Yagudina Roza Ismailovna

Serpik V.G., Yagudina R.I. 1553

Summary: Abstract: Pharmacoeconomic analysis is becoming more common as a decisionmaking tool in healthcare of the Russian Federation. On the one hand, this process is accompanied with the complexity of the used methods. In particular, the simultaneous use of both types of analysis (budget impact analysis and costeffectiveness analysis) is intended. It’s important to note that pharmacoeconomic assessment based on these indicators often has controversial character. Thus, the results of one type of analysis can characterize assessed health technology favorably, and the results of other critically. On the other hand, the use of pharmacoeconomic approaches at the system level requires formalization of the decision-making on the basis of pharmacoeconomic evaluations. In this regard, there is a problem of correct interpretation of the results of both types of pharmacoeconomic analysis when making a unified formalized pharmacoeconomic report. In this article, we offer our methodological solution of the stated problem. This solution is a useful tool in making unite pharmacoeconomic report based on cost-effectiveness analysis and budget impact analysis results. Use of this model preserves the meaning and significance of each type of pharmacoeconomic analysis. The article also presents the concept of a practical embodiment of the described methodology - the creation of «3D» pharmacoeconomic model.

Sorokovikov I.V., Yagudina R.I. 1526

Main aspects and possible directions of pharmacoeconomic and clinical economic studies on tuberculosis are covered. The main directions of the described possibilities of pharmacoeconomics are the analysis of both individual health technologies (drugs and diagnostic tests), modes of therapy, and assessment of changes in clinical guidelines and standards of treatment of TB patients. Described changing epidemic affect the structure of the disease, the innovative antituberculosis drugs and new practice in the treatment of patients affect on the effectiveness of the treatment and its cost. Features of the methodology of pharmacoeconomic analysis in tuberculosis are paid attention to in this article.

Kulikov A.Y., Serpik V.G., Yagudina R.I. 1501

Currently the health care system of the Russian Federation has gone through the stages of systematic changes to meet the modern requirements and realize the settled objectives. However, the mentioned changes are not only limited to the incorporation of innovative prophylactic, medical-diagnostic and rehabilitative technologies but they mainly affect the areas of management and decision-making in the health system. One of the most important tips in the health system management is the development of rules/algorithms including medical technologies in public health programs. Taking into account the ongoing public deliberations on the draft of the rules on forming the lists of medicines, it’s an actual point to submit to the professional community the author’s vision on the algorithm of decision-making in regard to the inclusion/exclusion of medicines in public programs/lists on the basis of pharmacoeconomic assessment. The offered algorithm of the article involves two stages. The goal of the first stage is the expertise on the pharmacoeconomic assessment of the considered medicament. The requirements applicable to the pharmacoeconomic research of the considered medicine are designed and introduced in the scopes of the expertise. The second stage applies to the actual decision-making algorithm based on the pharmacoeconomic assessment (in the case of the expertise is conducted). The algorithm is a list of strict formal rules interpreting the outcomes of pharmacoeconomic assessments. The rules are seen as sufficient conditions to deliver a recommendation for the approval or refusal on including/ leaving of the medicine in the public program of medicine supply.

Serpik V.G., Sorokovikov I.V., Yagudina R.I. 1471

Summary: The paper presents the basic methodology for the conduct of analysis of «cost-effectiveness» and incremental analysis of «cost-effectiveness». Among other aspects, the mathematical apparatus of these species of pharmacoeconomic analysis is discussed, their semantic content is described. In the scopes of the paper we focus on the order of these types of analysis, with a brief description of each stage and its features. In particular, the requirements of the selection of compared alternatives are illustrated, as well as the importance of the selection of effectiveness criterion and types of accounted costs are stressed. The approach toward the results in the frames of each considered types of pharmacoeconomic analysis is described in details. In conclusion, a detailed graphic of the algorithm on the described types of the analysis is illustrated. Keywords: Pharmacoeconomics, cost-effectiveness/efficacy, methodology of pharmacoeconomic analysis, incremental cost-effectiveness ratio, threshold of willingness-to-pay, interpretation of results of the (incremental) “costeffectiveness” analysis, decision-making in the health system

