口服直接作用抗病毒药物治疗中国慢性丙型肝炎患者的成本效果分析。
Cost-Effectiveness Analysis of Oral Direct-Acting Antivirals for Chinese Patients with Chronic Hepatitis C.
机构信息
Department of Health Economics, China Pharmaceutical University, Nanjing, China.
Center for Pharmacoeconomics and Outcomes Research, China Pharmaceutical University, Nanjing, China.
出版信息
Appl Health Econ Health Policy. 2021 May;19(3):371-387. doi: 10.1007/s40258-020-00623-3. Epub 2020 Nov 19.
BACKGROUND AND OBJECTIVE
All oral direct-acting antivirals (DAAs) have shown excellent efficacy and safety in Chinese patients with chronic hepatitis C (CHC). However, the cost of DAAs used to be expensive; therefore, large numbers of patients had no access to DAAs in China. Recently, prices have been greatly reduced. The objective of this study was to evaluate the cost-effectiveness of ledipasvir/sofosbuvir (LDV/SOF), sofosbuvir/velpatasvir (SOF/VEL), elbasvir/grazoprevir (EBR/GZR) and glecaprevir/pibrentasvir (GLE/PIB) in Chinese CHC patients stratified by hepatitis C virus (HCV) genotype (GT), cirrhosis status, and treatment history.
METHODS
On the basis of a Chinese healthcare perspective, a Markov model was constructed to estimate the lifetime costs and health outcomes of patients treated with different DAA regimens. Chinese-specific clinical, cost, and utility inputs were obtained or calculated from published sources and expert opinions. Costs, life-years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were reported as primary outcomes. Base-case analysis and sensitivity analysis were conducted.
RESULTS
At a willing-to-pay (WTP) threshold of US$30,081/QALY (calculated by three times the GDP per capita in China), SOF/VEL was cost-effective in patients with HCV GT 1, 3, and 6 infections, and the probabilities that SOF/VEL was cost-effective were 9.7-75.7%, 39.1-63.9%, and 35.6-88.0%, respectively. For GT2 patients, noncirrhotic patients, treatment-naïve patients, and treatment-experienced patients, LDV/SOF was the most cost-effective regimen, and the probabilities of cost-effectiveness for each of these groups was 92.1-99.8%, 89.9-99.0%, 61.6-91.2%, and 99.3-100.0%, respectively below the WTP threshold. The GLE/PIB regimen (12-week duration) was the most cost-effective in cirrhotic patients, whereas the probability of its cost-effectiveness varied with that of EBR/GZR (4.1-93.8% versus 6.2-93.3%) below the WTP threshold.
CONCLUSIONS
Overall, SOF/VEL and LDV/SOF regimens are more likely to be cost-effective among various subgroups of Chinese patients with CHC.
背景和目的
所有的口服直接作用抗病毒药物（DAAs）在慢性丙型肝炎（CHC）中国患者中均显示出良好的疗效和安全性。然而，DAAs 的成本曾经很高；因此，中国有大量的患者无法获得 DAAs。最近，价格大幅降低。本研究的目的是评估在中国丙型肝炎病毒（HCV）基因型（GT）、肝硬化状态和治疗史分层的 CHC 患者中，使用 ledipasvir/sofosbuvir（LDV/SOF）、sofosbuvir/velpatasvir（SOF/VEL）、elbasvir/grazoprevir（EBR/GZR）和 glecaprevir/pibrentasvir（GLE/PIB）治疗的成本效益。
方法
基于中国医疗保健视角，构建了一个马尔可夫模型，以估计接受不同 DAA 方案治疗的患者的终生成本和健康结果。从已发表的来源和专家意见中获得或计算了中国特有的临床、成本和效用输入。主要结果为成本、生命年（LY）、质量调整生命年（QALY）和增量成本效益比（ICER）。进行了基础案例分析和敏感性分析。
结果
在支付意愿（WTP）阈值为 30081 美元/QALY（根据中国人均 GDP 的三倍计算）时，SOF/VEL 在 HCV GT1、3 和 6 感染患者中具有成本效益，SOF/VEL 具有成本效益的概率分别为 9.7-75.7%、39.1-63.9%和 35.6-88.0%。对于 GT2 患者、非肝硬化患者、初治患者和治疗经验丰富的患者，LDV/SOF 是最具成本效益的方案，对于这些患者组，成本效益的概率分别为 92.1-99.8%、89.9-99.0%、61.6-91.2%和 99.3-100.0%，均低于 WTP 阈值。GLE/PIB 方案（12 周疗程）在肝硬化患者中最具成本效益，而在支付意愿阈值以下，EBR/GZR 的成本效益概率为 4.1-93.8%（相比之下为 6.2-93.3%）。
结论
总体而言，SOF/VEL 和 LDV/SOF 方案在 HCV 中国患者的各个亚组中更有可能具有成本效益。
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