Rybchenko Yulia Vitalievna

Kulikov A.Y., Rybchenko Y.V. 1483

Breast cancer is a global problem due to its wide prevalence which is increasing every year. The comparative pharmacoeconomic study of Herceptin in subcutaneous and intravenous formulations was conducted for optimization of drug supply for this nosology. Direct medical expenses without taking into account the drug price were compared. As a result of pharmacoeconomic evaluation of the alternative treatment options, it was established that subcutaneous Herceptin saves 39,806 roubles per patient during one treatment year due to the cost differences related to administration, medical staff, as well as hospitalization. Moreover, when IV formulation is used for one treatment year per patient, the medicinal substance is lost due to « throwing out» the remaining part of the drug in the vial, which may not be used in connection with breach of sterile dosage forms. The loss is as high as 166,208 roubles; this translates into 11% monetary loss from the whole treatment cycle.

Kulikov A.Y., Rybchenko Y.V. 1444

A pharmacoeconomic study of the treatment of phenylketonuria (PHU) treatment using Kuvan drug product combined with the diet or dietary therapy alone has been conducted. It has been established that the therapy is dominant in the first case when compared to the second case because it shows better therapeutic effectiveness and is characterized by a lower cost–effectiveness ratio. It has also been determined that the addition of Kuvan to the dietary therapy requires additional costs of 11,569,761 RUB per one patient over 16 years. Despite the increase in the costs linked to the use of the new and only drug for the treatment of PKU, the overall effect on the budget will be decreased due to the low prevalence of the disease.

Kulikov A.Y., Rybchenko Y.V. 1353

Follicular lymphoma is a disease requiring effective therapy that helps to improve a patient’s quality of life. In this study, a comparative analysis of subcutaneous administration of MabThera versus intravenous MabThera was performed. Considering that the formulations are equally effective, a cost minimization analysis was carried out, which showed that transition from intravenous to subcutaneous MabThera resulted in savings of 35,847 rubles per one patient during the treatment course due to the decreased drug administration expenses, medical staff costs, and expenses for hospitalization or day-time staying. The use of the subcutaneous formulation can also prevent economic damage caused by loss of the drug remaining in the vial with the use of the intravenous formulation where the dose depends on the body surface area.

Kulikov A.Y., Rybchenko Y.V. 1069

Currently, in treatment of patients with urothelial transitional cell carcinoma resistant to platinum-based regimen, only Javlor (vinflunine) shows the best evidence when using in second-line chemotherapy scheme. Vinflunine shows the advantage over best supportive care during a randomized Phase III study. The aim of this study is to compare Javlor therapy in combination with the best supportive therapy and the best supportive therapy alone in terms of pharmacoeconomic analysis. Budget impact analysis shows that the treatment of urothelial transitional cell carcinoma with Javlor requires additional expenses. Cost-effectiveness analysis shows that the ICER does not exceed “willingness-to-pay” threshold which means that from the point of view of incremental analysis the therapy in patients with urothelial transitional cell carcinoma using Javlor is cost-effective.

Abdrashitova G.T., Makarova E.I., Rybchenko Y.V., Ugrekhelidze D.T. 1078

Abstract: Main presentations and educational seminars which took place during Annual European congress of International Society For Pharmacoeconomics and Outcomes Research (ISPOR) are covered.

Alferova I.P., Velednitskiy V.B., Vinoglyadova S.V., Voronin S.V., Golihina T.A., Goroshko L.V., Davydova A.N., Zhukova T.P., Irinina N.A., Kapustina N.K., Kuzin A.V., Kulikov A.Y., Lukina N.V., Mardanova A.K., Maryashina T.M., Matulevich S.A., Mihalchuk V.V., Nelyubova Z.G., Nikonov A.M., Pushkina M.A., Rybchenko Y.V., Sahar O.V., Teunaeva M.M., Hramihina S.S., Chesnokova M.A., Shelkova E.V., Erbis G.A., Yudintseva T.V., Yagudina R.I. 1003

Phenylketonuria is a hereditary disease associated with a metabolic disorder of amino acids in the organism, the prevalence of which in the Russian Federation is 1:10000. Currently, the main treatment of phenylketonuria is diet therapy with specialized health food (a mixture of amino acids without phenylalanine). This research presents the results of a comparison of diet therapy with medicinal mixtures of MDmil PKU line taken from the first month of life of a child compared to food of other producers, taken in later periods. Efficiency analysis is based on data provided by the major regional genetics specialists from 24 regions of the Russian Federation on treatment of 1088 children suffering from phenylketonuria. Cost analysis of treatment of patients with PKU until their majority reveals least expensive diet therapy initiated from the first month of life with specialized health food of MDmil PKU line compared with diet, started in later periods with specialized products of different manufacturers. During the “cost-effectiveness” analysis and the “cost-utility”analysis indicators of CER and CUR are identified showing that when used from the first month of life diet therapy with MDmil PKU line compared with diet, started in later periods with various manufacturers, it is easy to determine treatment of the first group of children as dominant. Budget impact analysis shows that diet therapy with specialized health food of MDmil PKU line in treatment of phenylketonuria can achieve cost savings of 34% to 38% depending on periods of commencement of the diet.

