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骨科生物制剂不断发展领域中富血小板血浆的经济学与监管

The Economics and Regulation of PRP in the Evolving Field of Orthopedic Biologics.

作者信息

Jones Ian A, Togashi Ryan C, Thomas Vangsness C

机构信息

Department of Orthopaedic Surgery, Keck School of Medicine of USC, HCT 1520 San Pablo Street, Suite 2000, Los Angeles, CA, 90033, USA.

出版信息

Curr Rev Musculoskelet Med. 2018 Dec;11(4):558-565. doi: 10.1007/s12178-018-9514-z.

Abstract

PURPOSE OF REVIEW

This review provides an update on the current status of platelet-rich plasma (PRP). Topics covered include the current regulatory environment, economic outlook, and current clinical evidence.

RECENT FINDINGS

The global PRP market is expected to grow to between 380 million and 4.5 billion (USD) over the next 5-10 years. The cost of a single treatment, which is not covered by most insurance, is roughly $500-$2500, with patients often returning for additional treatments. While PRP is not 'FDA-approved', it can be legally offered in the clinic 'off-label' in the USA for a myriad of musculoskeletal indications. Recently published meta-analyses have demonstrated statistically significant improvements that, in some cases, suggest that PRP may have clinically meaningful effects. However, given the fact that clearance is not synonymous with approval, PRP is a costly treatment not covered by insurance, and clinical trials have not demonstrated definitive efficacy, we recommend informing patients when providing PRP 'off-label'.

摘要

综述目的

本综述提供了富血小板血浆(PRP)的当前状况更新。涵盖的主题包括当前的监管环境、经济前景和当前的临床证据。

最新发现

预计在未来5至10年内,全球PRP市场将增长至3.8亿至45亿美元之间。单次治疗费用约为500至2500美元,大多数保险不涵盖此项费用,患者常常需要再次接受治疗。虽然PRP未获得“美国食品药品监督管理局(FDA)批准”,但在美国临床上可合法地“超适应症”用于多种肌肉骨骼适应症。最近发表的荟萃分析显示出具有统计学意义的改善,在某些情况下表明PRP可能具有临床意义上的效果。然而,鉴于获批并不等同于获得批准,PRP是一种保险不涵盖的昂贵治疗方法,且临床试验尚未证明其确切疗效,我们建议在“超适应症”提供PRP时告知患者。

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