Balykina Yulia Efimovna

Balykina Y.E., Vilum I.A., Kolbin A.S., Proskurin M.A. 5339

It is the first time a comparative pharmacoeconomic analysis of telavancin (Vibativ®) use for treatment of patients suffering from nosocomial infections caused by resistant bacterial flora using the example of patients with complicated skin and soft tissue infections was held. The study was carried out using mathematical modelling with a one-month horizon. Cost-benefit analysis, budget-impact analysis, and sensitivity analysis were used. The study found that telavancin use showed high clinical efficacy and one of the best safety profiles among other medical treatment technologies for such groups of patients. Telavancin use makes more economic sense in terms of cost-efficacy ratio than daptomycin, tigecycline and linezolid. Telavancin use is more advantageous in terms of budget impact analysis as compared to linezolid and daptomycin use: saving up to 32,705,178 rubles from the budget, which enables to treat up to 126 more patients.

Balykina Y.E., Kolbin A.S., Kurylev A.A., Pavlysh A.V., Proskurin M.A. 4966

Abstract: A pharmacoeconomic evaluation of sunitinib as the firstline metastatic renal-cell carcinoma targeted agent in the Russian healthcare settings was performed in comparison with sorafenib and bevacizumab + interferon. A pharmacoeconomic Markov model was created and used to assess the costs and effectiveness (including mean overall survival in months) of each therapeutic regimen. The evaluation presented also includes a probabilistic multivariate sensitivity analysis. The results show that sunitinibbased treatment is dominant over sorafenib and bevacizumab + interferon, which makes it the most costeffectiveness treatment option.

Balykina Y.E., Kolbin A.S., Kurylev A.A., Proskurin M.A. 4581

Objective of this study was to determine cost-effectiveness of vemurafenib in treatment of inoperable or metastatic melanoma in patients with BRAF V600 mutation from Russian healthcare system perspective and a long-term use. Cost-effectiveness analysis (CEA) has been used and cost-effectiveness ratio (CER) has been calculated. Incremental analysis has been conducted with calculation of incremental cost-effectiveness ratio (ICER) when exceeding the costs and effectiveness of one of the studied regimens as compared to the other one. Cost analysis included calculation of the following direct costs (DC): the cost of the main disease treatment (cutaneous melanoma, CM) – costs of the drug; the cost of laboratory and instrumental methods of investigation as well as hospitalizations and out-patient treatment; the cost required to determine exon 15 BRAF mutation in melanoma; the cost of the drug therapy aimed at management of adverse events (AEs) caused by the drug when treating the main disease. Two medical technologies have been assessed (anti-tumor regimens depending on the chosen method): vemurafenib at a dose of 960 mg twice a day; dacarbazine at a dose of 1000 mg/m2 i/v every 3 weeks. Mathematical modelling underlies this study. As a result it has been demonstrated that the use of vemurafenib strategy in treatment of metastatic melanoma in patients with BRAF V600 mutation had better progression-free survival (PFS) rate throughout the entire modelling horizon. The use of vemurafenib in treatment of metastatic and inoperable melanoma in patients with BRAF V600 mutation is economically advisable taking into account the data on effectiveness (PFS). The use of vemurafenib in patients with BRAF V600 mutation is an absolutely innovative medical technology which currently does not have any alternative. Vemurafenib may be indicated for inclusion in reimbursement lists for treatment of patients with this mutation.

Balykina Y.E., Vilum I.A., Kolbin A.S., Proskurin M.A. 4457

It is the first time a comparative pharmacoeconomic analysis of telavancin (Vibativ®) use for treatment of patients suffering from nosocomial infections caused by resistant bacterial flora using the example of patients with nosocomial pneumonia was performed in Russia. The study was carried out using mathematical modelling with a one-month horizon. Cost-benefit analysis, budget-impact analysis, and sensitivity analysis were used. The study found that telavancin use showed high clinical efficacy and one of the best safety profiles among other medical treatment technologies for such groups of patients. Telavancin use makes economic sense in terms of cost-efficacy ratio as compared to vancomycin and linezolid. According to the results of analysis of budget impact, for wide use estimated strategy requires additional investment to the extent of 13% when compared with the strategies of the use of vancomycin and linezolid.

