Cost-Effectiveness Analysis of Ranibizumab Biosimilar for Neovascular Age-Related Macular Degeneration in Japan

Yasuo Yanagi; Kanji Takahashi; Tomohiro Iida; Fumi Gomi; Junko Morii; Eriko Kunikane; Taiji Sakamoto

doi:10.1007/s40123-023-00715-y

Cost-Effectiveness Analysis of Ranibizumab Biosimilar for Neovascular Age-Related Macular Degeneration in Japan

Ophthalmol Ther. 2023 Aug;12(4):2005-2021. doi: 10.1007/s40123-023-00715-y. Epub 2023 May 12.

Authors

Yasuo Yanagi¹, Kanji Takahashi², Tomohiro Iida³, Fumi Gomi⁴, Junko Morii⁵, Eriko Kunikane⁶, Taiji Sakamoto⁷

Affiliations

¹ Department of Ophthalmology and Microtechnology, Yokohama City University, Kanagawa, Japan. yanagi-tky@umin.ac.jp.
² Department of Ophthalmology, Kansai Medical University, Osaka, Japan.
³ Department of Ophthalmology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.
⁴ Department of Ophthalmology, Hyogo Medical University, Hyogo, Japan.
⁵ IQVIA Solutions Japan, K.K., Tokyo, Japan.
⁶ Senju Pharmaceutical Co., Ltd., Osaka, Japan.
⁷ Department of Ophthalmology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.

Abstract

Introduction: Neovascular age-related macular degeneration (nAMD) is the world's leading cause of blindness in elderly people. While anti-vascular endothelial growth factor (VEGF) treatments are used as the first option for patients with nAMD, they are generally expensive and need repeated injections. This study aimed to evaluate the cost-effectiveness of anti-VEGF therapies, focusing on the newly launched ranibizumab biosimilar (RBZ BS) in patients with nAMD from a Japanese societal perspective.

Methods: A Markov model was developed to simulate the lifetime transitions of a cohort of treatment-naïve patients with nAMD through health states that were based on the involvement of nAMD (single eye vs. both eyes), the treatment status of the patients, and decimal best-corrected visual acuity. The model compared RBZ BS with branded RBZ, aflibercept (AFL), and AFL as loading dose switched to RBZ BS in maintenance in the treat-and-extend (TAE) regimen (RBZ TAE, AFL TAE, and AFL to RBZ BS TAE, respectively), and with branded RBZ in the pro re nata (PRN) regimen, as well as best supportive care (BSC). All processes were validated by five clinical experts.

Results: When TAE regimens were compared, RBZ BS was dominant (higher quality-adjusted life-years (QALYs) and lower total cost) to AFL TAE and AFL to RBZ TAE. The result was robust regardless of whether the clinical data were taken from the direct head-to-head clinical trial or from indirect treatment comparison. RBZ BS TAE was cost-saving compared to RBZ TAE. RBZ BS TAE was estimated to be dominant to BSC owing to a lower societal cost. Like TAE regimens, RBZ BS was cost-saving compared to RBZ PRN and was dominant to BSC in PRN regimens.

Conclusion: This study suggests that RBZ BS is dominant to other anti-VEGF treatments in patients with nAMD in both TAE and PRN regimens and BSC from a Japanese societal perspective.

Keywords: Cost-effectiveness; Costs and cost analysis; Dosing regimens; Japan; Markov model; Neovascular age-related macular degeneration; Ranibizumab biosimilar; Societal perspective.