Skripnik A R

Kulikov A.Y., Petrovskiy A.V., Rybchenko Y.V., Skripnik A.R. 1161

According to the World Health Organization, breast cancer is the most common form of cancer in women worldwide. The steady increase in the prevalence of breast cancer, followed by an increase in the state budget expenditures on drug supply for this category of patients, determines the relevance of pharmacoeconomic evaluation of treatment of HER2-positive breast cancer using a combination of lapatinib and capecitabine and trastuzumab emtansine monotherapy. A subgroup analysis of the therapeutic outcomes in patients with HER2+ breast cancer conducted by the EMILIA study failed to find a statistically significant difference in median overall survival in patients receiving either trastuzumab emtansine or a combination of lapatinib and capecitabine as second-line treatment, or in patients with non-visceral metastases. Analysis of overall survival of the entire population of patients in the EMILIA study revealed that trastuzumab emtansine is more effective than a combination of lapatinib and capecitabine. Despite this, NICE does not recommend treatment with trastuzumab emtansine due to high cost of treatment. The EMILIA study results were used as a basis for pharmacoeconomic models for HER2+ breast cancer therapy, using such methods of pharmacoeconomic analysis as budget impact analysis, cost-effectiveness analysis, and costminimization analysis for these subgroups of patients. Result of budget impact analysis revealed that the use of the lapatinib and capecitabine combination can reduce health system expenditures by 3,985,271 rubles per patient per year or by 5,851,484 rubles over three years per one patient, which allows treating 4 additional patients given the fixed budget. Cost-effectiveness ratio of lapatinib + capecitabine equals to 869,705 rubles and 3,461,960 rubles with LYG and QALY as efficacy endpoints, respectively, which identifies this therapy as cost-effective in pharmacoeconomic terms. Cost-minimization analysis of lapatinib+capecitabine patient groups in the second-line treatment, and a group of patients with non-visceral metastases showed that the use of this treatment may reduce costs by 78% in comparison with trastuzumab emtansine.

Kulikov A.Y., Skripnik A.R. 765

Melanoma is a malignant tumor that develops from transformed melanocytes, located mainly in the skin. According to Russian statistics, the incidence of melanoma in 2014 was 9,390 new cases [4]. In 2004-2014, melanoma prevalence rate per 100,000 population increased on average by 4.2% per year. High prevalence of melanoma and frequent poor prognosis necessitate search of innovative treatment methods and use of high-tech drugs.

Kulikov A.Y., Skripnik A.R. 645

Melanoma is a malignant tumor that develops from transformed melanocytes, located mainly in the skin. According to Russian statistics, the incidence of melanoma in 2014 was 9,390 new cases. In 2004-2014, melanoma prevalence rate per 100,000 population increased on average by 4.2% per year. High prevalence of melanoma and frequent poor prognosis necessitate search of innovative treatment methods and use of high-tech drugs. The unmet need for oncology therapies is substantial. The introduction of innovative, highcost treatments, coupled with mounting budgetary pressures, will necessitate value trade-offs across cancer types. Defining value will be critical to informing decision-making. The purpose of this study was to perform relative value analysis (RVA) of the ipilimumab use in patients with metastatic melanoma among the entire group of oncology products selected for comparison. Relative value analysis (RVA) can be used to benchmark the clinical and economic value delivered by one product versus others in a broad therapeutic class, using acceptable statistical methods applied to clinical and economic measures. These are naive comparisons with no adjustment for differences in trial characteristics or patient populations. The analysis could not be consider as a substiture for ITC/NMA or more sophisticaled cost effectiveness modeling.

