Faculdade de Ciências Farmacêuticas de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Brasil.
Faculdade de Ciências Farmacêuticas, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brasil.
Cad Saude Publica. 2020 Jan 31;36(2):e00036619. doi: 10.1590/0102-311X00036619. eCollection 2020.
Cost-effectiveness analysis is essential in health decision making. Several countries use it as synthesis of evidence to incorporate health technologies. The protease inhibitors (PI) boceprevir (BOC) and telaprevir (TVR) are indicated for chronic hepatitis C treatment and were incorporated in guidelines worldwide. Pre-marketing clinical trials showed higher sustained virological response rates in relation to previous therapies, but the incorporation of PIs generated a significant financial impact. The aim of this study was to discuss the relevance of cost-effectiveness analysis through a study that involved the inclusion of PIs in a clinical protocol. The analysis was part of a real-life study that included patients infected with hepatitis C virus genotype 1 treated in a tertiary university hospital in Brazil. Triple therapies (TT) with ribavirin (RBV), peginterferon α-2a (Peg-INF α-2a) and BOC or TVR were compared to dual therapy with RBV and Peg-INF α-2a. Sensitivity analysis of the cost-effectiveness ratio indicated an 88.2% chance of TTs presenting a higher cost per cure. The incremental cost-effectiveness ratios (ICER) exceeded the Brazilian gross domestic product (GDP) per capita by three times in all proposed scenarios. The sensitivity of ICER showed an 88.4% chance of TT not being cost-effective. The impact of PI incorporation was negative and the conduct about this could have been different if a previous cost-effectiveness analysis had been conducted.
成本效益分析在卫生决策中至关重要。一些国家将其作为综合证据，纳入卫生技术。蛋白酶抑制剂（PI）博赛泼维（BOC）和特拉泼维（TVR）适用于慢性丙型肝炎的治疗，并被纳入全球指南。上市前临床试验显示，与之前的治疗方法相比，持续病毒学应答率更高，但 PI 的纳入产生了重大的财务影响。本研究旨在通过一项涉及将 PI 纳入临床方案的研究来讨论成本效益分析的相关性。该分析是一项真实世界研究的一部分，该研究纳入了巴西一家三级大学医院治疗的丙型肝炎病毒 1 型感染患者。含利巴韦林（RBV）、聚乙二醇干扰素 α-2a（Peg-INF α-2a）和 BOC 或 TVR 的三联疗法（TT）与含 RBV 和 Peg-INF α-2a 的二联疗法进行了比较。成本效益比的敏感性分析表明，TT 每治愈一例的成本更高的可能性为 88.2%。在所有提出的方案中，增量成本效益比（ICER）都超过了巴西人均国内生产总值（GDP）的三倍。ICER 的敏感性表明，TT 没有成本效益的可能性为 88.4%。PI 纳入的影响是负面的，如果事先进行了成本效益分析，其实施方式可能会有所不同。
