Study: Ranibizumab Biosimilar Is the Most Cost-Effective Option for nAMD

Compared with other anti-vascular endothelial growth factor (anti-VEGF) treatments, a ranibizumab biosimilar (RBZ BS) was considered to be the most cost-effective option when used in treat-and-extend (TAE) regimens and pro re nata (PRN) regimens and best societal care (BSC) for patients with neovascular age-related macular degeneration (nAMD), according to a Japanese societal viewpoint.

The study, published in Ophthalmology and Therapy, intended to analyze the cost-effectiveness of anti-VEGD therapies, concentrating on the most recent-launched RBZ BS product in patients with nAMD from a Japanese societal viewpoint.

nAMD is the planet’s leading cause of blindness in elderly populations. While anti-VEGF treatments are usually used as first-line treatment for patients with nAMD, they are usually expensive and require repeated injections.

The disease is characterized as a progressive condition that leads to severe visual impairment as age increases. nAMD is considered late-stage AMD. Typical treatments for nAMD are anti-VEGF agents and photodynamic therapy (PDT), but PDT is less commonly used since the start of anti-VEGF therapy with the use of PDT is limited to a special AMD subtype.

A Markov model was created to stimulate the lifetime transitions of a cohort of treatment-naïve patients with nAMD through health states that were established on the involvement of nAMD (single eye vs both eyes), patients’ treatment status, 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 TAE regimen (RBZ TAE, AFL TAE, and AFL to RBZ BS TAE, respectively), and with branded RBZ in the PRN regimen, and BSC. RBZ BS was better at achieving cost savings compared to RBZ PRN-like TAE regimens and performed better than BSC in PRN regimens.

Data showed that RBZ BS was dominant (higher quality-adjusted life-years [QALYs] and lower total cost) to AFL TAE and AFL to RBZ TAE when TAE regiments were compared. The result was strong regardless of whether the clinical data were taken from the direct head-to-head clinical trial or from indirect treatment comparison. Compared to RBZ TAE, RBZ BS was cost saving. RBZ BS TAE was predicted to be dominant to BSC owing to a lower societal cost.

Of note, the model allowed for the simulation of lifetime transitions of a cohort of patients with nAMD through health states based on involvement of nAMD (single-eye vs both-eye involvement), patients’ treatment status (ie, on or off treatment), and visual impairment severity defined by decimal best corrected visual acuity (BCVA).

Also of note, the magnitude of difference in 2-year treatment frequencies (number of injections) between RBZ (or RBZ BS) TAE and AFL TAE in the indirect comparison study was 5.9 times higher, which seems to be larger than the predicted outcome from real-world practice, as suggested by retrospective observational studies conducted in Japan and other foreign settings.

To the best of the researchers’ knowledge, this is the first study comparing the cost-effectiveness of RBZ BS with present anti-VEGF agents among treatment-naïve patients with nAMD.

The researchers stated that the results of the study need to be interpreted with caution due to some limitations regarding the modelling approach, such as the transition probabilities and treatment frequencies following the third year were assumed to be comparable between RBX and AFL TAE.

This was because of the long-term changes in visual acuity and treatment frequency for these regimens, which weren’t well recorded in the literature. Also, the discontinuation rates for all treatments and treatment regimens were assumed to be the same because these values weren’t available, particularly in the Japanese clinical setting. This could be a strong assumption, as discontinuation rates could vary according to the economic status and treatment types of patients.

“Based on the currently available evidence, our analyses show with a high degree of certainty that RBZ BS 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,” concluded the researchers.

Reference

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;12(4):2005-2021. doi:10.1007/s40123-023-00715-y