Bokeria O.L., Eremenko A.A., Kudzoeva Z.F., Kulikov A.Y., Skripnik A.R., Yavorovskiy A.G. 487

Cardiovascular disease (CVD) is the main mortality factor and the main reason of disability of the working-age population both in the Russian Federation and in the world. Due to the state statistical data, 1,878 persons per every 100,000 population died in Russia in 2014. 50.1 % of these deaths have been caused by CVD and more than half of them (52.3 %) have been caused by ischemic heart disease (IHD). The aim of this study was to determine the preferential scheme of medical therapy in perioperative management of cardiac surgery patients with extracorporeal circulation, with IHD or with chronic heart insufficiency (CHI) from the point of view of pharmacoeconomic analysis by comparing ratios between expenses and efficacy, safety and quality of life associated with the use of Neoton (phosphocreatine) in comparison with the control group. Due to the efficacy analysis, the scheme “standard therapy + phophocreatine” is more effective. Cost-effectiveness analysis has shown that the standard therapy + phosphocreatine is a preferable method of treatment in comparison with the standard therapy as it shows better clinical efficacy and lower “costeffectiveness ratio. Results of the budget impact analysis have shown that the use of the standard therapy + phosphocreatine instead of the standard therapy itself in perioperative management of cardiac surgery patients with extracorporeal circulation, with IHD or with CHI has saved money.

Kulikov A.Y., Skripnik A.R. 437

Iron-deficiency anemia occupies the first place among the most common diseases. Approximately 700 million people worldwide suffer from iron deficiency anemia. In Russia, iron deficiency anemia is diagnosed in 6-30% of the population. The objective of this study was the comparative pharmacoeconomic analysis Cosmofer (Iron III - hydroxide dextran) compared with Venofer (Iron III - hydroxide sucrose complex) in the treatment of iron deficiency anemia for patients with chronic kidney disease. An analysis of the value of the direct costs of patient treatment for 6 months amounted to 17,077 rubles for the treatment of Iron III - hydroxide dextran and 17,792 rubles for the treatment of Iron III - hydroxide sucrose complex. Result of budget impact analysis revealed that the use of the treatment of Iron III - hydroxide dextran as compared with Iron III - hydroxide sucrose complex for one patient, leads to budget savings for 715 rubles. The sensitivity analysis shows that a simultaneous increase the cost of Iron III - hydroxide dextran and decrease the cost of Iron III - hydroxide sucrose complex at 5%, will require additional funding in the amount of 157 ruble.

Kulikov A.Y., Petrovskiy A.V., Rybchenko Y.V., Skripnik A.R. 1161

According to the World Health Organization, breast cancer is the most common form of cancer in women worldwide. The steady increase in the prevalence of breast cancer, followed by an increase in the state budget expenditures on drug supply for this category of patients, determines the relevance of pharmacoeconomic evaluation of treatment of HER2-positive breast cancer using a combination of lapatinib and capecitabine and trastuzumab emtansine monotherapy. A subgroup analysis of the therapeutic outcomes in patients with HER2+ breast cancer conducted by the EMILIA study failed to find a statistically significant difference in median overall survival in patients receiving either trastuzumab emtansine or a combination of lapatinib and capecitabine as second-line treatment, or in patients with non-visceral metastases. Analysis of overall survival of the entire population of patients in the EMILIA study revealed that trastuzumab emtansine is more effective than a combination of lapatinib and capecitabine. Despite this, NICE does not recommend treatment with trastuzumab emtansine due to high cost of treatment. The EMILIA study results were used as a basis for pharmacoeconomic models for HER2+ breast cancer therapy, using such methods of pharmacoeconomic analysis as budget impact analysis, cost-effectiveness analysis, and costminimization analysis for these subgroups of patients. Result of budget impact analysis revealed that the use of the lapatinib and capecitabine combination can reduce health system expenditures by 3,985,271 rubles per patient per year or by 5,851,484 rubles over three years per one patient, which allows treating 4 additional patients given the fixed budget. Cost-effectiveness ratio of lapatinib + capecitabine equals to 869,705 rubles and 3,461,960 rubles with LYG and QALY as efficacy endpoints, respectively, which identifies this therapy as cost-effective in pharmacoeconomic terms. Cost-minimization analysis of lapatinib+capecitabine patient groups in the second-line treatment, and a group of patients with non-visceral metastases showed that the use of this treatment may reduce costs by 78% in comparison with trastuzumab emtansine.