Abdrashitova G.T., Kotenko O.N., Serpik V.G., Yagudina R.I. 1468

For the first time in Russia, economic burden of chronic kidney disease on a national scale was determined The economic burden of chronic kidney disease was calculated based on the methodology of a special kind of pharmacoeconomic analysis, the «cost of illness» analysis. The analysis included both direct and indirect costs associated with the disease in question. In the course of the study, the cost of individual stages of chronic kidney disease per patient per year was determined. The most expensive stages were those, at which the patients received renal replacement therapy. At the same time, the cost of illness analysis based on the entire population carried out at the next stage revealed that most of the cost falls on the early stages of chronic kidney disease as a result of a significant number of patients at these stages. The cumulative economic burden of chronic kidney disease in Russia exceeded 451 billion rubles.

Babiy V.V., Yagudina R.I. 1322

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.

Kulikov A.Y., Ugrekhelidze D.T., Yagudina R.I. 1081

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.

Abdrashitova G.T., Serpik V.G., Yagudina R.I. 1023

In the framework of the presented study, we have performed a pharmacoeconomic analysis of medical care for chronic kidney disease patients who need renal replacement therapy via peritoneal dialysis and hemodialysis. The study results demonstrates that the aggregate costs of peritoneal dialysis therapy, on the average, are lower than those of hemodialysis by 12 % due to the lower costs of treatment of the chronic kidney disease and renal replacement therapy related complications and lower indirect costs due to longer preservation of the capacity for work. Peritoneal dialysis demonstrated higher clinical effectiveness and lower aggregate costs and, as consequence, lower cost-utility ratio, i.e. demonstrated the advantages over hemodialysis.

Serpik V.G., Ugrekhelidze D.T., Yagudina R.I. 1042

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.

Tishchenko D.G., Yagudina R.I. 1032

This document represents the results of validation of pharmacoeconomic model of introduction of medicinal product Ibrutinib into chronic lymphatic leukemia therapy practice within the programme of drug provision for patients with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, haematopoietic and related tissues, multiple sclerosis, as well as patients after transplantation of organs and/or tissues (hereafter referred to as ‘7 cost-intensive nosologies (7 CIN) programme’). Budget impact analysis demonstrated the possibility to provide all patients requiring Ibrutinib therapy without budget increase using only a part of savings within the programme during a period of 2016 – 2018.

Serpik V.G., Yagudina R.I. 907

The increase of practical application of pharmacoeconomics in the organization of medicinal provision the Russian Federation requires clarification of the definition of the concepts of pharmacoeconomics. Thus, in the context of the academic approach the term «pharmacoeconomics» can be defined as an independent science that studies in comparative terms the ratio between cost and effectiveness, safety and quality of life of patients with different treatment regimens or disease prevention. However, from the perspective of practical application it will be more accurate to consider pharmacoeconomics as a tool for decision support, providing decision-makers, relevant and reliable information in order to create from them a clear understanding of the situation and the possibility of taking appropriate optimal solutions. Herewith, wide opportunities of pharmacoeconomics are based on the application of pharmacoeconomic modeling. In this connection, the authors, based on their own practical experience create a domestic and adapted foreign foreign pharmacoeconomic models, set out the methodological basis of pharmacoeconomic modeling in this article in the form in which they meet the requirements and demands imposed by owners, using the results of pharmacoeconomic evaluations in the modern system of medicine provision in the Russian Federation

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. 879

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.

Serpik V.G., Yagudina R.I. 790

Cost analysis is an essential step of pharmacoeconomic research. It is the basis for carrying out special methods of pharmacoeconomic analysis: “cost-effectiveness” and “budget impact”. This article deals with methodological basis of cost analysis in pharmacoeconomic studies. In particular, the authors describe the classification of costs and various methods of their calculation. In the publication the attention is paid to sourcing prices and cost structure in conducting pharmacoeconomic studies. Thus, the possibilities and limitations of using different types of prices depending on the position of pharmacoeconomic studies. The advantages and disadvantages of cost analysis based on standards of medical care, clinical and statistical groups and evaluation of real clinical practice are also described. The article deals with the features that must be considered when calculating direct and indirect costs. The authors list the problems of accounting the intangible costs.

