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伊朗泛基因型通用直接作用抗病毒治疗方案治疗慢性丙型肝炎的经济性评价:成本效果研究。

Economic evaluation of pan-genotypic generic direct-acting antiviral regimens for treatment of chronic hepatitis C in Iran: a cost-effectiveness study.

机构信息

Health Services Management Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.

Middle East Liver Diseases (MELD) Center, Tehran, Iran.

出版信息

BMJ Open. 2022 Jun 8;12(6):e058757. doi: 10.1136/bmjopen-2021-058757.

Abstract

INTRODUCTION

Low-cost generic direct-acting antiviral (DAA) regimens for treatment of hepatitis C virus (HCV) are available in several low-income/middle-income countries, important for treatment scale-up. This study evaluated the cost-effectiveness of genotype-dependent and pan-genotypic DAA regimens in Iran as an example of a resource-limited setting.

METHODS

A Markov model was developed to simulate HCV natural history. A decision tree was developed for HCV treatment, assuming four scenarios, including scenario 1: genotyping, sofosbuvir/ledipasvir (SOF/LDV) for genotype 1, and sofosbuvir/daclatasvir (SOF/DCV) for genotype 3; scenario 2: genotyping, SOF/LDV for genotype 1, and sofosbuvir/velpatasvir (SOF/VEL) for genotype 3; scenario 3: no genotyping and SOF/DCV for all; and scenario 4: no genotyping and SOF/VEL for all. A 1-year cycle length was used to calculate the cumulative cost and effectiveness over a lifetime time horizon. We calculated quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER) using a health system perspective. Costs were converted to US dollars using purchasing power parity exchange rate ($PPP). All costs and outcomes were discounted at an annual rate of 3%.

RESULTS

Among people with no cirrhosis, scenario 3 had the minimum cost, compared with which scenario 4 was cost-effective with an ICER of 4583 $PPP per QALY (willingness-to-pay threshold: 9,311 $PPP per QALY). Among both people with compensated or decompensated cirrhosis, scenario 4 was cost saving. In sensitivity analysis, scenario 4 would be also cost-saving among people with no cirrhosis provided a 39% reduction in the cost of 12 weeks SOF/VEL.

CONCLUSION

Initiating all patients on pan-genotypic generic DAA regimens with no pretreatment genotyping was cost-effective compared with scenarios requiring pretreatment HCV genotype tests. Among generic pan-genotypic DAA regimens, SOF/VEL was cost-effective, for people with no cirrhosis and cost-saving for those with cirrhosis.

摘要

简介

在一些低收入和中等收入国家,已经有了价格低廉的通用直接作用抗病毒药物(DAA)疗法,用于治疗丙型肝炎病毒(HCV),这对扩大治疗规模很重要。本研究以资源有限的伊朗为例,评估了基于基因型和泛基因型的 DAA 疗法的成本效益。

方法

我们开发了一个 Markov 模型来模拟 HCV 的自然史。为 HCV 治疗开发了一个决策树,假设了四种情况,包括情况 1:进行基因分型,对于基因型 1 使用索磷布韦/维帕他韦(SOF/LDV),对于基因型 3 使用索磷布韦/达卡他韦(SOF/DCV);情况 2:进行基因分型,对于基因型 1 使用 SOF/LDV,对于基因型 3 使用索磷布韦/维帕他韦(SOF/VEL);情况 3:不进行基因分型,所有患者均使用 SOF/DCV;情况 4:不进行基因分型,所有患者均使用 SOF/VEL。采用 1 年的周期长度,在终生时间范围内计算累积成本和效果。我们从卫生系统角度计算了质量调整生命年(QALY)和增量成本效益比(ICER)。使用购买力平价汇率($PPP)将成本转换为美元。所有成本和结果均以每年 3%的贴现率贴现。

结果

在无肝硬化患者中,与方案 3 相比,方案 4 的成本最低,而方案 4 的增量成本效益比(ICER)为每 QALY 4583 美元 PPP(意愿支付阈值:每 QALY 9311 美元 PPP)。在代偿期和失代偿期肝硬化患者中,方案 4 也具有成本效益。在敏感性分析中,如果 12 周 SOF/VEL 的成本降低 39%,方案 4 在无肝硬化患者中也具有成本效益。

结论

与需要 HCV 基因型检测的方案相比,对所有患者初始使用无预处理基因分型的泛基因型通用 DAA 方案具有成本效益。在通用泛基因型 DAA 方案中,SOF/VEL 具有成本效益,对于无肝硬化患者具有成本效益,对于肝硬化患者具有成本节约。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c659/9185662/bdb2742ba116/bmjopen-2021-058757f01.jpg

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