Latin America

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Beyond the Price Tag: Understanding Colombia’s New Pricing Policy

In August 2023, the Colombian government published a new pricing policy outlining that the list price of new medicines in Colombia will be established based on their therapeutic value category, resulting from an assessment conducted by the Instituto de Evaluation Tecnológica en Salud (IETS). The outcomes of the therapeutic assessment are then reported to the […]

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Brazil’s Latest Updates to Drug Coverage in the Private Sector: Anticipated Impact and Implications

Executive Summary Introduction Agência Nacional de Saúde Suplementar (ANS) is the Brazilian regulatory agency linked to the Ministry of Health that oversees the private healthcare sector and insurance companies within the country. Key responsibilities of ANS include defining the legislation to regulate private plans and defining the minimum coverage that plans must offer to affiliates, […]

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How Effective is ANVISA’s Rare Diseases Expedited Approval Pathway [RDC 205]?

An analysis was conducted of all the orphan therapies registered by the FDA and ANVISA before and after 2018 to effectively evaluate approval times once the RDC 205 pathway was implemented. The main takeaways from the analysis can be found below […]

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