Ugrekhelidze D.T., Yagudina R.I. 521

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.

Novikov I.V., Yagudina R.I. 455

Retrospective analysis of using fixed combinations of metformine and glibenclamide against separate scheme was carried out using the following methods: “cost-effectiveness”, “budget impact” and “sensitivity analysis”. For assessment of long-term impact of the compared methods of therapy on the results of the cost-effectiveness analysis, in terms of QALYs, and cost analysis, a Markov model with a 20-year model horizon was used. The compared alternatives were a fixed dose combination (FDC)of metformin and glibenclamide (Glucovance) and non-fixed dose combinations (nFDC) of glibenclamide (Maninil) and each of the three generics of metformin, consumption of which took a leading position in consumption in the Russian Federation (Siofor, Metformin-Richter and Formetine). The effectiveness analysis showed that the total QALY for 20 years made 6.7121 and 6.2416 for the therapy with metformin FDC and nFDC respectively. And the cumulative cost made 2,512 thousand roubles, 2,687 thousand roubles, 2,690 thousand roubles and 2,696 thousand roubles for the therapy with Glucovance and combinations of Maninil and Formetine, Metformin-Richter and Siofor respectively.

Molchanova N.B., Yagudina R.I. 366

Hemophilia is one of the rare, socially significant, hereditary diseases drug supply of which centralized in the framework of the program “7 nosologies” at the expense of the Federal budget. According to IMS Health, in 2015 the consumption of medicinal drugs used in the treatment of hemophilia reached 11.2 billion RUB that shows an increase of 16.9% compared to 2010. The main drivers of market growth have become the primarily raising awareness of the disease and the increase in diagnosis led to growth of the patient population as a whole, as well as understanding of the need for effective and quality care that led to a rise of the prescription of the preventive therapy, in which a comparably larger consumption of the medicines for the patient leads to a significant improvement in outcomes and safety of patients. The improving of the quality of medical care is also implemented through the inclusion into the program of modern recombinant medicines, possessing the best safety profile in comparison to the medicines obtained from the plasma of donated blood. Every year the budgetary allocation for the treatment of high-cost nosology in general and for hemophilia increases, that indicates the primary focus of health aimed for improving of the quality of life of patients.

Babiy V.V., Yagudina R.I. 305

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.

Kulikov A.Y., Tishchenko D.G., Yagudina R.I. 199

Pharmacoeconomic analysis of long-term effects of more widespread use of in vitro fertilization (IVF) in infertility treatment at the regional and federal level from the standpoint of society in the Russian Federation was carried out in this research. The research was performed by means of forecasting of future monetary flows produced by a human born with the aid of in vitro fertilization throughout life. The methods of cost analysis, discounted monetary flows, age shifting and model building were used in the research. The result is that net present value (NPV) of tax payments produced within anticipated life period by the human born with of IVF in the Russian Federation was equal to 822,258 rubles. Return on investments (ROI) was 27%. Net present value (NPV) of GDP produced within the state per one human born with the aid of IVF in the Russian Federation was equal to 34.9 million rubles. Return on investments (ROI) was 985%. Additional carrying out of 24,450 IVF cycles on the basis of OMI CMI (Obligatory Medical Insurance) (the level of 2013) results in increase of total growth of population of the Russian Federation by 22.5%, annual additional carrying out of IVF procedure in the quantity carried out in 2013 will allow to produce additional population growth by 2075 estimated at 319 thousand people in productive age, and 222 thousand people aged up to 20 years.

