P-041 Cost per Clinical Response, Clinical Remission, and Mucosal Healing of Adalimumab, Golimumab, and Infliximab Among Patients with Ulcerative Colitis (UC)

Abstract

BACKGROUND: Ulcerative colitis (UC) affects between 37 and 238 people per 100,000 in the United States. Adalimumab (ADA), golimumab (GLM), and infliximab (IFX) are 3 anti-TNF therapies approved for the treatment of moderate to severe UC. Increasing concerns about the budgetary impact of biologic therapies has intensified the need to understand their cost implications. The primary objective of this study was to compare the cost effectiveness and number needed to treat (NNT) for ADA, GLM, or IFX maintenance therapy among patients with moderate to severe UC using the published clinical studies. METHOD(S): A cost effectiveness model was developed using the results of 3 trials: ULTRA 2 (ADA), PURSUIT-M (GLM), and ACT 1 (IFX). This analysis evaluated the placebo-adjusted cost per clinical response (CPRes), cost per clinical remission (CPR), and cost per mucosal healing (CMH). The NNT was calculated for each of these endpoints. ULTRA 2 had an induction period of 4 weeks and patients were followed for a total of 52 weeks. Patients enrolled in the PURSUIT-M trial had an induction period of 6 weeks and were followed for a total of 60 weeks. ACT 1 had an induction period of 6 weeks and patients were followed for a total of 54 weeks. All patients were anti-TNF naive. Patients were assumed to follow FDA-approved labeled dosing requirements, which resulted in 26 doses for adalimumab, 13 doses for golimumab, (Table presented) and 6 doses for infliximab. Medication costs were calculated by applying the July, 2013 wholesale acquisition costs. Infusion costs were included for IFX. RESULT(S): The CPR, CPRes, CMH and the respective NNT results are presented in Table 1 for ADA, GLM, and IFX. CONCLUSION(S): A comparison of the cost effectiveness of ADA, GLM, and IFX is challenging due to different study designs, populations, and time points among the 3 clinical trials. The results suggest that IFX and GLM may be more cost effective than ADA across the 3 clinical endpoints. The results were similar for the NNT. Additional studies using real-world data may provide a better understanding of the cost effectiveness of anti-TNF therapies and allow for better comparisons among the medications.