Download Full Text (905 KB)
Background For pediatric patients with a diagnosis of inflammatory bowel disease (IBD), initiation of biologic therapy can be essential to attain disease control. Unfortunately, patients often experience delays in receiving the first dose of these medications due to the need for insurance companies to approve medication prior authorizations (PA). Physicians and support staff spend many working hours collating and transferring information regarding urgency to payors. To our knowledge, no studies exist to evaluate the factors that contribute to how quickly a medication is approved in pediatric patients. We set out here to evaluate which demographic and disease factors contribute to the lag time between submission of medication prior authorization for IBD biologic therapy and administration of that therapy. Methods Our pilot cohort consists of 102 patients with IBD who initiated biologics as an outpatient at our tertiary care hospital between the years of 2018-2023. Clinical information regarding disease status, previous therapies, surgical history, laboratory information, and medication administration information was obtained from the chart. Descriptive statistics were performed and followed by bivariate summaries for insurance status (Medicaid users vs. not), initial denial of biologic, and type of biologic. Wilcoxon Rank Sum Tests and Kruskal-Wallis Test were used to compare time from PA to first dose depending on variable of interest. Results Demographics are included in Table 1. Patients were median age of 14.7 years (interquartile range [IQR] 11.5-17.0) and were 52.9% male. Most patients (80/102; 78.4%) have Crohn’s disease. In this cohort, the median time from submission of prior authorization to administration of medication (lag time) was 15.0 days (IQR 12.0-24.0) with maximum times up to 53 days. When evaluating between medications, infliximab had a significantly lower median lag time (median 14d; IQR 10-16d) compared to ustekinumab (17.5d; IQR 13-28) or adalimumab (18d; IQR 14-25d) but not vedolizumadb (16d; IQR 11-26) (Figure 1). No other pairings showed a significant difference. Pediatric Ulcerative Colitis Activity Index (PUCAI) decreased the lag time 1.5 days for every 10-point increase in PUCAI. Hemoglobin, albumin, ESR, and CRP contributions to lag time varied between medications. Lag time does not vary significantly between state insurance (Medicaid) and private insurance (Figure 2). Additionally, an initial denial of the prior authorization requiring appeal does not prolong lag time. Conclusion Early initiation of biologic therapy can delay the progression of disease to stricturing or penetrating disease 2 . However, providers experience significant challenges administering these medications in a timely manner. Notably, pediatric patients with IBD often wait at least two weeks to receive their first dose of biologic therapy. Our preliminary analysis does not indicate that severity of illness or type of insurance make clinically significant differences. It is important to remark that our population was limited in the number of Medicaid patients, so more data will be essential to corroborate this analysis. Infliximab shows the quickest availability perhaps due to its long history on the market, availability of biosimilars, or widespread use. Further analysis of our collected cohort of approximately 400 patients is pending including analysis of outcomes.
Gastroenterology | Pediatrics
Capraro, Shannon; Noel-Macdonnell, Janelle R. PhD; Disselhoff, Lauren; Sieve, Layne; and Chevalier, Rachel, "Latency Time From Prior Authorization Submission To Initiation Of Biologic Therapy In Inflammatory Bowel Disease" (2023). Posters. 351.