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再包装玻璃体内注射贝伐单抗的供应链波动:美国视网膜专家协会的一项调查

Supply Chain Volatility of Repackaged Intravitreal Bevacizumab: A Survey of the American Society of Retina Specialists.

作者信息

Al-Khersan Hasenin, Busquets Miguel, Ghorayeb Ghassan, Gong Dan, Kolomeyer Anton, Leung Ella H, Niles Philip, Patel Nimesh A, Shah Ankoor R, Wykoff Charles C, Blim Jill, Jumper Michael, Lai Michael M

机构信息

Retina Consultants of Texas, Houston, TX, USA.

Retina Associates of Kentucky, EyeCare Partners, Lexington, KY, USA.

出版信息

J Vitreoretin Dis. 2025 Jul 8:24741264251352889. doi: 10.1177/24741264251352889.

Abstract

To characterize retina specialists' perceptions of the intravitreal (IVT) bevacizumab supply chain after the manufacturer, Pine Pharmaceuticals, announced they would no longer produce the formulation. A 22-question survey was created to assess retina physicians' use of IVT bevacizumab, perceptions of the supply chain, and how the decision will affect patient care. The survey was electronically distributed to all members of the American Society of Retina Specialists. The survey was completed by 287 retina specialists. In the 3 months before the survey, 194 (67.6%) physicians reported receiving IVT bevacizumab from Pine Pharmaceuticals. Approximately 85% of physicians were either very concerned (158 [55.4%]) or concerned (85 [29.8%]) about their access to the medication in the next 3 months. Most physicians anticipated needing to delay or change patient appointments (142 [50.4%]) or change patient treatment plans (179 [63.9%]) because of shortages of IVT bevacizumab. Respondents overwhelmingly believed that patients with step-therapy requirements were most likely to be affected by appointment delays (119 [83.8%]) and changes in treatment plans (140 [78.2%]). The majority of retina specialists surveyed expect the decision to halt production of IVT bevacizumab will significantly disrupt access to the medication and adversely affect patient care. Most physicians predict delays and changes in treatment, particularly for patients with IVT bevacizumab step-therapy requirements. Therefore, to minimize negative effects on patient care, we recommend that carriers suspend step-therapy requirements, especially given that the disruption to the supply chain is likely to be longstanding.

摘要

在制造商派恩制药公司宣布将不再生产玻璃体内(IVT)贝伐单抗制剂后,了解视网膜专家对该制剂供应链的看法。为此设计了一项包含22个问题的调查问卷,以评估视网膜医生对IVT贝伐单抗的使用情况、对供应链的看法,以及这一决定将如何影响患者护理。该调查问卷通过电子方式分发给美国视网膜专家协会的所有成员。共有287名视网膜专家完成了调查。在调查前的3个月里,194名(67.6%)医生报告从派恩制药公司获得了IVT贝伐单抗。约85%的医生对未来3个月获取该药物的情况非常担忧(158名[55.4%])或有所担忧(85名[29.8%])。大多数医生预计,由于IVT贝伐单抗短缺,需要推迟或更改患者预约(142名[50.4%])或更改患者治疗方案(179名[63.9%])。受访者压倒性地认为,有阶梯治疗要求的患者最有可能受到预约延迟(119名[83.8%])和治疗方案更改(140名[78.2%])的影响。大多数接受调查的视网膜专家预计,停止生产IVT贝伐单抗的决定将严重扰乱该药物的获取,并对患者护理产生不利影响。大多数医生预测治疗会出现延迟和更改,尤其是对于有IVT贝伐单抗阶梯治疗要求的患者。因此,为尽量减少对患者护理的负面影响,我们建议医保机构暂停阶梯治疗要求,特别是考虑到供应链中断可能会持续很长时间。

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