| Summary: | Background. Currently, treatment of recurrent / refractory chronic lymphocytic leukemia (CLL) involves the appointment of regimens with innovative drugs, which include ibrutinib and a combination of venetoclax and rituximab. Wherein said combination provides continuing over time high frequency eradication of minimal residual disease. Thereby, this regimen can be canceled if patients do not progress after 2 years from therapy start.The objective of the study was to assess the pharmacoeconomic aspects of therapy with venetoclax and rituximab combination in patients with recurrent / refractory CLL compared with ibrutinib monotherapy.Materials and methods. Analysis was performed by a simulation method from a position of the health care system. In accordance with network meta-analysis results of clinical studies in the recurrent / refractory CLL treatment (MURANO for venetoclax + rituximab combination and RESONATE and HELIOS for ibrutinib), which showed the absence of statistically significant differences in progression-free and overall survival between these treatment options, the cost-minimization method was used in the analysis. In the basic version, the model time horizon is 4 years. The price of venetoclax, rituximab and ibrutinib in the calculation corresponded to that registered (for rituximab – the median of the registered prices) with the value-added tax and the weighted average wholesale allowance taking into account the population in Russia.When analyzing the healthcare system budget impact, the time horizon of the study was 4 years. Therapy with combination of venetoclax + rituximab starting from the first year was suggested in 100 % of newly identified recurrent / refractory CLL patients. In the base case, it was estimated that 100 patients would need therapy every year.In the basic version of analysis, the cost of therapy after progression was not taken into account. In sensitivity analysis, an option taking into account therapy cost after progression, suggesting the appointment of venetoclax in the ibrutinib group and ibrutinib in the venetoclax + rituximab group, was also evaluated. In addition, variants with disease progression were additionally evaluated in 15 % of patients per year in the venetoclax therapy group at the end of the 2-year treatment course, as well as with an increase and decrease in the disease progression rate by 15 % in both comparison groups.As part of the sensitivity analysis, an assessment is made of a 15 % decrease and increase in Venetoclax price, a 30 % decrease in Ibrutinib price compared to registered price and the option with a 3-year study time horizon. When analyzing the budget impact, options with an increase in the number of patients annually identified and requiring treatment by 10, 20, 30 and 50 % were evaluated. Clinical and economic analysis was carried out with a discount rate of 3.5 % per year. A budget impact analysis was performed without discounting.Results. According to the results of cost-effectiveness analysis in the basic version, a regimen including venetoclax can reduce costs by 46.3 % compared with ibrutinib (cost for 4 years per patient is 10.422 and 19.413 million rubles, respectively). Therapy with combination of venetoclax + rituximab in 100 newly identified recurrent / refractory CLL patients annually instead of ibrutinib monotherapy will result in a reduction in therapy costs by 29.0 %, or by 1.579 billion rubles for 4 years per 100 patients starting therapy annually. The sensitivity analysis demonstrated the high reliability of the results. Conclusion. The treatment of recurrent / refractory CLL with a combination of venetoclax and rituximab is comparable in clinical efficacy with ibrutinib monotherapy and can significantly reduce the cost of the healthcare system, and therefore increase the availability of innovative therapy for this group of patients.
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