Serpik V.G., Yagudina R.I. 203

This article is devoted to the evaluation of the use of dalbavancin (Xydalba) in the treatment of skin and soft tissue infections in hospital settings in the Russian Federation. The main methods of pharmacoeconomic analysis in the study were the following: cost-minimization analysis and budget impact analysis. The results of the pharmacoeconomic evaluation of dalbavancin treatment of patients with skin and soft tissue infection in Russia hospitals showed its stable advantage from the point of view of cost analysis and budget impact analysis in comparison with telavancin and tigecycline. The results of the cost-minimization analysis indicate of the dominance of dalbavancin in comparison with telavancin. At the same time, a comparative cost-minimization analysis of dalbavancin and tigecycline showed the advantage of the former, which, however, is not preserved when assessing the stability of the results through a one-factor sensitivity analysis with an increase in the price of dalbavancin by 15%. In accordance with the quantitative assessment of clinical and economic effectiveness, regulated by Decree of the Government of the Russian Federation N871 dated August 28, 2014, dalbavancin obtains +8 points on the pharmacoeconomic criterion.

Serpik V.G., Yagudina R.I. 165

The limited financing of the program of pharmacological support of high-cost nosologies emphasizes the importance of more effective use of the available resources. In order to improve the efficiency of use of the available resources of pharmacological support of inhibitor hemophilia patients receiving therapy in the prophylactic regimen, a budget impact analysis of prophylactic treatment by BPA anti-inhibitor coagulant complex and eptacog alfa [activated] was performed. In accordance with the instructions for use of eptacog alfa, this medicinal product is not indicated for long-term preventive treatment of bleedings, however, as eptacog alfa is used in the said regimen, it was included in the analysis. The analysis horizon period made 1 year and 75 patients were included in the analysis. The analysis shows that prophylactic anti-inhibitor coagulant complex therapy offers better control over the disease and reduces the costs. The incidence of bleedings in prophylactic anti-inhibitor coagulant complex therapy is reduced by 72.5%, while the incidence of bleedings in prophylactic treatment by eptacog alfa is reduced by 59% as compared to on demand therapy. The annual costs of prophylactic anti-inhibitor coagulant complex therapy per patient make 58.8 million rub (per adult patient) and 23.5 million rub (per pediatric patient), while the annual costs of bleeding prophylactic eptacog alfa treatment proved to be higher by 37.4% and made 94 million rub per adult patient and 37.6 million rub for pediatric patient. Transfer of all patients who respond to anti-inhibitor coagulant complex therapy and receive therapy with this medicinal product in prophylaxis regimen will save 765 million rub or 17.3% of the budget, provided that the current distribution of patients is preserved. Thus, the budget impact analysis demonstrates that the transfer of patients receiving therapy with eptacog alfa in prophylaxis regimen to AICC will improve the control over disease and save the budget funds under the 7N Program.

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Kulikov A.Y., Serpik V.G., Yagudina R.I. 1501

Currently the health care system of the Russian Federation has gone through the stages of systematic changes to meet the modern requirements and realize the settled objectives. However, the mentioned changes are not only limited to the incorporation of innovative prophylactic, medical-diagnostic and rehabilitative technologies but they mainly affect the areas of management and decision-making in the health system. One of the most important tips in the health system management is the development of rules/algorithms including medical technologies in public health programs. Taking into account the ongoing public deliberations on the draft of the rules on forming the lists of medicines, it’s an actual point to submit to the professional community the author’s vision on the algorithm of decision-making in regard to the inclusion/exclusion of medicines in public programs/lists on the basis of pharmacoeconomic assessment. The offered algorithm of the article involves two stages. The goal of the first stage is the expertise on the pharmacoeconomic assessment of the considered medicament. The requirements applicable to the pharmacoeconomic research of the considered medicine are designed and introduced in the scopes of the expertise. The second stage applies to the actual decision-making algorithm based on the pharmacoeconomic assessment (in the case of the expertise is conducted). The algorithm is a list of strict formal rules interpreting the outcomes of pharmacoeconomic assessments. The rules are seen as sufficient conditions to deliver a recommendation for the approval or refusal on including/ leaving of the medicine in the public program of medicine supply.

