Babiy Vladimir Vyacheslavovich

Babiy V.V., Kulikov A.Y. 1640

The aim of this study was to determine the optimal medical technique of treatment of human immunodeficiency virus (HIV) infected adults with HIV-1 RNA<100 000 copies/ml by assessing costs and effectiveness of highly active antiretroviral therapy: rilpivirine/ tenofovir/ emtricitabine (single tablet regimen (STR)), efavirenz + tenofovir/ emtricitabine (multi-pill regimen), lopinavir + tenofovir/ emtricitabine (multi-pill regimen). The obtained results have demonstrated that prescription of rilpivirine-containing combined Highly Active Antiretroviral Therapy (HAART) (STR) is associated with additional costs on ambulatory treatment, that are overlaid by lower costs (direct and indirect) on new persons with HIV, infected by the analyzed group. Therefore, cost savings, as compared to mentioned schemes of HAART, accompany prescription of the scheme rilpivirine/ tenofovir/ emtricitabine (Eviplera), according to the «budget impact» analysis.

Babiy V.V., Kulikov A.Y. 1335

In this study, a pharmacoeconomic analysis of chronic lymphocytic leukemia therapy in previously untreated patients was conducted, using treatment regimens obinutuzumab (Gazyva) + chlorambucil and rituximab +chlorambucil. The results of the study showed that though the costs of the first treatment course with obinutuzumab + chlorambucil are significantly higher, this regimen reduces the cumulative cost of subsequent therapy lines in patients with CLL (due to a longer progression-free survival). In the end of the third year of therapy, cumulative costs become relatively similar: with the use of the obinutuzumab + chlorambucil regimen, the cumulative cost per 1 patient/year will be 38,390 rubles higher compared to the rituximab + chlorambucil regimen. At the same time, the obinutuzumab regimen showed a lower cost-effectiveness ratio, i.e. it had an advantage over the alternative technology.

Abdrashitova G.T., Babiy V.V., Komarov E.A., Pochuprina A.A., Serpik V.G., Ugrekhelidze D.T. 1294

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

Babiy V.V., Yagudina R.I. 1274

The article presents the methodological basics of the effectiveness analysis in pharmacoeconomic studies of medicinal drugs or health technologies. In particular, the main challenge that researchers face is the defining criterionof the effec tiveness of the evaluated alternatives is described. What is more, main positive and negative sides of using surrogate and final performance criteria, as well as provide methodological recommendations for their selection and evaluation.

Babiy V.V., Kulikov A.Y. 1240

The aim of this study was to determine optimal medical technique based on assessing cost and efficacy of treatment of von Willebrand disease using blood clotting factor concentrates (blood clotting factor VIII + von Willebrand factor): Wilate, Haemate P, Immunate. It was determined that in studies on assessing the efficiency of the concentrates more than 95% of patients rated hemostasis excellent/good. However, the studies were based on different scales of efficiency assessment, different vWF:RСo doses and different data for vWD patients (severity of the disease), therefore the efficiency of blood clotting factor concentrates might be not equal. Results of present study with the assumption about equality of groups, that were analyzed in studies on assessing the efficiency of the concentrates (although, studies on Wilate included more severe patients),evidence that prescribing blood clotting factor concentrate Wilate lead to cost savings compared to the older generation products.

Babiy V.V., Kulikov A.Y. 1135

The article deals with the results of validation of the pharmacoeconomic model of emtricitabin/ rilpivirine/ tenofovir (Eviplera) inclusion in highly active antiretroviral therapy of HIV/AIDS in the Russian Federation.

Babiy V.V., Kulikov A.Y., Shestakova I.V. 811

The goals of this study was: 1. to evaluate the superior regimen of antiviral drug treatment of chronic hepatitis C (daclatasvir + asunaprevir (a combination of the medicinal products) versus perginterferon alfa + ribavirin or peginterferon alfa + ribavirin + simeprevir or paritaprevir + ritonavir + ombitasvir + dasabuvir) in treatment-naive and treatment-experienced patients (HCV genotype 1b) without liver cirrhosis and with liver cirrhosis based on comparison of cost, effectiveness and safety; 2. To define, using «budget impact» analysis, economic outcomes of including daclatasvir + asunaprevir in current practice of HCV treatment This analysis was performed using two scenarios of the adjusted model “The MONARCH Cost-effectiveness Model”. «Budget impact» analysis was conducted using adapted model «ALLY: Daklinza® (Daclatasvir) Budget Impact Model». The study demonstrated that the first study hypothesis was correct: the combination of the medicinal products for treatment of HCV-infection (HCV genotype 1) daclatasvir + asunaprevir was found to have advantages over the combinations peginterferon alfa + ribavirin, peginterferon alfa + ribavirin + simeprevir and dasabuvir, ombitasvir + paritaprevir + ritonavir in respect of the cost-effectiveness ratio. Furthermore, results of «budget impact» analysis confirmed the second study hypothesis – introduction of DCV + ASV in current practice of HCV treatment will lead to decreasing of complication treatment costs.

