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Ophthalmology. 2020 Jan;127(1):P66-P145. doi: 10.1016/j.ophtha.2019.09.025. Epub 2019 Sep 25.
3
Treatment outcomes and predicting factors for diabetic macular edema treated with ranibizumab - One-year real-life results in Taiwan.接受雷珠单抗治疗的糖尿病黄斑水肿的治疗结果和预测因素 - 台湾的一年真实世界研究结果。
J Formos Med Assoc. 2019 Jan;118(1 Pt 1):194-202. doi: 10.1016/j.jfma.2018.03.009. Epub 2018 Mar 30.
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Mechanisms of macular edema: Beyond the surface.黄斑水肿的机制:不止于表面。
Prog Retin Eye Res. 2018 Mar;63:20-68. doi: 10.1016/j.preteyeres.2017.10.006. Epub 2017 Nov 7.
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Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial.阿柏西普、贝伐单抗或雷珠单抗治疗糖尿病性黄斑水肿:一项比较疗效随机临床试验的两年结果。
Ophthalmology. 2016 Jun;123(6):1351-9. doi: 10.1016/j.ophtha.2016.02.022. Epub 2016 Feb 27.
6
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PLoS One. 2015 Jul 24;10(7):e0133968. doi: 10.1371/journal.pone.0133968. eCollection 2015.
7
Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema.阿柏西普、贝伐单抗或雷珠单抗治疗糖尿病性黄斑水肿。
N Engl J Med. 2015 Mar 26;372(13):1193-203. doi: 10.1056/NEJMoa1414264. Epub 2015 Feb 18.
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Clinical utilization of anti-vascular endothelial growth-factor agents and patient monitoring in retinal vein occlusion and diabetic macular edema.抗血管内皮生长因子药物在视网膜静脉阻塞和糖尿病性黄斑水肿中的临床应用及患者监测
Clin Ophthalmol. 2014 Aug 26;8:1611-21. doi: 10.2147/OPTH.S60893. eCollection 2014.
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Br J Ophthalmol. 2015 Feb;99(2):220-6. doi: 10.1136/bjophthalmol-2014-305327. Epub 2014 Sep 5.
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Twenty-four-month efficacy and safety of 0.5 mg or 2.0 mg ranibizumab in patients with subfoveal neovascular age-related macular degeneration.24 个月时 0.5mg 或 2.0mg 雷珠单抗治疗中心性浆液性脉络膜视网膜病变的疗效和安全性。
Ophthalmology. 2014 Nov;121(11):2181-92. doi: 10.1016/j.ophtha.2014.05.009. Epub 2014 Jul 9.

真实世界中雷珠单抗和阿柏西普治疗新生血管性年龄相关性黄斑变性和糖尿病性黄斑水肿的注射频率和费用。

Real-World Injection Frequency and Cost of Ranibizumab and Aflibercept for the Treatment of Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema.

机构信息

Weill Cornell Medical College, New York, New York.

IBM Watson Health, Cambridge, Massachusetts.

出版信息

J Manag Care Spec Pharm. 2020 Mar;26(3):253-266. doi: 10.18553/jmcp.2020.19245. Epub 2020 Feb 5.

DOI:10.18553/jmcp.2020.19245
PMID:32020843
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10390935/
Abstract

BACKGROUND

Ranibizumab and aflibercept are FDA-approved treatments for patients with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Although these agents differ in cost and labeled dosing, it is unclear whether these differences are reflected in clinical practice.

OBJECTIVE

To compare the real-world frequency and cost of ranibizumab and aflibercept injections among treatment-naive and previously treated patients with nAMD and DME.

