Aim: to assess the socio-economic burden of smoking in the Russian Federation for 2017.

Materials and methods. The socio-economic burden was calculated and extrapolated to the entire population of smokers in Russia and then compared with equal sized populations of quitters and non-smokers.

Results. In 2017, the burden of tobacco smoking (including the direct costs of medical care and payment for temporary disability, as well as indirect costs - the under-received gross domestic product (GDP) due to temporary disability) was 510.6 billion rubles. The difference between the smokers and the equal-sized non-smoking population is 327.6 billion rubles. The difference between the smokers and the equalsized population of quitters was 216.1 billion rubles.

Conclusion. Costs associated with smoking are sizable. Helping quit tobacco smoking (government anti-smoking measures, pharmacotherapy etc.) will not only improve the quality of life and health expectancy of smokers but also save a considerable amount of budget funds.

Aim: to assess the economic outcomes of using ceftazidime + avibactam (compared with the recommended treatments) in adult patients with sepsis caused by carbapenem-resistant enterobacteria.

Methods. The economic assessment was made using the cost-effectiveness analysis and budget impact analysis. The cost-effectiveness and budget impact analyses were performed using the Microsoft Excel software.

Results. The treatment efficacy analysis showed that patients treated with the fixed-dose combination ceftazidime + avibactam had fewer days spent in the ICU and higher clinical cure rates than patients receiving the reference drug combinations (8 vs 18 days and 75% vs 34.8%, respectively, p=0.031). The cost of treatment with ceftazidime + avibactam amounted to 228.3 thousand rubles, which was lower than the cost of using the alternative treatment regimens by 34.5-229.5 thousand rubles or 13.12-50.14%. According to the cost-effectiveness analysis, the use of ceftazidime + avibactam is pharmacoeconomically effective as it reduces the cost of patient clinical cure case by 61-72% (depending on the treatment regimen used); in addition, the ceftazidime + avibactam allows for managing the hospitalized patient at a cost lower by 76270 thousand rubles or 16-40% than the compared treatment. The median economic benefit from using the fixed dose combination ceftazidime + avibactam is 154 thousand rubles (28% savings compared with the current practice). The budget impact analysis showed that the reduction in the health budget burden would reach 29% or 34.3 million rubles in year. The sensitivity analysis confirmed the above results.

Conclusion. Based on the obtained results, we conclude that the ceftazidime + avibactam combination in patients with sepsis caused by carbapenem-resistant bacteria is economically preferable as compared with the current antibiotic therapy regimens.

The Eurasian Economic Union (EAEU) is an international organization for regional economic integration, established by the Treaty on the Eurasian Economic Union, which currently includes 5 countries - Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan. The EAEU ensures the freedom of goods movement, as well as services, capital and labor, conducting a coordinated, agreed/unified economic policy. The current practice of pharmacovigilance in the EAEU is of interest to potential foreign investors and market players.

The aim of this study was to analyze the recent changes in pharmacovigilance in the EAEU countries in order to adopt the strategy of the pharmaceutical industry players.

Materials and methods. The regulatory base of pharmacovigilance in the EAEU countries and the unified EAEU provisions on adverse reactions (ADR) were analyzed. A critical analysis of the current periodic safety update reports (PSUR) and risk management plans (RMP) was also carried out.

Results. The united EAEU drug market is a complex system that incorporates 35 regulations, including the variety of good practice guidelines regarding the circulation of medicinal products (GMP, GCP, GLP, GDP, and GVP). This group of regulations contains basic documents on the inspection of production lines, the assessment of generic equivalence, the development of biological drugs, and the pharmacovigilance (PV). Currently, the ADR reporting in the EAEU countries is at a level lower than that in Russia. The common EAEU database of identified ADRs has been already initiated, but the number of incoming signals is quite small. The most common flaws of the PSUR are the late reports, the incorrect format and contents of those; the inconsistent information about the product, different from that of Roszdravnadzor, the discrepancy between the Patients information leaflet (“Instruction for medical use”) and the Summary of Product Characteristics (SmPC), and the lack of important and relevant scientific and clinical information. In the EAEU, the submission of Risk Management Plan (RMP) as part of the registration dossier is required for any new medication (New Chemical Entity), including a new combination of drugs. The present article also covers other updates in the Pharmacovigilance system, regulated by the Good Pharmacovigilance practice, which entered into effect on 01.01.2017, as well as the updated tasks for harmonization within the EAEU.