Babiy V.V., Yagudina R.I. 216

This article compares for the first time in the Russian-speaking literature two approaches of survival modeling in pharmacoeconomic studies. Markov model and partitioned survival model were examined. The following text contains methodological issues, key differences and selection guideline.

Babiy V.V., Kulikov A.Y. 130

The objective of this study was to conduct cost-effectiveness analysis and budget impact analysis of antiviral drug treatment of chronic hepatitis C (peginterferon alfa + ribavirin 24 weeks (F0-F4), daclatasvir + sofosbuvir 12 weeks (F0-F3), daclatasvir + sofosbuvir + ribavirin 12 weeks (F4), sofosbuvir + ribavirin 24 weeks (F0-F4)) among treatment-experienced patients (HCV genotype 3). Both analyses were based on the developed pharmacoeconomic model (Markov model). Literature review showed absence of clear effectiveness data on using of peginterferon alfa + ribavirin in the targeted group therefore subsequent pharmacoeconomic analysis for this comparator was aborted. Obtained results showed that daclatasvir + sofosbuvir and daclatasvir + sofosbuvir + ribavirin was dominant in compares with sofosbuvir + ribavirin in the F0-F3 and F4 groups. In budget impact analysis total costs per one patient decreased on 283 623 rubles and 290 168 rubles in case of using daclatasvir + sofosbuvir instead of sofosbuvir + ribavirin among F0-F3 patients and daclatasvir + sofosbuvir + ribavirin instead of sofosbuvir + ribavirin among F4 patients, respectively.

Babiy V.V., Kulikov A.Y. 116

In conducted pharmacoeconomic study we analyzed treatment of nonresectable stage III-IV melanoma among BRAF-mutated treatment-naïve patients: monotherapy with nivolumab, scheme dabrafenib + trametinib and scheme vemurafenib + cobimetinib. Cost-effectiveness analysis and budgetimpact analysis were based on a modeling approach. Progression free survival (PFS) was used as an effectiveness criteria. Only direct costs of medical help at first-line of antitumor treatment were taken into account. Time horizon was equal to PFS of mentioned treatment schemes. Results of cost-effectiveness analysis showed that the lowest CERPFS was on the monotherapy with nivolumab. In budget-impact analysis using of nivolumab instead of dabrafenib + trametinib and vemurafenib + cobimetinib leaded to decrease of both antitumor treatment costs and total medical costs of first-line treatment of melanoma, resulting in possibility of treatment in 3,3 and 3,6 times more patients within equal budget, respectively (in case of treatment with nivolumab). Obtained results of costeffectiveness analysis were stable to increase of nivolumab price within 1,5-2,0 or to decrease of alternative schemes prices within 1,5-2,0.

Abdrashitova G.T., Babiy V.V., Komarov E.A., Pochuprina A.A., Serpik V.G., Ugrekhelidze D.T. 1294

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

Babiy V.V., Yagudina R.I. 1274

The article presents the methodological basics of the effectiveness analysis in pharmacoeconomic studies of medicinal drugs or health technologies. In particular, the main challenge that researchers face is the defining criterionof the effec tiveness of the evaluated alternatives is described. What is more, main positive and negative sides of using surrogate and final performance criteria, as well as provide methodological recommendations for their selection and evaluation.

Babiy V.V., Kulikov A.Y. 1640

The aim of this study was to determine the optimal medical technique of treatment of human immunodeficiency virus (HIV) infected adults with HIV-1 RNA<100 000 copies/ml by assessing costs and effectiveness of highly active antiretroviral therapy: rilpivirine/ tenofovir/ emtricitabine (single tablet regimen (STR)), efavirenz + tenofovir/ emtricitabine (multi-pill regimen), lopinavir + tenofovir/ emtricitabine (multi-pill regimen). The obtained results have demonstrated that prescription of rilpivirine-containing combined Highly Active Antiretroviral Therapy (HAART) (STR) is associated with additional costs on ambulatory treatment, that are overlaid by lower costs (direct and indirect) on new persons with HIV, infected by the analyzed group. Therefore, cost savings, as compared to mentioned schemes of HAART, accompany prescription of the scheme rilpivirine/ tenofovir/ emtricitabine (Eviplera), according to the «budget impact» analysis.

Babiy V.V., Kulikov A.Y. 1335

In this study, a pharmacoeconomic analysis of chronic lymphocytic leukemia therapy in previously untreated patients was conducted, using treatment regimens obinutuzumab (Gazyva) + chlorambucil and rituximab +chlorambucil. The results of the study showed that though the costs of the first treatment course with obinutuzumab + chlorambucil are significantly higher, this regimen reduces the cumulative cost of subsequent therapy lines in patients with CLL (due to a longer progression-free survival). In the end of the third year of therapy, cumulative costs become relatively similar: with the use of the obinutuzumab + chlorambucil regimen, the cumulative cost per 1 patient/year will be 38,390 rubles higher compared to the rituximab + chlorambucil regimen. At the same time, the obinutuzumab regimen showed a lower cost-effectiveness ratio, i.e. it had an advantage over the alternative technology.

