Successful biosimilar adoption in oncology: strategic approach to system standardization.

Abstract

e18605 Background: In the United States, therapeutic substitution with oncologic biosimilars offer opportunities to reduce the rising costs of cancer care while improving access to safe and effective treatment. Current challenges include integration into clinical practice, state laws for biosimilar interchangeability and payer reimbursement policies. Methods: We developed an approach to standardize biosimilar utilization across our oncology enterprise by leveraging the electronic health record to integrate with clinical algorithm pathways and financial information. Institutionally preferred biosimilars drugs were selected through the oncology Pharmacy & Therapeutics committee as part of the formulary process. Physicians were permitted to opt-out of substitution within the electronic order sets. Patients were divided into two groups based as 1) main medical center 2) affiliated sites to assess feasibility of the enterprise-wide substitution, defined as an 80% compliance rate at the main medical center and a 75% compliance rate at the affiliates sites. This provided a minimum detectable difference of 5.7% and 8.9%, respectively using an exact one-sided Binomial test with 80% of power at 2.5% significance level with Sidak correction. Results: Between January and December 2021, a total of 811 cancer patients who initiated treatment with bevacizumab, rituximab or trastuzumab were identified, of whom 535 were eligible for this analysis (age 18-96; 61% female, 39% male). The overall substitution rate to biosimilars was 83% (76%-97%) compared to baseline of 55%, representing a 51% improvement. The conversion rate was higher at the main medical center compared to the affiliated sites (85% vs. 81%). Among 92 patients who did not have substitution to biosimilars, the most common reasons were off-label indication (35%), patient assistance program (17%), payer preferred alternative brand (15%) and clinician preferred reference brand (12%). Four patients (< 1%) were not converted due to infusion reactions possibly related to biosimilars. Based on the wholesale acquisition cost, we estimate reduction in direct spending of $1.2 million per month or an average 23% cost savings. Conclusions: This real-world data suggest use of an integrated electronic health record to standardize biosimilar utilization in oncology and reduce costs. This approach leverages existing infrastructure for successful biosimilar adoption in oncology while preserving quality and safety.[Table: see text]