Clinical and economic effectiveness of using immunotherapeutic drugs in patients with urothelial carcinoma in the healthcare system of the Russian Federation

Aim. To perform pharmacoeconomic evaluation of chemotherapy schemes GC (gemcitabine, cisplatin) and GemCarbo (gemcitabine, carboplatin) in comparison with immunotherapy drugs atezolizumab, pembrolizumab or avelumab in patients with locally advanced or metastatic urothelial carcinoma.Materials and methods. Pharmacoeconomic cost–effectiveness analysis, sensitivity analysis in context of changes of initial model parameters were performed.Results. Literature data analysis allows to make a conclusion of better clinical effectiveness and safety of immunotherapy drugs compared to chemotherapy in patients with urothelial carcinoma. Cost of medications was significantly lower for platinum-based chemotherapy (103,625.61 rubles for GC and 88,733.63 rubles for GemCarbo) compared to a course of immunotherapy (950,092.39 rubles for atezolizumab, 953,340.21 rubles for pembrolizumab, 1,328,999.43 rubles for GC + avelumab). However, the cost of treatment of complications arising during platinum-based chemotherapy was more than 20-fold higher than cost of treatment of immunotherapy complications: 578,853.02 rubles versus 15,336.78– 26,994.52 rubles). Cost–effectiveness analysis favored atezolizumab for which cost–effectiveness ratio was 53,230.69 rubles for 1 month of patient’s life. Atezolizumab had better value than standard 1st line GC chemotherapy by 10,671.80 rubles, as well as immunotherapy courses using pembrolizumab by 9,697.57 rubles and GC + avelumab by 10,824.66 rubles. The highest costs were observed for GemCarbo chemotherapy course: it is 18,522.82 rubles more expensive than atezolizumab course. Sensitivity analysis performed for the cost–effectiveness ratio showed stability of the developed model in regards to increased cost of atezolizumab course up to +18 % and decrease in overall survival with this course up to –15 %.Conclusion. Atezolizumab is a clinically effective and economically justified option for treatment of adults with locally advanced or metastatic urothelial carcinoma and PD-L1 expression ≥5 % in the healthcare system of the Russian Federation.