S49 Insurance Delays Biologic Treatment of Pediatric IBD in Tertiary Care Center

Abstract

Background: Use of biologic medications, such as anti-TNF inhibitors, anti-integrins, and anti-IL-12/23s, for treating pediatric inflammatory bowel disease (IBD) has shown great success in controlling disease and inducing remission. They are often now the therapy of choice in pediatric IBD with evidence of enhanced utility when used early in the disease course. However, the process to get a biologic medication approved for IBD, particularly in pediatrics where FDA approvals lag, is often lengthy and delayed due in large part to the insurance pre-authorization process. While others have reported on insurance delays, it has not been well described how delays are associated with drug choice, payor, past drug failures, and year of initiation. Methods: Patients under 22 years of age at biologic order date were included from a Prospective BioBank Program, which includes longitudinal, clinical patient data, at the IBD Center and Infusion Center of a large, US tertiary care center from 2014-2022. Biologic medications with at least one infusion treatment were considered (infliximab and biosimilars, ustekinumab, vedolizumab). Biologic order date, first infusion date, and insurance at infusion time were recorded. Available prior biologic failures at time of order were also recorded. Results: Data from 211 infusion biologic orders (with known order and initiation date) was recorded, representing 158 individual patients (105 CD, 45 UC, 5 IBD-U; median age at biologic order = 15.12 years). There was a mean delay of 20 days (median = 15, IQR = 16) between medication order and first treatment infusion. Patients ordered ustekinumab (n = 86) experienced significantly more delays of greater than 2 weeks to first infusion than patients ordered infliximab (n = 81, P = 0.0044) or vedolizumab (n = 44, P = 0.035). Though limited sample size, patients with public insurance (n = 8) experienced a similar proportion of delays greater than 2 weeks as patients with private insurance (n = 151) (62.5% and 60%, respectively). There was no significant difference in delay when comparing patient health insurance company at time of infusion (Aetna, n = 23; Cigna, n = 23; Empire Bluecross Blueshield, n = 35; Oxford, n = 20; and United Healthcare n = 33). Over half (57%) of patients with a previously-failed biologic of known order-to-infusion delay time (n = 45) had a greater delay to get their second biologic than their previous biologic. Delays of greater than 2 weeks to first infusion were significantly more likely for biologics ordered 2018-2022 (n = 135) than biologics ordered 2014-2018 (n = 76, P = 0.0049). Conclusion(s): Long delays to receive crucial medication are commonplace in IBD in the US. Documentation of prior failures is often required to achieve approval, but history of prior failures lengthened the approval process. Though biologic treatments have advanced and shown success over the time period considered, patients were more likely to experience lengthy delays to treatment in more recent years. While insurance type and company do not seem to play an important role in treatment delay, biologic choice does. Further research is required to explore how delays may influence physician biologic selection and hinder attempts at precision therapy.