Kourlaba Georgia, Rapti Vasiliki, Alexopoulos Athanasios, Relakis John, Koumakis Georgios, Chatzikou Magdalini, Maniadakis Nikos, Georgoulias Vassilis
The Stavros Niarchos Foundation-Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO), National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.
HYGEIA Hospital, Maroussi, Greece.
BMC Health Serv Res. 2015 Aug 5;15:307. doi: 10.1186/s12913-015-0971-4.
The objective of our study was to conduct a cost-effectiveness (CE) study of combined everolimus (EVE) and exemestane (EXE) versus the common clinical practice in Greece for the treatment of postmenopausal women with HR+/HER2- advanced breast cancer (BC) progressing on nonsteroidal aromatase inhibitors (NSAI). The combinations of bevacizumab (BEV) plus paclitaxel (PACL) and BEV plus capecitabine (CAPE) were selected as comparators.
A Markov model, consisting of three health states, was used to describe disease progression and evaluate the CE of the comparators from a third-party payer perspective over a lifetime horizon. Efficacy and safety data as well as utility values considered in the model were extracted from the relevant randomized Phase III clinical trials and other published studies. Direct medical costs referring to the year 2014 were incorporated in the model. A probabilistic sensitivity analysis was conducted to account for uncertainty and variation in the parameters of the model. Primary outcomes were patient survival (life-years), quality-adjusted life years (QALYs), total direct costs and incremental cost-effectiveness ratios (ICER).
The discounted quality-adjusted survival of patients treated with EVE plus EXE was greater by 0.035 and 0.004 QALYs, compared to BEV plus PACL and BEV plus CAPE, respectively. EVE plus EXE was the least costly treatment in terms of drug acquisition, administration, and concomitant medications. The total lifetime cost per patient was estimated at €55,022, €67,980, and €62,822 for EVE plus EXE, BEV plus PACL, and BEV plus CAPE, respectively. The probabilistic analysis confirmed the deterministic results.
Our results suggest that EVE plus EXE may be a dominant alternative relative to BEV plus PACL and BEV plus CAPE for the treatment of HR+/HER2- advanced BC patients failing initial therapy with NSAIs.
我们研究的目的是开展一项成本效益（CE）研究，比较依维莫司（EVE）与依西美坦（EXE）联合用药与希腊治疗HR + / HER2-晚期乳腺癌（BC）且在非甾体类芳香化酶抑制剂（NSAI）治疗中出现进展的绝经后女性的常见临床实践。选择贝伐单抗（BEV）加紫杉醇（PACL）以及BEV加卡培他滨（CAPE）的联合用药作为对照。
采用包含三种健康状态的马尔可夫模型来描述疾病进展，并从第三方支付方的角度评估对照方案在整个生命周期内的成本效益。模型中考虑的疗效和安全性数据以及效用值均从相关的随机III期临床试验和其他已发表研究中提取。纳入了2014年的直接医疗成本。进行概率敏感性分析以考虑模型参数的不确定性和变异性。主要结局指标为患者生存期（生命年）、质量调整生命年（QALY）、总直接成本和增量成本效益比（ICER）。
与BEV加PACL和BEV加CAPE相比，接受EVE加EXE治疗的患者经贴现的质量调整生存期分别延长了0.035和0.004个QALY。就药物采购、给药和伴随用药而言，EVE加EXE是成本最低的治疗方案。每位患者的终身总成本估计分别为：EVE加EXE为55,022欧元，BEV加PACL为67,980欧元，BEV加CAPE为62,822欧元。概率分析证实了确定性结果。
我们的结果表明，对于初始接受NSAI治疗失败的HR + / HER2-晚期BC患者，EVE加EXE相对于BEV加PACL和BEV加CAPE可能是更具优势的选择。
