Cost-Effectiveness Analysis of Triple Therapy with Protease Inhibitors in Treatment-Naive Hepatitis C Patients
Cost-Effectiveness Analysis of Triple Therapy with Protease Inhibitors in Treatment-Naive Hepatitis C Patients
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DOI：
10.1007/s40273-013-0080-3
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发表时间：
2013-10-01
影响因子：
4.4
通讯作者：
Mar, Javier
中科院分区：
文献类型：
--
作者：
Blazquez-Perez, Antonio;San Miguel, Ramon;Mar, Javier
慢性丙型肝炎是慢性肝病的主要原因，在发病率，死亡率和成本方面构成了重大负担。随着两种有效的HCV蛋白酶抑制剂（PI）与标准治疗（SOC）的联合批准，正在建立一种治疗丙型肝炎病毒（HCV）基因型1感染的新方案，我们的目的是评估与新的干扰素联合治疗的成本效果根据临床试验（CT）获得的数据，（博赛匹韦和特拉匹韦）联合聚乙二醇干扰素和利巴韦林与SOC在未经治疗的HCV基因型1患者中的比较在西班牙国家公共卫生保健系统中，使用模拟慢性HCV进展的马尔可夫模型来估计疾病治疗成本和对患者一生的影响。目标人群为未经治疗的慢性HCV基因型1患者，其人口统计学特征来自已发表的关键CT SPRINT和ADVANCE。根据两个CT的结果，对每个PI分析了三种选择：通用三联疗法、白细胞介素（IL）-28 B指导疗法和聚乙二醇干扰素和利巴韦林双重疗法。进行单变量敏感性分析以评估某些参数的不确定性：治疗开始时的年龄、转移概率、药物成本、CT疗效结果和慢性HCV患者全因死亡率的较高风险比。同时进行了概率敏感性分析，增量成本-效果比（ICER）为a，而不是2012年每获得质量调整生命年（QALY）。根据基础病例分析，使用双联治疗作为比较，替代IL 28 B指导治疗显示出更有利的ICER（a，boceprevir无显著性18，079/QALY，a，telaprevir无显著性25，914/QALY）（a，boceprevir未签署27，594/QALY，a，telaprevir未签署33，751/QALY），ICER明显低于西班牙医疗干预的有效阈值。敏感性分析显示，治疗开始时的年龄是影响ICER的重要因素。PI成本的潜在降低也将明显改善ICER，并且过渡概率影响结果，但程度较小。概率敏感性分析显示，95%的模拟显示ICER低于a，而不是40，000/QALY。事后估计持续的病毒学反应的IL-28 B引导的治疗选项代表了研究的局限性。分析的基础病例队列的治疗选项可以被认为是西班牙医疗保健框架的成本效益的干预措施。敏感性分析估计了年龄小于60岁的患者的IL 28 B指导策略的可接受阈值。
Chronic hepatitis C is the leading cause of chronic liver disease, representing a significant burden in terms of morbidity, mortality and costs. A new scenario of therapy for hepatitis C virus (HCV) genotype 1 infection is being established with the approval of two effective HCV protease inhibitors (PIs) in combination with the standard of care (SOC), peginterferon and ribavirin.Our objective was to estimate the cost effectiveness of combination therapy with new PIs (boceprevir and telaprevir) plus peginterferon and ribavirin versus SOC in treatment-naive patients with HCV genotype 1 according to data obtained from clinical trials (CTs).A Markov model simulating chronic HCV progression was used to estimate disease treatment costs and effects over patients' lifetimes, in the Spanish national public healthcare system. The target population was treatment-naive patients with chronic HCV genotype 1, demographic characteristics for whom were obtained from the published pivotal CTs SPRINT and ADVANCE. Three options were analysed for each PI based on results from the two CTs: universal triple therapy, interleukin (IL)-28B-guided therapy and dual therapy with peginterferon and ribavirin. A univariate sensitivity analysis was performed to evaluate the uncertainty of certain parameters: age at start of treatment, transition probabilities, drug costs, CT efficacy results and a higher hazard ratio for all-cause mortality for patients with chronic HCV. Probabilistic sensitivity analyses were also carried out.Incremental cost-effectiveness ratios (ICERs) of a,not sign2012 per quality-adjusted life-year (QALY) gained were used as outcome measures. According to the base-case analysis, using dual therapy as the comparator, the alternative IL28B-guided therapy presents a more favorable ICER (a,not sign18,079/QALY for boceprevir and a,not sign25,914/QALY for telaprevir) than the universal triple therapy option (a,not sign27,594/QALY for boceprevir and a,not sign33,751/QALY for telaprevir), with an ICER clearly below the efficiency threshold for medical interventions in the Spanish setting. Sensitivity analysis showed that age at the beginning of treatment was an important factor that influenced the ICER. A potential reduction in PI costs would also clearly improve the ICER, and transition probabilities influenced the results, but to a lesser extent. Probabilistic sensitivity analyses showed that 95 % of the simulations presented an ICER below a,not sign40,000/QALY. Post hoc estimations of sustained virological responses of the IL28B-guided therapeutic option represented a limitation of the study.The therapeutic options analysed for the base-case cohort can be considered cost-effective interventions for the Spanish healthcare framework. Sensitivity analysis estimated an acceptability threshold of the IL28B-guided strategy of patients younger than 60 years.