METHODS

Claims data from MarketScan Research Databases were retrospectively reviewed to identify treatment-naive patients with nAMD who initiated intravitreal ranibizumab or aflibercept between January 1, 2014, and January 1, 2016, and treatment-naive patients with DME who initiated intravitreal ranibizumab or aflibercept between July 29, 2014, and July 1, 2016. Patients who switched to subsequent-line aflibercept or ranibizumab during the study period were eligible to enter previously treated subgroups. Multivariable regression models were derived to compare the per-patient frequency and cost of injections between ranibizumab- and aflibercept-treated patients with nAMD over 12 months (treatment-naive: n = 1,087 and n = 1,578; previously treated: n = 221 and n = 751) and 24 months (treatment-naive: n = 454 and n = 568; previously treated: n = 93 and n = 284) and in patients with DME over 6 months (treatment-naive: n = 507 and n = 681; previously treated: n = 53 and n = 223) and 12 months (treatment-naive: n = 326 and n = 382; previously treated: n = 24 and n = 122).

RESULTS

After adjusting for patient demographics and clinical characteristics, per-patient injection frequency and cost were not significantly different between treatment-naive patients with nAMD who received ranibizumab versus aflibercept over 12 months (5.62 vs. 5.54; = 0.52, and $11,351 vs. $10,702; = 0.06, respectively) and 24 months (7.86 vs. 8.37; = 0.16, and $16,286 vs. $16,666; = 0.69, respectively). In previously treated patients with nAMD, injection frequency was significantly lower among ranibizumab- versus aflibercept-treated patients over 24 months (7.98 vs. 9.63; = 0.03), whereas treatment costs were comparable over 12 months ($11,512 vs. $12,050; = 0.44) and 24 months ($16,303 vs. $19,361; = 0.13). In treatment-naive patients with DME, ranibizumab was associated with significantly fewer injections and lower costs than aflibercept over 6 months (2.60 vs. 2.92 and $3,379 vs. $5,925, respectively; both < 0.001) and 12 months (3.33 vs. 3.87 and $4,136 vs. $7,656, respectively; both < 0.001). Similar cost savings were observed among previously treated patients with DME who received ranibizumab over 6 months ($3,834 vs. $6,775 for aflibercept; = 0.0001) and 12 months ($4,606 vs. $9,190; = 0.02), despite nonsignificant differences in injection frequency during follow-up.

CONCLUSIONS

Although the frequency and cost of ranibizumab and aflibercept injections were generally comparable among patients treated for nAMD, ranibizumab was associated with estimated per-patient-per-year cost savings of $3,500-$4,500 in those treated for DME. Most patients received fewer injections than any FDA-indicated dosing schedule, suggesting potential undertreatment that may result in suboptimal vision outcomes.

DISCLOSURES

Study funding was provided by Genentech, a member of the Roche Group. The sponsor participated in the design of the study; collection, analysis, and interpretation of the data; preparation of the manuscript; and the decision to submit the article for publication. Kiss has been a consultant for and received honoraria from Alcon, Alimera, Allergan, BioMarin, Novartis, and Spark; has been on the advisory board for, a consultant for, received honoraria from, and held stock options in Adverum and Regenxbio; has been a consultant for, received honoraria from, and held stock/stock options in Fortress; has been on the advisory board for, a consultant and investigator for, and received grants and honoraria from Genentech and Regeneron; and has been on the advisory board for, a consultant for, and received grants and honoraria from Optos. Malangone-Monaco, Wilson, Varker, Stetsovsky, and Smith are employees of IBM Watson Health, which received funding from Genentech to undertake this study. Garmo is an employee of Genentech. Data reported in this manuscript were presented in part at the Academy of Managed Care Pharmacy (AMCP) Managed Care and Specialty Pharmacy Annual Meeting; April 23-26, 2018; Boston, MA.

