Health) in conjunction with the CNPQ (National Council for Scientific and Technological Development), has formally recognized this need by including, in its call for methodological innovation in HTA, the development of good practice guides in the evaluation and critical analysis of real-world evidence. The question is whether the existing infrastructure will allow this evidence to be produced that meets the standards of those guidelines.  

Peru 

In Peru, the institutionalization of HTA is advancing through RENETSA, coordinated by the National Institute of Health. However, the decision-making use of RWD/RWE still faces barriers: fragmentation between national agencies (MINSA, EsSalud, Armed and Police Forces) regional governments and the private sector; limited interoperability; and heterogeneous quality of records. RWE can complement international evidence on cancer, rare diseases, and high-cost conditions, provided that methodological standards, data governance, and local analytical capabilities are in place.  

Chile 

A relevant application of real-world evidence in Chile has been the development of open databases by the National Health Fund (FONASA), which make up a significant volume of hospital discharges classified by Diagnosis-Related Groups (DRGs). This system provides structured information covering sociodemographic, clinical, resource consumption, production and efficiency variables throughout the healthcare network. The availability of these data has facilitated the development of applied studies, such as cost-effectiveness evaluations, budget impact analyses, and cost estimates based on observational data, thus strengthening decision-making processes based on information generated by the network of providers.  

In this context, the use of real-world data contributes to greater relevance and external validity of health analyses. However, the implementation of this approach has required a sustained effort at the country level, particularly in training for correct clinical and administrative coding, as well as in the development of local analytical tools that allow an adequate interpretation of the indicators derived from the DRM system. These advances have been fundamental in consolidating the effective use of information in health management and in the formulation of public policies.

Colombia 

In the case of Colombia, economic evaluations in health (EES) and HTA that aspire to be based on real-world data have a repertoire of official sources that allow studies or reports to be prepared for decision-making in health. The backbone of administrative data is the integrated social protection information system (SISPRO), which houses the individual records of the provision of RIPS services (use of services in the social security system and costs of care billed by health institutions and vital statistics, mortality and birth). On the other hand, there is a mandatory technology reporting tool called MIPRES that supports the prescriptions of technologies that are or are not covered by the Colombian health benefits plan. Information corresponding to prioritized chronic pathologies is recorded with the so-called high-cost account (CAC), which has audited records of chronic kidney disease, cancer, HIV, hemophilia, rheumatoid arthritis and hepatitis C, and annual reports with cost reference values.  

For the value of the technologies, the Drug Price Information System (SISMED) provides the reference prices, while the National Institute for Drug and Food Surveillance (INVIMA) It is the agency responsible for the approval of new technologies. Epidemiological information comes from the National Institute of Health (INS)⁹, which operates the National Epidemiological Surveillance System (SIVIGILA)¹⁰, source of the mandatory reporting events disseminated in bulletins, and prepares the national, departmental and municipal Health Situation Analyses (ASIS). Demographic data, household out-of-pocket expenditure and other economic and social indicators are consulted in the National Administrative Department of Statistics (DANE). Despite the availability of these sources, their marked fragmentation conditions the real reach of RWE in Colombia.  

Argentina 

In Argentina, real-life data in health decision making has been in use longer than the current pay-for-results schemes. Its development began mainly linked to post-marketing pharmacovigilance and, subsequently, to administrative mechanisms of tutelage and reimbursement managed by the social security for certain high-cost technologies that required documented clinical information to authorize, sustain, or audit coverage. This trajectory shows a progressive evolution from the passive collection of adverse events to more structured forms of monitoring effectiveness, safety and appropriate use in real conditions of clinical practice.  

The use of RWE in coverage decisions has reached one of its most concrete and relevant expressions in the program for patients with spinal muscular atrophy (SMA), managed by the National Commission for Patients with SMA (CONAME). Through payment-for-results agreements between laboratories and the Ministry of Health of the Nation, applied to nusinersen and onasemnogene abeparvovec, the country leveraged the records of the Argentine Integrated Health Information System (SISA) as the technical and legal basis for the conditional reimbursement of these treatments, constituting a pioneering precedent in the region for high-cost therapies. However, this model coexists with a structurally fragmented health system that restricts the systematic generation of robust evidence and  challenges the consolidation of RWE for use in HTA and decision-making at the population scale.  

The Argentine experience is particularly relevant because it illustrates a transition from data as an administrative requirement to data as an instrument of health governance. In this journey, the Emerging Health Technologies Mentoring System, the Single Reimbursement System, the institutionalization of health technology assessment through CONETEC—and, more recently, the follow-up of very high-priced treatments in SMA through CONAME—configure a trajectory in which RWE ceases to be an accessory issue and begins to support decisions on eligibility, therapeutic continuity, financing, and eventual divestment. This trajectory also exposes a central tension: RWE can improve the legitimacy and efficiency of coverage decisions, but only if it is supported by interoperable registries, explicit clinical criteria, data quality auditing, and sustainable analytical capabilities.  

Central America and the Caribbean 

In Central America and the Caribbean, the need to generate local evidence through RWE is expressed under heterogeneous institutional configurations, which illustrate different degrees of maturity in the articulation between data and decision[20, 21]. In Costa Rica, the integrated system of the Costa Rican Social Security Fund allows for longitudinal data continuity that is rare in the region, which has facilitated the use of routine information for health management and epidemiological analysis; however, the formal translation of this data into evidence for explicit decisions of technological incorporation is still incipient.  

In contrast, countries such as Panama, with a dual system between the Ministry of Health and the Social Security Fund, have relevant volumes of administrative and clinical data, particularly in chronic diseases, but face interoperability and governance limitations that restrict their integrated analytical use at the population scale.  

For its part, the Dominican Republic shows significant institutional progress with the implementation of the health technology assessment framework (EVTESA)¹³ by the Superintendence of Health and Occupational Risks (SISALRIL), conceived as a structured process to evaluate benefits, risks and costs of health technologies, with the aim of Family Health Insurance coverage decisions and improving the efficiency of spending. This process, developed with the support of the Pan American Health Organization and accompanied by methodological manuals and regulatory frameworks, seeks to strengthen evidence-based decision-making and the financial sustainability of the system. However, as in other contexts in the region, the Dominican experience still focuses on the pre-market evaluation of technologies, with an incipient use of real-world data generated within the system itself for post-incorporation monitoring.