Abstract

Abstract BACKGROUND In phase 3 studies, mirikizumab (MIRI), an IL-23p19 antibody, demonstrated efficacy vs placebo in adult patients with moderately-to-severely active ulcerative colitis (UC). It is being developed for the United States Food and Drug Administration approval for the treatment of UC. Ustekinumab (USTE), an IL-12/23p40 antibody, is currently the most utilized second line treatment in UC patients. Physicians may prescribe MIRI in a similar placement to USTE, and payers may compare them when making formulary decisions for IL-23 inhibitors. Given the need for continued maintenance therapy to manage UC, it is of interest to evaluate the relative cost-efficiency of MIRI vs USTE. We estimated and compared the cost of MIRI vs USTE for achieving remission in one additional patient during the maintenance phase in biologic/Janus kinase inhibitor (JAKi)-experienced patients with UC. METHODS This study used a network meta-analysis (NMA) of published randomized controlled trials of maintenance phase therapy to derive the number needed to treat (NNT) for achieving clinical remission among those who responded to induction therapy. In NMA, clinical remission was defined as a total Mayo score of ≤2 points, with no individual sub-score >1. An Excel-based analytic model was developed to estimate cost per additional patient achieving clinical remission at the end of maintenance trial period. The model included the cost of maintenance therapy from a US commercial payer perspective and the NNT of achieving clinical remission for MIRI and USTE in the biologic/JAKi-experienced population. Wholesale Acquisition Cost (WAC) of USTE was taken from Micromedex Redbook. A scenario with USTE biosimilar was also considered where NNT was considered the same as USTE, but the WAC was considered 50% lower than the current WAC of USTE. RESULTS The costs per biologic/JAKi-experienced patient achieving clinical remission during the maintenance phase were $501,472 and $1,027,799 for MIRI and USTE. The lower cost per remission for MIRI in maintenance was the result of both lower relative NNT and lower anticipated WAC of MIRI compared to USTE. The scenario also resulted in a comparable cost per remission for MIRI vs a USTE biosimilar. CONCLUSION MIRI is projected to have a lower cost per remission during maintenance therapy compared to USTE. Given the need for long-term treatment for this chronic condition, MIRI appears to be a cost-efficient treatment option based on its lower NNT and anticipated acquisition cost in the maintenance phase.

Full Text
Published version (Free)

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call