Analysis Suggests Cost-Effectiveness of Ranibizumab Biosimilar for nAMD Treatment

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An analysis based in Japan suggests ranibizumab biosimilar is dominant to other anti-VEGF treatments in patients with nAMD in both treat-and-extend and PRN regimens.

A ranibizumab biosimilar may be the most cost-effective treatment option compared with other available anti-VEGF therapies by both treat-and-extend (TAE) and pro re nata (PRN) regimens for patients with neovascular age-related macular degeneration (nAMD), according to new research.1

The study, based in Japan, suggested ranibizumab biosimilar TAE was dominant to aflibercept TAE, and cost-saving compared to both ranibizumab TAE and PRN; in addition, ranibizumab biosimilar was dominant to best supportive care in both TAE and PRN regimens.

“Based on the currently available evidence, our analyses show with a high degree of certainty that ranibizumab biosimilar can be the most cost-saving treatment option compared with the existing anti-VEGF agents by both TAE and PRN regimens in patients with nAMD from a Japanese societal perspective,” wrote the investigative team, led by Yasuo Yanagi, MD, PhD, from the department of ophthalmology and microtechnology at Yokohama City University.

Global estimates suggest the number of people with AMD is projected to reach 288 million by 2040; as Japan has one of the most aged populations in the world, the number of AMD patients is expected to grow concurrently with the aging population.2 Vascular endothelial growth factor inhibitors are first-line treatments for nAMD, but their cost and need for repeated injections to maintain visual acuity can be prohibitive. In September 2021, a ranibizumab biosimilar was approved in Japan and served as the first biosimilar of an ophthalmic VEGF inhibitor in the country.

With a lower price compared to the originator, ranibizumab biosimilar may reduce the economic burden on both patients with nAMD and society. The current analysis assessed the cost-effectiveness of the anti-VEGF therapy using both TAE and PRN regimens in patients with nAMD from a Japanese societal perspective. Investigators developed a Markov model to simulate the lifetime transitions of a cohort of treatment-naive patients with nAMD through health states based on the involvement of nAMD (single-eye vs. both eyes), the treatment status of the patient, and decimal best-corrected visual acuity (BCVA).

For the purpose of analysis, the cost-effectiveness model compared long-term healthcare costs and quality-adjusted life-years (QALYs) of patients treated with ranibizumab biosimilar versus other active anti-VEGF treatments and best supportive care. In TAE regimens, investigators compared ranibizumab biosimilar TAE with ranibizumab TAE, aflibercept tAE, aflibercept as the loading dose, as well as best supportive care. In PRN regimens, the team compared ranibizumab biosimilar PRN with ranibizumab PRN and best supportive care.

Upon analysis, investigators found ranibizumab biosimilar TAE accumulated 8.081 quality-adjusted life-years (QALYs) compared to 8.067, 8.072, and 7.772 QALYs on aflibercept TAE, aflibercept to ranibizumab biosimilar TAE, and BSC, respectively. Data showed the incremental difference in QALYs was 0.015, 0.009, and 0.310 QALYs, with ranibizumab biosimilar TAE relative to aflibercept TAE, aflibercept to ranibizumab biosimilar TAE, and best supportive care, respectively.

Meanwhile, the total treatment costs over a lifetime determined ranibizumab biosimilar TAE was dominant to ranibizumab TAE, aflibercept TAE, aflibercept to ranibizumab biosimilar TAE, and best supportive care. Ranibizumab biosimilar TAE was associated with a lower total cost relative to the reference product TAE. Overall, investigators suggested treatment with ranibizumab biosimilar TAE was dominant over anti-VEGF treatment, as well as best supportive care, by slightly higher or equal incremental QALYs at a lower total cost.

The team noted that with the comparison with best supportive care, although best supportive care did not incur drug and administration costs, the higher societal costs due to daily care for best supportive care led to a lower total cost for ranibizumab biosimilar TAE. Similar to TAE regimens, ranibizumab biosimilar was considered cost-saving compared to ranibizumab PRN and was dominant to best supportive care in PRN regimens. Results were considered robust, regardless of whether clinical data were taken from the direct head-to-head clinical trial or from in-direct treatment comparison, according to investigators.

“These findings provide valuable insights into the treatment of nAMD and the cost-effective treatment option in treatment-naive patients with nAMD following the advent of ranibizumab biosimilar,” the team wrote.


  1. Yanagi, Y., Takahashi, K., Iida, T. et al. Cost-Effectiveness Analysis of Ranibizumab Biosimilar for Neovascular Age-Related Macular Degeneration in Japan. Ophthalmol Ther (2023).
  2. Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2(2):e106–16.