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医疗器械采购中卫生技术评估的应用演变——全球系统评价:ISPOR 特别兴趣小组报告。

Evolving Use of Health Technology Assessment in Medical Device Procurement-Global Systematic Review: An ISPOR Special Interest Group Report.

机构信息

Endoscopy, Boston Scientific, Marlborough, MA, USA.

Economic Modeling, IQVIA, Gurgaon, India.

出版信息

Value Health. 2023 Nov;26(11):1581-1589. doi: 10.1016/j.jval.2023.06.005. Epub 2023 Jun 21.

Abstract

OBJECTIVES

To review the current academic evidence describing how data from health technology assessments (HTAs) informs procurement decisions for medical devices.

METHODS

A systematic literature review was performed to identify relevant studies and criteria used in medical device purchasing or procurement decisions. Included articles were screened for relevancy and risk of bias. The included studies were summarized qualitatively.

RESULTS

A total of 292 studies were screened, of which 11 matched the inclusion criteria. Included studies' geographies and HTA maturity varied. Some studies described hospital-level HTA processes, whereas others focused on national-level recommendations. Criteria for procurement decisions included standard HTA factors, such as efficacy, cost, cost-effectiveness, and budget impact; broader issues were also noted, including impact on the organization, ethical aspects, staff workload, and volume. There was little consideration of device-specific characteristics, such as life cycle, learning curve, or incremental technical innovation. Few decisions referred to HTA reports as part of the procurement decision; similarly, few HTA reports included a procurement perspective to help guide the procurement bodies.

CONCLUSIONS

There is minimal evidence that notes HTA influencing medical device procurement. Procurement bodies and hospitals may not be incentivized to publish their work and transparency could be improved; further research would better describe the link between HTA and procurement. Such research would enable the HTA agencies to meaningfully assess devices to target procurement bodies and allow device sponsors to prioritize evidence. This could limit redundancy, improve evidence, and ultimately promote savings to healthcare systems and expand access.

摘要

目的

回顾当前描述医疗技术评估 (HTA) 数据如何为医疗器械采购决策提供信息的学术证据。

方法

进行了系统文献回顾,以确定医疗器械采购或采购决策中使用的相关研究和标准。对纳入的文章进行了相关性和偏倚风险筛选。对纳入的研究进行了定性总结。

结果

共筛选出 292 篇研究,其中 11 篇符合纳入标准。纳入研究的地理位置和 HTA 成熟度存在差异。一些研究描述了医院层面的 HTA 流程,而另一些则侧重于国家层面的建议。采购决策的标准包括标准的 HTA 因素,如疗效、成本、成本效益和预算影响;还注意到了更广泛的问题,包括对组织的影响、伦理方面、员工工作量和数量。很少考虑到设备的具体特点,如生命周期、学习曲线或增量技术创新。很少有决策将 HTA 报告作为采购决策的一部分;同样,很少有 HTA 报告包括采购视角来帮助指导采购机构。

结论

几乎没有证据表明 HTA 影响医疗器械采购。采购机构和医院可能没有动力公布其工作,透明度可以提高;进一步的研究将更好地描述 HTA 和采购之间的联系。这种研究将使 HTA 机构能够对设备进行有意义的评估,以针对采购机构,并使设备赞助商能够优先考虑证据。这可以减少冗余,提高证据质量,最终为医疗保健系统节省资金并扩大获得医疗服务的机会。

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