.., Balykina Y.E., Gomon Y.M., Ivanov V.V., Kolbin A.S., .., .., .. 3493

Aim: To assess economic efficiency of complicated intra-abdomibal infections treatment in real practice compared to alternative scenario (treatment with carbapenem Ertapanem) taking in to account E. coli resistance. Methods: Cost-effectiveness analysis were performed. Mathematic modelling was done to assess prognosis of bacterial resistance. Results: Cost of 1 case of complicated intra-abdomibal infections in real practice is 83048,08 rub compared to 91706,06 rub according to alternative strategy. Cost-effectiveness analysis revealed that real practice of treatment intra-abdomibal infections dominated alternative scenario: less effectiveness lead to lower cost. Additional effectiveness (1,95%) demand additionally 443316,97 rub. Taking into account dynamic of E. Coli resistance ICER during 2011-2015 period decreased up to 40%. Conclusion: Antimicrobial resistance of bacterial agents is important criteria which should be used to estimate economic effectiveness of any medical strategy. Key words: complicated intra-abdominal infection, bacterial resistance, pharmacoeconomic analysis

Balykina Y.E., Globin M.V., Kolbin A.S., Litvinova A.A., Proskurin M.A. 2305

Balykina Y.E., Globin M.V., Kolbin A.S., Litvinova A.A., Proskurin M.A. 2295

Balykina Y.E., Globin M.V., Kolbin A.S., Kurylev A.A., Litvinova A.A., Proskurin M.A. 1482

Balykina Y.E., Kolbin A.S., Kurylev A.A., .., Proskurin M.A. 1107

Glycemic control is a clinical goal in the treatment of diabetes mellitus. Currently available bolus insulin analogues do not follow the physiological pattern of insulin secretion after meals because they are slowly absorbed from the injection site. Insulin aspart+nicotinamide is an ultra-fast acting human insulin analog that can be administered before or after meals and the nicotinamide (vitamin B3) molecule provides optimal glycemic control. Aim. To evaluate clinical and economic efficacy of the drug insulin aspart+nicotinamide in comparison with insulin aspart in patients with diabetes mellitus. Materials and Methods. Clinical and economic analysis was performed in accordance with the standards and recommendations valid in the Russian Federation, the method of cost-effectiveness analysis for the first model population of patients with type 1 diabetes and the method of cost-minimization analysis for the second model population of patients with type 2 diabetes, modeling horizon was 26 weeks. Since the study is conducted from the per- spective of the health care system only direct medical costs were considered, that is, the cost of insulin therapy and the cost of complications treatment (hypoglycemia). During the budget impact analysis, the source of data on the target population was the registry of patients with diabetes mellitus of the Russian Federation. Probabilistic sensitivity analysis was performed to assess the impact of changes in the input parameters of the models. Results. Insulin aspart+nicotinamide has a clinical advantage in the effective- ness of HbA1c reduction in type 1 diabetes population. In patients with type 2 diabetes, the effectiveness of insulin aspart+nicotinamide and insulin aspart is comparable by a similar criterion. Direct medical costs of insulin aspart+nicotinamide are 10.64% lower in comparison with insulin aspart use in type 1 and type 2 diabetes patients’ population. The CER value in type 1 diabetes patient population for insulin aspart is 70% higher compared to insulin aspart+nicotinamide (7,410,353.83 and 4,348,513.94 RUR respectively). Budget impact analysis results are the following: that complete replacement of insulin aspart with insulin aspart+nicotinamide over 3 years is accompanied by a 5.3% re- duction of regional drug benefit budget costs. Conclusion. The clinical and economic analysis confirms the economic feasibility of insulin aspart + nicotinamide use

Balykina Y.E., Kasimova A.R., Kolbin A.S., Proskurin M.A. 741

Diabetic retinopathy (DR) is a specific neuromicrovascular complication of diabetes mellitus. Diabetic macular edema (DME) is a retinal thickening associated with fluid accumulation in the intercellular space of the neuroep- ithelium due to hematoretinal barrier failure and mismatch between fluid transudation and reabsorption ability of the pigment epithelium cells. Treat- ment of DR and DME appears to be costly, but there are no data on the economic burden of the disease in the Russian Federation. The analysis of direct (the cost of medications, laboratory and instrumental methods of research, the cost of medical products, etc.), indirect (the patient’s lost income in connection with temporary disability, disability payments) and indirect (loss of gross domestic product, etc.) expenses for DR and DMD was carried out. When calculated for the total population of patients with DR and DMD, the total costs amounted to 466,777,104,440 rubles. Of these, RUB 24,059,855,774 were costs for patients with DR, RUB 11,428,438,452 were costs for patients with DMO, RUB 260,078,000,343 were costs for patients with clinically significant DMO, and RUB 171,210,809,871 were costs for patients with clinically significant DMO in both eyes. Direct medical costs accounted for most of the total economic burden (62.44%).

