School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, Jiangsu, China.
PLoS One. 2018 Apr 10;13(4):e0195117. doi: 10.1371/journal.pone.0195117. eCollection 2018.
Hepatitis C is the second fastest growing infectious disease in China. The standard-of-care for chronic hepatitis C in China is Pegylated interferon plus ribavirin (PR), which is associated with tolerability and efficacy issues. An interferon- and ribavirin-free, all-oral regimen comprising daclatasvir (DCV) and asunaprevir (ASV), which displays higher efficacy and tolerability, has recently been approved in China.
This study is to estimate the cost-effectiveness of DCV+ASV (24 weeks) for chronic hepatitis C genotype 1b treatment-naïve patients compared with PR regimen (48 weeks) in China.
A cohort-based Markov model was developed from Chinese payer perspective to project the lifetime outcomes of treating 10,000 patients with an average age of 44.5 with two hypothetical regimens, DCV+ASV and PR. Chinese-specific health state costs and efficacy data were used. The annual discount rate was 5%. Base-case analysis and sensitivity analysis were conducted.
For HCV Genotype 1b treatment-naïve patients, DCV+ASV proved to be dominant over PR, with a cost saving of ¥33,480(5,096 USD) and gains in QALYs and life years of 1.29 and 0.85, respectively. The lifetime risk of compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma and liver-related death was greatly reduced with DCV+ASV. Univariate sensitivity analysis demonstrated that key influencers were the discount rate, time horizon, initial disease severity and sustained virological response rate of DCV+ASV, with all scenarios resulting in additional benefit. Probabilistic sensitivity analysis demonstrated that DCV+ASV has a high likelihood (100%) of being cost-effective.
DCV+ASV is not only an effective and well-tolerated regimen to treat chronic HCV genotype 1b infection treatment-naïve patients, but also is more cost-effective than PR regimen. DCV+ASV can benefit both the public health and reimbursement system in China.
在中国,丙型肝炎是增长第二快的传染病。中国慢性丙型肝炎的标准治疗方法是聚乙二醇干扰素联合利巴韦林(PR),但这种方法存在耐受性和疗效问题。最近,一种无干扰素和利巴韦林、全口服的达卡他韦(DCV)和阿舒瑞韦(ASV)方案在我国获得批准,该方案显示出更高的疗效和耐受性。
本研究旨在评估与 PR 方案(48 周)相比,DCV+ASV(24 周)治疗慢性丙型肝炎基因型 1b 初治患者的成本效益。
从中国支付者的角度出发,建立了一个基于队列的马尔可夫模型,以预测两种假设方案(DCV+ASV 和 PR)治疗 10000 名平均年龄为 44.5 岁的患者的终生结局。使用了中国特有的健康状态成本和疗效数据。年贴现率为 5%。进行了基础案例分析和敏感性分析。
对于丙型肝炎基因型 1b 初治患者,DCV+ASV 方案优于 PR 方案,节省了 33480 元人民币(5096 美元),并增加了 1.29 个 QALY 和 0.85 个生命年。使用 DCV+ASV 可大大降低代偿性肝硬化、失代偿性肝硬化、肝细胞癌和与肝脏相关的死亡风险。单变量敏感性分析表明,关键影响因素是贴现率、时间范围、DCV+ASV 的初始疾病严重程度和持续病毒学应答率,所有方案均产生了额外的收益。概率敏感性分析表明,DCV+ASV 极有可能(100%)具有成本效益。
DCV+ASV 不仅是一种有效且耐受性良好的治疗慢性丙型肝炎基因型 1b 感染初治患者的方案,而且比 PR 方案更具成本效益。DCV+ASV 可以使中国的公共卫生和报销系统受益。