摘要

背景

雷珠单抗和阿柏西普已获美国食品药品监督管理局批准,用于治疗新生血管性年龄相关性黄斑变性(nAMD)和糖尿病黄斑水肿(DME)患者。尽管这两种药物在成本和规定剂量上存在差异,但尚不清楚这些差异是否反映在临床实践中。

目的

比较治疗 nAMD 和 DME 的初治和既往治疗患者中雷珠单抗和阿柏西普注射的实际频率和成本。

方法

回顾性分析 MarketScan Research Databases 的索赔数据,以确定自 2014 年 1 月 1 日至 2016 年 1 月 1 日期间接受玻璃体腔内雷珠单抗或阿柏西普治疗的 nAMD 初治患者,以及自 2014 年 7 月 29 日至 2016 年 7 月 1 日接受玻璃体腔内雷珠单抗或阿柏西普治疗的 DME 初治患者。在研究期间转换为后续线阿柏西普或雷珠单抗治疗的患者符合进入既往治疗亚组的条件。采用多变量回归模型比较 nAMD 患者(初治:n = 1087 和 n = 1578;既往治疗:n = 221 和 n = 751)和 DME 患者(初治:n = 507 和 n = 681;既往治疗:n = 53 和 n = 223)在 12 个月和 24 个月(初治:n = 454 和 n = 568;既往治疗:n = 93 和 n = 284),以及 DME 患者在 6 个月(初治:n = 326 和 n = 382;既往治疗:n = 24 和 n = 122)和 12 个月(初治:n = 306 和 n = 382;既往治疗:n = 24 和 n = 122)的雷珠单抗和阿柏西普治疗患者的每患者注射频率和成本。

结果

在调整了患者的人口统计学和临床特征后,nAMD 初治患者接受雷珠单抗与阿柏西普治疗的 12 个月(5.62 与 5.54; = 0.52,和 11351 与 10702; = 0.06)和 24 个月(7.86 与 8.37; = 0.16,和 16286 与 16666; = 0.69)的注射频率和成本无显著差异。在 nAMD 既往治疗患者中,雷珠单抗治疗患者的注射频率在 24 个月时显著低于阿柏西普治疗患者(7.98 与 9.63; = 0.03),而 12 个月(11512 与 12050; = 0.44)和 24 个月(16303 与 19361; = 0.13)的治疗成本相当。在 DME 初治患者中,雷珠单抗的注射次数和成本均显著低于阿柏西普,6 个月(2.60 与 2.92 和 3379 与 5925,均 < 0.001)和 12 个月(3.33 与 3.87 和 4136 与 7656,均 < 0.001)。在 DME 既往治疗患者中,雷珠单抗治疗患者的注射频率在 6 个月(3834 与 6775,阿柏西普; = 0.0001)和 12 个月(4606 与 9190; = 0.02)时差异无统计学意义,但成本降低,与雷珠单抗治疗相比,估计每个患者每年节省 3500-4500 美元。

结论

尽管 nAMD 患者雷珠单抗和阿柏西普的注射频率和成本通常相似,但在 DME 患者中,雷珠单抗的治疗估计每个患者每年可节省 3500-4500 美元的成本。大多数患者接受的注射次数少于任何 FDA 规定的剂量方案,这表明可能存在治疗不足的情况,可能导致视力结果不理想。

披露

研究资金由罗氏集团成员基因泰克提供。赞助商参与了研究的设计;数据的收集、分析和解释;手稿的准备;以及提交文章供出版的决定。Kiss 曾担任 Alcon、Alimera、Allergan、BioMarin、Novartis 和 Spark 的顾问,并获得过这些公司的酬金;曾担任 Adverum、Regenxbio 的顾问、接受过这些公司的酬金并持有这些公司的股票期权;曾担任 Fortress 的顾问、接受过这些公司的酬金并持有这些公司的股票/股票期权;曾担任 Genentech 和 Regeneron 的顾问、研究员,并从这些公司获得过研究经费和酬金;曾担任 Optos 的顾问、研究员,并从这些公司获得过研究经费和酬金。Malangone-Monaco、Wilson、Varker、Stetsovsky 和 Smith 是 IBM Watson Health 的员工,该公司获得了基因泰克的资助,以进行这项研究。Garmo 是基因泰克的员工。本文报告的数据部分在 2018 年 4 月 23 日至 26 日举行的美国医疗保健管理协会(AMCP)管理式医疗和专科药房年会;波士顿,MA 上发表。