Serpik Vjacheslav Gennadievich

Serpik V.G., Yagudina R.I. 1799

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.

Kulikov A.Y., Serpik V.G., Yagudina R.I. 1745

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.

Abdrashitova G.T., Kotenko O.N., Serpik V.G., Yagudina R.I. 1738

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.

Serpik V.G. 1678

Summary: The pharmacoeconomic evaluation of the treatment of infectious bacterial conjunctivitis by the medicaments of fluoroquinolones: moxifloxacin (Vigamox), levofloxacin (Oftaquix, Signicef), ciproflaxacinum (Cipromed) and ofloxacin (Floksal) have been conducted in regards to the conditions of the Russian health care system. The results of analysis of the «cost-effectiveness» have shown that the medicament of moxifloxacin (Vigamox) is dominant over the comparator medicaments, requiring the least cost to achieve the successful treatment of bacterial conjunctivitis per patient. The «budget impact» analysis have illustrated that the replacement of the fluoroquinolone medicament of the II-III generation for the moxifloxacin (Vigamox) in the treatment of bacterial conjunctivitis is accompanied by cost savings. Keywords: pharmacoeconomic studies, infectious bacterial conjunctivitis, fluoroquinolones, moxifloxacin, levofloxacin, ciprofloxacin, ofloxacin, analysis of the «cost-benefit», “budget impact» analysis.

Serpik V.G., Sorokovikov I.V., Yagudina R.I. 1711

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. 1545

Budget impact analysis and cost-effectiveness analysis for the therapy of chronic myeloid leukemia (CML) by tyrosine kinase inhibitors were performed by means of a developed analytical model of decisionmaking. This analysis defined potential budget impact of nilotinib as the second-line therapy in the frame of drug reimbursement program for subjects with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher’s disease, tumors of the lymphoid, haemopoietic and related tissues, multiple sclerosis, as well as for patients subjects to organ (tissue) transplantation (hereafter reimbursement program for high-cost drugs). Budget impact analysis has shown that conversion from imatinib to nilotinib for all subjects with chronic myeloid leukemia (CML) in Russian Federation receiving second-line therapy, based on theoretic consumption, would lead to RUR 1.985 billion increase of the federal budget (compared to imatinib only). Taking into account the actual nilotinib consumption, budget of the Scenario 1 does not exceed the real cumulative amount for chronic myeloid leukemia (CML) treatment in the framework of the reimbursement program for high-cost drugs and regional subsidized drug lists. In addition, it was demonstrated that nilotinib compared to imatinib can be characterized as a strictly preferable drug from the costeffectiveness analysis point of view, as it has a lower cost - effectiveness ratio.

Abdrashitova G.T., Babiy V.V., Komarov E.A., Pochuprina A.A., Serpik V.G., Ugrekhelidze D.T. 1548

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. 1439

Orphan drugs designed for rare disease management is a special group of drugs from the perspective of the pharmacoeconomic analysis being a mandatory part of any proposal for inclusion in the Restrictive lists. Thanks to unique opportunities offered by orphan drugs for rare disease management through acting at the pathogenetic level, these drugs have high social significance. But inherently high cost of these innovative drugs associated with their narrow market limited due to small target population, precludes from using the conventional pharmacoeconomic approach which involves comparison of pharmacoeconomic indicators — results of cost-effectiveness and budget impact analyses — of the innovative drug vs. current medical treatment (or palliative treatment in case of no treatment option available). As such, the authors have investigated the special pharmacoeconomic approach — “precedential” — in case of ruxolitinib in treatment of primary myelofibrosis. This approach implies comparison of the studied drug vs. other orphan and high-cost medicinal products included in the National drug lists. As a result, it has been shown that the pharmacoeconomic indicators of ruxolitinib are not higher than the same of the drugs included in the Essential Drug List .

