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The National Committee for the Incorporation of Technologies in the Unified Health System (Conitec) is playing a crucial role in advising the Brazilian Ministry of Health. Its responsibilities include providing recommendations on the incorporation, exclusion, or alteration of health technologies within the Unified Health System (SUS). Decisions regarding technology incorporation are guided by Health Technology Assessment (HTA) studies, which consider scientific evidence, efficacy, accuracy, safety, and comparative economic evaluation. HTA is a multidisciplinary process aimed at informing decision-making to promote an equitable, efficient, and high-quality healthcare system. The evaluation of Medical Devices (MD) poses an additional challenge due to gaps in the availability of clinical and economic evidence. The technological dynamism and competitiveness in the medical devices sector underscore the need for a more targeted approach to address the priority demands of the healthcare system. The study highlights significant changes in the structure and configuration of Conitec in 2022, including the establishment of subcommittees and thematic committees specifically dealing with MD. A case study on dynamic phototherapy for the treatment of basal cell carcinoma, developed at a Brazilian University, illustrates the evolution of the evaluation process: initially not recommended in 2020, it received a favorable recommendation in 2023 following review, underscoring the importance of specialist involvement and real-world data collection. In conclusion, the study demonstrates the evolution of the HTA process in Brazil, emphasizing the importance of specialized subcommittee participation and contextual data collection for a comprehensive evaluation of demands.

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Advances in the Incorporation of Medical Devices in the SUS: The First Experience of Incorporating Technology Developed and Demanded for Evaluation by a Brazilian University

  • 会议论文

  • 发表日期：

    2025年

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  • Fotini Santos Toscas,
  • Nadja Naira Valente Mayrink,
  • Vania Cristina Canuto Santos,
  • Luciene Fontes Schluckebier Bonan,
  • Eduardo Mario Dias

摘要

The National Committee for the Incorporation of Technologies in the Unified Health System (Conitec) is playing a crucial role in advising the Brazilian Ministry of Health. Its responsibilities include providing recommendations on the incorporation, exclusion, or alteration of health technologies within the Unified Health System (SUS). Decisions regarding technology incorporation are guided by Health Technology Assessment (HTA) studies, which consider scientific evidence, efficacy, accuracy, safety, and comparative economic evaluation. HTA is a multidisciplinary process aimed at informing decision-making to promote an equitable, efficient, and high-quality healthcare system. The evaluation of Medical Devices (MD) poses an additional challenge due to gaps in the availability of clinical and economic evidence. The technological dynamism and competitiveness in the medical devices sector underscore the need for a more targeted approach to address the priority demands of the healthcare system. The study highlights significant changes in the structure and configuration of Conitec in 2022, including the establishment of subcommittees and thematic committees specifically dealing with MD. A case study on dynamic phototherapy for the treatment of basal cell carcinoma, developed at a Brazilian University, illustrates the evolution of the evaluation process: initially not recommended in 2020, it received a favorable recommendation in 2023 following review, underscoring the importance of specialist involvement and real-world data collection. In conclusion, the study demonstrates the evolution of the HTA process in Brazil, emphasizing the importance of specialized subcommittee participation and contextual data collection for a comprehensive evaluation of demands.