The aim – assess the clinical advantages and economic burden of various treatment strategies in patients with hemophilia A in the Russian Federation and propose the ways of optimizing this area of medical care.

Materials and methods. A mathematical model describing the current (2017) approach to therapy of hemophilia A in the RF and two additional treatment scenarios are proposed. A partial switch of patients from the “therapy on demand” to the standard and personalized preventive therapy was also simulated. Based on this mathematical model, the treatment outcomes, the costs of outpatient, hospital and social care were evaluated for the treatment of hemophilia A and its complication; a cost-effectiveness analysis was also performed.

Results. Published reports demonstrated a high efficacy of preventive therapy with replacement of coagulation factors VIII in comparison with therapy on demand in the treatment of hemophilia A. Segmentation of the current population of patients with hemophilia A in the RF revealed that the on-demand therapy is the most common approach in adult patients (64%), whereas the standard prophylaxis is used in most children (80%). As calculated, under the current treatment approach, the total number of bleedings is about 58,710 per year, and the number of potentially targeted joints – 3,409 in adults; the figures for children are 3, 817 and 213, respectively. The application of scenario 1 allows for a significant reduction in negative outcomes: i.e. by 62.1% and 62.4% for the risk of bleedings and targeted joints (respectively) in adults if the prevention strategy is increased to 80%; and by 44.2% and 46.2% in children if the prevention is increased to 100%. Simulated scenario 2 allows for achieving even more significant results – a reduction in the number of bleedings and targeted joints by 62.4 and 62.7% in adults and by 47.9 and 50% in children. Transition to simulated scenarios in most cases requires an increase in the overall budget expenses, and also implies a reshuffle of the expenses between different items. For example, increasing the share of prevention therapy leads to increased expenses for the replacement pharmacotherapy in parallel to a reduction in expenses associated with negative outcomes of the disease (endoprosthetics, disability, etc.). In the next 50 years, in terms of the costs, the difference between scenarios 1 and 2, on the one hand, and the current therapy, on the other, is expected to decrease from 26 to 17% and from 26 to 15%, respectively, due to the reduced cost of temporary disability, treatment of bleeding and replacement / re-replacement of joints. According to the "cost-effectiveness" analysis, the best-fit therapy regimen is scenario 2 (personalized prophylaxis), whereas the "current therapy" scenario is the least effective. Based on the ICER analysis, the additional expenses associated with a wider use of preventive therapy in scenarios 1 and 2 do not exceed one GDP per capita, and the technologies are cost-effective.

Conclusion. In both clinical and economic aspects, the most effective method of treating severe and moderate haemophilia A is preventive therapy with coagulation factor VIII. Expanding this approach will improve the quality of medical care for patients with hemophilia A.

Objective. In this review, we analyzed the policies for price controls on generics and biosimilars in the European Union.

Materials and methods. We conducted a literature review regarding government price controls on generics and biosimilars in 28 EU countries and in the Russian Federation.

Results. Most of the reviewed countries have policies controlling prices for generic drugs and employ the internal reference pricing. Prices are predominantly determined by setting a discount on the generic price as compared to the price of the original drug. In some countries, the price is set through free competition within the reference group of drugs. However, today’s control of biosimilar pricing in Europe is just building up. A number of countries have no defined procedure for pricing biosimilars, while others utilize the same mechanism as they use for generics, yet with a lower discount. In the Russian Federation, the price control policy is focused on promoting the development and manufacture of generics and biosimilars and, therefore, the discount is lower than the average discount level set in Europe.

The current approaches to the drug pricing commonly used worldwide allow for incorporating the therapeutic value of the drug into its consumer price. The drug pricing system existing in the Russian Federation restricts the availability of highly effective innovative drugs and leads to unnecessary expenses of the national budget. In this article, we propose a novel concept of price control relevant to Russia, which is based on the approaches used elsewhere.

Self-assessed health (SAH) is a widely used measure in public health research. The World Health Organization in 1996 recommended the use of SAH as one of the main indicators for monitoring the health and quality of life of the population. However, SAH is a subjective indicator and subject to bias stemming from individual characteristics and external factors. In this review paper, we classify self-reported health and the sources of potential bias in this measure which must be considered by academic researchers as well as in the evaluation and comparison of these indicators.

Objective. In this review, we analyzed the policies for price controls on generics and biosimilars in the European Union.

Materials and methods. We conducted a literature review regarding government price controls on generics and biosimilars in 28 EU countries and in the Russian Federation.

Results. Most of the reviewed countries have policies controlling prices for generic drugs and employ the internal reference pricing. Prices are predominantly determined by setting a discount on the generic price as compared to the price of the original drug. In some countries, the price is set through free competition within the reference group of drugs. However, today’s control of biosimilar pricing in Europe is just building up. A number of countries have no defined procedure for pricing biosimilars, while others utilize the same mechanism as they use for generics, yet with a lower discount. In the Russian Federation, the price control policy is focused on promoting the development and manufacture of generics and biosimilars and, therefore, the discount is lower than the average discount level set in Europe.

Since recently, a number of normative legal acts aimed at increasing the salaries of medical professionals in the Russian Federation have been implemented. As these decisions are not supported by increasing the financial bases of medical organizations, those institutions may develop the accounts payable status. Under these conditions, the efficient usage of hospital beds may bring a financial relief to these medical institutions. The present study addresses the assessment of bed usage and suggests a well-rationalized set of methods to evaluate and characterize the bed usage efficiency. The main indicators of this efficiency are: the number of beds, the bed turnover, the number of hospitalized patients, the average length of hospital stay per patient per year, and the average bed occupancy per year. In this study, we analyze the available data on the hospital bed usage taken from the annual statistical information published by the Ministry of Health of the Russian Federation. Using the method of chain substitutions we have found ways to improve the quality of medical services and reduce economic losses in medical organizations. Our results recommend implementing periodical analysis of the hospital bed usage both in general and in specialized clinics. The results also suggest mobilizing more reserves to increase the performance of hospital bed usage, mainly by increasing the bed occupancy in specialized round-the-clock hospitals. It is recommended to conduct a comparative analysis of the planned vs factual bed usage, to restructure the hospital setting with a possible change in the number of specialized beds, to optimize the routing of patients when providing primary medical care, as well as routing the patients when providing emergency service including emergency specialized medical care.

The paper examines the international experience of drug supply and the risks faced by countries using various systems of drug provision to the population in the outpatient settings. The option of introducing a system of drug supply or drug insurance with co-payment by outpatients is discussed.

According to the current legislation, the standards of medical care lay the ground for the development of a program on state guarantees (SGP) to deliver free medical care to the citizens. While this standard provides an opportunity for calculating the costs of implementing the SGP, the past experience indicates the need for changes to produce new standards that would consider the “completed treatment” factor. The article proposes approaches to updating the standards and improving the methodology of cost calculation. In addition, this analysis is expected to help optimize the cost of medical care in various clinical and statistical groups.