P1617 - Delay in Insurance Approval of Biologic Therapy Dose Escalation Is Associated With Increased Disease Activity in Patients With Inflammatory Bowel Disease

Nisha Shah, PharmD, Josh DeClercq, MS, Laura Cherry, BS, Autumn Zuckerman, PharmD, BCPS, AAHIVP, CSP, Praveen Vimalathas, BS, Leena Choi, PhD, Charles A. Donoho, BS, Baldeep Pabla, MD, MSCI, Elizabeth Scoville, MD, MSCI, Robin Dalal, MD, Dawn Beaulieu, MD, David Schwartz, MD, Sara Horst, MD, MPH, FACG
Vanderbilt University Medical Center, Nashville, TN

Introduction: Patients receiving biologic therapy for the management of inflammatory bowel disease (IBD) often require dose escalation to counteract loss of response and/or low drug levels. However, this usually requires completion of a complex insurance approval pathway, including prior authorization (PA). We previously reported a delay for many patients as a result.¹ The goal of this study was to evaluate the impact of time to insurance approval on disease activity.
1. Coe C, Cherry L, Shah N, et al. Am J Gastroenterol 2020;115:S45



Methods: This was a retrospective analysis of adult patients with IBD prescribed a higher dose of self-injectable biologic therapy (adalimumab, certolizumab, ustekinumab, or golimumab) at a tertiary care center with an integrated specialty pharmacy team from January-December 2018. Patients for whom the PA was not completed by the center’s specialty pharmacy were excluded. Outcomes included C-reactive protein (CRP) and Harvey Bradshaw Index (HBI) at least 45 days following dose escalation. Multiple linear regression analyses were used to examine the associations between the outcomes and time to insurance approval of dose escalation after adjusting for the baseline measurement defined for each.

Results: Of 227 patients reviewed, 114 patients with relevant outcome data were included. Demographics and dosing regimens are shown in Table 1. Mean time from decision to escalate dose to insurance approval was 11.1 days (SD = 20.9). Baseline median CRP was 4.2 mg/dL (interquartile range [IQR] 1.3 – 9.7). Follow-up median CRP, evaluated after a median of 92 days (IQR 72 – 119), was 4.5 mg/dL (IQR 1.4 – 9.8). Using multiple linear regression, a longer time to insurance approval significantly decreased the likelihood of CRP improvement (Figure 1) (p = 0.019). Baseline median HBI was 3 (IQR 1 – 7, n= 62). Follow-up median HBI, evaluated after a median of 95 days (IQR 89 -118) was 4 (IQR 2 - 6). Time to insurance approval did not have a significant impact on HBI.

Discussion: This study found that longer time to insurance approval of a higher biologic dosing regimen was associated with an increase in CRP in follow up, suggesting the longer time to approval, the less likely to see an improvement in CRP. This highlights that the complex dose escalation process of biologic therapy can negatively impact clinical outcomes.


Figure: Figure 1. Multiple linear regression result for the association between CRP and time to approval of biologic therapy dose escalation

Age, mean (SD) - years	40 (14)
Gender, female, n (%)	60 (53%)
Crohn's disease, n (%)	100 (88%)
Race, n (%)	White: 109 (6%); Black: 5 (4%)
Medication Alternate Dosing n (%)
Adalimumab	40 mg weekly: 42 (38%); Other: 3 (2%)
Ustekinumab	90 mg every 6 weeks: 50 (45%); 90 mg every 4 weeks: 16 (14%)
Certolizumab	200 mg every 2 weeks: 1 (0.5%)
Golimumab	100 mg every 2 weeks: 2 (0.5%)

Table: Table 1. Demographic and alternate dosing characteristics for study cohort


Disclosures:
Nisha Shah indicated no relevant financial relationships.
Josh DeClercq indicated no relevant financial relationships.
Laura Cherry indicated no relevant financial relationships.
Autumn Zuckerman indicated no relevant financial relationships.
Praveen Vimalathas indicated no relevant financial relationships.
Leena Choi indicated no relevant financial relationships.
Charles Donoho indicated no relevant financial relationships.
Baldeep Pabla indicated no relevant financial relationships.
Elizabeth Scoville indicated no relevant financial relationships.
Robin Dalal indicated no relevant financial relationships.
Dawn Beaulieu: abbvie – Consultant. Pfizer – Consultant. Takeda – Consultant. UCB – Consultant.
David Schwartz: Abbvie – Consultant. Gilead – Consultant. Janssen – Consultant. Pfizer – Consultant. Takeda – Consultant. Tract – Advisory Committee/Board Member. UCB – Consultant, Grant/Research Support.
Sara Horst: Abbvie – Consultant. Gilead – Consultant. Janssen – Consultant. Takeda – Consultant. UCB – Consultant, Grant/Research Support.


Nisha Shah, PharmD, Josh DeClercq, MS, Laura Cherry, BS, Autumn Zuckerman, PharmD, BCPS, AAHIVP, CSP, Praveen Vimalathas, BS, Leena Choi, PhD, Charles A. Donoho, BS, Baldeep Pabla, MD, MSCI, Elizabeth Scoville, MD, MSCI, Robin Dalal, MD, Dawn Beaulieu, MD, David Schwartz, MD, Sara Horst, MD, MPH, FACG. P1617 - Delay in Insurance Approval of Biologic Therapy Dose Escalation Is Associated With Increased Disease Activity in Patients With Inflammatory Bowel Disease, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.