Kulikov A.Y., Serpik V.G. 1420

Pharmacoeconomic study comparing luteinizing hormonereleasing hormone agonists (LHRH-A), used for prostate cancer treatment was conducted. The study included drugs: buserelin, goserelin, triptorelin and leuprorelin. Pharmacoeconomic study included the following methods:cost analysis, cost-effectiveness analysis, cost minimization analysis and budget impact analysis. The time horizon for cost analysis, cost minimization analysis and budget impact analysis amounted to 1 year, whereas for costeffectiveness analysis it was equal to 6 months. Direct costs were taken into account. As a result, it was found that annual costs for the treatment of one patient for each of the considered drugs (buserelin, goserelin, triptorelin and leuprorelin) respectively accounted for 55 169 rubles, 90 130 rubles, 90 133 rubles и 94 599 rubles. Results of the budget impact analysis showed that the annual budget per patient using drug therapy buserelin, goserelin, triptorelin and leuprorelin respectively amounted to 129 545 rubles, 164 506 rubles, 164 509 rubles and 168 974 rubles. Cost minimization analysis demonstrated that under the assumption of equal clinical effectiveness review of medications, annual treatment of one patient using buserelin is characterized with 34 961 rubles compared with goserelin and 39 430 rubles compared with leuprorelin. Cost-effectiveness analysis using the criterion of decreasing the prostatespecific antigen (PSA) level, it was found that buserelin is characterized with the greatest rate of decrease in the PSA value, so it has the smallest value of the cost-effectiveness ratio and, thus, relative to the comparison drugs is strictly preferred drug.

Abdrashitova G.T., Serpik V.G., Yagudina R.I. 1296

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. 1286

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. 1166

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

Serpik V.G., Yagudina R.I. 1003

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.

Serpik V.G. 988

A pharmacoeconomic evaluation of follitropin alpha (Gonal-F®), follitropin beta (Puregon) and menotropin (Menopur) to stimulate ovulation during the in vitro fertilization procedure has been performed. The results of the effectiveness analysis demonstrated the superiority of follitropins over menotropin in terms of the number of oocytes obtained, occurrence of pregnancy and live birth, all three taken as effectiveness criteria. There were no data to support statistically significant differences in effectiveness between follitropin alpha and follitropin beta. In this connection the main method of pharmacoeconomic analysis to compare follitropin alpha and menotropin was the “cost-effectiveness” analysis while for pharmacoeconomic evaluation of follitropin alpha and follitropin beta the “cost-minimization” analysis was applied. The results of “cost-effectiveness” analysis has shown that follitropin alpha (Gonal-F®) is more cost-effective across all three above criteria compared to Menopur. The “cost-minimization” analysis has revealed that administration of Gonal-F® instead of Puregon enables to save on treatment between 1,973 rubles and 4,861 rubles. Therefore, from the pharmacoeconomic standpoint, Gonal-F® is characterized as a dominant (strictly preferable) drug for ovarian stimulation during assisted reproductive technology (ART) as compared to Menopur and Puregon.

Serpik V.G., Ugrekhelidze D.T. 959

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

Arinina E.E., Serpik V.G. 708

This article provides a comparative pharmacoeconomic evaluation of ambrisentan and bosentan used in the treatment of patients with functional class II or III pulmonary arterial hypertension (PAH) in Russia. The evaluation included methods of cost analysis, cost -minimization analysis, cost-utility analysis and budget impact analysis. The cost analysis revealed that the Volibris (ambrisentan) and Tracleer (bosentan) – associated costs, based on the per-patient per year treatment cost for one patient with PAH regardless of its functional class, were 1 585 649 rubles and 2 488 878 rubles, respectively. The results of cost-minimization analysis, based on the assumption of equal effectiveness of compared drugs, have shown that the per-patient per year treatment costs for Volibris (ambrisentan) allow cost savings of 909 789 rubles as compared to Tracleer (bosentan). The values of a cost-utility analysis for Volibris (ambrisentan) appeared to be lower than those for Tracleer (bosentan). For the former, depending on the functional class of the disease and drug dosage, the values of a cost-utility analysis varied from 2 321 771 rubles to 3 535 685 rubles per QALY, whereas for Tracleer (bosentan) the corresponding values were 4 335 477 rubles and 5 718 143 rubles per QALY in patients with functional class II PAH and functional class III PAH, respectively. The budget impact analysis, based on the estimated number of patients with PAH in RF of 3292 subjects, has shown that the total annual costs for Tracleer (bosentan) would be 8,193 billion rubles versus 5,219 billion rubles had the same patients been treated with Volibris (ambrisentan). Therefore, the possible cost savings with Volibris (ambrisentan) would be 2,973 billion rubles had it been used instead of Tracleer (bosentan), thus indicating that from the pharmacoeconomic perspective treatment with Volibris (ambrisentan) is a dominant choice.

Serpik V.G., Yagudina R.I. 441

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. 373

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.

Babiy V.V., Serpik V.G., Ugrekhelidze D.T., Yagudina R.I. 291

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.

