National perspectives of barriers by insurance and pharmacy benefit managers in pediatric inflammatory bowel disease.

Objectives: Early biologic initiation, dose optimization, and therapy modification based on disease phenotype are key to improving outcomes in pediatric inflammatory bowel disease (IBD). Enacting optimized therapy is often impeded by the lack of United States Food and Drug Administration (FDA) approval for pediatric use of newer advanced therapies or intensified dosing regimens. These barriers often result in initial payor denial of coverage and added prior authorization burden on physicians, leading to patient delays in medication initiation and therapy optimization, and development of disease-related morbidity. Methods: A sample of pediatric patients experiencing payor barriers to IBD biologic treatment, containing data on treatment delays and adverse outcomes, was obtained through a nationwide survey of pediatric gastroenterology providers via a longstanding, widely used pediatric gastroenterology Listserv (housed at University of Vermont) from January 2023 to August 2023. Results: Providers across the United States reported information for 113 patients experiencing payor barriers for biologics IBD treatment. Ultimately, 77% of initial denials were approved. The median time to receiving medication was 18 days, with administrative time (prior authorization and appeal) requiring a median of 180 min. More than half (60%) of patients experienced adverse outcomes or worsened quality of life due to delays in treatment, including 21% of patients who were hospitalized. Conclusions: These findings highlight the detrimental impact of payor barriers to treatment for children with IBD. Reforms that minimize delays in care and provider administrative burden are imperative to ensure that children receive timely evidence-based treatment that improves disease outcomes and prevents adverse events.