S0819 Evaluating Cost Per Remission and Cost of Serious Adverse Events in Advanced Therapies for Ulcerative Colitis

INTRODUCTION: Patients with ulcerative colitis (UC) incur >3-fold higher direct costs of care compared to the general patient population, largely due to use of biologic therapy.1 Direct2 and indirect3 comparisons of advanced therapies (AT) for UC have demonstrated differences in effectiveness and safety. We compared cost per remission for UC at 52 weeks, considering probability of clinical remission, as well as costs of serious adverse events (SAE) and serious infections (SI) for different ATs for UC. METHODS: Comparators were vedolizumab IV (VDZ), infliximab 5 and 10 mg/kg (IFX-5 and IFX-10), adalimumab 40 mg (ADA), tofacitinib 5 and 10 mg (TOF-5 and TOF-10), ustekinumab 90 mg (UST), and golimumab 100 mg (GOL). Numbers needed to treat and to harm (NNT/NNH), derived from network meta-analysis (NMA) of pivotal trials,3 were clinical inputs. Wholesale acquisition costs, derived from REDBOOK,4 were used to calculate costs of induction and maintenance regimens for labeled dosing. Infusion-related costs were included for IV AT. NNT for induction and maintenance was combined with regimen costs to calculate cost per clinical remission, as defined in the pivotal trials. Patients who were nonresponders to induction treatment did not incur maintenance costs. NNH for SAE and SI was used to incorporate costs attributed to treating AE, with VDZ used as reference because its SAE rate was lowest in the NMA.2 AE costs were derived from the Healthcare Cost and Utilization Project and weighted from AE rates comprising SAE and SI. RESULTS: Costs per remission after 52 weeks of treatment were lowest for TOF-10 ($187K) and TOF-5 ($228K), and highest for UST ($730K) (Figure 1). Mean SAE and SI costs per 100 patients in comparison to VDZ as the reference ($ = 0) were lowest for UST ($6K), and highest for TOF-5 ($118K) (Figure 2). CONCLUSION: Using data from pivotal trials and REDBOOK to estimate costs of treatment, accounting for probability of clinical remission and costs of SAE/SI, we found that TOF-5, TOF-10, IFX-5, and VDZ are less than half the cost of GOL, ADA, and UST. When considering AE-related costs, TOF-5 and GOL cost an additional ∼$100K per 100 patients treated compared to VDZ.Figure 1.: Cost per Remitter at 52 Weeks. Q8W, every 8 weeks; SC, subcutaneous.Figure 2.: Average AE Cost per 100 Patients (serious AEs). Dollar amounts represent the total combined costs of both serious AEs and serious infections. Bars to the left of the dark line represent costs that are less than those of the reference treatment, vedolizumab, and that partially offset the costs that are greater than those of the reference treatment (to the right of the line). AE, adverse event; Q8W, every 8 weeks; SC, subcutaneous.

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