Análise crítica da literatura sobre diretrizes para avaliação de dispositivos médicos
Análise crítica da literatura sobre diretrizes para avaliação de dispositivos médicos
Arquivos
Data
2018
Autores
Contó, Murilo
Journal Title
Journal ISSN
Volume Title
Publisher
Instituto Nacional de Cardiologia
Resumo
A Avaliação de Tecnologias em Saúde (ATS) é um conjunto de práticas que visa aplicar as melhores evidências e estudos econômicos para a tomada de decisão quanto à utilização de tecnologias em saúde. Dentre essas tecnologias estão os dispositivos médicos (DM) que compreendem um universo amplo e heterogêneo de produtos. O objetivo deste trabalho foi realizar um levantamento e análise crítica de diretrizes e publicações sobre a avaliação de DM, obtidas por meio da busca por documentos específicos junto aos membros da Rede Internacional de Agências de ATS (INAHTA); por publicações sobre ATS em DM na literatura; e, marcos legais da ATS e a incorporação de DM no Brasil. Junto às agências da INAHTA, foram selecionados 11 documentos, de onde foram extraídos os principais pontos críticos da ATS em DM e como cada país os aborda. Da literatura foram selecionados 9 artigos de onde também foram identificados gargalos e recomendações na ATS para DM. O levantamento do arcabouço legal brasileiro permitiu mapear as etapas, desde o registro sanitário até o acesso, onde a ATS em DM é aplicada no país, bem como a forma como os mesmos são classificados pelos órgãos de governo. Os principais aspectos críticos encontrados foram: a heterogeneidade dos DM agravada pela falta de uma nomenclatura padronizada; a curva de aprendizagem e o fato de DM serem operador-dependente; o ciclo de vida com inovações incrementais constantes; preços dinâmicos por diferentes modelos de negócios e inovação acelerada; custos além da aquisição associados ao ciclo de vida; requisitos de infraestrutura e itens periféricos; e a dificuldade de se obter evidências consideradas de melhor qualidade por questões práticas e éticas que limitam a realização de Ensaios Clínicos Randomizados. Em conclusão, verifica-se que ações estruturantes deveriam ser promovidas no sentido de harmonizar a classificação dos DM e as metodologias de ATS, facilitando a transferabilidade de avaliações realizadas por diferentes países. A maior integração dentre os órgãos responsáveis pelas avaliações nas diferentes etapas da incorporação do DM também representaria uma maior sinergia de esforços. Além disso, a abordagem mais criteriosa dos aspectos críticos identificados, contribuirão para que a ATS em DM seja mais completa e abrangente, diminuindo incertezas nas tomadas de decisão que impactam na oferta de tecnologias para a população.
Health Technology Assessment (HTA) is a set of practices that aims to apply the best evidences and economic analysis for the decision making regarding the use of health technologies. Among these technologies are medical devices (MD) that comprise a broad and heterogeneous universe of products. The objective of this work was to conduct a search and critical analysis of guidelines and publications about evaluation of MD, obtained through the search for specific documents with the members of the International Network of Agencies for HTA (INAHTA); by publications on HTA in MD in the literature; and, legal frameworks of HTA and the adoption of MD in Brazil. In the INAHTA agencies, 11 documents were selected, from which the main HTA critical points in MD were extracted and how each country addresses them. From the literature, 9 articles were selected from which bottlenecks and recommendations were also identified for HTA on MD. The search for Brazilian legal framework allowed mapping the steps, from the sanitary registration to the patient access, where the HTA in MD is applied in the country, as well as the way in which they are classified by the governing bodies. The main critical aspects were: the heterogeneity of MD aggravated by the lack of a standardized nomenclature; the learning curve and the fact that MD are operator-dependent; the lifecycle with constant incremental innovations; dynamic pricing for different business models and accelerated innovation; extra costs, beyond the acquisition, associated with the lifecycle; infrastructure requirements and peripheral items; and the difficulty of obtaining evidence considered of better quality due practical and ethical issues that limit the performance of Randomized Clinical Trials. In conclusion, structural actions should be promoted to harmonize MD classification and HTA methodologies, facilitating the transferability of evaluations carried out by different countries. The greater integration among the agencies responsible for evaluations in the different stages of MD adoption would represent a greater synergy of efforts as well. In addition, a more careful approach to the critical aspects identified in this work will contribute with the HTA in MD being more complete and comprehensive, reducing uncertainties in the decision making that impact on the provision of technologies to the population.
Health Technology Assessment (HTA) is a set of practices that aims to apply the best evidences and economic analysis for the decision making regarding the use of health technologies. Among these technologies are medical devices (MD) that comprise a broad and heterogeneous universe of products. The objective of this work was to conduct a search and critical analysis of guidelines and publications about evaluation of MD, obtained through the search for specific documents with the members of the International Network of Agencies for HTA (INAHTA); by publications on HTA in MD in the literature; and, legal frameworks of HTA and the adoption of MD in Brazil. In the INAHTA agencies, 11 documents were selected, from which the main HTA critical points in MD were extracted and how each country addresses them. From the literature, 9 articles were selected from which bottlenecks and recommendations were also identified for HTA on MD. The search for Brazilian legal framework allowed mapping the steps, from the sanitary registration to the patient access, where the HTA in MD is applied in the country, as well as the way in which they are classified by the governing bodies. The main critical aspects were: the heterogeneity of MD aggravated by the lack of a standardized nomenclature; the learning curve and the fact that MD are operator-dependent; the lifecycle with constant incremental innovations; dynamic pricing for different business models and accelerated innovation; extra costs, beyond the acquisition, associated with the lifecycle; infrastructure requirements and peripheral items; and the difficulty of obtaining evidence considered of better quality due practical and ethical issues that limit the performance of Randomized Clinical Trials. In conclusion, structural actions should be promoted to harmonize MD classification and HTA methodologies, facilitating the transferability of evaluations carried out by different countries. The greater integration among the agencies responsible for evaluations in the different stages of MD adoption would represent a greater synergy of efforts as well. In addition, a more careful approach to the critical aspects identified in this work will contribute with the HTA in MD being more complete and comprehensive, reducing uncertainties in the decision making that impact on the provision of technologies to the population.
Description
Palavras-chave
Dispositivo médico, Avaliação de Tecnologias em Saúde, Medical devices, Health Technology Assessment
Citação
Contó M. Análise crítica da literatura sobre diretrizes para avaliação de dispositivos médicos. Rio de Janeiro. Dissertação [Mestrado Profissional em Avaliação de Tecnologias em Saúde] - Instituto Nacional de Cardiologia; 2018.