O uso de limiares de custo-efetividade nas decisões em saúde: recomendações da comissão nacional de incorporação de tecnologias no SUS

Abstract

Since its creation, the National Commission for the Incorporation of Technologies into the Unified Health System (Conitec), in the exercise of its powers and governed by the pillars of universality, comprehensiveness and equity, has advised the Ministry of Health on the attributions related to the incorporation, exclusion or modification of health technologies by the Unified Health System (SUS), through rational criteria and parameters of efficacy, effectiveness and safety appropriate to health needs. With cost-effectiveness also being one of the explicit dimensions for evaluating requests for the incorporation of new technologies into the Unified Health System (SUS), the debate on the decision on whether or not to adopt a cost-effectiveness threshold is a topic that has been long awaited by the main actors involved in Health Technology Assessment (HTA) in our country. This report is the final result of the process promoted by the Department of Management and Incorporation of Health Technologies (DGITS/SCTIE/MS), in its capacity as Executive Secretariat of Conitec, on the use of cost-effectiveness thresholds in the Unified Health System (SUS). In line with the actions of the DGITS, legislative efforts to promote transparency in decisions on the incorporation of health technologies into the SUS stand out. Originating from Senate Bill No. 415 of 2015 [1], Law No. 14,313 of 03/21/2022 [2] amended Law No. 8,080 of September 19, 1990 [3] (Organic Health Law), to provide for the processes for incorporating technologies into the SUS. According to the new wording of Article 19-Q of Law No. 8,080/90, the need to establish explicit cost-effectiveness indicators is explicitly stated in §3, which is reproduced here in full: “§3 The methodologies used in the economic evaluation referred to in item II of §2 of this article shall be set forth in regulations and widely disseminated, including in relation to the cost-effectiveness indicators and parameters used in combination with other criteria.” Thus, as a result of this convergence of flows, methodological improvements and recent public policies, it was considered appropriate and necessary for Conitec to consolidate proposals and issue recommendations to guide discussions with society on cost-effectiveness parameters in decision-making on the incorporation of health technologies in the SUS. A first aspect, fundamental for the recommendations issued to be formulated and published here, was the prior preparation of a study on the methodologies used in defining cost-effectiveness thresholds with the presentation of methodological proposals for the SUS. With the objective of training Conitec members, presenting them with methodological proposals to promote discussion and the preparation of recommendations, two workshops were held, the first in 2020 and the second in 2022, both in Brasília-DF. At the time of the first workshop, the summary of these proposals was published in the document “The use of cost-effectiveness thresholds in health decisions: proposal for the incorporation of technologies in the Unified Health System” [4], which constituted the methodological basis for the second workshop when Conitec's preliminary recommendations were prepared. In order to expand social participation in this process, these recommendations were then made available in a Public Consultation (CP), held between June 21, 2022 and August 1, 2022 (CP No. 41/2022). In addition, a public hearing (No. 02/2022) was opened to capture society's understanding and suggestions on Conitec's methodological proposals and recommendations. The contributions received in the CP and the hearing were systematized and discussed at the 112th Conitec meeting (on August 31, 2022), when the Final Recommendations were deliberated, which are presented here, together with the results of these processes. It is worth mentioning that, in addition to the Ministry of Health, partners in the field of HTA participated in the preparation of the proposals, notably the Health Technology Assessment Centers (NATS) of the Brazilian Health Technology Assessment Network (Rebrats).