Reduced healthcare costs of crohn's disease-related hospitalizations and surgeries in patients initiated with ustekinumab in the im-unitilte study

BACKGROUND:

Crohn's disease (CD) is a chronic inflammatory bowel disease affecting a growing number of people in the U.S. The goal of treatment is to achieve and maintain remission, thereby avoiding costly hospitalizations and/or surgeries associated with significant economic burden for patients (pts) and payers. Ustekinumab (UST) was approved for treatment of moderately‐to‐severely active CD in the U.S. in 2016. However, evidence of its impact on healthcare costs from CD‐related hospitalizations and surgeries remains limited.

OBJECTIVE:

To assess healthcare costs for CD‐related hospitalizations and surgeries in pts initiated with either placebo (PBO) or UST 90 mg q8w in the IM‐UNITI long‐term extension (LTE) study over a period of 2 years.

METHODS:

Eligible CD pts were first enrolled in the UNITI‐1&2 IV induction studies. Clinical responders were then randomized 1:1:1 in the IM‐UNITI maintenance study to PBO, UST 90 mg q12w, or UST 90 mg q8w. All pts completing week 44 were eligible to enter the LTE study. Only the pts on PBO or UST 90 mg q8w (FDA approved dosing regimen, UST hereafter) in the LTE study were analyzed. Number of pts with a CD‐related hospitalization and/or surgery was recorded. Mean annual costs for CD‐related hospitalizations and surgeries were obtained from the literature, and adjusted to 2018 U.S. dollars. Number needed to treat (NNT) and per‐pt‐per‐year (PPPY) costs were calculated.

RESULTS:

103 UST and 82 PBO pts from the IM‐UNITI LTE study were analyzed. In 2 years, UST pts had fewer CD‐related hospitalizations without surgery (hospitalizations hereafter, 3.9% vs. 11.0% for PBO) and CD‐related surgeries with or without hospitalization (surgeries hereafter, 3.9% vs. 11.0% for PBO). The NNT was 14 to avoid either a CD‐related hospitalization or a surgery for UST pts. UST pts had PPPY cost reduction of $1,103 and $2,113 in CD‐related hospitalizations and surgeries, relative to PBO, respectively. Overall, UST pts had total PPPY cost reduction of $3,216 for healthcare costs from CD‐related hospitalizations and surgeries compared to PBO. The 103 UST pts had total cost reduction of $662,459 from fewer CD‐related hospitalizations and surgeries over 2 years.

CONCLUSIONS:

UST reduced the costs associated with CD‐related hospitalizations and surgeries in moderately‐to‐severely active CD pts in the IM‐UNITI LTE study over the course of 2 years. Results are likely conservative as only single events per pt were recorded and placebo treated pts in maintenance were induced with UST prior to rerandomization.