Ugrekhelidze Dzhumber Tengizovich

Kulikov A.Y., Ugrekhelidze D.T. 1816

According to the World Health Organization, the prevalence of post-stroke spasticity is 200 people per 100 thousand inhabitants and the total number of patients in the world exceeds 12 million people. Approximately 450 000 people have a cerebrovascular accident (CVA) annually in the Russian Federation and the post-stroke spasticity is developed in about one third of the survivors. The main goal of this study is to conduct pharmacoeconomic analysis of three bestselling in the Russian Federation botulinum toxin type A preparations - Dysport®, Botox®, Xeomin compared with standard therapy without botulinum toxin type A. According to the conducted cost-effectiveness analysis where Modified Ashworth scale score is used as a main outcome Dysport® is a dominated alternative compared with other studied therapy schemes. What is more, budget impactanalysis shows that therapy with Dysport® during one year leads to the saving of 45 563 rubles compared with Botox® and saving of 44 408 rubles compared with Xeomin per one patient.

Abdrashitova G.T., Babiy V.V., Komarov E.A., Pochuprina A.A., Serpik V.G., Ugrekhelidze D.T. 1595

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., Ugrekhelidze D.T., Yagudina R.I. 1363

In this paper, the main methodological aspects of the willingnessto-pay analysis are highlighted. The values of the willingness-to-pay threshold according to the methodology of the World Health Organization are calculated, the ones of the Russian Federation and the countries of the Group of Twenty and the Commonwealth of Independent States were compared. The international experience of the calculation of willingness-to-pay threshold is covered. Advantages and disadvantages of various methods of calculation of the willingness-to-pay threshold are presented.

Kulikov A.Y., Ugrekhelidze D.T. 1393

Pharmacoeconomic study of different preparations of botulinum toxin type A used for the treatment of cerebral palsy in terms of health of the Russian Federation was conducted. The aim of this study was to determine the most appropriate therapy of cerebral palsy from the pharmacoeconomic point of view. We compared three regimens: botulinum toxin type A - Dysport® in combination with standard therapy, botulinum toxin type A - Botox® in combination with standard therapy and standard therapy without the use of botulinum toxin. It should be noted that centrally acting muscle relaxant (Baclofen) was used in standard therapy, but BTA in this treatment scheme is not used to eliminate unwanted relaxation of the muscles. As a result, it was found that the regimen Dysport®+standard therapy has the lowest cost-effectiveness ratio (11 608 rubles) in comparison with drug therapy Botox®+standard therapy (12 879 rubles) and standard therapy with a centrally acting muscle relaxant without BTA (25 222 rubles) by the end of 2 years of treatment. According to the budget impact analysis at the end of 2 years for 1 patient the scheme Dysport®+standard therapy was the least expensive form of therapy (1 079 500 rubles) in comparison with therapy Botox®+standard therapy (1 159 085 rubles) and standard therapy with a centrally acting muscle relaxant without BTA (1 210 678 rubles).

Serpik V.G., Ugrekhelidze D.T., Yagudina R.I. 1339

Budget impact analysis is one of the main methods of pharmacoeconomic analysis and obligatory one for pharmacoeconomic assessment during the apply for inclusion in state reimbursement list in the Russian Federation. Results of budget impact analysis being presented in monetary values are the most convincing ones among the pharmacoeconomic values for healthcare decision-makers. The conduct of budget impact analysis includes such stages as choice of effectiveness criteria, costs analysis. During this type of pharmacoeconomic assessment the following factors are taken into account: time horizon, the peculiarities of choice of patients’ models, characteristics of market penetration with health technologies. Budget impact analysis presents wide opportunities for conducted pharmacoeconomic assessment, defining the total economic impact under basic scenario. In the same time budget impact analysis allows to compare the figures of total economic impacts for several technologies, showing the least costly alternatives. If it is necessary using budget impact analysis it is possible to make accurate models describing the budgets of any healthcare programme of ones for treatment of certain nosologies with the function of prognosis and optimization.

