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Insurance Approval Delay of Biologic Therapy Dose Escalation Associated with Disease Activity in Patients with Inflammatory Bowel Disease

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An Invited Commentary to this article was published on 04 October 2023

Abstract

Background

Dose escalation of self-injectable biologic therapy for inflammatory bowel diseases may be required to counteract loss of response and/or low drug levels. Payors often require completion of a prior authorization (PA), which is a complex approval pathway before providing coverage. If the initial PA request is denied, clinic staff must complete a time and resource-intensive process to obtain medication approval.

Aims

This study measured time from decision to dose escalate to insurance approval and evaluated impact of approval time on disease activity.

Methods

This was a single-center retrospective analysis of adult patients with IBD prescribed an escalated dose of biologic therapy at an academic center with an integrated specialty pharmacy team from January to December 2018. Outcomes included time to insurance approval and the association between approval time and follow-up C-reactive protein (CRP) and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores. Associations were tested using linear regression analyses.

Results

220 patients were included, median age 39, 53% female, and 96% white. Overall median time from decision to dose escalate to insurance approval was 7 days [interquartile range (IQR) 1, 14]. Approval time was delayed when an appeal was required [median of 29 days (IQR 17, 43)]. Patients with a longer time to insurance approval were less likely to have CRP improvement (p = 0.019). Time to insurance approval did not significantly impact follow-up SIBDQ scores.

Conclusion

Patients who had a longer time to insurance approval were less likely to have improvement in CRP, highlighting the negative clinical impact of a complex dose escalation process.

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Authors and Affiliations

  1. Vanderbilt University Medical Center, 784 Melrose Avenue, Nashville, TN, 37211, USA

    Nisha B. Shah, Autumn D. Zuckerman, Katie R. Hosteng, Jessica Fann, Josh DeClercq, Leena Choi, Laura Cherry, David A. Schwartz & Sara Horst

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Corresponding author

Correspondence to Autumn D. Zuckerman.

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Conflict of interest

Dr. Sara Horst has been a consultant for Janssen, Takeda, Abbvie, and BMS. Dr. David Schwartz has been a consultant for Abbvie, Genetech, Gilead, Janssen, Pfizer, Takeda, Tigenix, and UCB. Dr. Schwartz has also received research grant support from UCB and is a data safety and monitoring board member for Tract. Dr. Nisha Shah received research grant support from Pfizer Inc. and AstraZeneca. Dr. Autumn Zuckerman receives research support from Pfizer Inc. and AstraZeneca. Dr. Jessica Fann has been a consultant for Abbvie.

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This research study was conducted retrospectively from data obtained for clinical purposes and approved by the Vanderbilt University Medical Center IRB.

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Shah, N.B., Zuckerman, A.D., Hosteng, K.R. et al. Insurance Approval Delay of Biologic Therapy Dose Escalation Associated with Disease Activity in Patients with Inflammatory Bowel Disease. Dig Dis Sci 68, 4331–4338 (2023). https://doi.org/10.1007/s10620-023-08098-7

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