Serpik V.G., Sorokovikov I.V., Yagudina R.I. 1471

Summary: The paper presents the basic methodology for the conduct of analysis of «cost-effectiveness» and incremental analysis of «cost-effectiveness». Among other aspects, the mathematical apparatus of these species of pharmacoeconomic analysis is discussed, their semantic content is described. In the scopes of the paper we focus on the order of these types of analysis, with a brief description of each stage and its features. In particular, the requirements of the selection of compared alternatives are illustrated, as well as the importance of the selection of effectiveness criterion and types of accounted costs are stressed. The approach toward the results in the frames of each considered types of pharmacoeconomic analysis is described in details. In conclusion, a detailed graphic of the algorithm on the described types of the analysis is illustrated. Keywords: Pharmacoeconomics, cost-effectiveness/efficacy, methodology of pharmacoeconomic analysis, incremental cost-effectiveness ratio, threshold of willingness-to-pay, interpretation of results of the (incremental) “costeffectiveness” analysis, decision-making in the health system

Serpik V.G., Yagudina R.I. 1553

Summary: Abstract: Pharmacoeconomic analysis is becoming more common as a decisionmaking tool in healthcare of the Russian Federation. On the one hand, this process is accompanied with the complexity of the used methods. In particular, the simultaneous use of both types of analysis (budget impact analysis and costeffectiveness analysis) is intended. It’s important to note that pharmacoeconomic assessment based on these indicators often has controversial character. Thus, the results of one type of analysis can characterize assessed health technology favorably, and the results of other critically. On the other hand, the use of pharmacoeconomic approaches at the system level requires formalization of the decision-making on the basis of pharmacoeconomic evaluations. In this regard, there is a problem of correct interpretation of the results of both types of pharmacoeconomic analysis when making a unified formalized pharmacoeconomic report. In this article, we offer our methodological solution of the stated problem. This solution is a useful tool in making unite pharmacoeconomic report based on cost-effectiveness analysis and budget impact analysis results. Use of this model preserves the meaning and significance of each type of pharmacoeconomic analysis. The article also presents the concept of a practical embodiment of the described methodology - the creation of «3D» pharmacoeconomic model.

Sorokovikov I.V., Yagudina R.I. 1526

Main aspects and possible directions of pharmacoeconomic and clinical economic studies on tuberculosis are covered. The main directions of the described possibilities of pharmacoeconomics are the analysis of both individual health technologies (drugs and diagnostic tests), modes of therapy, and assessment of changes in clinical guidelines and standards of treatment of TB patients. Described changing epidemic affect the structure of the disease, the innovative antituberculosis drugs and new practice in the treatment of patients affect on the effectiveness of the treatment and its cost. Features of the methodology of pharmacoeconomic analysis in tuberculosis are paid attention to in this article.

Abdrashitova G.T., Kotenko O.N., Serpik V.G., Yagudina R.I. 1468

For the first time in Russia, economic burden of chronic kidney disease on a national scale was determined The economic burden of chronic kidney disease was calculated based on the methodology of a special kind of pharmacoeconomic analysis, the «cost of illness» analysis. The analysis included both direct and indirect costs associated with the disease in question. In the course of the study, the cost of individual stages of chronic kidney disease per patient per year was determined. The most expensive stages were those, at which the patients received renal replacement therapy. At the same time, the cost of illness analysis based on the entire population carried out at the next stage revealed that most of the cost falls on the early stages of chronic kidney disease as a result of a significant number of patients at these stages. The cumulative economic burden of chronic kidney disease in Russia exceeded 451 billion rubles.

Babiy V.V., Yagudina R.I. 1322

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.

Kulikov A.Y., Ugrekhelidze D.T., Yagudina R.I. 1081

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.

Tishchenko D.G., Yagudina R.I. 1032

This document represents the results of validation of pharmacoeconomic model of introduction of medicinal product Ibrutinib into chronic lymphatic leukemia therapy practice within the programme of drug provision for patients with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, haematopoietic and related tissues, multiple sclerosis, as well as patients after transplantation of organs and/or tissues (hereafter referred to as ‘7 cost-intensive nosologies (7 CIN) programme’). Budget impact analysis demonstrated the possibility to provide all patients requiring Ibrutinib therapy without budget increase using only a part of savings within the programme during a period of 2016 – 2018.

