Cost-Effectiveness of Therapeutic Drug Monitoring of Anti-TNF Therapy in Inflammatory Bowel Disease: A Systematic Review

Abstract

Infliximab and adalimumab are monoclonal antibodies against tumor necrosis factor (anti-TNF) used to manage inflammatory bowel disease (IBD). Therapeutic Drug Monitoring (TDM) has been proven to prevent immunogenicity, to achieve better long-term clinical results and to save costs in IBD treatment. The aim of this study was to conduct a systematic review on cost-effectiveness analyses of studies that apply TDM of anti-TNF in IBD and to provide a critical analysis of the best scientific knowledge available in the literature. The quality of the included studies was assessed using Consolidated Health Economic Evaluation Reporting Standards (CHEERS). Cost-effectiveness of the TDM strategies was presented as total costs, cost savings, quality-adjusted life-years (QALY) and incremental cost-effectiveness ratio (ICER). Thirteen studies that examined the health economics of TDM of anti-TNF in IBD from 2013 to 2021 were included. Eight of them (61.5%) achieved a score between 17 and 23 on the CHEERS checklist. The comparison between the TDM strategy and an empirical strategy was cost saving. The ICER between reactive TDM and an empirical strategy was dominated (favorable) by reactive TDM, whereas the ICER value for proactive TDM compared to an empirical strategy ranged from EUR 56,845 to 3,901,554. This systematic review demonstrated that a TDM strategy is cost-effective or cost-saving in IBD.

Challenges in Therapeutic Drug Monitoring: Optimizing Biological Treatments in Patients With Inflammatory Bowel Disease and Other Immune-Mediated Inflammatory Diseases

“…A Spanish group undertook a systematic review of cost-effectiveness analyses of studies that applied TDM of anti-TNFs in IBD. 59 Of 13 studies identified for inclusion (12 of infliximab), 4 modeling studies, [60][61][62][63] 1 prospective observational study, 64 1 retrospective observational study, 65 1 nonrandomized clinical trial, 66 and 1 RCT 17 reported economic outcomes for proactive TDM. Overall, the incremental costeffectiveness ratio for proactive TDM versus an empirical strategy ranged from €57,000 to €3.9 million, indicating cost-effectiveness.…”

“…Proactive TDM can rationalize the use of anti-TNF agents in pediatric IBD and permit treatment de-escalation in suitable patients. 81,82 In the pediatric Crohn's disease adalimumab levelbased optimization treatment (PAILOT) RCT, proactive versus reactive TDM of adalimumab was associated with a significantly higher rate of corticosteroid-free clinical remission (82% versus 48%; P = 0.002). 20 Elsewhere, proactive TDM was associated with a significant reduction in the number of children requiring a switch of their primary biological and with superior clinical outcomes including a higher rate of steroid-free clinical remission at 1.5-year follow-up and fewer IBD-related surgeries.…”

Four‐year review of New Zealand laboratory infliximab and adalimumab concentration results indicating potential for improved dosing

“…Therapeutic drug monitoring (TDM) of infliximab and adalimumab is recommended in several national guidelines for the treatment of inflammatory bowel disease 1–3 and now in rheumatological conditions 4 . TDM and dose adjustment of the antitumour necrosis factor (TNF) drugs are associated with improved patient outcomes and are cost‐effective 5 . Reported thresholds for drug concentrations above which efficacy is improved vary from 3 to 5 mg/L for infliximab and 5 to 9 mg/L for adalimumab 1,6–9 .…”

“…4 TDM and dose adjustment of the antitumour necrosis factor (TNF) drugs are associated with improved patient outcomes and are cost-effective. 5 Reported thresholds for drug concentrations above which efficacy is improved vary from 3 to 5 mg/L for infliximab and 5 to 9 mg/L for adalimumab. 1,[6][7][8][9] Prior to the introduction of the World Health Organization infliximab and adalimumab standards in 2019, the accuracy of measurement methods was variable.…”

90K/Mac-2 BP Is a New Predictive Biomarker of Response to Infliximab Therapy in IBD Patients

“…In particular, therapeutic drug monitoring (TDM) has been proven to maintain the efficacy of biologic agents, prevent immunogenicity, and hence improve clinical results and reduce costs in IBD patients management [ 24 , 25 , 26 , 27 , 28 ].…”