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

October 14, 2022 Executive Summary The “ANS rol” defines the minimum mandatory coverage of services (diagnostics, procedures, and treatments) in the private sector. While private providers could opt to provide coverage beyond this list, in practice, the “ANS rol” has traditionally been seen as the maximum coverage that would be provided with anything beyond the “ANS Rol” being typically rejected Law 14.454/2022 published in September 2022 establishes that the “ANS Rol” will dictate the minimum coverage that private payers need…

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

March 18, 2022 Key Takeaways 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:​ ​The difference between FDA and ANVISA time to approval for orphan drugs is four times shorter after the implementation of the RDC 205 / 2017 pathway​ The RDC 2015 pathway regulated the deadlines for…

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HTA/Reimbursement Evolution and Priorities for Assessment in a Value-Based Healthcare Environment in Latin America

This session will discuss trends in the HTA/Reimbursement environment in Latin America and the drivers for value-based health care (VBHC) implementation within the region. The potential benefits of VBHC, stakeholders’ roles in VBHC, contextual barriers and facilitators for VBHC implementation, and potential future impact of VBHC to healthcare in the region will be discussed by a panel of speakers. Note: The webinar will be presented in Spanish and Portuguese with PowerPoint Slides shown in English.Dr. Hector Castro will moderate the session and…

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