Cost-Benefits, Efficacy of Biosimilar Ranibizumab vs Aflibercept for nAMD in Japan

A ranibizumab biosimilar proved to be a cost-saving and clinically effective treatment option compared with aflibercept and other alternatives that treat neovascular age-related macular degeneration (nAMD) subtypes in Japan, according to a review.1

The study, published in Ophthalmology and Therapy, was conducted to evaluate the cost-effectiveness of ranibizumab biosimilar compared to aflibercept and other anti–vascular endothelial growth factor (VEGF) therapies for nAMD in Japan, addressing 2 critical knowledge gaps:

1. Lack of subtype-specific cost-effectiveness analyses
2. Absence of patient perspective in economic evaluations

Anti-VEGF therapies may have different effects on the major subtypes of neovascular age-related macular degeneration (nAMD), which include typical nAMD, polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP). A previous retrospective study conducted in Japan found that 54.7% of patients diagnosed with nAMD had PCV, 35.3% had typical nAMD, and 4.5% had RAP.2 These findings underscore the need for a cost-effectiveness analysis of anti-VEGF therapies for each nAMD subtype, yet none have been conducted globally

Additionally, previous economic evaluations primarily focused on societal and third-party payer perspectives. However, the patient perspective is particularly important in Japan’s health care system due to age-based co-payment structure and caps on monthly medical expenses designed to reduce financial burden.

By analyzing cost-effectiveness from both societal and patient perspectives, the study aimed to provide valuable insights for policymakers developing health care policies and for patients navigating age-specific financial burdens, which could ultimately support sustainable and equitable treatment strategies for nAMD.

The study used a Markov model to simulate health transitions in patients with nAMD over 20 years. Key parameters were set through expert input and included factors like nAMD involvement, treatment status, and visual acuity. The model analyzed subtypes of nAMD, comparing a ranibizumab biosimilar with reference aflibercept, using data from previously conducted studies focusing on Japanese patients. Researchers also examined multiple treatment strategies, adjusting for patient co-payments. A cost-effectiveness analysis was conducted, calculating the incremental cost-effectiveness ratio (ICER) with a ¥5,000,000 ($31,937) per quality-adjusted life years (QALY) threshold. Sensitivity analysis was performed using Monte Carlo simulations.

Lastly, to address uncertainties in clinical parameters, scenario analyses were performed using different transition probabilities and treatment frequencies. For typical nAMD and PCV, these parameters were sourced from the Bundang study, while for RAP, data from Gunma University were used for year 1.

The analysis showed that the ranibizumab biosimilar and aflibercept produced similar QALYs across all nAMD subtypes. In typical nAMD, the ranibizumab biosimilar resulted in 7.529 QALYs, slightly fewer than aflibercept (QALY, 7.544; difference, −0.015). In PCV, the ranibizumab biosimilar accumulated 8.142 QALYs, slightly higher than aflibercept (QALY, 8.115; difference, 0.026). In RAP, the biosimilar yielded marginally higher QALYs than aflibercept (QALY, 4.994 vs 4.984; difference, 0.009).

In terms of cost, the ranibizumab biosimilar was less expensive across all subtypes. For typical nAMD, the ranibizumab biosimilar cost ¥23,994,476, compared with ¥24,044,923 for aflibercept (savings, ¥50,447). For PCV, the ranibizumab biosimilar cost ¥24,303,915, compared with ¥25,301,158 for aflibercept (savings, ¥997,243). For RAP, the biosimilar cost ¥24,413,899 vs ¥25,700,469 for aflibercept (savings, ¥1,286,570).

Scenario analysis confirmed the ranibizumab biosimilar was less costly and similarly effective, showing savings of ¥537,347 for typical nAMD, ¥1,805,440 for PCV, and ¥1,893,175 for RAP. The incremental QALYs were 0.009 for typical nAMD, 0.062 for PCV, and 0.014 for RAP.

The study had several limitations, including uncertainties in parameter assumptions due to limited data from Japanese clinical settings; the use of expert-determined values for caregiver productivity loss; a lack of long-term, high-quality clinical data; and the exclusion of newer anti-VEGF drugs like brolucizumab and faricimab due to insufficient evidence.

References

1. Yanagi Y, Takahashi K, Iida T, et al. Cost-effectiveness analysis of ranibizumab biosimilar for neovascular age-related macular degeneration and its subtypes from the societal and patient perspectives in Japan. Ophthalmol Ther. 2024;13(10):2629-2644. doi:10.1007/s40123-024-01011-z.

2. Maruko I, Iida T, Saito M, Nagayama D, Saito K. Clinical characteristics of exudative age-related macular degeneration in Japanese patients. Am J Ophthalmol. 2007;144(1):15-22. doi:10.1016/j.ajo.2007.03.047