Inflamm Bowel Dis. 2021 May 25;izab110. doi: 10.1093/ibd/izab110. Online ahead of print.

Grant A Morris ¹, Megan McNicol ², Brendan Boyle ^1 3, Amy Donegan ¹, Jennifer Dotson ^1 3 4, Hilary K Michel ^1 3, Ross M Maltz ^1 3 5

Author information

• ¹Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Nationwide Children's Hospital, Columbus, Ohio, USA.
• ²Department of Pharmacy, Nationwide Children's Hospital, Columbus, Ohio, USA.
• ³Department of Pediatrics, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
• ⁴The Center for Innovation in Pediatric Practice, The Research Institute, Nationwide Children's Hospital, Columbus, Ohio, USA.
• ⁵The Center of Microbial Pathogenesis, Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, Ohio, USA.

Abstract

Background: Tumor necrosis factor-alpha inhibitors (anti-TNFs) are a primary treatment for inflammatory bowel disease. Pharmaceutical expenditures and usage of specialty drugs are increasing. In the United States, biosimilars continue to be underutilized, despite opportunities for health care cost savings. Through quality improvement (QI) methodology, we aimed to increase biosimilar utilization among eligible patients initiating intravenous (IV) anti-TNF therapy and describe patient outcomes and associated cost savings.

Methods: Beginning in July 2019, all patients initiating IV anti-TNF therapy were identified and tracked. Using the Institute of Healthcare Improvement Plan-Do-Study-Act cycle, a four-stage problem-solving model used for carrying out change, we trialed interventions to increase biosimilar utilization, including provider, staff, and family education, and utilization of a clinical pharmacist and insurance specialist. Statistical process control charts were used to show improvement over time. Patients' clinical outcome and cost savings were reviewed.

Results: Using QI methodology, we increased biosimilar utilization from a baseline of 1% in June 2019 to 96% by February 2021, with sustained improvement. The originator (infliximab) was the insurance company's preferred product for 20 patients (20%). Patient outcomes (IV anti-TNF levels, absence of antidrug antibodies, and physician global assessment) between biosimilars and originators were similar. Estimated cost savings over the project duration were nearly $381,000 (average sales price) and $651,000 (wholesale acquisition cost).

Conclusions: Through QI methodology, we increased biosimilar utilization from 1% to 96% with sustained improvement, without compromising patient outcomes or safety. Estimated cost savings were substantial. Similar methodology could be implemented at other institutions to increase biosimilar utilization and potentially decrease health care costs.