Abstract

Therapy of metastatic renal cell carcinoma (mRCC) involves the use of a number of alternative targeted drugs that demonstrate high clinical efficacy, but at the same time, require substantial costs of the health care system. Purpose of the study: cost-effectiveness assessment for axitinib and everolimus as a second-line target therapy in patients with mRCC. Materials and methods: The assessment was carried out by minimizing costs and budgetary impact from the standpoint of the health care system based on the results of meta-analyzes of randomized clinical trials (RCTs). The time horizont of study was 1 year. Results: in accordance with the results of meta-analyzes of RCTs, axitinib and everolimus provide improved patient prognosis compared with sorafenib and do not significantly differ in terms of overall survival (HR = 1,3 [0,46–3,67]) and progression-free survival (HR = 1,09 [0,7–1,68]). At the same time, the manufacturer’s maximum price for everolimus and the manufacturer’s recommended price for inclusion in the list of vital and essential drugs for axitinib – the use of the latter will reduce the cost of treatment for the patient by 451,516 rubles. (20,2%) per year. Also, the treatment with axitinib was characterized by the best safety indicators (OR = 0,14 [0,05–0,38]), allowing to reduce the associated costs of the health care system for stopping adverse events. The results of the analysis of the impact on the budget demonstrated the possibility of achieving savings in the resources of the health care system with the inclusion of аxitinib in the restrictive lists of drugs, demonstrating savings of 640,51–778,82 million rubles (11,5–14,0%) based on the target patient population – 2,659 people per year. The results of the sensitivity analysis showed the sustainability of the obtained results of the minimization of costs and the budget impact of the fluctuation of the drugs cost evaluated and the volume of the target population of patients, as well as indicators of PFS. Findings: Considering the results obtained, we can conclude about the clinical and economic advantage of axitinib in comparison with the everolimus and recommend it for inclusion in the list of vital and essential drugs.

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