Kulikov A.Y., Larionova V.B., Snegovoy A.V., Ugrekhelidze D.T. 1229

As part of this work a pharmacoeconomic study of prophylaxis for febrile neutropenia with granulocyte colony-stimulating factor drugs was carried out. Four prevention schemes of G-CSFs were compared: lipegfilgrastim, pegfilgrastim, filgrastim, lenograstim. As a result, it was found that prophylaxis with lipegfilgrastim is characterized by the lowest “cost-effectiveness” ratio (217,352 rubles) as compared to prophylaxis with pegfilgrastim (342,748 rub.), filgrastim (302,077 rub. for 11 days of prophylaxis), lenograstim (788,582 rub. for 11 days of prophylaxis) by the end of the 1st year of prophylaxis. In the context of budget impact analysis, the least costly scheme was prophylaxis with lipegfilgrastim (211,484 rubles) by the end of the 1st year when calculating per 1 patient. Costs in pegfilgrastim group resulted in 314,986 rubles, in filgrastim group (11 days of treatment) – 264,620 rubles, in lenograstim group (11 days of treatment) – 690,798 rubles. In the context of pharmacoeconomic analysis it is preferable to use lipegfilgrastim for prophylaxis of febrile neutropenia as compared to other G-CSFs (pegfilgrastim, filgrastim, lenograstim), as it allows to increase the number of patients who responded to prophylaxis of febrile neutropenia while reducing costs as compared to other granulocyte colonystimulating factor drugs.

Abdrashitova G.T., Makarova E.I., Rybchenko Y.V., Ugrekhelidze D.T. 1242

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

Serpik V.G., Ugrekhelidze D.T. 1006

This article presents an overview of the main performances at the X National Congress with international participation “Development of pharmacoeconomics and pharmacoepidemiology in the Russian Federation”, Nizhny Novgorod, Russia, April 4-5, 2016

Ugrekhelidze D.T., Yagudina R.I. 790

Grading of Recommendations Assessment, Development and Evaluation approach is a method of assessing the certainty in evidence and it is used in systematic reviews, health technology assessment and clinical guidelines development. In this article authors cover the process of making this assessment, the criteria of grading the evidence, determining the quality and strength of evidence.

Zubarev P.D., Kulikov A.Y., Protsenko M.V., Telnova E.A., Ugrekhelidze D.T. 656

To assess the level of development of pharmacoeconomics in the Russian Federation as a branch of science analysis of pharmacoeconomic and clinical economic studies published in the scientific electronic library “eLIBRARY.RU” (RSCI) for the period from 2005 through 2015 was performed. As a result, it was determined that the number of such studies from year to year is steadily increasing. The leader among the countries who publish their researches on the platform of the scientific electronic library “eLIBRARY. RU” was Russia, the second and the third places were shared by Ukraine and Belarus, respectively. The research was carried out in 52 subjects of the Russian Federation, which is represented by 63 Universities. Leader out of them was the I.M. Sechenov First Moscow State Medical University. It turned out that most pharmacoeconomic and clinical-economic research during the specified time interval was devoted to cardiovascular, pulmonary, oncological and endocrinological diseases. As a result of analysis, it was found that among pharmacoeconomic research methods most commonly used “cost– effectiveness” analysis (45,1%). In addition, on the basis of the analyzed data of Russian science citation index and the total number of published works, the rating of the authors who conducted research in the field of pharmacoeconomics in the country.

Kulikov A.Y., Snegovoy A.V., Ugrekhelidze D.T. 410

This article deals with pharmacoeconomic study of erythropoietin use in patients with chemotherapy-induced anemia. Four treatments were evaluated, i.e. Epoetin alfa, Epoetin beta, Epoetin theta and Darbepoetin alfa. The results of pharmacoeconomic analysis show that use of Epoetin theta (Eporatio) is the most cost-effective regimen for anemia treatment in cancer patients. Cost-cutting upon patient’s transition to Eporatio amounts up to 9,129 rubles (transition from Epoetin beta), up to 13,812 rubles (transition from Epoetin alfa) and 165,527 rubles (transition from Darbepoetin alfa). Budget impact analysis demonstrated a possibility of total cost-cutting in the amount of 197,075,449 rubles if purchase share of Eporatio increases to 30% via reducing purchase share of Epoetin alfa by 15%, Epoetin beta by 13% and Darbepoetin alfa by 2%.

Ugrekhelidze D.T., Yagudina R.I. 420

This article touches upon the main methodological aspects of conducting pharmacoeconomic analysis of treatment of spasticity in patients with cerebral palsy. The authors evaluated the relevance of conduct of such studies basing on epidemiological and social and economic data. The stages of information retrieval and inclusion criteria in the effectiveness analysis are covered in detail. Special attention is paid to assessing the methodological quality of the studies. The authors highlighted the components of the cost analysis and assessment of the economic burden of this disease and describes the features of assessing the quality of life in children with cerebral palsy using a variety of methods.