Kulikov A.Y., Petrovskiy A.V., Rybchenko Y.V., Skripnik A.R. 980

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.

Gulo S.L., Istomin D.A., Kudryavtsev I.Y., Kulikov A.Y., Nikolaev I.Y., Rybchenko Y.V., Sheko S.S., Shinkarev S.A. 919

Breast cancer is a malignant neoplasm that develops from the epithelial cells of ducts and lobules of the glandular parenchyma, which according to the World Health Organization (WHO) is the most common form of cancer among women (16% of all cases) in the world. In 2014, in Kaluga, Lipetsk, Smolensk and Tula regions the mortality from breast cancer reached 3.2%, 3.1%, 4% and 4.7%, respectively. One of the aggressive forms of breast cancer is a HER2positive (HER2+) subtype (14 to 20% of all subtypes), which is treated with targeted therapy. The appearance of trastuzumab for subcutaneous administration has a number of advantages compared to the intravenous formulation. A pharmacoeconomic analysis of treatment of HER2+ breast cancer was performed by comparing trastuzumab in two formulations in Kaluga, Lipetsk, Smolensk and Tula regions. According to the “cost minimization” analysis in the analyzed regions, the use of trastuzumab for subcutaneous administration compared to intravenous administration saves from 29.7 to 34% of funds. The forecasted budget savings as a result of the budget impact analysis for 10 patients is 8,068,360 rubles in Kaluga region, 7,047,430 rubles in Lipetsk region, 6,534,750 rubles in Smolensk region, and 7,188,980 rubles in Tula region for the treatment course with trastuzumab in subcutaneous formulation as compared to the intravenous formulation. The results showed that the use of trastuzumab therapy in the subcutaneous formulation allows treatment of 4 additional patients with HER2+ breast cancer in Smolensk region, and 5 patients in Kaluga, Lipetsk and Tula regions within a fixed budget.

Kulikov A.Y., Rybchenko Y.V. 1483

Breast cancer is a global problem due to its wide prevalence which is increasing every year. The comparative pharmacoeconomic study of Herceptin in subcutaneous and intravenous formulations was conducted for optimization of drug supply for this nosology. Direct medical expenses without taking into account the drug price were compared. As a result of pharmacoeconomic evaluation of the alternative treatment options, it was established that subcutaneous Herceptin saves 39,806 roubles per patient during one treatment year due to the cost differences related to administration, medical staff, as well as hospitalization. Moreover, when IV formulation is used for one treatment year per patient, the medicinal substance is lost due to « throwing out» the remaining part of the drug in the vial, which may not be used in connection with breach of sterile dosage forms. The loss is as high as 166,208 roubles; this translates into 11% monetary loss from the whole treatment cycle.

Kulikov A.Y., Rybchenko Y.V. 1444

A pharmacoeconomic study of the treatment of phenylketonuria (PHU) treatment using Kuvan drug product combined with the diet or dietary therapy alone has been conducted. It has been established that the therapy is dominant in the first case when compared to the second case because it shows better therapeutic effectiveness and is characterized by a lower cost–effectiveness ratio. It has also been determined that the addition of Kuvan to the dietary therapy requires additional costs of 11,569,761 RUB per one patient over 16 years. Despite the increase in the costs linked to the use of the new and only drug for the treatment of PKU, the overall effect on the budget will be decreased due to the low prevalence of the disease.

Kulikov A.Y., Rybchenko Y.V. 1353

Follicular lymphoma is a disease requiring effective therapy that helps to improve a patient’s quality of life. In this study, a comparative analysis of subcutaneous administration of MabThera versus intravenous MabThera was performed. Considering that the formulations are equally effective, a cost minimization analysis was carried out, which showed that transition from intravenous to subcutaneous MabThera resulted in savings of 35,847 rubles per one patient during the treatment course due to the decreased drug administration expenses, medical staff costs, and expenses for hospitalization or day-time staying. The use of the subcutaneous formulation can also prevent economic damage caused by loss of the drug remaining in the vial with the use of the intravenous formulation where the dose depends on the body surface area.

