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德国 1 型丙型肝炎病毒感染者使用索非布韦的成本效益:已发表结果的重新分析。

Cost-effectiveness of sofosbuvir in hepatitis C genotype 1 infection in Germany: A reanalysis of published results.

机构信息

Frankfurt School of Finance & Management, Frankfurt, Germany.

出版信息

PLoS One. 2020 Oct 2;15(10):e0236543. doi: 10.1371/journal.pone.0236543. eCollection 2020.

Abstract

OBJECTIVES

Recently, the results of two economic evaluations were published both of which seemingly demonstrate the cost-effectiveness of sofosbuvir-based regimens for the treatment of chronic hepatitis C genotype 1 infection in Germany. Both analyses were sponsored by the manufacturer of sofosbuvir and use a different methodology: Whereas one evaluation is based on a conventional cost-utility analysis, the other rests upon the efficiency-frontier method used by the German Institute for Quality and Efficiency in Health Care (IQWiG). The purpose of this study is to reanalysis the results of both economic evaluations in combination.

DESIGN

Reanalysis of published decision modelling results.

SETTING

Primary care in Germany.

PARTICIPANTS

Patients with chronic hepatitis C genotype 1 infection (treatment-naïve and -experienced, cirrhotic and non-cirrhotic).

INTERVENTIONS

Sofosbuvir, other anti-hepatitis C virus drugs, and no treatment.

PRIMARY AND SECONDARY OUTCOME MEASURES

Cost per unit of health benefit and cost per quality-adjusted life year.

RESULTS

Reanalysis of the results of both economic evaluations in combination reveals an unclear rationale for choosing the selected cost-effectiveness methods as well as a potential publication bias, favoring the product of the manufacturer. Based on the reanalysis, sofosbuvir is not cost-effective in treatment-experienced non-cirrhotic patients, potentially lacks cost-effectiveness in treatment-experienced cirrhotic patients, and is only partially cost-effective in treatment-naïve non-cirrhotic patients. Taken together, these results indicate a lack of cost-effectiveness in three quarters of the German patient population.

CONCLUSIONS

Two economic evaluations on sofosbuvir suggest, in combination, that sofosbuvir cannot be considered a cost-effective treatment in three quarters of the German patient population.

摘要

目的

最近,两项经济评估的结果相继公布,这两项研究似乎都表明索非布韦为基础的方案治疗德国慢性丙型肝炎基因型 1 感染具有成本效益。这两项分析均由索非布韦的制造商赞助,并使用不同的方法:一项评估基于传统的成本效益分析,另一项则基于德国卫生保健质量和效率研究所(IQWiG)使用的效率前沿方法。本研究的目的是对这两项经济评估的结果进行联合再分析。

设计

对已发表的决策模型结果进行再分析。

设置

德国初级保健。

参与者

慢性丙型肝炎基因型 1 感染患者(初治和经治、肝硬化和非肝硬化)。

干预措施

索非布韦、其他抗丙型肝炎病毒药物和无治疗。

主要和次要结果测量

每单位健康效益的成本和每质量调整生命年的成本。

结果

对这两项经济评估结果进行联合再分析,发现选择所选成本效益方法的理由不明确,存在潜在的发表偏倚,有利于制造商的产品。基于再分析,索非布韦在经治非肝硬化患者中不具有成本效益,在经治肝硬化患者中可能缺乏成本效益,在初治非肝硬化患者中仅部分具有成本效益。综上所述,这些结果表明在四分之三的德国患者人群中缺乏成本效益。

结论

两项关于索非布韦的经济评估结果表明,联合起来,索非布韦不能被认为是四分之三的德国患者人群的一种具有成本效益的治疗方法。

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