BACKGROUND: Currently 2 novel treatment options for disseminated renal cell carcinoma resistant to angiogenesis inhibitors (RCC) were included in Russian clinical guidelines: lenvatinib in combination with everolimus (LEN+EV) and nivolumab. The indirect treatment comparison showed no statistical difference in overall survival for these therapies. At the moment lenvatinib is not included in the Government Drug Reimbursement Program (GDRP), thus patients with limited treatment options have a restricted access to the recommended therapy with proven efficacy.

OBJECTIVES: To compare the costs of LEN+EV or nivolumab treatment in patients with RCC and analize budget impact of inclusion of lenvatinib into GDRP.

METHODS: The costs of treatments were calculated based on the registered prices for nivolumab and everolimus and proposed price for lenvantinib, using average treatment duration from published trials. In Budget impact analysis we also took into account administration and adverse events costs, evaluated using public health insurance tariffs. Two scenarios were compared: all eligible patients are treated with nivolumab or 60% of them are treated with LEN+EV and 40% - with nivolumab.

RESULTS: The drug cost for an average duration of treatment was €33.1 thousands per patient in case of LEN+EV (€4.3 thousands per month), which was 20.9% lower compared to nivolumab (€7.6 thousands per month). In budget impact analysis administration and adverse events costs were less than 0,49% of treatment costs. Inclusion of lenvatinib in GDRP and subsequent introduction into clinical practice reduced the budget for treating patients with RCC by 12.56%. In one-way deterministic sensitivity analysis results were stable up to 49% increase of lenvatinib price or 21% reduction of nivolumab price.

CONCLUSIONS: LEN+EV is a cost-saving option compared to nivolumab and thus lenvatinib should be recommended for inclusion into the GDRP in Russia.