Objective
To evaluate the cost-effectiveness of tisotumab vedotin (TV) versus single-agent chemotherapy in recurrent or metastatic cervical cancer (r/mCC) after failure of first-line treatment, from the perspective of the Spanish National Health System.
Methods
Cost-utility analysis was conducted using a partitioned survival model with three health states, over a 60-month time horizon. Efficacy data ‒overall survival (OS) and progression free survival‒ were derived from innovaTV-301 trial and modeled using parametric survival functions. Costs and utilities were obtained from national databases and literature, with outcomes expressed in quality-adjusted life years (QALYs). Incremental cost-utility ratio (ICUR) was calculated, and sensitivity analyses were performed to explore uncertainty.
Results
TV provided an additional 0.341 QALYs over chemotherapy (1.229 vs. 0.889) at an incremental cost of €12,138, resulting in an ICUR of €35,600/QALY, assuming a cost equivalent to cemiplimab. Sensitivity analyses showed ICURs ranging from €33,483-€37,564/QALY depending on modeling assumptions. Drug price and OS benefit were the most influential parameters. Using the foreign list price for TV, the ICUR increased to €950,017/QALY.
Conclusions
TV offers a modest benefit over chemotherapy in r/mCC and reaches or surpasses the upper bounds of ICER applied in Spain when priced comparably to cemiplimab. The magnitude of clinical benefit remains uncertain.