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The NICE recommendation for drug-coated balloons and its global impact

机译：NICE关于药物涂层气球的建议及其全球影响

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摘要

The clinical efficacy and safety of drug-coated balloon (DCB) angioplasty in patients with coronary in-stent restenosis (ISR) has been demonstrated. The objective of this article is to provide comparative cost efficacy data for DCB angioplasty in various countries based on the original methodology of the Medical Technologies Evaluation Programme (MTEP) at the National Institute for Health and Clinical Excellence (NICE) in 2010. Published and unpublished Health Technology Assessment (HTA) reports were evaluated for comparison in selected countries. Furthermore, a systematic review of economic evaluations of DCB angioplasty versus standard treatments (uncoated balloon angioplasty or drug-eluting stent implantations) was conducted. National cost efficacy data were evaluated using Markov state transition models which were adapted to fit each country’s device and procedure related costs. The clinical input for adverse events was defined with two relevant trials for in-stent restenosis of bare metal stents (BMS-ISR) and of drug-eluting stents (DES-ISR). In the UK, Germany, Switzerland, South Africa, Japan and Brazil, DCB angioplasty is cost-effective when compared with drug-eluting stents to treat either BMS-ISR or DES-ISR. DCB angioplasty ought to be the preferred treatment option for patients with BMS-ISR and DES-ISR from the payers’ point of view.
机译：已证明药物涂层球囊（DCB）血管成形术在冠状动脉支架内再狭窄（ISR）患者中的临床疗效和安全性。本文的目的是根据2010年美国国家卫生与临床卓越研究所（NICE）的医学技术评估计划（MTEP）的原始方法，提供不同国家DCB血管成形术的成本效益比较数据。已出版和未出版评估了卫生技术评估（HTA）报告，以在选定的国家中进行比较。此外，对DCB血管成形术与标准疗法（未涂层球囊血管成形术或药物洗脱支架植入物）的经济评价进行了系统评价。使用马尔可夫状态转换模型评估了国家成本效益数据，该模型适用于每个国家/地区与设备和程序相关的成本。通过两项有关裸金属支架（BMS-ISR）和药物洗脱支架（DES-ISR）的支架内再狭窄的相关试验定义了不良事件的临床输入。在英国，德国，瑞士，南非，日本和巴西，与药物洗脱支架治疗BMS-ISR或DES-ISR相比，DCB血管成形术具有成本效益。从付款人的角度来看，DCB血管成形术应该是BMS-ISR和DES-ISR患者的首选治疗选择。

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