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医疗器械采购招标:使成本效益规则适应欧洲公共采购指令的要求。

Tenders for the Procurement of Medical Devices: Adapting Cost-Effectiveness Rules to the Requirements of the European Public Procurement Directive.

机构信息

HTA Unit, ESTAR and University of Florence, Regional Health System, Via di San Salvi 12, 50100, Florence, Italy.

出版信息

Ther Innov Regul Sci. 2020 Jan;54(1):226-231. doi: 10.1007/s43441-019-00049-7. Epub 2020 Jan 6.

DOI:10.1007/s43441-019-00049-7
PMID:32008234
Abstract

BACKGROUND

In evaluating 3 or more comparators, pharmacoeconomic analyses can be improved by using the methodology of net monetary benefit (NMB) as opposed to incremental cost-effectiveness ratio (ICER). NMB is particularly suitable for managing competitive tenders that evaluate 3 or more devices in the same lot. For scientific purposes, the methodology of NMB is perfectly adequate. However, when tenders are managed in European countries, the Public Procurement Directive states that the tender score for price should be kept separate from that of clinical benefits. As a result, the traditional mathematical approach of NMB must be rearranged to comply with this administrative requirement.

METHODS

In this report, we describe how the classic equations of NMB should be modified to achieve this purpose. The mathematical principle of proportionality, which is typical of the ICER, must be replaced by the principle of mathematical additivity, which is typical of NMB. Furthermore, to rearrange the scale of benefits according to the NMB, an estimate is needed of the minimum acceptable benefit converted into monetary units, which is associated with 0 in the benefit scale.

RESULTS

A detailed example is presented to explain the practical application of these mathematical equations. These equations are widely applicable in the field of implantable devices.

CONCLUSION

Since the expenditure for medical devices in European hospitals is close to that of hospital medicines, tenders for the in-hospital procurement of devices may represent a decisive tool to manage sustainability and ensure access to innovation. In this context, the methodology for managing clinical outcomes through tenders requires a specific mathematical approach that we have described in the present article.

摘要

背景

在评估 3 个或更多对照时,与增量成本效益比(ICER)相比,净货币效益(NMB)方法可改善药物经济学分析。NMB 特别适合于管理竞争性招标,这些招标评估同一批次中的 3 个或更多设备。就科学目的而言,NMB 方法是完全足够的。但是,在欧洲国家管理招标时,《公共采购指令》规定,应将价格招标评分与临床效益评分分开。因此,必须重新排列 NMB 的传统数学方法以符合此管理要求。

方法

在本报告中,我们描述了如何修改经典 NMB 方程以达到此目的。NMB 典型的数学加性原则必须替代典型的 ICER 比例性数学原则。此外,为了根据 NMB 重新排列效益规模,需要估计转换为货币单位的最小可接受效益,这与效益规模中的 0 相关联。

结果

详细示例说明了这些数学方程的实际应用。这些方程在植入式设备领域具有广泛的适用性。

结论

由于欧洲医院医疗器械的支出接近医院药品的支出,因此医院内部采购设备的招标可能是管理可持续性和确保创新机会的决定性工具。在这种情况下,通过招标管理临床结果的方法需要我们在本文中描述的特定数学方法。

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