Abdrashitova G.T., Serpik V.G., Yagudina R.I. 1023

In the framework of the presented study, we have performed a pharmacoeconomic analysis of medical care for chronic kidney disease patients who need renal replacement therapy via peritoneal dialysis and hemodialysis. The study results demonstrates that the aggregate costs of peritoneal dialysis therapy, on the average, are lower than those of hemodialysis by 12 % due to the lower costs of treatment of the chronic kidney disease and renal replacement therapy related complications and lower indirect costs due to longer preservation of the capacity for work. Peritoneal dialysis demonstrated higher clinical effectiveness and lower aggregate costs and, as consequence, lower cost-utility ratio, i.e. demonstrated the advantages over hemodialysis.

Serpik V.G., Ugrekhelidze D.T., Yagudina R.I. 1042

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.

Serpik V.G., Yagudina R.I. 907

The increase of practical application of pharmacoeconomics in the organization of medicinal provision the Russian Federation requires clarification of the definition of the concepts of pharmacoeconomics. Thus, in the context of the academic approach the term «pharmacoeconomics» can be defined as an independent science that studies in comparative terms the ratio between cost and effectiveness, safety and quality of life of patients with different treatment regimens or disease prevention. However, from the perspective of practical application it will be more accurate to consider pharmacoeconomics as a tool for decision support, providing decision-makers, relevant and reliable information in order to create from them a clear understanding of the situation and the possibility of taking appropriate optimal solutions. Herewith, wide opportunities of pharmacoeconomics are based on the application of pharmacoeconomic modeling. In this connection, the authors, based on their own practical experience create a domestic and adapted foreign foreign pharmacoeconomic models, set out the methodological basis of pharmacoeconomic modeling in this article in the form in which they meet the requirements and demands imposed by owners, using the results of pharmacoeconomic evaluations in the modern system of medicine provision in the Russian Federation

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. 879

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.

Serpik V.G., Yagudina R.I. 790

Cost analysis is an essential step of pharmacoeconomic research. It is the basis for carrying out special methods of pharmacoeconomic analysis: “cost-effectiveness” and “budget impact”. This article deals with methodological basis of cost analysis in pharmacoeconomic studies. In particular, the authors describe the classification of costs and various methods of their calculation. In the publication the attention is paid to sourcing prices and cost structure in conducting pharmacoeconomic studies. Thus, the possibilities and limitations of using different types of prices depending on the position of pharmacoeconomic studies. The advantages and disadvantages of cost analysis based on standards of medical care, clinical and statistical groups and evaluation of real clinical practice are also described. The article deals with the features that must be considered when calculating direct and indirect costs. The authors list the problems of accounting the intangible costs.

Ugrekhelidze D.T., Yagudina R.I. 521

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.

Novikov I.V., Yagudina R.I. 455

Retrospective analysis of using fixed combinations of metformine and glibenclamide against separate scheme was carried out using the following methods: “cost-effectiveness”, “budget impact” and “sensitivity analysis”. For assessment of long-term impact of the compared methods of therapy on the results of the cost-effectiveness analysis, in terms of QALYs, and cost analysis, a Markov model with a 20-year model horizon was used. The compared alternatives were a fixed dose combination (FDC)of metformin and glibenclamide (Glucovance) and non-fixed dose combinations (nFDC) of glibenclamide (Maninil) and each of the three generics of metformin, consumption of which took a leading position in consumption in the Russian Federation (Siofor, Metformin-Richter and Formetine). The effectiveness analysis showed that the total QALY for 20 years made 6.7121 and 6.2416 for the therapy with metformin FDC and nFDC respectively. And the cumulative cost made 2,512 thousand roubles, 2,687 thousand roubles, 2,690 thousand roubles and 2,696 thousand roubles for the therapy with Glucovance and combinations of Maninil and Formetine, Metformin-Richter and Siofor respectively.

