Standardizing Utilization of Biosimilars in Oncology

Current challenges associated with the uptake of biosimilars include integration into clinical practice, state laws for biosimilar interchangeability, and payer reimbursement policies. In the United States, the use of oncologic biosimilars offers opportunities to ease the escalating health care costs related to oncology care and enhances patient access to safe and effective treatments.

Suwicha Limvorasak, BCOP, PharmD, Cedars-Sinai Medical Center, Los Angeles, CA, and colleagues designed an approach to standardize biosimilar utilization across the oncology enterprise by leveraging the electronic health record to integrate with clinical algorithm pathways and financial information. As part of the formulary process, institutionally preferred biosimilar drugs were selected through the oncology Pharmacy and Therapeutics committee. 

Prescribers were permitted to opt-out of substitution within the electronic order sets. Patients were divided into two groups based as either main medical center or 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.

The researchers revealed that 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%, indicating a 51% improvement. The conversion rate was greater 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 popular reasons cited 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, the researchers estimate reduction in direct spending of $1.2 million per month or an average 23% cost savings.

In conclusion, the authors wrote, “This real-world data suggest use of an integrated electronic health record to standardize biosimilar utilization in oncology and reduce costs,” adding, “This approach leverages existing infrastructure for successful biosimilar adoption in oncology while preserving quality and safety.”

Reference

Limvorasak S, Leung C, Kim J, et al. Successful biosimilar adoption in oncology: strategic approach to system standardization.  Abstract presented at: ASCO Annual Meeting; June 3-7, 2022; Chicago, IL, and virtual. Abstract e18605.