Abstract

Background. Currently there exists a wide range of advanced renal cell carcinoma (RCC) treatment schemes, among them cabozantinib, registered in Russia in 2019, was approved as a second-line therapy in both foreign and domestic guidelines. Objective: to conduct a comparative clinical and economic analysis of cabozantinib and alternative drugs in adult patients with advanced RCC after previous systemic therapy. Materials and methods. A literature review was conducted on clinical efficacy and safety of various second-line therapy drugs for advanced RCC in the available databases. The foreign partitioned survival model, reflecting the development of widespread RCC when using 4 different second-line therapy drugs (cabosantinib, nivolumab, axitinib and everolimus), was adapted considering 3 consecutive mutually exclusive conditions (before progression, after progression, death). Pharmacoeconomic analysis included “cost-effectiveness” and “cost-utility” analysis. We estimated direct medical costs for second- and third-line therapy and maintenance therapy (outpatient monitoring and palliative care). To estimate drug costs we used prices from the State Register of maximum selling prices, for cabozanthinib — price presented by the manufacturer. Costs of maintenance therapy were estimated based on the normal standardfor financial costs in accordance with the Program of state guarantees for 2020. Results. Efficacy analysis based on the partitioned survival model showed the highest rates of life-years gained (3.18 life-years-gained (LYG)) and quality adjusted life-years (1.87quality adjusted life-years (QALY)) for cabozanthinib compared with nivolumab (2.53 LYG and 1.6 QALY), axitinib and everolimus (2.21 LYG and 1.31 QALY). Total costs for advanced RCC patients when treated with cabozanthinib were 4.3 million rubles, which is 5 % less than when using nivolumab (4.5 million rubles). Total costs for axitinib were 2.1 million rubles, while its effectiveness was lower compared with the cabozanthinib one. Costs of 1 life-year saved for cabozantinib were 1.4 million rubles, which is 25 % less compared to those for nivolumab. Costs of 1 quality-life year saved when using cabozantinib amounted 2.3 million rubles, which is 19 % less than those for nivolumab. Conclusion. The study results showed that using cabozantinib to treat advanced RCC after previous systemic treatment is both clinically and cost-effective for adult patients with advanced RCC in the Russian Federation.

Highlights

  • There exists a wide range of advanced renal cell carcinoma (RCC) treatment schemes, among them cabozantinib, registered in Russia in 2019, was approved as a second-line therapy in both foreign and domestic guidelines

  • Efficacy analysis based on the partitioned survival model showed the highest rates of life-years gained (3.18 life-years-gained (LYG)) and quality adjusted life-years (1.87 quality adjusted life-years (QALY)) for cabozanthinib compared with nivolumab (2.53 LYG and 1.6 QALY), axitinib and everolimus (2.21 LYG and 1.31 QALY)

  • Total costs for advanced RCC patients when treated with cabozanthinib were 4.3 million rubles, which is 5 % less than when using nivolumab (4.5 million rubles)

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Summary

Background

There exists a wide range of advanced renal cell carcinoma (RCC) treatment schemes, among them cabozantinib, registered in Russia in 2019, was approved as a second-line therapy in both foreign and domestic guidelines. Цель исследования – проведение сравнительного клинико-экономического анализа применения кабозантиниба и альтернативных препаратов для лечения распространенного ПКР у взрослых пациентов после предшествующей системной терапии. В соответствии с гипотезой исследования о том, что применение препарата кабозантиниб при лечении взрослых пациентов с распространенным ПКР после предшествующей системной терапии является клинически эффективной и экономически оправданной стратегией организации помощи больным на территории России, в рамках настоящей работы была проведена фармакоэкономическая оценка применения различных препаратов, используемых в рамках данного показания. Для оценки показателей эффективности и полезности была адаптирована зарубежная модель разделенной выживаемости [20], которая является распространенным методом моделирования в фармакоэкономике и отражает динамику развития распространенного ПКР при применении 4 альтернативных вариантов 2‐й линии терапии: кабозантиниб, ниволумаб, акситиниб и эверолимус.

FR TKI
Режим дозирования Dosage regimen
Акситиниб Axitinib
Частота назначения Frequency of prescription
На паллиативную помощь Palliative care
Therapy control and
Findings
Кабозантиниб Ниволумаб Акситиниб Эверолимус
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