Clinical and economic study of the use of ibrutinib in combination with venetoclax in patients with chronic lymphocytic leukemia

Objective. Evaluation of the economic consequences (clinical and economic analysis - CEA and budget impact analysis) of combination targeted therapy with ibrutinib + venetoclax for the treatment of adult patients with high-risk chronic lymphocytic leukemia (CLL) within the framework of preferential drug provision.

Methods. An analytical decision-making model was built In MS Excel, which allows to carry out CEA with the use of a fixed duration combination of ibrutinib + venetoclax in comparison with the use of FCR (fludarabine, cyclophosphamide and rituximab) and budget impact analysis when using a fixed duration combination of ibrutinib + venetoclax compared with a targeted therapy (acalabrutinib, ibrutinib, venetoclax + obinutuzumab combination) in the first-line therapy of patients with high-risk CLL. Only direct medical costs per patient (drug therapy costs) were taken into account in the model.

Results. As a result of CEA, it was shown that the mean number of progression-free years lived during the 20-year modeling period in CLL when using ibrutinib in combination with venetoclax was 12.63 years, which was 8.16 years more than the mean number of progression-free years in case of use of FCR – 4.47 years. The median number of years lived during a 20-year modeling period in CLL using ibrutinib in combination with venetoclax would be 18.12 years, which is 3.7 years more than the average number of years that one patient lives if he receives FCR – 14.41 years. Compared to the FCR therapy regimen included in the high-cost nosology (HCN) program, already at the 7-year horizon, the cost of the ibrutinib + venetoclax regimen for the healthcare system becomes lower than the cost of FCR due to a fixed duration with superior efficacy rates and allows to increase life expectancy without progression in adult patients with CLL, the cost of an additional year of life without progression is 2,770,241.80 rubles/year. The method is dominant from an economic point of view, because the cost-effectiveness ratio in terms of progression-free life year for ibrutinib with venetoclax is 7,341,534,177 lower than for FCR. Compared to other targeted therapy drugs for CLL, the burden on the healthcare budget can be reduced to 26.4%, or by 7,342 million rubles, when using ibrutinib + venetoclax. for 5 years of therapy.

Conclusion. Ibrutinib + venetoclax is the dominant method due to the lower cost with greater efficiency compared to the current option of therapy within the framework of the HCN and other targeted CLL therapy options.