Samantha A. Mehta, PharmD1, Timothy E. Ritter, MD2, Christopher C. Fernandes, 3, Siri Tummala, 3, Brooklin C. Smith, 4, Lucinda J. Van Anglen, PharmD1 1Healix Infusion Therapy, LLC, Sugar Land, TX; 2GI Alliance Research, Southlake, TX; 3TCU & UNTHSC School of Medicine, Southlake, TX; 4Kansas City University Medicine and Biosciences, Southlake, TX
Introduction: Payors have adopted policies mandating non-medical switches from originator to biosimilar products based on clinical studies demonstrating similar efficacy and safety, coupled with possible drug cost savings and increased accessibility. Real-world logistics associated with forced non-medical switches, such as those related to benefit verification or appeals, may result in dosing delays. The purpose of this study is to assess the impact of non-medical biosimilar switching on adherence to infliximab dose regimens in inflammatory bowel disease (IBD).
Methods: We performed a retrospective analysis of all IBD patients on infliximab (IFX) at a large multicenter gastroenterology private practice in Texas. Patients undergoing payor-mandated non-medical switches to infliximab-axxq, infliximab-abda, and infliximab-dyyb from February 1st through June 1st, 2021 were identified. Data collection included demographics, payor, dose regimen, and infusion administration dates. Date of the last infliximab infusion was compared to date of the first biosimilar infusion to capture dosing delays greater than 1 week. Outcome measures included clinical deterioration defined as worsening IBD or extraintestinal symptoms, corticosteroid use, and healthcare utilization.
Results: A total of 790 patients were receiving IFX. Sixty-two (8%) patients underwent a payor-mandated non-medical switch to biosimilar (59 infliximab-axxq, 2 infliximab-abda, 1 infliximab-dyyb). Dose and frequency remained the same as originator infliximab for all but one patient whose frequency was increased following bowel resection surgery. Biosimilar dosing delays of at least 1 week were observed in 30 (48%) patients [Figure 1]. Median duration of dosing delay was 3.1 weeks (IQR 1.9-5.1). Clinical consequences of worsening IBD or extraintestinal symptoms were observed in 7 patients with delays, and 2 required corticosteroids. One patient underwent re-induction with infliximab-axxq due to a delay of 14 weeks.
Discussion: Payor-mandated non-medical switching from infliximab to biosimilar resulted in dosing delays in nearly half of patients. Such delays were commonly associated with disease flares. Payor cost savings should be balanced against the risk of dosing delays with subsequent potential for uncontrolled disease, immunogenicity, and drug discontinuation.
Figure: Figure 1. Dosing Delays due to Payor-Mandated Non-Medical Switching from Infliximab to Biosimilar
Samantha Mehta indicated no relevant financial relationships.
Christopher Fernandes indicated no relevant financial relationships.
Siri Tummala indicated no relevant financial relationships.
Brooklin Smith indicated no relevant financial relationships.
Lucinda Van Anglen indicated no relevant financial relationships.
Samantha A. Mehta, PharmD1, Timothy E. Ritter, MD2, Christopher C. Fernandes, 3, Siri Tummala, 3, Brooklin C. Smith, 4, Lucinda J. Van Anglen, PharmD1. P1621 - Payor-Mandated Non-Medical Switching From Infliximab to Biosimilar Creates Dosing Delays, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.