Yagudina Roza Ismailovna

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.

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.

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.

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.

This article presents a methodology for calculating QALY using questionnaires to study the quality of life of a patient. The review and classification of the most frequently used questionnaires of quality of life measurement validated to QALY are presented, their main features, advantages and disadvantages are highlighted. The main elements of universal questionnaires, as well as the stages of obtaining the utility index, are described in detail. In addition, alternative methods to obtaining health state utility values for generic questionnaires have been explored, using forecasting (mapping) based on data on other indicators of the patient’s health status.

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.

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.

Moscow State Medical University I.M. Sechenov (Sechenov University), Moscow, Russia

First Moscow State Medical University I.M. Sechenov (Sechenov University), Moscow, Russia

1 Clinical Trials and Healthcare Technology Assessment Centre of Moscow Department of Healthcare, Moscow, Russia 2 First Moscow State Medical University I.M. Sechenov (Sechenov University), Moscow, Russia

Moscow State Medical University I.M. Sechenov (Sechenov University), Moscow, Russia

The authors carried out a comparative analysis of the economic consequences of smoking in the Russian Federation (from 2009 to 2016). The calculations are carried out as direct costs the cost of economicburden of tobacco-related diseases) and indirect costs (losses due to premature disability, premature death, reduced productivity, damage from fires due to smoking). During the simulation it was determined that the total economic damage from smoking in 2016 amounted to 3.86 trillion rubles, which amounted to about 4.5% of GDP for the year. Compared to 2009, the economic burden of smoking has decreased by 16% (adjusted for inflation).

The fifth year in the system of state drug provision at the federal level, the Decree of the Government of the Russian Federation N871 of 08.28.2014 introduced the requirement of pharmacoeconomic evaluation of drugs when they are included in the lists of drugs. At the end of 2018, the second edition of this document was adopted and brought dramatic changes to the rules of pharmacoeconomic evaluation. This fact prompted us to conduct a comparative analysis of the old and new versions of the document from the point of view of pharmacoeconomics in order to retrospectively identify and systematize the shortcomings and advantages of the rules of pharmacoeconomic evaluation given by the original version of the document and prospectively determine to what extent the new version of the Russian Federation Resolution N871 of 28.08. 2014 (ed. From 10.29.2018) managed to overcome the identified problems and whether it contains any new contradictions. The adoption of the first edition of the Decree of the Government of the Russian Federation N871 of 08.28.2014 approved the mandatory status of pharmacoeconomic evaluation when including drugs in the lists. At the same time, practical experience in applying the developed rules for pharmacoeconomic evaluation revealed their imbalance: due to the minimum number of scores received by a drug according to the cost-effectiveness analysis, the probability of including innovative or even modern effective drugs in the lists was very small. The lack of clear requirements for the interpretation of the results of the cost-effectiveness analysis (and the incremental cost- effectiveness analysis), the conduct of the budget impact analysis and the selection of comparative drugs with an unbalanced integral scale led to pharmacoeconomic studies aimed at achieving positive pharmacoeconomic evaluation (preparation of the minimum required number of points on an integrated scale). The new version of the document largely corrected the lack of the first version of the rules, increasing the number of scores awarded by the cost-effectiveness analysis and introducing various scenarios of this analysis method, which undoubtedly should make the new rules more focused on the evaluation of innovative and effective drugs. At the same time, the “country-specific” methodology for assessing the results of the incremental cost-effectiveness analysis was included in the updated rules. It can be predicted with high probability that an insufficiently complete and accurate description of it in Government Decree N871 of August 28, 2014 (as amended on 10.29.2018) will cause discrepancies in the integral scoring of this type of analysis, creating difficulties for all participants in the listing process: for customers of pharmacoeconomic evaluations, researchers, as well as expert organizations. Attention is drawn to the contradictions that arise when evaluating drugs according to the “cost minimization” analysis scenario, in which the required minimum passing score does not provide for the very fact of cost savings on the considered drug, but only the condition that the savings will exceed 20%. Unfortunately, the new version of the document did not solve the problem of the validity of the used gradation of the integral score scale, and moreover, this problem was increased, violating the logic of interpretation of the results of the cost-effectiveness analysis and the cost-effectiveness incremental analysis.

Possessing a high prevalence and disability, psoriatic arthritis (PsA) is a serious socio-economic burden for the patient and for society. Therefore, the choice of the PsA treatment strategy requires focusing on not only the prevention and control of the disease but also the effective allocation of the available resources of the healthcare system. Objective. In this regard, the purpose of this study was to conduct a comparative pharmacoeconomic evaluation of biologics: secukinumab (Cosentyx), golimumab (Simponi®), certolizumab pegol (Cimzia®), Ustekinumab (Stelara®), adalimumab (Humira®), etanercept (Enbrel®) and infliximab (Remicade®, Flammegis®, Infliximab produced by local BIOCAD company). Materials and methods. Based on data on the effectiveness of compared treatment regimens, data on the cost of drugs and medical services, as well as the frequency of their provision, an analysis of direct costs, cost-effectiveness analysis, as well as budget impact analysis were carried out. Results. The cost analysis educed that the amount of direct costs for treatment with secukinumab 150 mg for ‘biologic-naive’ patients with active PsA is on average 28% and 40% lower than the cost of treatment with certolizumab pegol, golimumab, ustekinumab, adalimumab, etanercept and infliximab in the first and subsequent years of therapy, in accordance. Estimation of costs and efficacy showed that treatment of PsA with secukinumab 150 mg is characterized by lower costs per unit of effectiveness (ACR 20/50/70 response), relative to the indicators of the compared drugs in the first and subsequent years of therapy. The assumed prescription of secukinumab instead of certolizumab pegol, golimumab, ustekinumab, adalimumab, etanercept, and infliximab (including biosimilar) 19% of patients with active PsA leads to budget savings of 468 million rubles and 1.5 billion rubles for the first and three years of treatment, in accordance, on the calculated patient population. Conclusion. According to the results of the study, the pharmacoeconomic feasibility of using secukinumab 150 mg as a first-line line biologic for the treatment of active PsA has been established.

