Avaliação econômica de Vildagliptina para o tratamento de pessoas vivendo com Diabetes Mellitus Tipo 2: perspectiva do Sistema Público de Saúde Brasileiro

Abstract

In Brazil, health is a citizens right. To ensure it, Brazil has adopted a universal system - the Unified Health System (SUS), which has to perform integrated therapeutic care actions, including pharmaceutical services. One of the steps in pharmaceutical services is the selection of medicines. To support a choice between treatments has gained importance the set of concepts and methods called Health Technology Assessment. This approach uses scientific and economic evidence to support the health decisions. In Brazil, about 6% of all deaths are attributed to diabetes mellitus and 41% of them occur before the age of seventy. Among people living with this disease, type 2 diabetes mellitus (T2DM) is the type diagnosed in 85% to 95% of them. In Brazil, the drugs considered essential by SUS for people living with T2DM are metformin, glibenclamide, gliclazide, regular insulin and NPH insulin. Patients with a medical prescription of other drugs go to court to force the SUS to provide them. In Minas Gerais, vildagliptin was the most frequently acquired oral hypoglycemic agent to meet legal demands. The aim of this study is to define the cost-effectiveness of vildagliptin for the treatment of people living with T2DM. A cross-sectional study was conducted to identify the average price recorded for purchases of oral hypoglycemic agents by SUS. These prices were compared to federal subsidies in the "Aqui Tem Farmácia Popular" co-pay program and to reimbursements from other countries with universal health systems - Portugal, Spain, Canada and the United Kingdom. A systematic review of the literature was conducted to obtain data on the efficacy and effectiveness of vildagliptin-containing treatments and its comparators. Markov models were built to establish the cost-effectiveness of vildagliptin-containing treatments. Probabilistic sensitivity analysis was performed to evaluate the uncertainties of models and a GDP per capita was considered as the willingness to pay threshold. The amount subsidized by the federal government for each essential drug tablet for T2DM may reach 1023% of the average value of the SUS acquisitions. Overall, the average price in the SUS is lower than that reimbursed in other countries. On the other hand, the copayment with public funds in Brazil is higher than other studied countries. The incremental cost-effectiveness ratio (ICER) of vildagliptin monotherapy compared to metformin alone was approximately $ 20,000, considered above the willingness to pay in Brazil. For the comparison between associations with metformin, vildagliptin presented ICER of around $ 4,700. Evaluating data from observational studies, the ICER of dual vildagliptin-containing treatment was approximately $ 8,600. Although these two ICER are below established willingness to pay threshold, sensitivity analyzes have shown that these values are likely to be above a GDP per capita. Thus, according to the conditions of this study, it is not recommended to include vildagliptin- containing treatments in the SUS care line for the treatment of people living with T2DM.