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Latin America and the Caribbean has made significant progress toward universal health coverage (UHC), but health spending efficiency, equity, and sustainability remain major challenges-and progress is hindered by the difficult macroeconomic context. Health technology assessment (HTA) can make resource allocation more efficient and equitable when systematically used to inform coverage decisions. We highlight five considerations that need to be taken into account to realize the full potential of HTA in the LAC region: i) explicitly link HTA to decision-making and anchor it in legal frameworks, ii) systematically incorporate the opportunity cost as a core principle into HTA activities informing coverage decisions, iii) make the internationally available evidence more fit for purpose for low- and middle-income countries (LMICs), iv) incorporate pragmatism as a key principle of HTA activities in the region, and v) institutionalize the monitoring of HTA processes and results.

In a multiday conference, a panel of Latin American experts in biological cancer therapies and health economics were provided with questions to address the barriers restricting access to biosimilars in Latin America, specifically for patients with breast cancer and colorectal cancer, for whom biosimilars can be a path forward to increasing access to care. During the conference, responses were discussed and edited until a consensus was achieved. The regulatory challenges identified in the conference included heterogenous regulations, non-adherence to regulatory pathways, scarcity of market opportunity, inadequate naming of biosimilars by only using international non-proprietary names, imprecise use of interchangeability and substitution, and insufficient traceability and pharmacovigilance. Recommendations were developed to improve the implementation of regulatory pathways and reliable procurement strategies that increase access to these therapies with adequate traceability and outcome measures; efforts from all involved stakeholders will be crucial. These recommendations can serve as a strategy for biosimilar adoption in other countries in a similar situation., Competing Interests: Declaration of interests ET reports honoraria from Abbott, Bayer, Janssen, Heel, Medicamenta, Merck, MSD, Novartis, Pfizer, Roche, and Sanofi, outside of the submitted work. HG reports consulting fees and honoraria from Bristol Myers Squibb (BMS), MSD, Roche, and AstraZeneca, outside of the submitted work. DH reports honoraria from MSD, Roche, Tecnofarma, and Pfizer, outside of the submitted work. WM reports grants from Pfizer and Amgen, and honoraria from Pfizer, Amgen, and Novartis, outside of the submitted work. MAE reports grants from Fondo Nacional de Desarrollo Científico y Tecnológico, Agencia Nacional de Investigación y Desarrollo, Asociación Chilena para el Estudio del Dolor, Roche, Boehringer Ingelheim, LivaNova, AbbVie, GSK, Novartis, BMS, and Novo Nordisk, consulting fees from UN Office for Project Services, Inter-American Development Bank, WHO, Alliance for Health Policy and Systems Research, and UNDP, and honoraria from Merck, MSD, Grünenthal, Novartis, AbbVie, Boehringer Ingelheim, and Roche, outside of the submitted work. All other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

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., (Copyright © 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)