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The Biosimilar Paradox: How Anti-Vascular Endothelial Growth Factor Biosimilars Could Increase Patient and Overall Health Care Costs.

Publication ,  Journal Article
Zhang, C; Friedman, S; Mruthyunjaya, P; Parikh, R
Published in: Ophthalmology
September 2023

PURPOSE: Anti-vascular endothelial growth factor (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 Food and Drug Administration (FDA) approval (bevacizumab-vikg), paradoxically may increase the cost burden of intravitreal anti-VEGF agents, because off-label repackaged drugs may no longer be allowed per the Drug Quality and Security Act (DQSA). We aimed to investigate the potential impact of biosimilars on costs in the United States. DESIGN: Cost analysis of anti-VEGF medications. PARTICIPANTS: Medicare data from October 2022 and previously published market share data from 2019. METHODS: Average sales prices (ASPs) of ranibizumab, aflibercept, and bevacizumab were calculated from Medicare allowable payments. The ASPs of biosimilars were calculated from wholesale acquisition costs from a representative distributor. The cost of an intraocular bevacizumab formulation is modeled at $500/1.25-mg dose and $900/1.25-mg dose. MAIN OUTCOME MEASURES: Costs of anti-VEGF drugs to Medicare Part B and patients. RESULTS: 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 receiving ranibizumab or aflibercept to respective biosimilars would compensate for only 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/injection, $1027.97/injection, and $1436.88/injection for ranibizumab 0.3 mg, ranibizumab 0.5 mg, and aflibercept, respectively. CONCLUSIONS: An FDA-approved bevacizumab biosimilar for ophthalmic use could increase costs to the health care system and patients, raising concerns for access. This increase 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. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

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Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

September 2023

Volume

130

Issue

9

Start / End Page

966 / 972

Location

United States

Related Subject Headings

  • Vascular Endothelial Growth Factor A
  • United States
  • Recombinant Fusion Proteins
  • Receptors, Vascular Endothelial Growth Factor
  • Ranibizumab
  • Ophthalmology & Optometry
  • Medicare Part B
  • Intravitreal Injections
  • Humans
  • Health Care Costs
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Zhang, C., Friedman, S., Mruthyunjaya, P., & Parikh, R. (2023). The Biosimilar Paradox: How Anti-Vascular Endothelial Growth Factor Biosimilars Could Increase Patient and Overall Health Care Costs. Ophthalmology, 130(9), 966–972. https://doi.org/10.1016/j.ophtha.2023.04.019
Zhang, Casey, Scott Friedman, Prithvi Mruthyunjaya, and Ravi Parikh. “The Biosimilar Paradox: How Anti-Vascular Endothelial Growth Factor Biosimilars Could Increase Patient and Overall Health Care Costs.Ophthalmology 130, no. 9 (September 2023): 966–72. https://doi.org/10.1016/j.ophtha.2023.04.019.
Zhang, Casey, et al. “The Biosimilar Paradox: How Anti-Vascular Endothelial Growth Factor Biosimilars Could Increase Patient and Overall Health Care Costs.Ophthalmology, vol. 130, no. 9, Sept. 2023, pp. 966–72. Pubmed, doi:10.1016/j.ophtha.2023.04.019.
Zhang C, Friedman S, Mruthyunjaya P, Parikh R. The Biosimilar Paradox: How Anti-Vascular Endothelial Growth Factor Biosimilars Could Increase Patient and Overall Health Care Costs. Ophthalmology. 2023 Sep;130(9):966–972.

Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

September 2023

Volume

130

Issue

9

Start / End Page

966 / 972

Location

United States

Related Subject Headings

  • Vascular Endothelial Growth Factor A
  • United States
  • Recombinant Fusion Proteins
  • Receptors, Vascular Endothelial Growth Factor
  • Ranibizumab
  • Ophthalmology & Optometry
  • Medicare Part B
  • Intravitreal Injections
  • Humans
  • Health Care Costs