Siebert Uwe, Sroczynski Gaby
Program on Health Technology Assessment and Decision Sciences, Bavarian Public Health Research and Coordinating Center, Institute of Medical Informatics, Biometry, and Epidemiology, Ludwig-Maximilians-University Munich, Germany.
Ger Med Sci. 2003 Nov 3;1:Doc07.
The purpose of this health technology assessment (HTA), commissioned by the German Agency for HTA at the German Federal Ministry of Health and Social Security, was to systematically review the evidence on effectiveness and cost-effectiveness of antiviral treatment (AVT) for initial chronic hepatitis C (CHC) and to apply these data in the context of the German health care system.
A systematic literature search was conducted to identify randomised controlled trials (RCTs), meta-analyses, and HTAs that evaluated initial AVT for CHC. A modified version of the German Hepatitis C Model (GEHMO)--a decision-analytic Markov model--was used to determine long-term morbidity, life expectancy, quality of life, costs and cost-effectiveness of different treatment strategies. Model parameters were derived from German databases, international RCTs, and a Cochrane Review.
Overall, 9 RCTs, 2 HTA reports, 1 Cochrane review, and 2 meta-analyses examining medical effectiveness of antiviral combination therapy, as well as 7 economic evaluations, met the inclusion criteria. These studies indicate that combination therapy with peginterferon plus ribavirin produced the highest sustained virological response rates (54-61%), followed by interferon plus ribavirin with 38-54%, and interferon monotherapy with 11-21%. Based on international cost-effectiveness studies, interferon plus ribavirin is cost-effective compared to interferon monotherapy. No published articles were available regarding cost-effectiveness of peginterferon plus ribavirin. In our decision analysis, these findings were confirmed and the discounted incremental cost-effectiveness ratio for peginterferon plus ribavirin was euro 9,800 per quality-adjusted life-year gained compared to interferon monotherapy (as the next best non-dominated strategy). Sensitivity analyses showed robust results across a wide range of model parameters.
This HTA suggests that initial combination therapy prolongs life, improves quality of life, and is cost-effective in patients with CHC. Combination of peginterferon and ribavirin is the most effective and efficient treatment strategy among the examined options.
这项由德国联邦卫生与社会保障部下属的德国卫生技术评估机构委托开展的卫生技术评估（HTA），旨在系统回顾关于初始慢性丙型肝炎（CHC）抗病毒治疗（AVT）有效性和成本效益的证据，并将这些数据应用于德国医疗保健系统的背景下。
进行了系统的文献检索，以识别评估CHC初始AVT的随机对照试验（RCT）、荟萃分析和卫生技术评估。使用德国丙型肝炎模型（GEHMO）的改良版——一种决策分析马尔可夫模型——来确定不同治疗策略的长期发病率、预期寿命、生活质量、成本和成本效益。模型参数源自德国数据库、国际RCT和一篇Cochrane综述。
总体而言，9项RCT、2份HTA报告、1篇Cochrane综述和2项荟萃分析检验了抗病毒联合疗法的医学有效性，以及7项经济评估符合纳入标准。这些研究表明，聚乙二醇干扰素联合利巴韦林的联合疗法产生了最高的持续病毒学应答率（54 - 61%），其次是干扰素联合利巴韦林，为38 - 54%，干扰素单药治疗为11 - 21%。基于国际成本效益研究，与干扰素单药治疗相比，干扰素联合利巴韦林具有成本效益。关于聚乙二醇干扰素联合利巴韦林的成本效益，没有已发表的文章。在我们的决策分析中，这些发现得到了证实，与干扰素单药治疗（作为次优的非劣势策略）相比，聚乙二醇干扰素联合利巴韦林每获得一个质量调整生命年的贴现增量成本效益比为9800欧元。敏感性分析表明，在广泛的模型参数范围内结果稳健。
这项卫生技术评估表明，初始联合疗法可延长CHC患者的生命、提高生活质量且具有成本效益。在所研究的选项中，聚乙二醇干扰素和利巴韦林联合是最有效且高效的治疗策略。
