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从日本社会和患者角度看雷珠单抗生物类似药治疗新生血管性年龄相关性黄斑变性及其亚型的成本效益分析

Cost-effectiveness Analysis of Ranibizumab Biosimilar for Neovascular Age-Related Macular Degeneration and its Subtypes from the Societal and Patient Perspectives in Japan.

作者信息

Yanagi Yasuo, Takahashi Kanji, Iida Tomohiro, Gomi Fumi, Onishi Hiroshi, Morii Junko, Sakamoto Taiji

机构信息

Department of Ophthalmology and Micro-technology, Yokohama City University, Yokohama, Kanagawa, Japan.

Department of Ophthalmology, Kansai Medical University, Osaka, Japan.

出版信息

Ophthalmol Ther. 2024 Oct;13(10):2629-2644. doi: 10.1007/s40123-024-01011-z. Epub 2024 Aug 10.

Abstract

INTRODUCTION

This study evaluated the cost-effectiveness of anti-vascular endothelial growth factor (VEGF) therapies for subtypes of neovascular age-related macular degeneration (nAMD) from the societal perspective, and for any nAMD from the patient perspective in Japan.

METHODS

A Markov model was developed to simulate the lifetime transitions of a cohort of patients with nAMD through various health states based on the involvement of nAMD, the treatment status, and decimal best-corrected visual acuity. Ranibizumab biosimilar was compared with aflibercept from the societal perspective regardless of treatment regimen for the analysis of three subtypes (typical nAMD, polypoidal choroidal vasculopathy (PCV), and retinal angiomatous proliferation (RAP)). Two analyses from the patient perspective focusing on the treat-and-extend regimens were performed, one with a cap on patients' copayments and one without. Ranibizumab biosimilar was compared with branded ranibizumab, aflibercept, aflibercept as the loading dose switching to ranibizumab biosimilar during maintenance (aflibercept switching to ranibizumab biosimilar), and best supportive care (BSC), for patients with any nAMD.

RESULTS

In the subtype analyses, ranibizumab biosimilar when compared with aflibercept resulted in incremental quality-adjusted life years (QALYs) of - 0.015, 0.026, and 0.009, and the incremental costs of Japanese yen (JPY) - 50,447, JPY - 997,243, and JPY - 1,286,570 for typical nAMD, PCV, and RAP, respectively. From the patient perspective, ranibizumab biosimilar had incremental QALYs of 0.015, 0.009, and 0.307, compared with aflibercept, aflibercept switching to ranibizumab biosimilar, and BSC, respectively. The incremental costs for ranibizumab biosimilar over a patient lifetime excluding the cap on copayment were estimated to be JPY - 138,948, JPY - 391,935, JPY - 209,099, and JPY - 6,377,345, compared with branded ranibizumab, aflibercept, aflibercept switching to ranibizumab biosimilar, and BSC, respectively.

CONCLUSIONS

Ranibizumab biosimilar was demonstrated as a cost-saving option compared to aflibercept across all subtypes of nAMD, irrespective of the perspectives considered.

摘要

引言

本研究从社会角度评估了抗血管内皮生长因子(VEGF)疗法对新生血管性年龄相关性黄斑变性(nAMD)各亚型的成本效益,并从患者角度评估了其对日本所有nAMD患者的成本效益。

方法

建立了一个马尔可夫模型,以模拟一组nAMD患者基于nAMD的受累情况、治疗状态和小数最佳矫正视力,在不同健康状态下的终生转变。从社会角度比较了雷珠单抗生物类似药与阿柏西普,无论治疗方案如何,以分析三种亚型(典型nAMD、息肉状脉络膜血管病变(PCV)和视网膜血管瘤样增生(RAP))。从患者角度进行了两项侧重于治疗并延长方案的分析,一项对患者自付费用设限,另一项不设限。将雷珠单抗生物类似药与原研雷珠单抗、阿柏西普、维持期从阿柏西普转换为雷珠单抗生物类似药的阿柏西普(阿柏西普转换为雷珠单抗生物类似药)以及最佳支持治疗(BSC)进行比较,用于所有nAMD患者。

结果

在亚型分析中,与阿柏西普相比,雷珠单抗生物类似药导致的增量质量调整生命年(QALY)分别为-0.015、0.026和0.009,典型nAMD、PCV和RAP的增量成本分别为-50447日元、-997243日元和-1286570日元。从患者角度来看,与阿柏西普、阿柏西普转换为雷珠单抗生物类似药以及BSC相比,雷珠单抗生物类似药的增量QALY分别为0.015、0.009和0.307。与原研雷珠单抗、阿柏西普、阿柏西普转换为雷珠单抗生物类似药以及BSC相比,不包括自付费用上限的情况下,雷珠单抗生物类似药在患者一生中的增量成本估计分别为-138948日元、-391935日元、-209099日元和-6377345日元。

结论

无论从何种角度考虑,与阿柏西普相比,雷珠单抗生物类似药在所有nAMD亚型中均被证明是一种节省成本的选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cb98/11408455/5723b0e1156c/40123_2024_1011_Fig1_HTML.jpg

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