Cost-effectiveness analysis of enfortumab vedotin and pembrolizumab versus chemotherapy for patients with untreated advanced urothelial cancer in the United Kingdom.

[OBJECTIVES] Enfortumab vedotin and pembrolizumab (EV-Pem) have recently been shown to improve the prognosis of patients with untreated locally advanced or metastatic urothelial carcinoma (la/mUC) in a randomised phase three clinical trial. This study aims to evaluate the cost-effectiveness of EV-Pem as a first-line treatment for patients with la/mUC.

[DESIGN] We developed a three-state Markov model to simulate the treatment pathways for patients with la/mUC. Costs associated with drugs, treatment monitoring, adverse event management and utility inputs were obtained from national cost databases, trial data and existing literature. In addition to the base-case analysis, sensitivity, threshold and subgroup analyses were performed to assess uncertainty.

[SETTING] The National Health Service and Personal Social Services perspective.

[PARTICIPANTS] A hypothetical English cohort of patients with la/mUC.

[INTERVENTIONS] First-line treatment with either EV-Pem or chemotherapy.

[MAIN OUTCOME MEASURES] Costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) were calculated over a lifetime horizon as primary outcomes.

[RESULTS] In patients with la/mUC, EV-Pem increased health outcomes by 0.82 QALYs (95% uncertainty interval (UI) 0.66 to 0.92) at an incremental cost of £76 793.75 (95% UI 75 759.96 to 77 750.72) versus chemotherapy, yielding an ICER of £93 650.92 per QALY (95% UI £83 471.84 to 116 739.74). One-way sensitivity analysis revealed that factors such as utility values, EV prices and discount rates influence model outcomes, but these variations did not alter the conclusion. Probabilistic sensitivity analysis indicated that, at a willingness-to-pay threshold of £30 000 per QALY, the probability of cost-effectiveness is 0. Results remained robust across subgroup analyses.

[CONCLUSION] In this economic model analysis, EV-Pem is not cost-effective compared with first-line chemotherapy in the UK, and a price reduction may be necessary.