Scaled Integration of FDA-Approved Biosimilars

A biosimilar adoption integration process that included full staff education, physician consent, and systematic auto-conversion proved to be feasible and scalable, and resulted in rapid conversion from reference product to FDA-approved biosimilar.

To bridge biosimilar knowledge and adoption gaps, a formalized biosimilar policy and standard operating procedure was developed to include full staff education, physician consent, and systematic auto-conversion from the reference biologic product to its approved biosimilar; the integration process was described at the 2021 American Society of Clinical Oncology Annual Meeting.

Baseline utilization data for rituximab, trastuzumab, and bevacizumab, as well as their biosimilars, was collected from July 1, 2019, to December 31, 2020. Biosimilar conversion was initiated January 1, 2020. The following workflow changes were instituted: (1) mandatory biosimilar education of staff (physicians, advanced practice providers, pharmacists, nurses, financial navigators, and prior authorization team members) and patients was enforced and tracked using meeting attendance and the online e-learning system. Patient education was verified using established teaching visits by tracking documentation in the electronic health record. (2) Quantitative metrics and reports were developed to assist tracking of patients receiving the biosimilar or reference product. (3) Billed product units per month were also tracked to facilitate auditing.

During the baseline period (July 1, 2019, to December 31, 2019), biosimilar conversion (based on billed biosimilar units) was 0% for trastuzumab and 8.4% for rituximab. Following biosimilar conversion, conversion rates improved from 11.7% (baseline) to 90.2% (2021 Q1) for rituximab, from 8.4% to 87.4% for trastuzumab, and from 0% to 90.0% for bevacizumab.

Based on these results, the authors concluded that rapid and near-complete conversion from brand product to FDA-approved biosimilar is feasible, measurable, and can be scaled.

Source: Waterhouse DM, Burdette C, Davies D, et al. Scaled integration of FDA approved biosimilars: closing the knowledge and adoption gaps. J Clin Oncol. 2021;39(suppl_28):15.