Saint-Laurent Thibault Catherine, Moorjaney Divya, Ganz Michael L, Sill Bruce, Hede Shalini, Yuan Yong, Gorsh Boris
a Evidera , Montreal , QC , Canada.
b QuickPivot , Boston , MA , USA.
J Med Econ. 2017 Jul;20(7):692-702. doi: 10.1080/13696998.2017.1307204. Epub 2017 Apr 20.
A phase III trial evaluated the efficacy and safety of Daklinza (daclatasvir or DCV) in combination with sofosbuvir (SOF) for treatment of genotype (GT) 3 hepatitis C virus (HCV) patients.
This study evaluated the cost-effectiveness of DCV + SOF vs SOF in combination with ribavirin (RBV) over a 20-year time horizon from the perspective of a United States (US) payer.
A published Markov model was adapted to reflect US demographic characteristics, treatment patterns, costs of drug acquisition, monitoring, disease and adverse event management, and mortality risks. Clinical inputs came from the ALLY-3 and VALENCE trials. The primary outcome was the incremental cost-utility ratio. Life-years, incidence of complications, number of patients achieving sustained virological response (SVR), and the total cost per SVR were secondary outcomes. Costs (2014 USD) and quality-adjusted life years (QALYs) were discounted at 3% per year. Deterministic, probabilistic, and scenario sensitivity analyses were conducted.
DCV + SOF was associated with lower costs and better effectiveness than SOF + RBV in the base case and in almost all scenarios (i.e. treatment-experienced, non-cirrhotic, time horizons of 5, 10, and 80 years). DCV + SOF was less costly, but also slightly less effective than SOF + RBV in the cirrhotic and treatment-naïve population scenarios. Results were sensitive to variations in the probability of achieving SVR for both treatment arms. DCV + SOF costs less than $50,000 per QALY gained in 79% of all probabilistic iterations compared with SOF + RBV.
DCV + SOF is a dominant option compared with SOF + RBV in the US for the overall GT 3 HCV patient population.
一项III期试验评估了达可挥（达克他韦或DCV）联合索磷布韦（SOF）治疗基因3型丙型肝炎病毒（HCV）患者的疗效和安全性。
本研究从美国医保支付方的角度，评估了在20年时间范围内，DCV + SOF与SOF联合利巴韦林（RBV）相比的成本效益。
采用一个已发表的马尔可夫模型，以反映美国的人口特征、治疗模式、药物采购成本、监测、疾病及不良事件管理以及死亡风险。临床数据来源于ALLY - 3和VALENCE试验。主要结局为增量成本效用比。生命年、并发症发生率、实现持续病毒学应答（SVR）的患者数量以及每例SVR的总成本为次要结局。成本（2014年美元）和质量调整生命年（QALY）按每年3%进行贴现。进行了确定性、概率性和情景敏感性分析。
在基础病例以及几乎所有情景（即经治、非肝硬化、5年、10年和80年的时间范围）中，DCV + SOF与SOF + RBV相比，成本更低且效果更好。在肝硬化和初治人群情景中，DCV + SOF成本更低，但效果也略逊于SOF + RBV。结果对两个治疗组实现SVR的概率变化敏感。与SOF + RBV相比，在所有概率迭代中，79%的情况下DCV + SOF每获得一个QALY的成本低于50,000美元。
在美国，对于整体基因3型HCV患者群体，DCV + SOF与SOF + RBV相比是更具优势的选择。
