2025 Southeastern Residency Conference

TITLE: Evaluating the Access Process for Patients Transitioning from Intravenous to Subcutaneous Biologic Administration for Inflammatory Bowel Disease 
 
AUTHORS: Taylor Kissel, Miranda Kozlicki, Bridget Lynch, Josh DeClercq, Autumn Zuckerman
 
OBJECTIVE: Evaluate the medication access process and outcomes for patients with IBD referred to transition to or initiate SC vedolizumab or infliximab. 
 
SELF ASSESSMENT QUESTION:  What is the most common method of approval for patients approved to start subcutaneous vedolizumab or infliximab? A. Benefits investigation only B. PA approval only C. 1^st level appeal D. 2^nd level appeal 
 
BACKGROUND: The U.S. Food and Drug Administration (FDA) recently approved vedolizumab and infliximab for subcutaneous (SC) administration, providing patients with Inflammatory Bowel Disease (IBD) [Crohn’s Disease (CD) and Ulcerative Colitis (UC)] a convenient option to administer medication at home instead of clinic-administered intravenous (IV) infusions. SC formulations are most often covered on pharmacy insurance unlike infusions which are typically covered through medical insurance. Research is needed to evaluate the uptake and challenges associated with vedolizumab and infliximab SC formulations. 
 
METHODS: A single center, ambispective study evaluated patients with IBD with a referral to start or transition to SC vedolizumab or infliximab between September 1, 2023 and December 31, 2024. Patients were excluded if they were prescribed SC vedolizumab or infliximab from a non-Vanderbilt University Medical Center provider, lost to follow-up, or were not referred to Vanderbilt Specialty Pharmacy (VSP). Patients who used a manufacturer quickstart program or whose medication access was still ongoing as of February 18, 2025, were excluded from regression analyses. The primary outcome was time to SC formulation access. Secondary outcomes included whether patients were approved for SC therapy, method of approval for SC formulation, and number of patients not starting SC maintenance therapy after referral. Time to SC formulation access was calculated from the medication access process start date to the medication approval date, either through insurance or manufacturer. Multivariable regression analyses evaluated whether patients were approved to start SC (logistic regression) and time to approval for SC formulation (proportional odds [PO] logistic regression). Covariates of interest included: referral time (from FDA approval date of SC formulation), insurance type, remission status, referral medication, and IV status. 
 
RESULTS: Of the 274 patients referred for SC vedolizumab or infliximab, 262 were included in the study.  Exclusions were for the following reasons: 1 referred by non-VUMC provider, 2 lost to follow-up, and 9 never referred to VSP. Median age was 44 years (Interquartile range [IQR] 34 – 56); approximately half (55%) were female. Most patients were White (89%) and with commercial prescription insurance (84%). Diagnoses included CD (53%) and UC (47%) with a median disease duration of 14 years (IQR 7 – 23). Most referrals were for vedolizumab (81%), and most patients were established on IV therapy (81%). There were 32 patients still in progress or who used a manufacturer quickstart program. Of the remaining 230, most patients (n = 166, 72%) referred to SC were approved, with over half of those approvals occurring via PA (56%). Of the 166 patients approved to start therapy, 21% of patients did not start therapy (n=34/166), largely due to patient decision (47%, n =16/34). The median time to access was 10.5 days (IQR 1 – 42) with a range of 0 to 340 days. Patients with commercial pharmacy insurance were 3.4 times more likely to have a longer approval time (Odds ratio [OR]: 3.4, 95% confidence interval [CI]: 1.6 - 7.3, p = 0.001). Patients in remission at baseline and those with an infliximab referral were more likely to be approved (OR: 2.3, 95% CI: 1.04 - 5.1, p=0.041 and OR: 3.3, 95% CI 1.04 - 10.2, p=0.043). Patients with commercial pharmacy insurance were 80% less likely to be approved (OR: 0.2, 95% CI: 0.1 - 0.7, p=0.012).
 
CONCLUSIONS: Strict insurance formulary requirements, particularly in patients with commercial insurance, resulted in lengthy approval times for many patients and prevented a quarter of patients from being approved. Future studies should evaluate clinical and humanistic benefit of SC formulations.