Conclusions. The medicinal products circulating in the EAEU have to be checked for their efficacy and safety in order to identify possible negative consequences and/or individual patient intolerance. This information will serve to warn the medical staff and patients, veterinary specialists and animal owners about potential hazards of using these products. In the near future, the Eurasian Union plans to launch a “sanitation” campaign in the pharmaceutical market and get rid of low-effective and unsafe drugs. In this respect, the issues of pharmacovigilance become particularly relevant.

The subject of this article is the obvious crisis of evidence-based medicine in the 21st century. As a typical example of a contemporary “evidence-based study”, here we analyze in detail a text published in 2018 in the Cochrane Database Syst Rev journal under the code number “CD00317F. The authors claim that ω -3 polyunsaturated fatty acids (PUFAs) are not effective either for the prevention of cardiovascular mortality or for any other outcomes mentioned by the authors. A detailed analysis of this text, however, pointed to gross violations of data collection and processing. By using modern mathematical methods for big data analysis we were able to demonstrate clearly that the authors of the text CD003177 used clinically heterogeneous cohorts of patients. We then selected a subsample of 19 clinically homogeneous studies (total of 64771 patients) and conducted a meta-analysis of this data. According to the results, an increase in consumption of ω -3 PUFA -eicosapentaenoic (EPA) and docosahexaenoic (DHA) acids - by 1 g/day was associated with a significant decrease in the risk of mortality by an average of 5% (OR - 0.945, 95% CI - 0.907-1.008; P=0.054). This meta-analysis was based on the modified clinical, laboratory and anthropometric criteria in the selected studies. In addition, we used the most important characteristics of ω -3 PUFAs pharmaceutical forms and the modern statistical analysis of biomedical data. With the above modifications, we managed to select a homogeneous subsample of clinically relevant studies. We also applied methods of sentiment analysis to demonstrate a subjective approach used by the above authors regarding the role of PUFAs in the prevention of cardiovascular morbidity. Using the language of today social media, some adepts of evidence-based medicine implement propaganda techniques to literally “repress” ω -3 PUFAs.

Since generics and biosimilars have entered the Russian market of medications, there are new trends in the general picture of drug prices and consumption. In the present study, we analyze these trends to enable the prediction of possible savings or redistribution of funds in the area of anticancer drug supply, with a special view on highly expensive medications.

The aim of this study is to identify changes in the market prices and consumption of medications for the treatment of solid tumors.

Materials and methods. We analyzed the dynamics of prices and consumption rates of eight international non-proprietary names (INN) of anticancer drugs, whose generics or biosimilars entered the Russian pharmaceutical market in 2010-2018.

Results. With an overall downward trend in prices, differences between individual drugs become apparent with time of joint circulation in the market. The rates of increase/decrease in the prices of the reference drugs that circulate together with generics/biosimilars for at least 4 years, have changed from -50 to +22%; for the respective generics/biosimilars, the figures ranged from -35 to -69%. After generics/biosimilars have entered the market in the Russian Federations, the consumption of the INNs have been increasing, but again with different paces for different drugs.

Conclusion. With a general downward trend in prices and an increase in consumption of anticancer medications, there are significant differences in this dynamics as far as individual INNs are concerned. Additional studies are needed to identify factors having an impact on the prices and drug consumption of INNs after their generics/biosimilars have become available. For example, the number of original drugs with expired patent protection may be important. Without a good understanding of such factors, it is difficult to predict the size of savings and the possibility of their redistribution within the budget framework.

Aim - based on the existing regulations and recent documents from the regulatory bodies, determine the methodology for the development of clinical guidelines (CG) that meet the requirements of the legislation in the Russian Federation.

Materials and methods. We analyzed a number of regulatory and subordinate acts confirming the concept and status of the CG, in particular, the Federal Law № 323-ФЗ “On the principles of health care for citizens of the Russian Federation”, Federal Law № 489-ФЗ “On the amendments to article 40 of the Federal Law “On compulsory medical insurance in the Russian Federation” and the Federal Law “On the principles of health care for citizens of the Russian Federation” concerning clinical guidelines, Order № 102н of the Ministry of Health of the Russian Federation dated 28 Feb 2019 “Regulations on the scientific and practical council of the Ministry of Health of Russia” and Order № 103н of the Ministry of Health of the Russian Federation of 28 Feb 2019 “On Approval of the procedure and terms for the development of clinical guidelines and their revision, the model format of clinical guidelines and requirements to their structure, contents and scientific validity of the information included in the clinical guidelines”. In addition, we used the documents of regulatory bodies of the Russian Federation, expert opinions from medical professionals and non-profit organizations as well as leading opinions from public sources.