Infertility is successfully treated by IVF and ICSI methods. One of the most important stages in IVF protocol is control ovarian stimulation (COS). There are recombinant and menopausal drugs to develop and mature oocyte. In this article was compared the economic efficiency of follitropin-alpha+lutropin-alpha vs follitropin-alpa+menotropin vs menotropin based on cost-effectiveness, budget impact analysis. Folliropin-alpha+lutropin-alpha cost of treating per one patient estimate 51 520 rubles, menotropin – 49 104 rubles, follitropin- alpa+menotropin - 61 298 rubles. Cost-effectiveness analysis, provided on the number of retrieved oocytes, rate of implantation and rate of clinical pregnancy, shown that follitropin-alpha+lutropin-alpha is dominant therapy. According to the results of the budget impact analysis, the increasing use of follitropin- alpha+lutropin-alpha on the market to 51.5% will save 29.2 million rubles.

The article presents the concept of the development of the methodology of cost-effectiveness analysis. The classic cost-effectiveness analysis allows us to determine the cost per unit of efficiency of the technologies under consideration. If one of the technologies, which is characterized by the greatest efficiency, also has a minimum value of CER, then it is considered strictly preferable. The CER in this case reflects the cost of achieving the unit of efficiency on this technology. If the more expensive technology, which is more efficient, is also characterized by a large value of the cost-effectiveness ratio, then there is a need for an incremental cost-effectiveness analysis. Its result is a calculated incremental cost-effectiveness ratio (ICER), which reflects the additional cost of additional efficiency on a more efficient technology. Thus, the result of the incremental cost-effectiveness analysis directly depends on the choice of comparison technology, as well as the presence (or absence) of these alternatives on the market, and even the order of their registration in the country. The degree of acceptance by the health authorities of the notion of a “willingness to pay” threshold directly affects decisions made. In this regard, against the background of the registration of new innovative technologies, innovative approaches to their assessment are also required, which will adequately reflect in the assessment the factors of innovation and the increase in technology efficiency. This article presents the concept of the development of the cost- effectiveness analysis methodology with the transition to a new method of pharmacoeconomic evaluation - an analysis of the «relative value», which allows solving a number of methodological problems and making decisions under conditions of greater certainty.

In the pharmacoeconomic study, a comparative analysis of the insulin delivery was carried out: continuous subcutaneous insulin infusion (CSII) (using the Accu-Check Combo system as an example) in comparison with multiple daily injections (MDI) using pens in the treatment T1DM, as well as determining the economic consequences (cost-effectiveness analysis, impact budget analysis) of their application. This study was carried out by modeling with a time horizon of 15 years. As a result of the cost-effectiveness analysis, it was found that CSII is characterized by better efficiency (9,45 QALY), compared with MDI therapy patients with T1DM (8,70 QALY). The incremental cost-effectiveness ratio (ICER) is 1 100 503 rub / QALY, which is within the threshold of willingness to pay and, therefore, MDI is a cost-effectiveness analysis therapy. The switching from MDI therapy to CSII for the healthcare system requires additional funding of 54 749 rubles per year per patient and 821 228 rubles per patient for 15 years (excluding discounting).

In the first part of this publication, the methodology of analyzing the “cost of the disease”, the specifics of its calculation in the conditions of public health of the Russian Federation, various levels of research are considered in detail. The second part of the article is devoted to the presentation of the results of the first domestic study of the economic burden of multiple sclerosis, based on Russian data. The direct and indirect costs associated with multiple sclerosis were calculated. The results of the pharmacoeconomic analysis showed that the economic burden per patient per year depends on the form of the type of the underlying disease and amounts to 418,954 rubles for patients with a remitting type of flow, 556,150 rubles for patients with a returnable progressive type of flow with primary progressive course of multiple sclerosis. For the first time it has been shown that the ratio of direct and indirect costs for multiple sclerosis depends on the type of flow: with a remitting type of flow, direct costs prevail and they account for 65.7%, while for a backward-progressive and primary-progressive, a larger volume is occupied indirect costs, and they are 63.9% and 68.2%, respectively.

In recent years, due to the widespread use of pharmacoeconomic modeling for economic and decision analysis, the variety of pharmacoeconomic models has significantly increased, which from the point of view of methodology actualizes the problem of their systematization. The first step in solving this problem is to identify the key principles of a possible classification, for which, in turn, it is necessary to highlight and describe the interaction of the attributes of pharmacoeconomic models. In this article, the authors highlighted, grouped, and described 26 attributes of pharmacoeconomic models.

Over the past 20 years, a network of legislative acts has been introduces in Russia that regulates general aspects of conducting and specific approaches to application of the results of pharmacoeconomic researches. However, the system requires development. Most notably, further steps are legislative enshrinement of list of types of pharmacoeconomic analysis for assessment of health technologies, introduction of unified approach to assessing the methodological quality of the studies and establishment of a framework for assessment of the results.