Higher Rates of Delay in Starting Advanced Inflammatory Bowel Disease Therapy for Biologics Given Via Infusion Centers

Introduction: Because biologic and small molecule therapy is expensive, payors have mandated pre-authorization processes for these specialty medications often resulting in a lengthy approval process with delays between prescription and administration of appropriate therapy. The aims of this study are to assess the frequency of and risk factors for delays in starting advanced therapies and to compare patients with and without delays and the effects on IBD-related outcomes. Methods: Retrospective, multi-center study of adult inflammatory bowel disease (IBD) patients with prescriptions for a biologic or small molecule therapy in 1 of 2 academic gastroenterology practices in different regions of the country: the South (Site 1) and the Northeast (Site 2). A priori we defined a delay in starting therapy as more than 14 days between prescription and first dose. Outcomes included days on corticosteroids, IBD-related emergency department (ED) visits, hospitalizations, and surgeries at 3, 6, and 12 months. Results: A total of 334 patients (252 Crohn’s disease, 74 ulcerative colitis, 8 IBD undetermined) were prescribed a biologic or small molecule with 49% receiving their first dose within 14 days (mean 25 days, median 15 days). Overall, patients who were on time vs delayed in receiving their first dose were similar regarding age, sex, race, ethnicity, disease type and Charleston Comorbidity Index (CCI) score. Those with delays were less likely to have Medicaid, more likely to be starting a therapy with IV loading (as opposed to SQ or oral), and more likely to be receiving care at the site in the South. On subgroup analysis by study site, delays were more likely in those starting IV therapy at both sites (see Table 1). There were no differences in steroid use, IBD-related ED visits, hospitalizations, or surgeries at 3, 6, or 12 months between groups (see Figure 1). Conclusion: In a cohort of patients from 2 academic sites, we found that a delay between prescription and administration of first dose of an advanced therapy is common, with over 50% of patients having the first dose delayed more than 2 weeks. Further, we found that a delay in starting therapy was significantly more likely if given via IV induction. This held true on subgroup analysis between sites. We did not find any adverse outcomes from these delays but suspect that we may see a difference for patients who were specifically starting therapy for active disease. Further analyses are underway.Figure 1.: Outcomes at 3 months after prescribed therapy compared between patients who started therapy on time vs delayed > 14 days. All categories were not significantly different between on time and delayed. Data at 6 months and 12 months was similar. Table 1. - Comparison of insurance, advanced therapy type, and site subgroup analysis between patients with and without a delay in receiving their first dose of medication No delay (≤14 days) n=165 Delay (>14 days) n=169 P-value Insurance type Commercial (any) 108 (65.5%) 127 (75.1%) .06 Medicaid 40 (24.2%) 19 (11.2%) .0024 Medicare 16 (9.7%) 22 (13.0%) .39 Uninsured/self-pay 1 (0.6%) 1 (0.6%) 1.0 Drug being started Infliximab 8 (4.8%) 30 (17.8%) .0002 Adalimumab 94 (57.0%) 49 (39.0%) < 0.0001 Certolizumab 2 (1.2%) 4 (2.4%) .68 Golimumab 1 (0.6%) 0 (0%) .49 Vedolizumab 6 (3.6%) 15 (8.9%) .07 Ustekinumab 39 (23.6%) 67 (39.6%) .0022 Tofacitinib 15 (9.1%) 4 (2.4%) .0089 Drug delivery type IV loading 53 (33.1%) 112 (66.3%) < 0.0001 SQ loading 97 (58.8%) 53 (31.4%) < 0.0001 Oral 15 (9.1%) 4 (2.4%) .0089 Study site Site 1 13 (7.9%) 80 (47.3%) < 0.0001 Site 2 152 (92.1%) 89 (52.7%) Site 1 subgroup N=13 N=80 IV loading 6 (46.2%) 59 (73.8%) .056 SQ loading 7 (53.8%) 20 (25.0%) .048 Oral 0 (0%) 1 (1.3%) 1.0 Site 2 subgroup N=152 N=89 IV loading 47 (30.9%) 53 (59.6%) < 0.0001 SQ loading 90 (59.2%) 33 (37.1%) 0.0013 Oral 15 (9.9%) 3 (3.4%) .08