Medicines for the treatment of hemophilias in the United Health System in Brazil: critical analysis of Conitec evaluations

Abstract

 Introduction: For decision making, HTA includes evidence-based analysis, taking into account several dimensions, not only clinical and economic. In Brazil, the National Commission for the Incorporation of Technologies in the SUS (Conitec) is the agency responsible for the processes of incorporation of health technologies in the SUS. The objective of this study was to critically analyze the ATS published by Conitec and related to the treatment of hemophilia, focusing on the dimensions of analysis, criteria, results and decision factors relevant to decision making. Methods: Descriptive, exploratory and retrospective study on HTA at the federal level by Conitec from January 2012 to April 2020, for the treatment of patients with hemophilia. Results: Five reports, drug reviews, were included for analysis. The dimensions found were scientific evidence on efficacy, safety, issues related to diseases and unmet need, the use of technology, costs and social participation. The most relevant decision factors considered for decision making were unmet medical needs and lack of evidence of benefit of the drug against already available alternatives. Conclusion: Conitec‘s HTA and decision-making process for the treatment of hemophilia has developed, but despite advances and methodological guidelines, a continuous investment in the scientific rigor of HTA processes, in the transparency and independence of decisions is necessary.