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基于索磷布韦的治疗方案用于丙型肝炎病毒2型或3型感染的成本效益

The cost-effectiveness of sofosbuvir-based regimens for treatment of hepatitis C virus genotype 2 or 3 infection.

作者信息

Linas Benjamin P, Barter Devra M, Morgan Jake R, Pho Mai T, Leff Jared A, Schackman Bruce R, Horsburgh C Robert, Assoumou Sabrina A, Salomon Joshua A, Weinstein Milton C, Freedberg Kenneth A, Kim Arthur Y

出版信息

Ann Intern Med. 2015 May 5;162(9):619-29. doi: 10.7326/M14-1313.

DOI:10.7326/M14-1313
PMID:25820703
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4420667/
Abstract

BACKGROUND

Chronic infection with hepatitis C virus (HCV) genotype 2 or 3 can be treated with sofosbuvir without interferon. Because sofosbuvir is costly, its benefits should be compared with the additional resources used.

OBJECTIVE

To estimate the cost-effectiveness of sofosbuvir-based treatments for HCV genotype 2 or 3 infection in the United States.

DESIGN

Monte Carlo simulation, including deterministic and probabilistic sensitivity analyses.

DATA SOURCES

Randomized trials, observational cohorts, and national health care spending surveys.

TARGET POPULATION

8 patient types defined by HCV genotype (2 vs. 3), treatment history (naive vs. experienced), and cirrhosis status (noncirrhotic vs. cirrhotic).

TIME HORIZON

Lifetime.

PERSPECTIVE

Payer.

INTERVENTION

Sofosbuvir-based therapies, pegylated interferon-ribavirin, and no therapy.

OUTCOME MEASURES

Discounted quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs).

RESULTS OF BASE-CASE ANALYSIS: The ICER of sofosbuvir-based treatment was less than $100,000 per QALY in cirrhotic patients (genotype 2 or 3 and treatment-naive or treatment-experienced) and in treatment-experienced noncirrhotic patients but was greater than $200,000 per QALY in treatment-naive noncirrhotic patients.

RESULTS OF SENSITIVITY ANALYSIS

The ICER of sofosbuvir-based therapy for treatment-naive noncirrhotic patients with genotype 2 or 3 infection was less than $100,000 per QALY when the cost of sofosbuvir was reduced by approximately 40% and 60%, respectively. In probabilistic sensitivity analyses, cost-effectiveness conclusions were robust to uncertainty in treatment efficacy.

LIMITATION

The analysis did not consider possible benefits of preventing HCV transmission.

CONCLUSION

Sofosbuvir provides good value for money for treatment-experienced patients with HCV genotype 2 or 3 infection and those with cirrhosis. At their current cost, sofosbuvir-based regimens for treatment-naive noncirrhotic patients exceed willingness-to-pay thresholds commonly cited in the United States.

PRIMARY FUNDING SOURCE

National Institute on Drug Abuse and National Institute of Allergy and Infectious Diseases.

摘要

背景

丙型肝炎病毒(HCV)2型或3型的慢性感染可用索磷布韦进行无干扰素治疗。由于索磷布韦成本高昂,应将其益处与所使用的额外资源进行比较。

目的

评估美国基于索磷布韦治疗HCV 2型或3型感染的成本效益。

设计

蒙特卡洛模拟,包括确定性和概率性敏感性分析。

数据来源

随机试验、观察性队列研究和国家医疗保健支出调查。

目标人群

根据HCV基因型(2型与3型)、治疗史(初治与经治)和肝硬化状态(非肝硬化与肝硬化)定义的8种患者类型。

时间范围

终身。

视角

支付方。

干预措施

基于索磷布韦的疗法、聚乙二醇干扰素-利巴韦林和不进行治疗。

结局指标

贴现质量调整生命年(QALYs)、成本和增量成本效益比(ICERs)。

基线分析结果

对于肝硬化患者(基因型2或3型,初治或经治)以及经治的非肝硬化患者,基于索磷布韦治疗的ICER低于每QALY 100,000美元,但对于初治的非肝硬化患者,ICER高于每QALY 200,000美元。

敏感性分析结果

当索磷布韦成本分别降低约40%和60%时,基于索磷布韦治疗初治的基因型2或3型感染非肝硬化患者的ICER低于每QALY 100,000美元。在概率性敏感性分析中,成本效益结论对治疗效果的不确定性具有稳健性。

局限性

分析未考虑预防HCV传播的可能益处。

结论

对于HCV 2型或3型感染的经治患者以及肝硬化患者,索磷布韦物有所值。就目前成本而言,基于索磷布韦的初治非肝硬化患者治疗方案超出了美国通常提及的支付意愿阈值。

主要资金来源

国家药物滥用研究所和国家过敏与传染病研究所。

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