ABC | Volume 112, Nº4, April 2019

Review Article Ferrari et al PCSK9 Inhibitors in Clinical Practice Arq Bras Cardiol. 2019; 112(4):453-460 10-year CV risk >30%; and c) € 295,543.00 for patients with established CV disease and DM2, all per quality-adjusted life‑year (QALY) gained. 58 Additionally, the estimated annual cost of treatment is US$14,000.00. 59 This becomes particularly important when considering the (implicit and estimated) willingness-to-pay threshold in Brazilian, which seems to fluctuate between R$25,000.00 and R$185,000.00 per QALY. 60 Cost-effectiveness ratio and cost-utility ratio estimates indicate values much higher than the Brazilian thresholds, and, at least for the prospect of third-party payers, these drugs will have to spend some time on the market before their prices decline enough for consideration. According to Moore’s curve, when a new technology is incorporated, there is a non‑negligible gap in time for a reduction in estimated price (e.g., 60% to 70% of the current value). 61-63 Therefore, it is important to evaluate the cost-effectiveness and cost‑utility of PCSK9i and their market prices before they can be recommended as a therapeutic option – at this time, still from the patient perspective alone. Final considerations Since the discovery of their effect on LDL levels, PCSK9i have been an object of great research interest. The clear association between CV risk factors and the significant reduction in LDL obtained with their use are guiding the development of novel algorithms for the treatment of dyslipidemias and CV diseases as a whole. Major advances in the treatment of CAD have been achieved in recent decades. Among them, the greater understanding of the importance of LDL as a causal factor was particularly relevant. The results of the RCTs described in this paper have provided the evidence base for the use of PCSK9i and indications for the use of these drugs, as well as the LDL targets to be achieved. Each patient should have their risk adequately assessed, taking into account the cost-effectiveness of treatment and the most appropriate medications for their clinical condition. The inhibition of PCSK9 represents a novel approach to reducing LDL levels and preventing adverse CV outcomes in high-risk patients who have not achieved recommended levels of LDL despite the use of a maximally optimized therapeutic arsenal. Finally, it is important to stress that the use of PCSK9i should not be indiscriminate, and that it is up to physicians to determine which patients will actually benefit from their use. On the other hand, high-risk patients and those who are intolerant to statins – and who can afford this therapy – certainly have in PCSK9i a treatment option that has so far proven to be safe and attractive. Acknowledgements Financial support was provided by the Hospital de Clínicas de Porto Alegre Research and Event Incentive Fund (FIPE-HCPA). Author contributions Conception and design of the research: Ferrari F, Moriguchi EH; acquisition of data, analysis and interpretation of the data and writing of the manuscript: Ferrari F, Stein R, Motta MT, Moriguchi EH; critical revision of the manuscript for intellectual content: Stein R, Moriguchi EH. 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 study is not associatedwith any thesis or dissertationwork. 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