Abstract

The importance of HTA bodies in healthcare decision-making in Latin American markets has increased significantly in recent years. Rapidly growing markets, political changes, state of healthcare infrastructure add to the complexity of patient access to medicines. HTA bodies in LatAm countries vary significantly in characteristics, attributes, methodologies employed, and referencing practices as do the payer reimbursement architypes. The objective was to characterize the different HTA bodies used in LatAm markets. We conducted a systematic review of HTA bodies’ documentation of 5 LatAm markets (Brazil, Chile, Colombia, Cuba and Mexico) and of peer-reviewed publications through PubMed. Over 350 characteristics, attributes assessed and methodologies used by each HTA were assessed and mapped. Documentation for all 5 markets had limited information available on HTA websites or in peer-reviewed publications. Cuba, Mexico and Brazil are among the longest established HTA bodies in LatAm. The HTA body in Brazil is a department of the national health ministry, while in Chile and Colombia HTA bodies are in-regulatory agencies. All markets consider clinical evidence including clinical trials, systematic literature reviews, meta-analyses and economic analysis. Specifically, Chile, Colombia and Mexico require budget-impact analyses. No markets utilize an explicit ICER thresholds, 2 markets publish reports online, 1 market considers rare diseases, 2 markets consider unmet needs, and all 5 markets are a part of Red ETSA, a commission that promulgates the integration of policies, information diffusion and evidence generation. Brazil, Colombia and Mexico have a Memorandum of Understanding with National Institute for Health and Care Excellence (NICE, UK). HTA bodies in LatAm are influenced by payer architypes in respective countries. HTA bodies rely on HTA reviews from other countries and regional inter-communication regarding evidence-based decision-making than most other regions in the world. These markets are currently developing policies regarding cost-effectiveness evidence and rare diseases.

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