Balykina Y.E., Kolbin A.S., Kurylev A.A., Pavlysh A.V., Proskurin M.A. 4966

Abstract: A pharmacoeconomic evaluation of sunitinib as the firstline metastatic renal-cell carcinoma targeted agent in the Russian healthcare settings was performed in comparison with sorafenib and bevacizumab + interferon. A pharmacoeconomic Markov model was created and used to assess the costs and effectiveness (including mean overall survival in months) of each therapeutic regimen. The evaluation presented also includes a probabilistic multivariate sensitivity analysis. The results show that sunitinibbased treatment is dominant over sorafenib and bevacizumab + interferon, which makes it the most costeffectiveness treatment option.

Balykina Y.E., Kolbin A.S., Kurylev A.A., Proskurin M.A. 4581

Objective of this study was to determine cost-effectiveness of vemurafenib in treatment of inoperable or metastatic melanoma in patients with BRAF V600 mutation from Russian healthcare system perspective and a long-term use. Cost-effectiveness analysis (CEA) has been used and cost-effectiveness ratio (CER) has been calculated. Incremental analysis has been conducted with calculation of incremental cost-effectiveness ratio (ICER) when exceeding the costs and effectiveness of one of the studied regimens as compared to the other one. Cost analysis included calculation of the following direct costs (DC): the cost of the main disease treatment (cutaneous melanoma, CM) – costs of the drug; the cost of laboratory and instrumental methods of investigation as well as hospitalizations and out-patient treatment; the cost required to determine exon 15 BRAF mutation in melanoma; the cost of the drug therapy aimed at management of adverse events (AEs) caused by the drug when treating the main disease. Two medical technologies have been assessed (anti-tumor regimens depending on the chosen method): vemurafenib at a dose of 960 mg twice a day; dacarbazine at a dose of 1000 mg/m2 i/v every 3 weeks. Mathematical modelling underlies this study. As a result it has been demonstrated that the use of vemurafenib strategy in treatment of metastatic melanoma in patients with BRAF V600 mutation had better progression-free survival (PFS) rate throughout the entire modelling horizon. The use of vemurafenib in treatment of metastatic and inoperable melanoma in patients with BRAF V600 mutation is economically advisable taking into account the data on effectiveness (PFS). The use of vemurafenib in patients with BRAF V600 mutation is an absolutely innovative medical technology which currently does not have any alternative. Vemurafenib may be indicated for inclusion in reimbursement lists for treatment of patients with this mutation.

Balykina Y.E., Vilum I.A., Kolbin A.S., Proskurin M.A. 5339

It is the first time a comparative pharmacoeconomic analysis of telavancin (Vibativ®) use for treatment of patients suffering from nosocomial infections caused by resistant bacterial flora using the example of patients with complicated skin and soft tissue infections was held. The study was carried out using mathematical modelling with a one-month horizon. Cost-benefit analysis, budget-impact analysis, and sensitivity analysis were used. The study found that telavancin use showed high clinical efficacy and one of the best safety profiles among other medical treatment technologies for such groups of patients. Telavancin use makes more economic sense in terms of cost-efficacy ratio than daptomycin, tigecycline and linezolid. Telavancin use is more advantageous in terms of budget impact analysis as compared to linezolid and daptomycin use: saving up to 32,705,178 rubles from the budget, which enables to treat up to 126 more patients.

Balykina Y.E., Vilum I.A., Kolbin A.S., Proskurin M.A. 4457

It is the first time a comparative pharmacoeconomic analysis of telavancin (Vibativ®) use for treatment of patients suffering from nosocomial infections caused by resistant bacterial flora using the example of patients with nosocomial pneumonia was performed in Russia. The study was carried out using mathematical modelling with a one-month horizon. Cost-benefit analysis, budget-impact analysis, and sensitivity analysis were used. The study found that telavancin use showed high clinical efficacy and one of the best safety profiles among other medical treatment technologies for such groups of patients. Telavancin use makes economic sense in terms of cost-efficacy ratio as compared to vancomycin and linezolid. According to the results of analysis of budget impact, for wide use estimated strategy requires additional investment to the extent of 13% when compared with the strategies of the use of vancomycin and linezolid.

