Narendran Nirodhini, Bailey Clare, Downey Louise, Gale Richard, Kotagiri Ajay, Pearce Ian, Rennie Christina A, Sivaprasad Sobha, Talks James, Morgan-Warren Peter, Napier Jackie, O'Neil Carolyn, Seeborne Timothy
The Royal Wolverhampton NHS Trust, Wolverhampton, UK.
School of Life & Health Sciences, Aston University, Birmingham, UK.
Clin Ophthalmol. 2024 Nov 2;18:3133-3142. doi: 10.2147/OPTH.S481772. eCollection 2024.
The inclusion of ranibizumab biosimilars into National Health Service England commissioning recommendations published in 2022 created a need for expert guidance to optimize treatment outcomes in patients with neovascular age-related macular degeneration (nAMD) who otherwise may not have received first-line ranibizumab. This article provides a consensus treatment pathway supporting timely identification and management of a suboptimal response to these therapies, thereby aiming to facilitate clinically meaningful outcomes and efficient management of service capacity under specific circumstances where ranibizumab biosimilars may be initiated as a first-line treatment.
Two structured round-table meetings of UK medical retina specialists were held in person and virtually on September 22 and November 3, 2022, respectively. These meetings were organized and funded by Bayer.
The panel provided guidance on the implementation of an early treatment optimization pathway in cases where ranibizumab biosimilars are used as a first-line treatment, including recommendations on patient suitability and capacity requirements, and criteria for identification and strategies for management of a suboptimal response. The panel discussed the role of aflibercept treatment and its potential benefits and outlined recommendations on switching ranibizumab biosimilar suboptimal responders to an aflibercept treat-and-extend regimen, where appropriate.
Developed by a retinal expert panel, this early treatment optimization pathway provides guidance to facilitate optimal long-term patient outcomes while addressing capacity and resourcing constraints in circumstances of first-line ranibizumab biosimilar use for nAMD, including how aflibercept may be used in cases with a suboptimal response. Therefore, this fills an important gap in guidance on navigating the new treatment landscape.
2022年英国国家医疗服务体系(NHS)发布的委托采购建议中纳入了雷珠单抗生物类似药,这就需要专家指导,以优化新生血管性年龄相关性黄斑变性(nAMD)患者的治疗效果,否则这些患者可能无法接受一线雷珠单抗治疗。本文提供了一种共识性治疗路径,以支持及时识别和管理对这些疗法的次优反应,从而旨在促进在特定情况下实现具有临床意义的结果,并有效管理服务能力,在这些情况下,雷珠单抗生物类似药可能作为一线治疗药物启动使用。
分别于2022年9月22日和11月3日亲自组织并通过视频会议形式召开了两次英国医学视网膜专家结构化圆桌会议。这些会议由拜耳公司组织并资助。
专家组针对将雷珠单抗生物类似药用作一线治疗的情况,提供了关于实施早期治疗优化路径的指导意见,包括患者适用性和能力要求的建议,以及识别次优反应的标准和管理策略。专家组讨论了阿柏西普治疗的作用及其潜在益处,并概述了在适当情况下将雷珠单抗生物类似药治疗效果不佳的患者转换为阿柏西普治疗并延长方案的建议。
该早期治疗优化路径由视网膜专家小组制定,提供了指导意见,以促进患者获得最佳长期治疗效果,同时解决在将雷珠单抗生物类似药用于nAMD一线治疗的情况下的能力和资源限制问题,包括在次优反应情况下如何使用阿柏西普。因此,这填补了新治疗格局指导方面的一个重要空白。