Kulikov A.Y., Skripnik A.R. 765

Melanoma is a malignant tumor that develops from transformed melanocytes, located mainly in the skin. According to Russian statistics, the incidence of melanoma in 2014 was 9,390 new cases [4]. In 2004-2014, melanoma prevalence rate per 100,000 population increased on average by 4.2% per year. High prevalence of melanoma and frequent poor prognosis necessitate search of innovative treatment methods and use of high-tech drugs.

Kulikov A.Y., Skripnik A.R. 645

Melanoma is a malignant tumor that develops from transformed melanocytes, located mainly in the skin. According to Russian statistics, the incidence of melanoma in 2014 was 9,390 new cases. In 2004-2014, melanoma prevalence rate per 100,000 population increased on average by 4.2% per year. High prevalence of melanoma and frequent poor prognosis necessitate search of innovative treatment methods and use of high-tech drugs. The unmet need for oncology therapies is substantial. The introduction of innovative, highcost treatments, coupled with mounting budgetary pressures, will necessitate value trade-offs across cancer types. Defining value will be critical to informing decision-making. The purpose of this study was to perform relative value analysis (RVA) of the ipilimumab use in patients with metastatic melanoma among the entire group of oncology products selected for comparison. Relative value analysis (RVA) can be used to benchmark the clinical and economic value delivered by one product versus others in a broad therapeutic class, using acceptable statistical methods applied to clinical and economic measures. These are naive comparisons with no adjustment for differences in trial characteristics or patient populations. The analysis could not be consider as a substiture for ITC/NMA or more sophisticaled cost effectiveness modeling.

Kulikov A.Y., Skripnik A.R. 437

Iron-deficiency anemia occupies the first place among the most common diseases. Approximately 700 million people worldwide suffer from iron deficiency anemia. In Russia, iron deficiency anemia is diagnosed in 6-30% of the population. The objective of this study was the comparative pharmacoeconomic analysis Cosmofer (Iron III - hydroxide dextran) compared with Venofer (Iron III - hydroxide sucrose complex) in the treatment of iron deficiency anemia for patients with chronic kidney disease. An analysis of the value of the direct costs of patient treatment for 6 months amounted to 17,077 rubles for the treatment of Iron III - hydroxide dextran and 17,792 rubles for the treatment of Iron III - hydroxide sucrose complex. Result of budget impact analysis revealed that the use of the treatment of Iron III - hydroxide dextran as compared with Iron III - hydroxide sucrose complex for one patient, leads to budget savings for 715 rubles. The sensitivity analysis shows that a simultaneous increase the cost of Iron III - hydroxide dextran and decrease the cost of Iron III - hydroxide sucrose complex at 5%, will require additional funding in the amount of 157 ruble.

Bokeria O.L., Eremenko A.A., Kudzoeva Z.F., Kulikov A.Y., Skripnik A.R., Yavorovskiy A.G. 487

Cardiovascular disease (CVD) is the main mortality factor and the main reason of disability of the working-age population both in the Russian Federation and in the world. Due to the state statistical data, 1,878 persons per every 100,000 population died in Russia in 2014. 50.1 % of these deaths have been caused by CVD and more than half of them (52.3 %) have been caused by ischemic heart disease (IHD). The aim of this study was to determine the preferential scheme of medical therapy in perioperative management of cardiac surgery patients with extracorporeal circulation, with IHD or with chronic heart insufficiency (CHI) from the point of view of pharmacoeconomic analysis by comparing ratios between expenses and efficacy, safety and quality of life associated with the use of Neoton (phosphocreatine) in comparison with the control group. Due to the efficacy analysis, the scheme “standard therapy + phophocreatine” is more effective. Cost-effectiveness analysis has shown that the standard therapy + phosphocreatine is a preferable method of treatment in comparison with the standard therapy as it shows better clinical efficacy and lower “costeffectiveness ratio. Results of the budget impact analysis have shown that the use of the standard therapy + phosphocreatine instead of the standard therapy itself in perioperative management of cardiac surgery patients with extracorporeal circulation, with IHD or with CHI has saved money.