Abstract

Abstract BACKGROUND Treatment with biologic medications for patients with inflammatory bowel disease (IBD) requires authorization by insurers. Insurance authorization denials are often a major obstacle in many clinical scenarios to use biologics, including specific denials of escalated dosing regimens directed by appropriate clinical indications. The objective of this study is to assess IBD-focused gastroenterologists’ (GIs) views and experiences on specific clinical scenarios resulting in biologic authorization denials. METHODS The survey was distributed by email to adult and pediatric IBD-focused GIs with 24 specific clinical scenarios, assessing experience and opinions on each authorization denial scenario. Survey data was recorded using REDCap software. RESULTS The survey was completed by 22 GIs including 17 adult GIs (81%), 4 pediatric GIs (19%), and one undisclosed provider. 70% or greater of participants disagreed with denials for (1) infliximab (IFX) dose-escalation, (2) Remicade in place of biosimilar, (3) facility-based IFX induction, (4) vedolizumab (VDZ) dose-escalation, (5) facility-based VDZ induction, (6) first-line ustekinumab (UST) therapy, (7) UST dose-escalation or re-induction, (8) UST maintenance after induction approval, (9) tofacitinib after mechanistic biologic failures, (10) VDZ or UST first-line in elderly or co-morbid patients, (11) facility-based biologic infusion for patients with prior acute infusion reactions. Variable experience was reported across the clinical scenarios ranging from 18.2% to 100%. In addition, variable experience was reported with the scenarios on whether specific denials were increasing in the past year, ranging from 16.7% to 90%. CONCLUSION This data portrays the collective experience of authorization denials as obstacles to using biologic medications, including escalated dosing, in multiple specific clinical scenarios. Many of these denial scenarios contradict treatment strategies that are utilized for optimal care of complex IBD patients. The data indicates many authorization denials reflect significant discrepancies between GIs and insurers on the clinical appropriateness of multiple different biologic treatment strategies. Broader survey data could better elucidate further experience with biologic treatment strategies that are being denied IBD patients, the nature of the obstacles created by insurers, and guide collaboration between physicians and insurers on best practices in the treatment of complex IBD patients.

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