Results. Order № 102н of the Ministry of Health of the Russian Federation secured the right of the scientific and practical council to consider and decide on the CG. Order № 103н of the Ministry of Health of the Russian Federation approved the procedure and deadlines for the development/revision of the CG; the typical format of CG; the requirements for the structure of CG, its contents and scientific validity of the information included in the CG. A step-by-step algorithm was created for the procedure and timing of CG development and update; the above documents elaborate on the requirements to the structure of CG, the contents and scientific validity of the information included. There are also comments on the development and design of each CG section (title page, table of contents, list of abbreviations, terms and definitions, brief information on the disease, diagnosis, treatment, medical rehabilitation, prevention and follow-up care, organization of medical care, additional information, criteria for assessing the quality of medical care, list of references, composition of the working group on the development and revision of the CG, methodology of the development of the CG, reference materials, algorithms for doctor’s actions, patient information, assessment scales, questionnaires, and other patient assessment tools). The recently adopted requirements for CG registration are compared with the previous methodological recommendations of the regulatory bodies.

Discussion. The unification of treatment strategies and the use of evidence-based reasoning in the updated CG will improve the quality of medical care and have a positive impact on the medical insurance segment and the judicial decisions. However, the presented concept of CG has attracted a number of critical comments from representatives of the medical community and medical lawyers. For example, the updated regulatory acts do not specify the deadlines and algorithms for updating the CG; these acts do not address the coordination between various medical non-profit organizations although such coordination is needed to avoid work duplication; the acts determine no specific resources required for the CG development (the latter flaw may have a negative impact on the quality and timing of the resulting CG). Some experts believe that it would be advisable to implement the system called GRADE. In addition, possible legal risks are analyzed in light of the fact that the CG are not regulatory legal documents.

Conclusion. Periodic improvements in the CG renewing and approving procedure are an integral part of this large-scale process that introduces changes in the regulatory framework and clinical practice. Compulsory adherence to the CG is a due element of today’s high quality medical care.

Aim: analyze the structure and funding of health technology assessment (HTA) agencies abroad.

Materials and methods. Here, we review the organizational structure and funding of HTA agencies in Europe (Austria, Belgium, Germany, Ireland, the Netherlands, the United Kingdom, France, and Sweden), Canada and Australia. The relevant information was found on web-sites of HTA agencies, in the Medline database, and via the searching engines Yandex and Google; the search was conducted using the specific descriptors: «organizational structure of HTA agency», «funding of HTA agency», «pharmaceutical», «reimbursement», «healthcare decision-making», and «funding».

Results. The identified HTA-agencies may have a status of either government-funded or nonprofit organization or a structural element of a governmental body. These hTa agencies are funded mainly from the national budget. The funding varies from €550 000 for Ireland to £63.1 mln (€70 million) for the National Institute for Clinical Excellence (NICE) in the UK. The number of employees in the reviewed HTA agencies varies from 6.8 full time employees (FTE) in the Health Information and Quality Authority (HIQA) in Ireland to 604 FTEs in the NICE.

The Italian healthcare system is historically structured by the difference in economic development between the northern and southern parts of this country. The Italian Medicines Agency (AIFA) is the national health technology assessment (HTA) authority in charge of the reimbursement and formulary-listing. Some regions have established their own HTA institutions to define the reimbursement policy for a specific region or organization. Because of that, the entire HTA system in Italy can be characterized by low inter-regional coherence and insufficient coordination. As a result, the access to medical services is not unified at the regional level; in addition, it is difficult to collect and analyze the data required for providing value-based healthcare. Although the cost-effectiveness of specific health technologies is taken into consideration for decision-making, in practice, the main focus rests on the budget impact and cost control. Along with that, the AIFA holds the leading positions in Europe in using such innovative approaches as the patient access schemes, early HTA and horizon scanning.