Abstract

Anti-vascular endothelial growth factor (anti-VEGF) medications for intraocular use are a major and increasing cost, and biosimilars may be a means of reducing the high cost of many biologic medications. However, a bevacizumab biosimilar, which is currently pending FDA approval (bevacizumab-vikg), may paradoxically increase the cost burden of intravitreal anti-VEGF, as "off-label" repackaged drug may no longer be allowed per the Drug Quality and Security Act (DQSA). We aim to investigate the potential impact of biosimilars on the health system and patient costs in the US.Cost analysis of anti-VEGF medications.Medicare data from October 2022, previously published market share data from 2019.Average sales price (ASP) of ranibizumab, aflibercept, and bevacizumab are calculated from Medicare allowable payments. ASPs of biosimilars are calculated from wholesale acquisition costs from a representative distributor. The cost of an intraocular bevacizumab formulation is modeled at $500 and $900/1.25mg dose.Overall costs of anti-VEGF drugs to Medicare Part B and patients.If an intraocular bevacizumab biosimilar were to be priced at $500, costs to Medicare would increase by $457 million from $3.01 billion to $3.47 billion (15.2% increase). Patient responsibility would increase by $117 million from $768 million to $884 million. Similarly, if intraocular bevacizumab were priced at $900, Medicare costs would increase by $897 million to $3.91 billion (29.8% increase), and patient responsibility would increase by $229 million to $997 million. If bevacizumab were $500/dose, switching all patients currently on ranibizumab or aflibercept to respective biosimilars would only compensate for 28.8% of the increased cost. Current prices of ranibizumab and aflibercept biosimilars would have to decrease by an aggregate of 15.7% to $616.80, $1027.97, and $1436.88/injection for ranibizumab 0.3 mg, 0.5 mg, and aflibercept, respectively.An FDA-approved bevacizumab biosimilar for ophthalmic use could significantly increase costs to the healthcare system and patients, raising concerns for access. This increase in cost would not be offset by ranibizumab and aflibercept biosimilar use at current prices. These data support the need for an exemption of section 503B of the DQSA and continued use of repackaged off-label bevacizumab.

View details for DOI 10.1016/j.ophtha.2023.04.019

View details for PubMedID 37116720