Ustekinumab infusion to subcutaneous transition: Coordinating care and identifying potential gaps.

Background: Ustekinumab, approved for the treatment of moderate to severe Crohn disease (CD) and ulcerative colitis (UC), requires a clinic-administered intravenous (IV) induction infusion (loading dose) followed by transition to self-administered, subcutaneous (SC) injection for maintenance every 8 weeks. Many patients need subsequent dose escalations to obtain or maintain effectiveness. As an increasing number of CD and UC therapies require a similar dosing and escalation strategy, research evaluating care coordination requirements and clinical outcomes for patients prescribed ustekinumab can help guide best practices.

Objective: To describe the care coordination process and response to therapy from decision to treat with ustekinumab through the first 12 months of initiating SC injection and evaluate differences in SC shipment timing between patients filling at a health-system specialty pharmacy (HSSP) compared with a non-HSSP.

Methods: A single-center, retrospective cohort study was conducted. Patients prescribed ustekinumab for CD or UC between November 1, 2021, and March 31, 2022, were included. Patients were excluded if they never received an infusion or SC dose, received the SC dose at an infusion center, or became lost to follow-up. Outcomes included time between clinical events (decision to treat to IV infusion, prior authorization [PA] submission, PA approval, and SC shipment), the occurrence of SC shipments between 4 and 8 weeks after infusion (most appropriate time frame to prevent waste), and the occurrence of a dose escalation within the first 12 months of therapy. The occurrence of SC shipments within the 4- to 8-week window were analyzed using a multiple logistic regression with the following covariates: age, insurance type, and filling pharmacy type.

Results: In the 70 included patients, the median age was 36 (IQR, 28-44) years. Most patients had commercial insurance (79%), and approximately half filled SC doses external to the HSSP (53%). Median time between events was as follows: decision to treat to PA submission: 3 days (IQR, 1-8); decision to treat to PA approval: 6 days (IQR, 3-14); decision to treat to infusion date: 20 days (IQR, 13-25); and PA approval to medication shipment: 49 days (IQR, 34-73). In the 70 SC doses shipped, 64% (n = 45) occurred within the 4- to 8-week window. Prescriptions filled with the HSSP had 2.5 times higher odds of being shipped in the appropriate window compared with non-HSSP prescriptions (95% CI, 0.8-7.8;  = 0.126). Thirty-nine patients (56%) had dose escalations.

Conclusions: Ustekinumab initiation and escalation within the first year can be a complex process requiring a high level of care coordination to ensure patients receive timely therapy while reducing potential waste.