Molchanova N.B., Yagudina R.I. 366

Hemophilia is one of the rare, socially significant, hereditary diseases drug supply of which centralized in the framework of the program “7 nosologies” at the expense of the Federal budget. According to IMS Health, in 2015 the consumption of medicinal drugs used in the treatment of hemophilia reached 11.2 billion RUB that shows an increase of 16.9% compared to 2010. The main drivers of market growth have become the primarily raising awareness of the disease and the increase in diagnosis led to growth of the patient population as a whole, as well as understanding of the need for effective and quality care that led to a rise of the prescription of the preventive therapy, in which a comparably larger consumption of the medicines for the patient leads to a significant improvement in outcomes and safety of patients. The improving of the quality of medical care is also implemented through the inclusion into the program of modern recombinant medicines, possessing the best safety profile in comparison to the medicines obtained from the plasma of donated blood. Every year the budgetary allocation for the treatment of high-cost nosology in general and for hemophilia increases, that indicates the primary focus of health aimed for improving of the quality of life of patients.

Serpik V.G., Yagudina R.I. 165

The limited financing of the program of pharmacological support of high-cost nosologies emphasizes the importance of more effective use of the available resources. In order to improve the efficiency of use of the available resources of pharmacological support of inhibitor hemophilia patients receiving therapy in the prophylactic regimen, a budget impact analysis of prophylactic treatment by BPA anti-inhibitor coagulant complex and eptacog alfa [activated] was performed. In accordance with the instructions for use of eptacog alfa, this medicinal product is not indicated for long-term preventive treatment of bleedings, however, as eptacog alfa is used in the said regimen, it was included in the analysis. The analysis horizon period made 1 year and 75 patients were included in the analysis. The analysis shows that prophylactic anti-inhibitor coagulant complex therapy offers better control over the disease and reduces the costs. The incidence of bleedings in prophylactic anti-inhibitor coagulant complex therapy is reduced by 72.5%, while the incidence of bleedings in prophylactic treatment by eptacog alfa is reduced by 59% as compared to on demand therapy. The annual costs of prophylactic anti-inhibitor coagulant complex therapy per patient make 58.8 million rub (per adult patient) and 23.5 million rub (per pediatric patient), while the annual costs of bleeding prophylactic eptacog alfa treatment proved to be higher by 37.4% and made 94 million rub per adult patient and 37.6 million rub for pediatric patient. Transfer of all patients who respond to anti-inhibitor coagulant complex therapy and receive therapy with this medicinal product in prophylaxis regimen will save 765 million rub or 17.3% of the budget, provided that the current distribution of patients is preserved. Thus, the budget impact analysis demonstrates that the transfer of patients receiving therapy with eptacog alfa in prophylaxis regimen to AICC will improve the control over disease and save the budget funds under the 7N Program.

Kulikov A.Y., Tishchenko D.G., Yagudina R.I. 199

Pharmacoeconomic analysis of long-term effects of more widespread use of in vitro fertilization (IVF) in infertility treatment at the regional and federal level from the standpoint of society in the Russian Federation was carried out in this research. The research was performed by means of forecasting of future monetary flows produced by a human born with the aid of in vitro fertilization throughout life. The methods of cost analysis, discounted monetary flows, age shifting and model building were used in the research. The result is that net present value (NPV) of tax payments produced within anticipated life period by the human born with of IVF in the Russian Federation was equal to 822,258 rubles. Return on investments (ROI) was 27%. Net present value (NPV) of GDP produced within the state per one human born with the aid of IVF in the Russian Federation was equal to 34.9 million rubles. Return on investments (ROI) was 985%. Additional carrying out of 24,450 IVF cycles on the basis of OMI CMI (Obligatory Medical Insurance) (the level of 2013) results in increase of total growth of population of the Russian Federation by 22.5%, annual additional carrying out of IVF procedure in the quantity carried out in 2013 will allow to produce additional population growth by 2075 estimated at 319 thousand people in productive age, and 222 thousand people aged up to 20 years.

Ugrekhelidze D.T., Yagudina R.I. 161

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., Yagudina R.I. 305

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.

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