Babiy V.V., Serpik V.G., Ugrekhelidze D.T., Yagudina R.I. 354

The article aims to review issues of choice of drugs clinical effectiveness evaluation during pharmacoeconomic studies. It also includes effectiveness criteria classification in pharmacoeconomics. Special attention is paid to the description of the effectiveness criteria using both duration and quality of life: description of their methodological basis, advantages and limitations. The authors provide recommendations for the choice of effectiveness criteria, depending on pharmacoeconomic analysis method; the target audience for results of pharmacoeconomic analysis, and the characteristics of nosology.

Beltukov E.K., Skorohodov I.S., Ugrekhelidze D.T., Yagudina R.I. 308

This work included a pharmaeconomic study of the efficacy of treatment of primary immunodeficiencies (PID) with antibody formation defects using normal human immunoglobulin medicinal products for intravenous administration in the Sverdlovsk Region health care system. Four treatment regimens were compared: 10% intravenous immunoglobulin (IVIG) Privigen and 5% IVIGs Octagam, Intratect, I.G.Vena. It appeared that, from the pharmacoeconomic analysis point of view, the use of 10% normal human immunoglobulin for intravenous administration, Privigen, is the most cost-effective regimen (per patient) of primary immunodeficiency therapy among the pediatric (n=9) and adult (n=20) populations of PID patients with impaired antibody formation in the Sverdlovsk Region. In per annum terms, one pediatric patient switched to Privigen from Octagam saves 65 605 roubles; from Intratect, 183 625 roubles; from I.G.Vena, 68 949 roubles. Over the same period, one adult patient switched to Privigen from Octagam saves 170 870 roubles; from Intratect, 459 911 roubles; from I.G.Vena, 68 958 roubles. The budget impact analysis, within the Sverdlovsk Region health care system, showed that a 70% increase in Privigen procurement due to 70% reduction in Intratect procurement for PID patients helps save a total of 6 076 471 roubles per year. The lost opportunity analysis showed that the 70% increase in Privigen purchases would have provided additional funding for treatment of 11 pediatric or 3 adult PID patients with antibody formation defects.

Kulikov A.Y., Ugrekhelidze D.T. 1816

According to the World Health Organization, the prevalence of post-stroke spasticity is 200 people per 100 thousand inhabitants and the total number of patients in the world exceeds 12 million people. Approximately 450 000 people have a cerebrovascular accident (CVA) annually in the Russian Federation and the post-stroke spasticity is developed in about one third of the survivors. The main goal of this study is to conduct pharmacoeconomic analysis of three bestselling in the Russian Federation botulinum toxin type A preparations - Dysport®, Botox®, Xeomin compared with standard therapy without botulinum toxin type A. According to the conducted cost-effectiveness analysis where Modified Ashworth scale score is used as a main outcome Dysport® is a dominated alternative compared with other studied therapy schemes. What is more, budget impactanalysis shows that therapy with Dysport® during one year leads to the saving of 45 563 rubles compared with Botox® and saving of 44 408 rubles compared with Xeomin per one patient.

Abdrashitova G.T., Babiy V.V., Komarov E.A., Pochuprina A.A., Serpik V.G., Ugrekhelidze D.T. 1595

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., Ugrekhelidze D.T., Yagudina R.I. 1363

In this paper, the main methodological aspects of the willingnessto-pay analysis are highlighted. The values of the willingness-to-pay threshold according to the methodology of the World Health Organization are calculated, the ones of the Russian Federation and the countries of the Group of Twenty and the Commonwealth of Independent States were compared. The international experience of the calculation of willingness-to-pay threshold is covered. Advantages and disadvantages of various methods of calculation of the willingness-to-pay threshold are presented.

