Healthcare Cost Offsets from Reductions in Ulcerative Colitis-Related Hospitalizations and Surgeries in Patients Treated with Ustekinumab in the UNIFI Study

INTRODUCTION:

Ulcerative colitis (UC) affects a growing number of patients (pts) in the US. Avoiding costly hospitalizations and surgeries is critical for all stakeholders including pts and payers. Ustekinumab (UST) was recently approved for treatment of moderately-to-severely active UC in the US, but evidence of its impact on healthcare cost reductions in UC-related hospitalizations and surgeries is lacking. Objective: To model costs from UC-related hospitalizations and surgeries in pts treated with either placebo (PBO) or UST (induction followed by UST 90 mg q8w) in the UNIFI Phase 3 trial over a period of 52 weeks (1 year).

METHODS:

Eligible UC pts were first enrolled in a randomized induction trial. Clinical responders to intravenous UST were then randomized 1:1:1 in the 44-week randomized-withdrawal maintenance trial to PBO, UST 90 mg q12w, or UST 90 mg q8w. Only the pts on PBO, 6 mg/kg (induction) or UST 90 mg q8w (FDA approved dosing regimen, UST hereafter) in the UNIFI study were analyzed. Number of pts with a UC-related hospitalization and surgery was recorded in both the induction and the maintenance trials of the UNIFI study. Mean costs for UC-related hospitalizations and surgeries were obtained from the literature (adjusted to 2019 US dollars). Per-pt-per-year (PPPY) costs were calculated

RESULTS:

322 UST and 319 PBO pts were analyzed in the induction trial of UNIFI, where UST pts had fewer UC-related hospitalizations (1.6% vs 4.4% for PBO) and UC-related surgeries (0% vs 0.6% for PBO) resulting in per-pt cost offsets of ≥638 and $372, respectively, for UST vs PBO during induction. 176 UST and 175 PBO pts were analyzed in the maintenance trial, where UST pts had fewer UC-related hospitalizations (1.7% vs 5.7% for PBO) and UC-related surgeries (0.6% vs 1.7% for PBO) resulting in per-pt cost offsets of ≥911 and $682, respectively, for UST vs PBO during maintenance. Overall, UST pts had per-pt-per year cost offsets of $2,603 from reductions in UC-related hospitalizations and surgeries compared to PBO.

CONCLUSION:

Moderately-to-severely active UC pts treated with UST had cost offsets vs PBO from fewer UC-related hospitalizations and surgeries in UNIFI study over 1 year. Results are likely conservative as only single events per pt were recorded, and PBO pts in maintenance were re-randomized following response to active induction with UST, meaning non-responders to active drug did not enter the maintenance trial.