Higher rates of delay in starting advanced inflammatory bowel disease therapies linked to insurance delays, intravenous infusions, and lack of pharmacy support.

Background: Because biologic and small molecule therapy is expensive, payors have mandated pre-authorizations for these medications, often resulting in a lengthy approval process. The aims of this study are to assess the frequency of and risk factors for delays in starting advanced therapies assessing insurance, care team, and patient-related factors.

Methods: Retrospective, multi-center study of adult inflammatory bowel disease patients with prescriptions for an advanced therapy in two geographically distinct academic gastroenterology practices; one with and the other without a dedicated pharmacist. A priori we defined a delay in starting therapy as >14 days between prescription and first dose. Logistic regression analysis was performed to assess for risk factors for delay.

Results: A total of 388 patients were prescribed advanced therapies with 46.6% receiving their first dose within 14 days. Patients who were on time vs delayed were similar in baseline demographics, disease characteristics, and disease activity. After adjusting for confounders, three independent risk factors remained significant as predictors for delay; study site (OR=5.2, 95% CI 2.894, 9.333), intravenous drug delivery as opposed to subcutaneous or oral (OR=3.07, 95% CI 1.845, 5.099), and insurance denial (OR=2.72, 95% CI 1.082, 6.825).

Conclusions: In a multicenter study, we found that a delay between prescription and administration of first dose of an advanced therapy is common, with >50% of patients having the first dose delayed by >2 weeks. Delays in starting therapy were significantly more likely if denied by insurance, given via IV induction, or at a study site without a dedicated pharmacist.