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[德国 licensed 玻璃体内疗法治疗抗血管内皮生长因子反应不足的累及黄斑中心凹糖尿病性黄斑水肿的成本比较] (注:“licensed”在这里不太明确准确含义,可能是有特定品牌之类的意思,这里暂且保留英文未翻译得很准确)

[Cost Comparison of Licensed Intravitreal Therapies for Insufficiently Anti-VEGF Responding Fovea Involving Diabetic Macular Edema in Germany].

作者信息

Neubauer Aljoscha S, Haritoglou Christos, Ulbig Michael W

机构信息

Praxis für Augenheilkunde und Institut für Gesundheitsökonomie (IfG), München.

Augenklinik Herzog Carl Theodor, München.

出版信息

Klin Monbl Augenheilkd. 2019 Feb;236(2):180-191. doi: 10.1055/s-0043-125076. Epub 2018 Feb 16.

Abstract

BACKGROUND

In the treatment of center-involving diabetic macular edema, despite initial therapy with an anti-VEGF compound, an insufficient response may occur. Further therapy options include a switch of anti-VEGF products or to corticosteroid implants, such as Fluocinolone acetonide or Dexamethasone.

OBJECTIVES

Firstly, to investigate systematically which evidence-based study data are available describing the efficacy of in-label treatments after primary anti-VEGF treatment, secondly, to investigate which costs go along for the healthcare provider.

METHODS

A systematic literature review (SLR) for randomized controlled trials (RCT) was performed in Medline and Embase. A short-term cost-cost model was built in MS Excel with a 3 year time horizon to compare in-label intravitreal options Ranibizumab (Lucentis), Aflibercept (Eylea), Fluocinolone acetonide implant (Iluvien), and Dexamethasone implant (Ozurdex). Cost components comprised of drug and injection costs, optical coherence tomography (OCT) procedures, and adverse events such as endophthalmitis, IOP-lowering drugs and surgery and cataract surgery.

RESULTS

A total of 42 publications of 20 RCTs were identified. No study had a clearly defined population after first line anti-VEGF treatment, thus no direct efficacy comparison was possible. In the short-term cost-cost model total costs were 17,542 € for Ranibizumab, 15,896 € for Aflibercept, 10,826 € for Fluocinolone acetonide implant and 12,365 € for Dexamethasone implant. For all treatment regimens, drug costs were the predominant cost component, followed by injection costs (with variations dependent on the specific drug) and OCT costs. In the uni- and multivariate sensitivity analyses, the results obtained were robust to changes of model inputs.

CONCLUSIONS

In summary, the short-term cost-cost comparison demonstrates that steroid implants can provide significant cost savings versus in-label anti-VEGF treatment for center-involving diabetic macular edema. Single application of the long-lasting Fluocinolone acetonide implant is the most cost-efficient in-label treatment option.

摘要

背景

在治疗累及黄斑中心的糖尿病性黄斑水肿时,尽管初始采用抗血管内皮生长因子(VEGF)化合物进行治疗,但仍可能出现疗效不足的情况。进一步的治疗选择包括更换抗VEGF产品或使用皮质类固醇植入物,如醋酸氟轻松或地塞米松。

目的

第一,系统研究有哪些基于证据的研究数据描述了初次抗VEGF治疗后标签内治疗的疗效;第二,调查医疗服务提供者所需承担的成本。

方法

在Medline和Embase数据库中对随机对照试验(RCT)进行系统文献综述(SLR)。在MS Excel中构建了一个为期3年的短期成本-成本模型,以比较标签内玻璃体内注射药物雷珠单抗(Lucentis)、阿柏西普(Eylea)、醋酸氟轻松植入物(Iluvien)和地塞米松植入物(Ozurdex)。成本组成包括药物和注射成本、光学相干断层扫描(OCT)检查费用,以及诸如眼内炎、降眼压药物和手术及白内障手术等不良事件的费用。

结果

共识别出20项RCT的42篇出版物。没有研究对一线抗VEGF治疗后的人群进行明确定义,因此无法进行直接疗效比较。在短期成本-成本模型中,雷珠单抗的总成本为17,542欧元,阿柏西普为15,896欧元,醋酸氟轻松植入物为10,826欧元,地塞米松植入物为12,365欧元。对于所有治疗方案,药物成本是主要的成本组成部分,其次是注射成本(因具体药物而异)和OCT成本。在单变量和多变量敏感性分析中,所得结果对模型输入的变化具有稳健性。

结论

总之,短期成本-成本比较表明,对于累及黄斑中心的糖尿病性黄斑水肿,与标签内抗VEGF治疗相比,类固醇植入物可显著节省成本。单次应用长效醋酸氟轻松植入物是最具成本效益的标签内治疗选择。

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