Kulikov A.Y., Ugrekhelidze D.T. 1393

Pharmacoeconomic study of different preparations of botulinum toxin type A used for the treatment of cerebral palsy in terms of health of the Russian Federation was conducted. The aim of this study was to determine the most appropriate therapy of cerebral palsy from the pharmacoeconomic point of view. We compared three regimens: botulinum toxin type A - Dysport® in combination with standard therapy, botulinum toxin type A - Botox® in combination with standard therapy and standard therapy without the use of botulinum toxin. It should be noted that centrally acting muscle relaxant (Baclofen) was used in standard therapy, but BTA in this treatment scheme is not used to eliminate unwanted relaxation of the muscles. As a result, it was found that the regimen Dysport®+standard therapy has the lowest cost-effectiveness ratio (11 608 rubles) in comparison with drug therapy Botox®+standard therapy (12 879 rubles) and standard therapy with a centrally acting muscle relaxant without BTA (25 222 rubles) by the end of 2 years of treatment. According to the budget impact analysis at the end of 2 years for 1 patient the scheme Dysport®+standard therapy was the least expensive form of therapy (1 079 500 rubles) in comparison with therapy Botox®+standard therapy (1 159 085 rubles) and standard therapy with a centrally acting muscle relaxant without BTA (1 210 678 rubles).

Serpik V.G., Ugrekhelidze D.T., Yagudina R.I. 1339

Budget impact analysis is one of the main methods of pharmacoeconomic analysis and obligatory one for pharmacoeconomic assessment during the apply for inclusion in state reimbursement list in the Russian Federation. Results of budget impact analysis being presented in monetary values are the most convincing ones among the pharmacoeconomic values for healthcare decision-makers. The conduct of budget impact analysis includes such stages as choice of effectiveness criteria, costs analysis. During this type of pharmacoeconomic assessment the following factors are taken into account: time horizon, the peculiarities of choice of patients’ models, characteristics of market penetration with health technologies. Budget impact analysis presents wide opportunities for conducted pharmacoeconomic assessment, defining the total economic impact under basic scenario. In the same time budget impact analysis allows to compare the figures of total economic impacts for several technologies, showing the least costly alternatives. If it is necessary using budget impact analysis it is possible to make accurate models describing the budgets of any healthcare programme of ones for treatment of certain nosologies with the function of prognosis and optimization.

Abdrashitova G.T., Makarova E.I., Rybchenko Y.V., Ugrekhelidze D.T. 1242

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., Larionova V.B., Snegovoy A.V., Ugrekhelidze D.T. 1229

As part of this work a pharmacoeconomic study of prophylaxis for febrile neutropenia with granulocyte colony-stimulating factor drugs was carried out. Four prevention schemes of G-CSFs were compared: lipegfilgrastim, pegfilgrastim, filgrastim, lenograstim. As a result, it was found that prophylaxis with lipegfilgrastim is characterized by the lowest “cost-effectiveness” ratio (217,352 rubles) as compared to prophylaxis with pegfilgrastim (342,748 rub.), filgrastim (302,077 rub. for 11 days of prophylaxis), lenograstim (788,582 rub. for 11 days of prophylaxis) by the end of the 1st year of prophylaxis. In the context of budget impact analysis, the least costly scheme was prophylaxis with lipegfilgrastim (211,484 rubles) by the end of the 1st year when calculating per 1 patient. Costs in pegfilgrastim group resulted in 314,986 rubles, in filgrastim group (11 days of treatment) – 264,620 rubles, in lenograstim group (11 days of treatment) – 690,798 rubles. In the context of pharmacoeconomic analysis it is preferable to use lipegfilgrastim for prophylaxis of febrile neutropenia as compared to other G-CSFs (pegfilgrastim, filgrastim, lenograstim), as it allows to increase the number of patients who responded to prophylaxis of febrile neutropenia while reducing costs as compared to other granulocyte colonystimulating factor drugs.

Serpik V.G., Ugrekhelidze D.T. 1006

This article presents an overview of the main performances at the X National Congress with international participation “Development of pharmacoeconomics and pharmacoepidemiology in the Russian Federation”, Nizhny Novgorod, Russia, April 4-5, 2016

Ugrekhelidze D.T., Yagudina R.I. 790

Grading of Recommendations Assessment, Development and Evaluation approach is a method of assessing the certainty in evidence and it is used in systematic reviews, health technology assessment and clinical guidelines development. In this article authors cover the process of making this assessment, the criteria of grading the evidence, determining the quality and strength of evidence.

