| Abstrakt: |
BACKGROUND: Bevacizumab and its biosimilar bevacizumab-awwb are vascular endothelial growth factor inhibitors that are frequently combined with other oncolytic agents for the treatment of various malignancies. Data on real-world outcomes and the financial impact of biosimilar use are limited, particularly for oncologic indications. In patients with non–small cell lung cancer, bevacizumab-awwb and bevacizumab have demonstrated similar clinical efficacy and safety. Data on outcomes for bevacizumab-awwb in other cancer subtypes are lacking. OBJECTIVE: To compare the safety and financial impact outcomes associated with the use of bevacizumab versus its biosimilar bevacizumab-awwb. METHODS: This institutional review board–approved, single-center, retrospective cohort study included adults with cancer who received bevacizumab-awwb or bevacizumab between June 2019 and May 2021 at University of California, San Francisco Helen Diller Comprehensive Cancer Center. To be eligible for treatment with bevacizumab-awwb, patients must not have received previous treatment with bevacizumab. Patients who switched from bevacizumab to its biosimilar bevacizumab-awwb or who participated in clinical trials were excluded from the trial. Common Terminology Criteria for Adverse Events Version 5.0 was used for the safety outcomes assessment. The primary safety outcome was new-onset grade ≥2 hypertension. The secondary safety outcomes were grade ≥2 proteinuria, hemorrhage, and gastrointestinal (GI) perforation. Another secondary outcome was the cost-savings of treatment with a biosimilar compared with the reference drug using the average wholesale acquisition price. RESULTS: A total of 377 patients were included in this study, of whom 200 were included in the bevacizumab arm and 177 were included in the bevacizumab-awwb arm. Excluding ovarian cancer and hepatocellular carcinoma, 11 cancer types had similar baseline characteristics among both groups. Although there was no significant difference in grade ≥2 hypertension, the initiation of new antihypertensive therapy was higher in the bevacizumab arm than in the bevacizumab-awwb arm (P=.002). Grade 2 proteinuria was lower in the bevacizumab-awwb arm than in the bevacizumab arm (P=.01). There were no significant differences in other safety outcomes. In 2020, the use of bevacizumab-awwb accounted for 34% of dispensed orders versus 66% for bevacizumab, saving $166,894. If the use of bevacizumab-awwb increased to 75%, approximately $403,367 could be saved annually. CONCLUSION: In this real-world analysis, bevacizumab-awwb had a comparable safety profile to bevacizumab in grade ≥2 hypertension, proteinuria, hemorrhage, and GI perforation, regardless of the primary cancer type. Replacing bevacizumab with its biosimilar bevacizumab-awwb can lower acquisition costs. [ABSTRACT FROM AUTHOR] |
