Evaluating cost per remission and cost of serious adverse events of advanced therapies for ulcerative colitis

Abstract

Background Determining the relative cost-effectiveness between advanced therapeutic options for ulcerative colitis (UC) may optimize resource utilization. We evaluated total cost per response, cost per remission, and cost of safety events for patients with moderately-to-severely active UC after 52 weeks of treatment with advanced therapies at standard dosing. Methods An analytic model was developed to estimate costs from the US healthcare system perspective associated with achieving efficacy outcomes and managing safety outcomes for advanced therapies approved for the treatment of UC. Numbers needed to treat (NNT) for response and remission, and numbers needed to harm (NNH) for serious adverse events (SAEs) and serious infections (SIs) were derived from a network meta-analysis of pivotal trials. NNT for induction and maintenance were combined with drug regimen costs to calculate cost per clinical remission. Cost of managing AEs was calculated using NNH for safety outcomes and published costs of treating respective AEs. Results Costs per remission were $205,240, $249,417, $267,463, $365,050, $579,622, $750,200, and $787,998 for tofacitinib 10 mg, tofacitinib 5 mg, infliximab, vedolizumab, golimumab, adalimumab, and ustekinumab, respectively. Incremental costs of SAEs and SIs collectively were $136,390, $90,333, $31,888, $31,061, $20,049, $12,059, and $0 for tofacitinib 5 mg, golimumab, adalimumab, tofacitinib 10 mg, infliximab, ustekinumab, and vedolizumab (reference), respectively. Conclusions Tofacitinib was associated with the lowest cost per response and cost per remission, while vedolizumab had the lowest costs related to SAEs and SIs. Balancing efficacy versus safety is important when evaluating the costs associated with treatment of moderate-to-severe UC.

Lack of Benefit for Early Escalation to Advanced Therapies in Ulcerative Colitis: Critical Appraisal of Current Evidence

“…It is likely that in the USA, these savings would be substantial, as the recently estimated costs of achieving remission were calculated to be $249 417, $267 463, $365 050, $579 622, $750 200, and $787 998 for tofacitinib 5 mg, infliximab, vedolizumab, golimumab, adalimumab, and ustekinumab, respectively. 65 In the USA, the yearly cost of 5-ASA medications is less than $10 000. 66 Whilst data on the recent costs of achieving remission incorporating the number needed to treat are lacking, in the period between 2006 and 2008 the cost of preventing a flare was estimated at $8810 per flare.…”

Editorial: If STRIDE‐II is the hammer, then Crohn's disease and ulcerative colitis are not the same nails

“…Recent modelling studies have also demonstrated cost-effectiveness with optimization of conventional therapies when compared to escalation to advanced therapies. 10 In principle, STRIDE-II goals offer a tremendous opportunity to dominate over the disease if not decimate it, yet their application at the ground level requires clarity. Further stratification is required in terms of disease situations where the application of STRIDE-II goals would be disease-altering, cost-effective and patient-friendly.…”

“…The increasing burden of IBD in developing countries has also complicated the issue, because the cost and concern for infectious side‐effects is an impediment to advanced therapy or treatment escalation in these regions. Recent modelling studies have also demonstrated cost‐effectiveness with optimization of conventional therapies when compared to escalation to advanced therapies 10 …”