Zubarev P.D., Kulikov A.Y., Protsenko M.V., Telnova E.A., Ugrekhelidze D.T. 656

To assess the level of development of pharmacoeconomics in the Russian Federation as a branch of science analysis of pharmacoeconomic and clinical economic studies published in the scientific electronic library “eLIBRARY.RU” (RSCI) for the period from 2005 through 2015 was performed. As a result, it was determined that the number of such studies from year to year is steadily increasing. The leader among the countries who publish their researches on the platform of the scientific electronic library “eLIBRARY. RU” was Russia, the second and the third places were shared by Ukraine and Belarus, respectively. The research was carried out in 52 subjects of the Russian Federation, which is represented by 63 Universities. Leader out of them was the I.M. Sechenov First Moscow State Medical University. It turned out that most pharmacoeconomic and clinical-economic research during the specified time interval was devoted to cardiovascular, pulmonary, oncological and endocrinological diseases. As a result of analysis, it was found that among pharmacoeconomic research methods most commonly used “cost– effectiveness” analysis (45,1%). In addition, on the basis of the analyzed data of Russian science citation index and the total number of published works, the rating of the authors who conducted research in the field of pharmacoeconomics in the country.

Kulikov A.Y., Snegovoy A.V., Ugrekhelidze D.T. 410

This article deals with pharmacoeconomic study of erythropoietin use in patients with chemotherapy-induced anemia. Four treatments were evaluated, i.e. Epoetin alfa, Epoetin beta, Epoetin theta and Darbepoetin alfa. The results of pharmacoeconomic analysis show that use of Epoetin theta (Eporatio) is the most cost-effective regimen for anemia treatment in cancer patients. Cost-cutting upon patient’s transition to Eporatio amounts up to 9,129 rubles (transition from Epoetin beta), up to 13,812 rubles (transition from Epoetin alfa) and 165,527 rubles (transition from Darbepoetin alfa). Budget impact analysis demonstrated a possibility of total cost-cutting in the amount of 197,075,449 rubles if purchase share of Eporatio increases to 30% via reducing purchase share of Epoetin alfa by 15%, Epoetin beta by 13% and Darbepoetin alfa by 2%.

Ugrekhelidze D.T., Yagudina R.I. 420

This article touches upon the main methodological aspects of conducting pharmacoeconomic analysis of treatment of spasticity in patients with cerebral palsy. The authors evaluated the relevance of conduct of such studies basing on epidemiological and social and economic data. The stages of information retrieval and inclusion criteria in the effectiveness analysis are covered in detail. Special attention is paid to assessing the methodological quality of the studies. The authors highlighted the components of the cost analysis and assessment of the economic burden of this disease and describes the features of assessing the quality of life in children with cerebral palsy using a variety of methods.

Babiy V.V., Serpik V.G., Ugrekhelidze D.T., Yagudina R.I. 354

The article aims to review issues of choice of drugs clinical effectiveness evaluation during pharmacoeconomic studies. It also includes effectiveness criteria classification in pharmacoeconomics. Special attention is paid to the description of the effectiveness criteria using both duration and quality of life: description of their methodological basis, advantages and limitations. The authors provide recommendations for the choice of effectiveness criteria, depending on pharmacoeconomic analysis method; the target audience for results of pharmacoeconomic analysis, and the characteristics of nosology.

Beltukov E.K., Skorohodov I.S., Ugrekhelidze D.T., Yagudina R.I. 308

This work included a pharmaeconomic study of the efficacy of treatment of primary immunodeficiencies (PID) with antibody formation defects using normal human immunoglobulin medicinal products for intravenous administration in the Sverdlovsk Region health care system. Four treatment regimens were compared: 10% intravenous immunoglobulin (IVIG) Privigen and 5% IVIGs Octagam, Intratect, I.G.Vena. It appeared that, from the pharmacoeconomic analysis point of view, the use of 10% normal human immunoglobulin for intravenous administration, Privigen, is the most cost-effective regimen (per patient) of primary immunodeficiency therapy among the pediatric (n=9) and adult (n=20) populations of PID patients with impaired antibody formation in the Sverdlovsk Region. In per annum terms, one pediatric patient switched to Privigen from Octagam saves 65 605 roubles; from Intratect, 183 625 roubles; from I.G.Vena, 68 949 roubles. Over the same period, one adult patient switched to Privigen from Octagam saves 170 870 roubles; from Intratect, 459 911 roubles; from I.G.Vena, 68 958 roubles. The budget impact analysis, within the Sverdlovsk Region health care system, showed that a 70% increase in Privigen procurement due to 70% reduction in Intratect procurement for PID patients helps save a total of 6 076 471 roubles per year. The lost opportunity analysis showed that the 70% increase in Privigen purchases would have provided additional funding for treatment of 11 pediatric or 3 adult PID patients with antibody formation defects.