Kulikov A.Y., Serpik V.G., Yagudina R.I. 1745

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. 1711

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. 1678

Summary: The pharmacoeconomic evaluation of the treatment of infectious bacterial conjunctivitis by the medicaments of fluoroquinolones: moxifloxacin (Vigamox), levofloxacin (Oftaquix, Signicef), ciproflaxacinum (Cipromed) and ofloxacin (Floksal) have been conducted in regards to the conditions of the Russian health care system. The results of analysis of the «cost-effectiveness» have shown that the medicament of moxifloxacin (Vigamox) is dominant over the comparator medicaments, requiring the least cost to achieve the successful treatment of bacterial conjunctivitis per patient. The «budget impact» analysis have illustrated that the replacement of the fluoroquinolone medicament of the II-III generation for the moxifloxacin (Vigamox) in the treatment of bacterial conjunctivitis is accompanied by cost savings. Keywords: pharmacoeconomic studies, infectious bacterial conjunctivitis, fluoroquinolones, moxifloxacin, levofloxacin, ciprofloxacin, ofloxacin, analysis of the «cost-benefit», “budget impact» analysis.

Serpik V.G., Yagudina R.I. 1799

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.

Abdrashitova G.T., Babiy V.V., Komarov E.A., Pochuprina A.A., Serpik V.G., Ugrekhelidze D.T. 1548

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

Abdrashitova G.T., Kotenko O.N., Serpik V.G., Yagudina R.I. 1738

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.

Kulikov A.Y., Serpik V.G. 1420

Pharmacoeconomic study comparing luteinizing hormonereleasing hormone agonists (LHRH-A), used for prostate cancer treatment was conducted. The study included drugs: buserelin, goserelin, triptorelin and leuprorelin. Pharmacoeconomic study included the following methods:cost analysis, cost-effectiveness analysis, cost minimization analysis and budget impact analysis. The time horizon for cost analysis, cost minimization analysis and budget impact analysis amounted to 1 year, whereas for costeffectiveness analysis it was equal to 6 months. Direct costs were taken into account. As a result, it was found that annual costs for the treatment of one patient for each of the considered drugs (buserelin, goserelin, triptorelin and leuprorelin) respectively accounted for 55 169 rubles, 90 130 rubles, 90 133 rubles и 94 599 rubles. Results of the budget impact analysis showed that the annual budget per patient using drug therapy buserelin, goserelin, triptorelin and leuprorelin respectively amounted to 129 545 rubles, 164 506 rubles, 164 509 rubles and 168 974 rubles. Cost minimization analysis demonstrated that under the assumption of equal clinical effectiveness review of medications, annual treatment of one patient using buserelin is characterized with 34 961 rubles compared with goserelin and 39 430 rubles compared with leuprorelin. Cost-effectiveness analysis using the criterion of decreasing the prostatespecific antigen (PSA) level, it was found that buserelin is characterized with the greatest rate of decrease in the PSA value, so it has the smallest value of the cost-effectiveness ratio and, thus, relative to the comparison drugs is strictly preferred drug.

Serpik V.G. 1545

Budget impact analysis and cost-effectiveness analysis for the therapy of chronic myeloid leukemia (CML) by tyrosine kinase inhibitors were performed by means of a developed analytical model of decisionmaking. This analysis defined potential budget impact of nilotinib as the second-line therapy in the frame of drug reimbursement program for subjects with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher’s disease, tumors of the lymphoid, haemopoietic and related tissues, multiple sclerosis, as well as for patients subjects to organ (tissue) transplantation (hereafter reimbursement program for high-cost drugs). Budget impact analysis has shown that conversion from imatinib to nilotinib for all subjects with chronic myeloid leukemia (CML) in Russian Federation receiving second-line therapy, based on theoretic consumption, would lead to RUR 1.985 billion increase of the federal budget (compared to imatinib only). Taking into account the actual nilotinib consumption, budget of the Scenario 1 does not exceed the real cumulative amount for chronic myeloid leukemia (CML) treatment in the framework of the reimbursement program for high-cost drugs and regional subsidized drug lists. In addition, it was demonstrated that nilotinib compared to imatinib can be characterized as a strictly preferable drug from the costeffectiveness analysis point of view, as it has a lower cost - effectiveness ratio.

