2021-12-102023-10-252023-10-252021-08-26Bretas, Janaína Martins. Avaliação de tecnologia em saúde no Brasil: análise dos relatórios de recomendação emitidos para as solicitações de incorporação de tecnologias no SUS no período de 2012 a 2019. 2021. 128 f. Dissertação (Programa de Mestrado em Administração Pública) - Fundação João Pinheiro, Belo Horizonte.http://repositorio.fjp.mg.gov.br/handle/tede/548Faced with the considerable rises in health care costs, the growing number of new products launched on the market, and ethical and legal pressures, health technology assessment (HTA) has become a premise for diligent resource allocation (BERTRAM et al., 2016; SHIELDS; ELVIDGE, 2020). In this way, the manager adds rationality to decision-making regarding the use of products and procedures, with the objective of providing greater coverage, quality, efficiency and safety of the policies related to this subject. In 2009, the Health Ministry published Ordinance 2690 of November 5, 2009, which instituted the National Health Technology Management Policy (PNGTS), which has as one of its principles the use of scientific evidence in the management of technologies, considering the attributes of safety, efficacy, effectiveness, efficiency and economic, ethical, social and environmental impacts of the technology in question. At the same time, the Health Ministry began an update of its regulatory framework related to this matter, making HTA research a mandatory step for the inclusion of products and protocols in the public health system (Law 12401 of 2011), which materialized with the institution of National Commission for the Incorporation of Technology in the SUS (CONITEC), through Decree 7646 of 2011. This paper aims to demonstrate the coherence between the performance of the National Commission for the Incorporation of Health Technology in the SUS and the guidelines of the National Health Technology Management Policy. In order to contribute to the analysis of the impacts of Health Technology Assessment research. The methodology used aimed, more specifically: a) to examine the profile of HTA demands analyzed by CONITEC in the period from 2012 to 2019 regarding the origin, type of technology, reason for request and outcome; b) tracking medicines and recurrent clinical indications in the demands analyzed by CONITEC, based on incorporation requests received in 2019; c) to analyze the relationship between scientific evidence about the efficacy and safety of a drug and CONITEC's final opinion on its incorporation into the SUS; d) to analyze the relationship between cost-effectiveness and the budge impact of incorporating a drug into the SUS and the final opinion of CONITEC; e) to analyze the profile of the population directly affected by the recommendations issued by CONITEC regarding requests for incorporation of medicines to the SUS; f) to analyze the reasons that led CONITEC to make changes to its preliminary recommendation after receiving contributions to the Public Consultations; g) to analyze the influence of technical-scientific opinions from CONITEC in the decision-making process of the public manager. In this regard, the CONITEC recommendation reports were analyzed using descriptive quantitative parameters and later submitted to a screening that selected one hundred elements for consideration by the content analysis method. The parameters of clinical benefits (effectiveness and safety), economic (cost and cost effectiveness) and social impacts (society participation and affected population) found in the recommendation demonstrated that CONITEC's technical advice have a multifactorial basis, with no absolute requirements. These findings support the understanding that HTA should not be associated with binding and one-dimensional guidelines, such as fixed cost-effectiveness thresholds. Often, it is necessary to deal with situations in which it is necessary to balance scarcity or uncertainties of parameters relevant to decision making, being essential a context judgment. Rarely, the reasons for certain technical advices were not absolutely clear. In a general view, CONITEC's positions are coherent with the principles and guidelines of the National Health Technology Management Policy. In these less than ten years of operation, CONITEC has shown commitment to improving its practices and based its work on a combination of analyzes that seek impartiality and identification of collective value for the recommendations sent to the public manager.application/pdfAcesso AbertoTecnologia - SaúdeComissão Nacional de Incorporação de Tecnologias no SUS (CONITEC)Sistema Único de Saúde (SUS)Avaliação de tecnologia em saúde no Brasil: análise dos relatórios de recomendação emitidos para as solicitações de incorporação de tecnologias no SUS no período de 2012 a 2019DissertaçãoSAUDE COLETIVA::SAUDE PUBLICA