背景:最近国际,随机化,安慰剂对照临床试验(SPRINT-2;RESPOND-2)表明,聚乙二醇干扰素(PEG),利巴韦林(RBV)和boceprevir(BOC)在治疗基因1型丙型肝炎病毒(HCV)慢性感染患者方面比标准的PEG和RBV双重治疗更有效.这项研究的目的是评估三联疗法在匈牙利初治和有治疗经验的患者中的成本效益。方法:从匈牙利付款人的角度开发了马尔可夫模型来评估三联疗法的长期临床益处和成本效益。模型状态为纤维化(F0-F4,使用METAVIR纤维化评分定义),失代偿期肝硬化(DC),肝细胞癌(HCC),肝移植,和肝脏相关死亡(LD)。根据SPRINT-2和RESPOND-2研究估计疗效。模型中使用的疾病进展率和健康状况效用是从已发表的研究中获得的。肝移植的可能性和成本的估计是基于对匈牙利疾病基金数据库的分析。所有成本和收益都以每年5%的价格打折。结果:与双重疗法相比,三联疗法预计将增加预期寿命0.98和2.42寿命年,并增加质量调整寿命年(QALY)0.59和1.13治疗初治和治疗经验丰富的患者,分别。相应的增量成本效益比分别为每QALYHUF7,747,962(26,717欧元)和HUF5,888,240(20,304欧元)。严重肝病事件的终生发生率(DC,HCC,LT,与PEG-RBV治疗相比,在接受三联疗法治疗的未治疗和有治疗经验的患者中,LD)预计将降低45%和61%。结论:在匈牙利,将boceprevir添加到治疗1型慢性HCV感染患者的标准疗法中,使用常用的支付意愿阈值为846万HUF(人均国内生产总值的3倍),预计具有成本效益。
Background: Recent international, randomized, placebo-controlled clinical trials (SPRINT-2; RESPOND-2) demonstrated that the triple combination of peginterferon (PEG), ribavirin (RBV) and
boceprevir (BOC) was more efficacious than the standard dual therapy of PEG and RBV in treatment of patients chronically infected with genotype 1 hepatitis C virus (HCV) infection. The objective of this study was to evaluate the cost-effectiveness of triple therapy in both treatment-naive and treatment-experienced patients in Hungary. Methods: A Markov model was developed to evaluate the long-term clinical benefits and the costeffectiveness of the triple therapy from the Hungarian payer perspective. Model states were fibrosis (F0-F4, defined using METAVIR fibrosis scores), decompensated cirrhosis (DC), hepatocellular carcinoma (HCC), liver transplantation (LT), and liver-related deaths (LD). Efficacy was estimated from SPRINT-2 and RESPOND-2 studies. Disease progression rates and health state utilities used in the model were obtained from published studies. Estimates of probability of liver transplantation and cost were based on an analysis of the Hungarian Sick Fund database. All cost and benefits were discounted at 5% per year. Results: Compared to dual therapy, triple therapy was projected to increase the life expectancy by 0.98 and 2.42 life years and increase the quality-adjusted life years (QALY) by 0.59 and 1.13 in treatment-naive and treatment-experienced patients, respectively. The corresponding incremental cost-effectiveness ratios were HUF7,747,962 (€26,717) and HUF5,888,240 (€20,304) per QALY. The lifetime incidence of severe liver disease events (DC, HCC, LT, LD) were projected to decrease by 45% and 61% in treatment-naïve and treatment-experienced patients treated with triple therapy groups in comparison with PEG-RBV treatment. Conclusion: The addition of
boceprevir to standard therapy for the treatment of patients with genotype 1 chronic HCV infection in Hungary is projected to be cost-effective using a commonly used willingness to pay threshold of HUF 8.46 million (3 times gross domestic product per capita).