.., Balykina Y.E., Gomon Y.M., Ivanov V.V., Kolbin A.S., .., .., .. 3493

Aim: To assess economic efficiency of complicated intra-abdomibal infections treatment in real practice compared to alternative scenario (treatment with carbapenem Ertapanem) taking in to account E. coli resistance. Methods: Cost-effectiveness analysis were performed. Mathematic modelling was done to assess prognosis of bacterial resistance. Results: Cost of 1 case of complicated intra-abdomibal infections in real practice is 83048,08 rub compared to 91706,06 rub according to alternative strategy. Cost-effectiveness analysis revealed that real practice of treatment intra-abdomibal infections dominated alternative scenario: less effectiveness lead to lower cost. Additional effectiveness (1,95%) demand additionally 443316,97 rub. Taking into account dynamic of E. Coli resistance ICER during 2011-2015 period decreased up to 40%. Conclusion: Antimicrobial resistance of bacterial agents is important criteria which should be used to estimate economic effectiveness of any medical strategy. Key words: complicated intra-abdominal infection, bacterial resistance, pharmacoeconomic analysis

Balykina Y.E., Globin M.V., Kolbin A.S., Litvinova A.A., Proskurin M.A. 2295

Balykina Y.E., Globin M.V., Kolbin A.S., Litvinova A.A., Proskurin M.A. 2305

Balykina Y.E., Globin M.V., Kolbin A.S., Kurylev A.A., Litvinova A.A., Proskurin M.A. 1482

Balykina Y.E., Kolbin A.S., Kurylev A.A., .., Proskurin M.A. 1107

Glycemic control is a clinical goal in the treatment of diabetes mellitus. Currently available bolus insulin analogues do not follow the physiological pattern of insulin secretion after meals because they are slowly absorbed from the injection site. Insulin aspart+nicotinamide is an ultra-fast acting human insulin analog that can be administered before or after meals and the nicotinamide (vitamin B3) molecule provides optimal glycemic control. Aim. To evaluate clinical and economic efficacy of the drug insulin aspart+nicotinamide in comparison with insulin aspart in patients with diabetes mellitus. Materials and Methods. Clinical and economic analysis was performed in accordance with the standards and recommendations valid in the Russian Federation, the method of cost-effectiveness analysis for the first model population of patients with type 1 diabetes and the method of cost-minimization analysis for the second model population of patients with type 2 diabetes, modeling horizon was 26 weeks. Since the study is conducted from the per- spective of the health care system only direct medical costs were considered, that is, the cost of insulin therapy and the cost of complications treatment (hypoglycemia). During the budget impact analysis, the source of data on the target population was the registry of patients with diabetes mellitus of the Russian Federation. Probabilistic sensitivity analysis was performed to assess the impact of changes in the input parameters of the models. Results. Insulin aspart+nicotinamide has a clinical advantage in the effective- ness of HbA1c reduction in type 1 diabetes population. In patients with type 2 diabetes, the effectiveness of insulin aspart+nicotinamide and insulin aspart is comparable by a similar criterion. Direct medical costs of insulin aspart+nicotinamide are 10.64% lower in comparison with insulin aspart use in type 1 and type 2 diabetes patients’ population. The CER value in type 1 diabetes patient population for insulin aspart is 70% higher compared to insulin aspart+nicotinamide (7,410,353.83 and 4,348,513.94 RUR respectively). Budget impact analysis results are the following: that complete replacement of insulin aspart with insulin aspart+nicotinamide over 3 years is accompanied by a 5.3% re- duction of regional drug benefit budget costs. Conclusion. The clinical and economic analysis confirms the economic feasibility of insulin aspart + nicotinamide use

Balykina Y.E., Kasimova A.R., Kolbin A.S., Proskurin M.A. 741

Diabetic retinopathy (DR) is a specific neuromicrovascular complication of diabetes mellitus. Diabetic macular edema (DME) is a retinal thickening associated with fluid accumulation in the intercellular space of the neuroep- ithelium due to hematoretinal barrier failure and mismatch between fluid transudation and reabsorption ability of the pigment epithelium cells. Treat- ment of DR and DME appears to be costly, but there are no data on the economic burden of the disease in the Russian Federation. The analysis of direct (the cost of medications, laboratory and instrumental methods of research, the cost of medical products, etc.), indirect (the patient’s lost income in connection with temporary disability, disability payments) and indirect (loss of gross domestic product, etc.) expenses for DR and DMD was carried out. When calculated for the total population of patients with DR and DMD, the total costs amounted to 466,777,104,440 rubles. Of these, RUB 24,059,855,774 were costs for patients with DR, RUB 11,428,438,452 were costs for patients with DMO, RUB 260,078,000,343 were costs for patients with clinically significant DMO, and RUB 171,210,809,871 were costs for patients with clinically significant DMO in both eyes. Direct medical costs accounted for most of the total economic burden (62.44%).