Babiy V.V., Kulikov A.Y. 1240

The aim of this study was to determine optimal medical technique based on assessing cost and efficacy of treatment of von Willebrand disease using blood clotting factor concentrates (blood clotting factor VIII + von Willebrand factor): Wilate, Haemate P, Immunate. It was determined that in studies on assessing the efficiency of the concentrates more than 95% of patients rated hemostasis excellent/good. However, the studies were based on different scales of efficiency assessment, different vWF:RСo doses and different data for vWD patients (severity of the disease), therefore the efficiency of blood clotting factor concentrates might be not equal. Results of present study with the assumption about equality of groups, that were analyzed in studies on assessing the efficiency of the concentrates (although, studies on Wilate included more severe patients),evidence that prescribing blood clotting factor concentrate Wilate lead to cost savings compared to the older generation products.

Babiy V.V., Kulikov A.Y. 1135

The article deals with the results of validation of the pharmacoeconomic model of emtricitabin/ rilpivirine/ tenofovir (Eviplera) inclusion in highly active antiretroviral therapy of HIV/AIDS in the Russian Federation.

Babiy V.V., Kulikov A.Y., Shestakova I.V. 811

The goals of this study was: 1. to evaluate the superior regimen of antiviral drug treatment of chronic hepatitis C (daclatasvir + asunaprevir (a combination of the medicinal products) versus perginterferon alfa + ribavirin or peginterferon alfa + ribavirin + simeprevir or paritaprevir + ritonavir + ombitasvir + dasabuvir) in treatment-naive and treatment-experienced patients (HCV genotype 1b) without liver cirrhosis and with liver cirrhosis based on comparison of cost, effectiveness and safety; 2. To define, using «budget impact» analysis, economic outcomes of including daclatasvir + asunaprevir in current practice of HCV treatment This analysis was performed using two scenarios of the adjusted model “The MONARCH Cost-effectiveness Model”. «Budget impact» analysis was conducted using adapted model «ALLY: Daklinza® (Daclatasvir) Budget Impact Model». The study demonstrated that the first study hypothesis was correct: the combination of the medicinal products for treatment of HCV-infection (HCV genotype 1) daclatasvir + asunaprevir was found to have advantages over the combinations peginterferon alfa + ribavirin, peginterferon alfa + ribavirin + simeprevir and dasabuvir, ombitasvir + paritaprevir + ritonavir in respect of the cost-effectiveness ratio. Furthermore, results of «budget impact» analysis confirmed the second study hypothesis – introduction of DCV + ASV in current practice of HCV treatment will lead to decreasing of complication treatment costs.

Babiy V.V., Yagudina R.I. 216

This article compares for the first time in the Russian-speaking literature two approaches of survival modeling in pharmacoeconomic studies. Markov model and partitioned survival model were examined. The following text contains methodological issues, key differences and selection guideline.

Babiy V.V., Kulikov A.Y. 130

The objective of this study was to conduct cost-effectiveness analysis and budget impact analysis of antiviral drug treatment of chronic hepatitis C (peginterferon alfa + ribavirin 24 weeks (F0-F4), daclatasvir + sofosbuvir 12 weeks (F0-F3), daclatasvir + sofosbuvir + ribavirin 12 weeks (F4), sofosbuvir + ribavirin 24 weeks (F0-F4)) among treatment-experienced patients (HCV genotype 3). Both analyses were based on the developed pharmacoeconomic model (Markov model). Literature review showed absence of clear effectiveness data on using of peginterferon alfa + ribavirin in the targeted group therefore subsequent pharmacoeconomic analysis for this comparator was aborted. Obtained results showed that daclatasvir + sofosbuvir and daclatasvir + sofosbuvir + ribavirin was dominant in compares with sofosbuvir + ribavirin in the F0-F3 and F4 groups. In budget impact analysis total costs per one patient decreased on 283 623 rubles and 290 168 rubles in case of using daclatasvir + sofosbuvir instead of sofosbuvir + ribavirin among F0-F3 patients and daclatasvir + sofosbuvir + ribavirin instead of sofosbuvir + ribavirin among F4 patients, respectively.

Babiy V.V., Kulikov A.Y. 116

In conducted pharmacoeconomic study we analyzed treatment of nonresectable stage III-IV melanoma among BRAF-mutated treatment-naïve patients: monotherapy with nivolumab, scheme dabrafenib + trametinib and scheme vemurafenib + cobimetinib. Cost-effectiveness analysis and budgetimpact analysis were based on a modeling approach. Progression free survival (PFS) was used as an effectiveness criteria. Only direct costs of medical help at first-line of antitumor treatment were taken into account. Time horizon was equal to PFS of mentioned treatment schemes. Results of cost-effectiveness analysis showed that the lowest CERPFS was on the monotherapy with nivolumab. In budget-impact analysis using of nivolumab instead of dabrafenib + trametinib and vemurafenib + cobimetinib leaded to decrease of both antitumor treatment costs and total medical costs of first-line treatment of melanoma, resulting in possibility of treatment in 3,3 and 3,6 times more patients within equal budget, respectively (in case of treatment with nivolumab). Obtained results of costeffectiveness analysis were stable to increase of nivolumab price within 1,5-2,0 or to decrease of alternative schemes prices within 1,5-2,0.