ABC | Volume 115, Nº1, July 2020

Original Article Pessoa et al. Cost-effectiveness comparison between drug-eluting stents and bare-metal stents Arq Bras Cardiol. 2020; 115(1):80-89 Cost-effectiveness Analysis In Brazil, the use of DESs for PCI is a rule in the supplementary health system, as this economicmodel bases its cost-effectiveness threshold on demand, considering how much the insured is willing to pay for it. However, the unrestricted use of DESs in the SUS is still a matter of controversy. As their use does not have an impact on mortality, with a decrease only in the number of re-interventions due to a reduction in restenosis, the cost- effectiveness threshold needs to be based on supply, that is, on howmuchmore the State is willing to pay to obtain such a benefit. Polanczyk et al., 3 in a previous non-randomized study conducted in Brazil for the economic analysis of DESs, reported that the cost in the first year of implantation was R$ 5,788.00 for BMSs and R$ 12,708.00 for DESs, with a 13.8% higher effectiveness in favor of DESs. Using a cost- effectiveness threshold of USD 10,000.00 per avoided event, extracted from the North American and Canadian systems, it was concluded that the ICER of R$ 47,643.00 for DESs per avoided restenosis was not cost-effective in the SUS. The present randomized study calculated the ICER of DESs in relation to BMSs only in the SUS. According to the SUS’s reference values, the annual cost of DESs was R$ 5,722.21 and the annual cost of BMSs was R$ 4,085.21, which has changed little since the study by Polanczyk et al. 3  The effectiveness by ISR and TLR was 8.7% for DESs and 5.9% for BMSs, with an ICER of R$ 18,816.09 and R$ 27,745.76, respectively. Based on these results, can we consider DESs cost-effective? In Brazil, there has never been an explicit threshold value for cost-effectiveness as a reference for assessing the economic viability of a technology to be implemented. CONITEC, 9 an adviser to the Ministry of Health for the incorporation of any treatment into the SUS, often uses the value of the GDP per capita in its reports to estimate this threshold. 18 -20 The use of the GDP per capita as a threshold for cost-effectiveness has recently been abandoned by the WHO 19  due to lack of specificity for decision-making on resource allocation. Because of a scenario of uncertainty, there is a bill in the Senate that proposes the creation of cost-effectiveness parameters to assist in the approval of drugs, orthoses, and prostheses in the SUS. 21  In the absence of a better alternative, the GDP per capita was the parameter used to define cost-effectiveness in the present study. The DES price has dropped dramatically. At the time of the study by Polanczyk et al., 3  the reference price of rapamycin-eluting stents was R$ 10,320.00, whereas, in the present study, the price of zotarolimus-eluting stents was around R$ 3,600.00. The price of BMSs decreased as well, while incorporating the same technological advances of the platform used in DESs. Interestingly, SUS has a peculiarity: the amounts paid for the procedures have changed little over recent years, where, although the price of DESs in the SUS remained unchanged, they are currently more expensive in relation to the market price. Despite the decrease in their cost, the latest CONITEC report 9  recommended the use of DESs in the SUS only for patients at greatest risk for restenosis, purchasing them at a price below the market price. 9  Their use in the SUS, therefore, is still restricted. In Europe, where the health care system is mostly public, DESs have been widely used for 5 years. In 2013, in France, 22  72.5% of implanted stents were DESs; in the United Kingdom, 89.0%; in Italy, 78.0%; in Germany, 77.0%; and in Spain, 74.0%. Barone-Rochette et al., 23  in a cohort study of patients who received sirolimus-eluting stents at different time points (2008 and 2012), demonstrated their cost-effectiveness after the price drop. The cost difference between DESs and BMSs was € 1200 in 2008 and € 400 in 2012. In2018,thenewEuropeanSocietyofCardiology(ESC)/European Association for Cardio-Thoracic Surgery (EACTS) 16  guideline for myocardial revascularization recommended the unrestricted use of DESs, regardless of the type of injury, planning for non-cardiac surgery, or concomitant anticoagulation. In short, the constant improvement of DESs and the variety of models available on the market tend to further reduce their price and increase their use. Technological advances in DESs tend to ultimately eliminate the use of BMSs in clinical practice, but a change of attitude of government managers is still lacking to implement their usemore broadly, as in developed countries. Conclusions DESs were cost-effective in the SUS patients participating in the study, compared with BMSs. There was no difference in mortality or other major adverse events between DESs and BMSs. Patients who received a DES had a significantly lower rate of ISR compared with those who received a BMS. Study Limitations Due to the random selection of patients with single- vessel coronary artery disease without previous angioplasty or history of CABG, less complex cases were probably selected, with a lower probability of developing restenosis, which may have influenced the difference in effectiveness between the groups. In addition, due to the small sample size, the number of adverse events was low, and the use of BMSs was the only independent predictor of restenosis, but with a wide confidence interval. Author contributions Conception and design of the research: Pessoa JA, Maia F, Oliveira MS, Araújo DV, Ferreira E, Albuquerque DC; Acquisition of data: Pessoa JA, Maia E, Maia F, Oliveira MS; Analysis and interpretation of the data and Statistical analysis: Pessoa JÁ; Obtaining financing: Araújo DV, Ferreira E, Albuquerque DC; Writing of the manuscript: Pessoa JA, Ferreira E; Critical revision of the manuscript for intellectual content: Pessoa JA, Araújo DV, Ferreira E, Albuquerque DC. Potential Conflict of Interest No potential conflict of interest relevant to this article was reported. Sources of Funding There were no external funding sources for this study. Study Association This article is part of the thesis of master submitted by João Addison Pessoa, fromUniversidade Estadual do Rio de Janeiro. 87