Therapeutic Drug Monitoring guided vedolizumab treatment in ulcerative colitis in Cyprus: a cost-effectiveness analysis.

BACKGROUND: Vedolizumab (VDZ) is indicated for patients with ulcerative colitis who have not responded to anti-TNF therapies. Lack of response often leads to surgical intervention due to exhaustion of pharmacological options, with surgery associated with substantial costs and morbidity. Emerging evidence suggests that therapeutic drug monitoring (TDM)-guided VDZ dose optimization may improve clinical response and reduce the need for surgery. This study assessed the cost-effectiveness of TDM-guided VDZ optimization in Cyprus. METHODS: An exploratory cost-utility analysis compared a TDM-guided VDZ strategy with standard VDZ care from the Cypriot healthcare payer perspective. A Markov model with a 10-year time horizon estimated costs and quality-adjusted life years (QALYs). Decision uncertainty was explored through probabilistic/ deterministic and Expected Value of Perfect Information (EVPI) analyses. RESULTS: Compared with standard care, TDM-guided VDZ resulted in an incremental cost of €16,924 and an incremental gain of 0.16 QALYs. The resulting incremental cost-effectiveness ratio (ICER) was €108,297 per QALY, exceeding the €90,000 per QALY threshold and indicating that TDM-guided VDZ was not cost-effective. Threshold analysis showed that reductions in VDZ acquisition costs would render the intervention cost-effective. Expected Value of Perfect Information (EVPI) analysis suggested that additional evidence would be valuable in the Cypriot context. CONCLUSION: TDM-guided vedolizumab improved health outcomes but increased costs and was not cost-effective at current prices. However, threshold analyses indicate that managed entry agreements linking price to real-world outcomes may enable cost-effective adoption by addressing patient heterogeneity and uncertainty.