Expert Panel Consensus for Optimizing Outcomes in Neovascular Age-Related Macular Degeneration in the Context of Suboptimal Response to a Biosimilar: The Role of Aflibercept

Abstract

Nirodhini Narendran,1,2 Clare Bailey,3 Louise Downey,4 Richard Gale,5 Ajay Kotagiri,6 Ian Pearce,7 Christina A Rennie,8 Sobha Sivaprasad,9 James Talks,10 Peter Morgan-Warren,11 Jackie Napier,11 Carolyn O’Neil,11 Timothy Seeborne11 1The Royal Wolverhampton NHS Trust, Wolverhampton, UK; 2School of Life & Health Sciences, Aston University, Birmingham, UK; 3University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK; 4Hull University Teaching Hospitals NHS Trust, Hull, UK; 5York and Scarborough Teaching Hospitals NHS Foundation Trust, York, UK; 6South Tyneside and Sunderland NHS Foundation Trust, Sunderland, UK; 7Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK; 8University Hospital Southampton NHS Foundation Trust, Southampton, UK; 9NIHR Moorfields Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK; 10Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK; 11Bayer plc, Reading, UKCorrespondence: Nirodhini Narendran, Ophthalmology Department, New Cross Hospital (Part of the Royal Wolverhampton NHS Trust), Wolverhampton Road, Wolverhampton, WV10 0QP, UK, Email [email protected]: 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.Methods: 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.Results: 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.Conclusion: 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.Keywords: anti-VEGF agents, capacity, consensus pathway, ranibizumab

Keywords

• anti-vegf agents
• capacity
• consensus pathway
• ranibizumab