Kulikov A.Y., Rybchenko Y.V. 1069

Currently, in treatment of patients with urothelial transitional cell carcinoma resistant to platinum-based regimen, only Javlor (vinflunine) shows the best evidence when using in second-line chemotherapy scheme. Vinflunine shows the advantage over best supportive care during a randomized Phase III study. The aim of this study is to compare Javlor therapy in combination with the best supportive therapy and the best supportive therapy alone in terms of pharmacoeconomic analysis. Budget impact analysis shows that the treatment of urothelial transitional cell carcinoma with Javlor requires additional expenses. Cost-effectiveness analysis shows that the ICER does not exceed “willingness-to-pay” threshold which means that from the point of view of incremental analysis the therapy in patients with urothelial transitional cell carcinoma using Javlor is cost-effective.

Abdrashitova G.T., Makarova E.I., Rybchenko Y.V., Ugrekhelidze D.T. 1078

Abstract: Main presentations and educational seminars which took place during Annual European congress of International Society For Pharmacoeconomics and Outcomes Research (ISPOR) are covered.

Kulikov A.Y., Petrovskiy A.V., Rybchenko Y.V., Skripnik A.R. 980

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.

Alferova I.P., Velednitskiy V.B., Vinoglyadova S.V., Voronin S.V., Golihina T.A., Goroshko L.V., Davydova A.N., Zhukova T.P., Irinina N.A., Kapustina N.K., Kuzin A.V., Kulikov A.Y., Lukina N.V., Mardanova A.K., Maryashina T.M., Matulevich S.A., Mihalchuk V.V., Nelyubova Z.G., Nikonov A.M., Pushkina M.A., Rybchenko Y.V., Sahar O.V., Teunaeva M.M., Hramihina S.S., Chesnokova M.A., Shelkova E.V., Erbis G.A., Yudintseva T.V., Yagudina R.I. 1003

Phenylketonuria is a hereditary disease associated with a metabolic disorder of amino acids in the organism, the prevalence of which in the Russian Federation is 1:10000. Currently, the main treatment of phenylketonuria is diet therapy with specialized health food (a mixture of amino acids without phenylalanine). This research presents the results of a comparison of diet therapy with medicinal mixtures of MDmil PKU line taken from the first month of life of a child compared to food of other producers, taken in later periods. Efficiency analysis is based on data provided by the major regional genetics specialists from 24 regions of the Russian Federation on treatment of 1088 children suffering from phenylketonuria. Cost analysis of treatment of patients with PKU until their majority reveals least expensive diet therapy initiated from the first month of life with specialized health food of MDmil PKU line compared with diet, started in later periods with specialized products of different manufacturers. During the “cost-effectiveness” analysis and the “cost-utility”analysis indicators of CER and CUR are identified showing that when used from the first month of life diet therapy with MDmil PKU line compared with diet, started in later periods with various manufacturers, it is easy to determine treatment of the first group of children as dominant. Budget impact analysis shows that diet therapy with specialized health food of MDmil PKU line in treatment of phenylketonuria can achieve cost savings of 34% to 38% depending on periods of commencement of the diet.

Gulo S.L., Istomin D.A., Kudryavtsev I.Y., Kulikov A.Y., Nikolaev I.Y., Rybchenko Y.V., Sheko S.S., Shinkarev S.A. 919

Breast cancer is a malignant neoplasm that develops from the epithelial cells of ducts and lobules of the glandular parenchyma, which according to the World Health Organization (WHO) is the most common form of cancer among women (16% of all cases) in the world. In 2014, in Kaluga, Lipetsk, Smolensk and Tula regions the mortality from breast cancer reached 3.2%, 3.1%, 4% and 4.7%, respectively. One of the aggressive forms of breast cancer is a HER2positive (HER2+) subtype (14 to 20% of all subtypes), which is treated with targeted therapy. The appearance of trastuzumab for subcutaneous administration has a number of advantages compared to the intravenous formulation. A pharmacoeconomic analysis of treatment of HER2+ breast cancer was performed by comparing trastuzumab in two formulations in Kaluga, Lipetsk, Smolensk and Tula regions. According to the “cost minimization” analysis in the analyzed regions, the use of trastuzumab for subcutaneous administration compared to intravenous administration saves from 29.7 to 34% of funds. The forecasted budget savings as a result of the budget impact analysis for 10 patients is 8,068,360 rubles in Kaluga region, 7,047,430 rubles in Lipetsk region, 6,534,750 rubles in Smolensk region, and 7,188,980 rubles in Tula region for the treatment course with trastuzumab in subcutaneous formulation as compared to the intravenous formulation. The results showed that the use of trastuzumab therapy in the subcutaneous formulation allows treatment of 4 additional patients with HER2+ breast cancer in Smolensk region, and 5 patients in Kaluga, Lipetsk and Tula regions within a fixed budget.