Avaliação econômica de uma vacina da dengue no Brasil baseado em seu valor terapêutico no Sistema Único de Saúde

Abstract

INTRODUCTION: Dengue is an infectious disease and its causal agent is a virus. In Brazil, the disease is notifiable, being a potential market for the first approved vaccine (CYD-TDV) in the country in 2015. OBJECTIVES: To evaluate the efficacy, safety and immunogenicity of CYD-TDV; to estimate the Brazilian consumer's willingness to pay for this vaccine; to demonstrate the economic and epidemiological impact of dengue in Brazil from a SUS perspective, as well as to estimate the cost-effectiveness ratio of CYD-TDV in Brazil from a SUS perspective. METHODS: A) Systematic review - A systematic review with metaanalysis was performed to evaluate the safety, efficacy and immunogenicity of CYD-TDV. Randomized controlled trials of phase II and III, available in the databases PUBMED, LILACS, COCHRANE (until March 2016) were included. All steps were performed according to the Cochrane Handbook. B) Disposal to Pay - A cross-sectional study was conducted with residents of Greater Belo Horizonte, Minas Gerais, regarding the disposition to pay for the vaccine (median value) CYD-TDV. C) From the deterministic probabilistic matching in the SUS databases (SIA / SIH / SIM), all the records referring to individuals who used the SUS for the treatment of severe dengue or dengue in the country from 2000 to 2015 were evaluated. D) Analysis Cost Effectiveness - Based on the transition probabilities of each health condition associated with the treatment of dengue and severe dengue by SUS, a Markov model was elaborated, considering the CYD-TDV vaccine (60% efficacy), time horizon of 16 years with annual cycles in a hypothetical population of 100,000 individuals. The effectiveness was measured from the DALYs. RESULTS: A) Systematic review - 9 studies were included (6 - phase II and 3 - phase III). From three clinical trials an average efficacy of 60% was found. This vaccine has been shown to be safe. B) Willingness to pay - The willingness to pay study has shown that the Brazilian consumer in the metropolitan area of Belo Horizonte is willing to pay R $ 120.00 for the three doses of the CYD-TDV vaccine for the prevention of dengue. C) In the period from 2000 to 2015, the SUS spent approximately US $ 159 million and US $ 10 million for the treatment of dengue and severe dengue, respectively, with more than 700 thousand individuals who used public health services. The vaccination strategy with CYD-TDV presented greater clinical benefit, however with a high incremental cost USD10,029.30 (ICER: USD 101,579,881.63) compared to the non-vaccination strategy. CONCLUSIONS: A) Systematic review and meta-analysis - The CYD-TDV vaccine was approved and indicated for individuals between 9 and 45 years old, with moderate efficacy and the need for further evaluation. B) Provision to pay for the CYDTDV vaccine - The willingness to pay of the population studied for the dengue vaccine was estimated at R $ 120.00 (median value) for a three-dose therapeutic regimen (R $ 40,00 per dose). The value found expresses the willingness to pay of the private consumer and is consistent with values observed in the literature. C) Dengue represents a substantial expense for the SUS during the 16 years of evaluation of the profile of services and procedures performed, making it necessary to continuously promote preventive actions to combat the vector. D) The current market prices for Dengvaxia® have been shown to be high for a potential incorporation into the SUS. It reinforces the need for seroprevalence studies for DENV in the country in order to better contribute to the discussions regarding the need to incorporate a vaccine in the country and / or to better evaluate potential age groups to be the target of a possible vaccination.