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

• Published in: BMC gastroenterology Vol. 22; no. 1; p. 501
• Main Authors: Jairath, Vipul, Cohen, Russell D, Loftus, Jr, Edward V, Candela, Ninfa, Lasch, Karen, Schultz, Bob G
• Format: Journal Article
• Language: English
• Published: England BioMed Central 06.12.2022; BMC
• Subjects: Adverse events; Biological products; Clinical trials; Cost analysis; Cost-effectiveness; Drug dosages; Drug safety; Endoscopy; Gastroenterology; Health care policy; Hospital costs; Infections; Inflammatory bowel disease; Infliximab; Literature reviews; Meta-analysis; Monoclonal antibodies; Patients; Remission; Remission (Medicine); Resource utilization; Safety; Systematic review; Tumor necrosis factor-TNF; Tumor necrosis factor-α; Ulcerative colitis; United States > US; Remission; Biological products; Cost-effectiveness; Drug safety; Ulcerative colitis
• ISSN: 1471-230X; 1471-230X
• DOI: 10.1186/s12876-022-02590-6

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. 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. 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. 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.