Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA.
Appl Health Econ Health Policy. 2013 Feb;11(1):65-78. doi: 10.1007/s40258-012-0007-8.
The recent approval of two protease inhibitors, boceprevir and telaprevir, is likely to change the management of chronic hepatitis C virus (HCV) genotype 1 infection.
We evaluated the long-term clinical outcomes and the cost effectiveness of therapeutic strategies using boceprevir with peginterferon plus ribavirin (PR) in comparison with PR alone for treating HCV genotype 1 infection in Portugal.
A Markov model was developed to project the expected lifetime costs and quality-adjusted life-years (QALYs) associated with PR alone and the treatment strategies outlined by the European Medicines Agency in the boceprevir summary of product characteristics. The boceprevir-based therapeutic strategies differ according to whether or not the patient was previously treated and whether or not the patient had compensated cirrhosis. The model simulated the experience of a series of cohorts of chronically HCV-infected patients (each defined by age, sex, race and fibrosis score). All treatment-related inputs were obtained from boceprevir clinical trials - SPRINT-2, RESPOND-2 and PROVIDE. Estimates of the natural history parameters and health state utilities were based on published studies. Portugal-specific annual direct costs of HCV health states were estimated by convening a panel of experts to derive health state resource use and multiplying the results by national unit costs. The model was developed from a healthcare system perspective with a timeframe corresponding to the remaining duration of the patients' lifetimes. Both future costs and QALYs were discounted at 5 %. To test the robustness of the conclusions, we conducted deterministic and probabilistic sensitivity analyses.
In comparison with the treatment with PR alone, boceprevir-based regimens were projected to reduce the lifetime incidence of advanced liver disease, liver transplantation, and liver-related death by 45-51 % and increase life expectancy by 2.3-4.3 years. Although the addition of BOC increased treatment costs by €13,300-€19,700, the reduction of disease burden resulted in a decrease of €5,400-€9,000 in discounted health state costs and an increase of 0.68-1.23 in discounted QALYs per patient. The incremental cost-effectiveness ratios of the boceprevir-based regimens compared with PR among previously untreated and previously treated patients were €11,600/QALY and €8,700/QALY, respectively. The results were most sensitive to variations in sustained virologic response rates, discount rates and age at treatment.
Adding boceprevir to PR was projected to reduce the number of liver complications and liver-related deaths, and to be cost effective in treating both previously untreated and treated patients.
两种蛋白酶抑制剂博赛匹韦和特拉匹韦的最近获批可能改变慢性丙型肝炎病毒（HCV）基因型 1 感染的治疗方法。
我们评估了在葡萄牙，与单用聚乙二醇干扰素加利巴韦林（PR）相比，博赛匹韦联合 PR 治疗 HCV 基因型 1 感染的长期临床结局和成本效益，并与产品特性摘要中欧洲药品管理局概述的治疗策略进行比较。
我们建立了一个马尔可夫模型，以预测单用 PR 以及博赛匹韦产品特性摘要中概述的治疗策略的预期终生成本和质量调整生命年（QALY），这些治疗策略根据患者是否既往接受过治疗以及是否患有代偿性肝硬化而有所不同。基于 SPRINT-2、RESPOND-2 和 PROVIDE 这三项博赛匹韦临床试验的治疗相关数据来模拟不同的博赛匹韦治疗策略。通过召集一组专家来确定 HCV 健康状况的资源利用，并将结果乘以国家单位成本，从而估算出葡萄牙特有的 HCV 健康状况的年度直接医疗成本。该模型从医疗保健系统的角度出发，时间范围与患者剩余寿命相对应。未来成本和 QALY 均以 5%贴现。为了检验结论的稳健性，我们进行了确定性和概率敏感性分析。
与单用 PR 相比，博赛匹韦方案预计将使晚期肝病、肝移植和与肝脏相关的死亡的终生发生率降低 45-51%，并使预期寿命延长 2.3-4.3 年。虽然添加 BOC 会使治疗费用增加 13300-19700 欧元，但疾病负担的减轻导致每个患者的折扣健康状态成本降低 5400-9000 欧元，折扣 QALY 增加 0.68-1.23。在未接受治疗和接受过治疗的患者中，博赛匹韦方案的增量成本效益比与 PR 相比分别为 11600 欧元/QALY 和 8700 欧元/QALY。结果对持续病毒学应答率、贴现率和治疗时的年龄等因素的变化最为敏感。
博赛匹韦联合 PR 可降低肝脏并发症和与肝脏相关的死亡数量，并在治疗未接受治疗和接受过治疗的患者方面具有成本效益。
