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Enfortumab vedotin for the treatment of patients with urothelial cancer after failure of the treatment with PD-1/PD-L1 inhibitor—cost-effectiveness analysis

Toni Vekov, Makreta Draganova, Nadia Veleva, Elena Daracheva, Valentina Belcheva, Jivko Kolev


Introduction: Bladder cancer (BC) is one of the most common malignancies in industrialized countries. The incidence of BC increases with age and is almost 3 times more common in men than in women. The therapy in adult patients with locally advanced or metastatic BC who have previously received chemotherapy containing platinum and a PD-1/PD-L1 inhibitor requires the inclusion of enfortumab vedotin (EV) or docetaxel- or paclitaxel-based chemotherapy.

Aim: The aim of the study is to model local data on long-term costs and health benefits from the application of alternative health technologies for the treatment of patients with BC to decide which therapy has an advantage in terms of the ratio of therapeutic efficacy and cost-effectiveness.

Materials and Methods: Inputs in the prognostic model used were measured and evaluated as clinical endpoints in the EV-301 multicentre randomized clinical trial. The modelled data on future health benefits and costs after the end of the clinical trial are based on Markov’s model with three health conditions, one of which is absorbent.

Conclusion: Despite therapeutic superiority of enfortumab vedotin over chemotherapy (docetaxel, paclitaxel), it is not a cost-effective approach to treat patients with urothelial carcinoma after failure with PD-1/PD-L1 inhibitors. The only reason for this is its high price. The value of the cost-benefit ratio of enfortumab vedotin is around BGN 659,000/QALY and significantly exceeds the cost-effectiveness threshold (ICER ≤ BGN 50,000/QALY), which is equal to three times the gross domestic product per capita of the population in Bulgaria for the previous year.


bladder cancer/locally advanced or metastatic/new therapies; enfortumab vedotin; chemotherapy/docetaxel or paclitaxel; cost-effectiveness analysis

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