Serpik V.G. 1439

Orphan drugs designed for rare disease management is a special group of drugs from the perspective of the pharmacoeconomic analysis being a mandatory part of any proposal for inclusion in the Restrictive lists. Thanks to unique opportunities offered by orphan drugs for rare disease management through acting at the pathogenetic level, these drugs have high social significance. But inherently high cost of these innovative drugs associated with their narrow market limited due to small target population, precludes from using the conventional pharmacoeconomic approach which involves comparison of pharmacoeconomic indicators — results of cost-effectiveness and budget impact analyses — of the innovative drug vs. current medical treatment (or palliative treatment in case of no treatment option available). As such, the authors have investigated the special pharmacoeconomic approach — “precedential” — in case of ruxolitinib in treatment of primary myelofibrosis. This approach implies comparison of the studied drug vs. other orphan and high-cost medicinal products included in the National drug lists. As a result, it has been shown that the pharmacoeconomic indicators of ruxolitinib are not higher than the same of the drugs included in the Essential Drug List .

Abdrashitova G.T., Serpik V.G., Yagudina R.I. 1296

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. 1286

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. 1166

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

Serpik V.G., Yagudina R.I. 1003

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.

Serpik V.G., Ugrekhelidze D.T. 959

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

Serpik V.G. 988

A pharmacoeconomic evaluation of follitropin alpha (Gonal-F®), follitropin beta (Puregon) and menotropin (Menopur) to stimulate ovulation during the in vitro fertilization procedure has been performed. The results of the effectiveness analysis demonstrated the superiority of follitropins over menotropin in terms of the number of oocytes obtained, occurrence of pregnancy and live birth, all three taken as effectiveness criteria. There were no data to support statistically significant differences in effectiveness between follitropin alpha and follitropin beta. In this connection the main method of pharmacoeconomic analysis to compare follitropin alpha and menotropin was the “cost-effectiveness” analysis while for pharmacoeconomic evaluation of follitropin alpha and follitropin beta the “cost-minimization” analysis was applied. The results of “cost-effectiveness” analysis has shown that follitropin alpha (Gonal-F®) is more cost-effective across all three above criteria compared to Menopur. The “cost-minimization” analysis has revealed that administration of Gonal-F® instead of Puregon enables to save on treatment between 1,973 rubles and 4,861 rubles. Therefore, from the pharmacoeconomic standpoint, Gonal-F® is characterized as a dominant (strictly preferable) drug for ovarian stimulation during assisted reproductive technology (ART) as compared to Menopur and Puregon.

Arinina E.E., Serpik V.G. 708

This article provides a comparative pharmacoeconomic evaluation of ambrisentan and bosentan used in the treatment of patients with functional class II or III pulmonary arterial hypertension (PAH) in Russia. The evaluation included methods of cost analysis, cost -minimization analysis, cost-utility analysis and budget impact analysis. The cost analysis revealed that the Volibris (ambrisentan) and Tracleer (bosentan) – associated costs, based on the per-patient per year treatment cost for one patient with PAH regardless of its functional class, were 1 585 649 rubles and 2 488 878 rubles, respectively. The results of cost-minimization analysis, based on the assumption of equal effectiveness of compared drugs, have shown that the per-patient per year treatment costs for Volibris (ambrisentan) allow cost savings of 909 789 rubles as compared to Tracleer (bosentan). The values of a cost-utility analysis for Volibris (ambrisentan) appeared to be lower than those for Tracleer (bosentan). For the former, depending on the functional class of the disease and drug dosage, the values of a cost-utility analysis varied from 2 321 771 rubles to 3 535 685 rubles per QALY, whereas for Tracleer (bosentan) the corresponding values were 4 335 477 rubles and 5 718 143 rubles per QALY in patients with functional class II PAH and functional class III PAH, respectively. The budget impact analysis, based on the estimated number of patients with PAH in RF of 3292 subjects, has shown that the total annual costs for Tracleer (bosentan) would be 8,193 billion rubles versus 5,219 billion rubles had the same patients been treated with Volibris (ambrisentan). Therefore, the possible cost savings with Volibris (ambrisentan) would be 2,973 billion rubles had it been used instead of Tracleer (bosentan), thus indicating that from the pharmacoeconomic perspective treatment with Volibris (ambrisentan) is a dominant choice.

Serpik V.G., Yagudina R.I. 373

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.

Serpik V.G., Yagudina R.I. 441

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.

Babiy V.V., Serpik V.G., Ugrekhelidze D.T., Yagudina R.I. 291

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.