Stahmeyer Jona T, Rossol Siegbert, Liersch Sebastian, Guerra Ines, Krauth Christian
Institute for Epidemiology, Social Medicine and Health Systems Research; Hannover Medical School; Hannover; Germany.
Department of Internal Medicine; Krankenhaus Nordwest; Steinbacher Hohl 2-26; Frankfurt am Main; Germany.
PLoS One. 2017 Jan 3;12(1):e0169401. doi: 10.1371/journal.pone.0169401. eCollection 2017.
Infections with the hepatitis C virus (HCV) are a global public health problem. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. Newly introduced direct acting antivirals, especially interferon-free regimens, have improved rates of sustained viral response above 90% in most patient groups and allow treating patients who were ineligible for treatment in the past. These new regimens have replaced former treatment and are recommended by current guidelines. However, there is an ongoing discussion on high pharmaceutical prices. Our aim was to assess the long-term cost-effectiveness of treating hepatitis C genotype 1 patients with sofosbuvir/ledipasvir (SOF/LDV) treatment in Germany.
We used a Markov cohort model to simulate disease progression and assess cost-effectiveness. The model calculates lifetime costs and outcomes (quality-adjusted life years, QALYs) of SOF/LDV and other strategies. Patients were stratified by treatment status (treatment-naive and treatment-experienced) and absence/presence of cirrhosis. Different treatment strategies were compared to prior standard of care. Sensitivity analyses were performed to evaluate model robustness.
Base-case analyses results show that in treatment-naive non-cirrhotic patients treatment with SOF/LDV dominates the prior standard of care (is more effective and less costly). In cirrhotic patients an incremental cost-effectiveness ratio (ICER) of 3,383 €/QALY was estimated. In treatment-experienced patients ICERs were 26,426 €/QALY and 1,397 €/QALY for treatment-naive and treatment-experienced patients, respectively. Robustness of results was confirmed in sensitivity analyses.
Our analysis shows that treatment with SOF/LDV is cost-effective compared to prior standard of care in all patient groups considering international costs per QALY thresholds.
丙型肝炎病毒（HCV）感染是一个全球性的公共卫生问题。其长期后果是发展为肝硬化和肝细胞癌。新推出的直接作用抗病毒药物，尤其是不含干扰素的治疗方案，在大多数患者群体中使持续病毒学应答率提高到了90%以上，并且能够治疗过去不符合治疗条件的患者。这些新方案已取代了以前的治疗方法，并被当前指南所推荐。然而，关于高昂的药价仍在持续讨论。我们的目的是评估在德国使用索磷布韦/维帕他韦（SOF/LDV）治疗丙型肝炎基因1型患者的长期成本效益。
我们使用马尔可夫队列模型来模拟疾病进展并评估成本效益。该模型计算SOF/LDV及其他治疗策略的终生成本和结局（质量调整生命年，QALYs）。患者按治疗状态（初治和经治）以及有无肝硬化进行分层。将不同的治疗策略与先前的标准治疗进行比较。进行敏感性分析以评估模型的稳健性。
基础病例分析结果显示，在初治无肝硬化的患者中，使用SOF/LDV治疗优于先前的标准治疗（更有效且成本更低）。在肝硬化患者中，估计增量成本效益比（ICER）为3383€/QALY。在经治患者中，初治和经治患者的ICER分别为26426€/QALY和1397€/QALY。敏感性分析证实了结果的稳健性。
我们的分析表明，考虑到国际上每QALY阈值的成本，与先前的标准治疗相比，在所有患者群体中使用SOF/LDV治疗具有成本效益。
