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The article presents a description of amendments of the Russian Federation Government Decree No. 871 from August 28, 2014 (with amendments from November 20, 2018). The authors analyzed the historical development of approaches for complex drug assessment in Russia, also criteria for its evaluation were under investigation. The changes affecting both the order and the procedure of forming the lists of medical drugs for medical use are reviewed. The particularities of the current procedure for the formation of lists of drugs for medical use are described in detail. In reliance on the analysis, further direction for improvement/development of the system of formation the lists of medical drugs for medical use are educed (List of Vital and Essential Medicines, List of Medical Drugs for Certain Categories of Citizens, List of High-Cost Medical Drugs).

Aim. To assess the cost and importance of the vital and essential medicines for the treatment of 12 groups of internal diseases purchased in 2017 by the «key» medical organizations in the subjects of Russian Federation with the funding from the system of compulsory medical insurance.Material and methods. We conducted the ABC and VEN analysis of the medications (according to the list of vital and essential medicines and clinical guidelines) treatment of 12 groups of internal diseases purchased in 2017 by the «key» medical organizations in the subjects of Russian Federation.Results. The study revealed that medical organizations show insufficient level of registration (less than 10% of the key medical organizations) regarding the medicines prescribed in the groups of diseases according to ICD-10, which complicates conducting large-scale research aimed at assessing the clinical and economical relevance of the provided treatment. Despite the fact that during the process of purchasing by medical organizations they are guided by the list of vital and essential medicines, the percent of expenses for the medicines which are not in the list, is still very high (more than 20%). At the same time in most of the groups being assessed, in the most expensive group A (80% of expenses) there were the medications not included in the list of vital and essential medicines. Conclusion. Assessment of correspondence between the medicines purchased by the medical organizations and those recommended by the guidelines is complicated due to the absence of clinical guidelines for the wide range of internal diseases. According to the preliminary assessments, the wide range of medications mentioned in clinical guidelines compared to the list of vital and essential medicines significantly broaden the number of essential medicines from the point of VEN-analysis.

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.

The existing model of financial support of medical assistance for clinical-statistical groups (CSGs) in 2018 provides for the reimbursement for hospital stay expenses by the compulsory medical insurance fund in patients claiming the need for genetically engineered biological products (GiBP) during their stay in a day-care or 24-hour inpatient facility. The payment is made to CSG no. 121 in a day care and to CSG no. 316 in a 24-hour inpatient facility. The heterogeneity of the expenses for therapy with GiBP necessitates further division of the Federal CSGs into subgroups located in the constituent parts of the Russian Federation. This process has been initiated in some parts of the country, and it is seen as a way of regional adaptation of the Federal Medical insurance model. The proposed subdivision of the Federal CSGs allows for setting the tariffs reflecting the real expenses incurred by a local medical organization due to the therapeutic use of GiBP. The models of such specific CSGs proposed by RF subjects (after an expert evaluation) can be taken as a basis for updating the Federal CSG model, taking into account the differences in the costs of different drug therapy regimens.

The present report reviews various aspects of legal regulation, function, guidelines for creation and sources of finance pertaining to the restrictive lists of drugs, which play a substantial role in the drug supply policy in theRussian Federation. The following restrictive lists (currently in effect) are carefully analyzed: the list of VED, the list of medications supplied to certain population groups, the list of “7 medical conditions”, the minimum assortment, the lists of regional benefits, the lists of medicines to treat rare diseases, in accordance with the list of rare (orphan) diseases, the list of strategically important medications, the list of drugs allowed for tax deduction.

Objective. To examine approaches to organization and planning as well as expenditures of inpatient care in countries outside of Russia.Methods. A narrative review of published articles and legal documents was conducted. The review focused on health systems organization, planning volumes and costs associated with inpatient care in nine foreign countries (Germany, France, Denmark, Norway, Austria, Great Britain, Canada, Belarus and Kazakhstan) was conducted.Results. In all countries, there is a growth in health care costs both in monetary terms and as a percentage of GDP. The primary policy responses to expenditure growth have focused on outpatient pharmaceuticals, evaluation of medical technologies and reducing volumes of provided hospital care by providing assistance in day hospitals, outpatient or with home-visiting teams. In most countries, responsibility for the organization and planning of inpatient care rests with regional authorities. In all of countries, quality measures are regularly taken as a means to optimize or reduce numbers of beds, reduce hospital length of stay or increase turnover as a means to reduce transaction costs and costs of infrastructure maintenance. The main method of payment for acute care services is based on per case of treatment for a relevant group of diseases (diagnosis related group (DRG)). Planning of medical care in many of these countries is based on financial capacity and performance of previous years. Approaches to planning are typically part of political decision-making, developed at regional or municipal level, leading to variable approaches in health systems characterized by a federation of health regions.

Introduction. Extent and financial expenses for the delivery of health care in hospitals are planned within the framework of the annual approval of the Program of state guarantees of the free public delivery of health care (PSG), as well as of Territorial programs of state guarantees of the free public delivery of health care (TPSG). The research purpose is to carry out the comparative analysis of norms of extent and financial expenses for the unit of delivery of health care in hospitals, established at the federal and regional levels within the frameworks of PSG and TPSG in 2015. Materials and methods. Comparative analysis of norms of the delivery of health care in hospitals (norms of extent and financial expenses per extent unit), established by PSG and TPSG for 2015. The above regional norms have been analyzed in eight entities of the Russian Federation (Моscow, Saint-Petersburg, Stavropol region, Novosibirsk region, Khabarovsk region, Sverdlovsk region, Volgograd region, Nizhny Novgorod region), representing eight federal districts of the Russian Federation. Results. PSG and TPSG annually undergo changes, including those related to norms of the delivery of health care and extent of financial expenses, including the segment of hospital health care. During the last years, not only values of such indices have changed (reduction of norms of extent, as well as the growth of norms of financial expenditures per extent unit in hospital conditions), but also its measurement units (transition from bed days to hospitalization cases). The extent norm, established by PSG in 2015, was 0,193 case per one resident and 0,172 case per one insurant per year; the norm of financial expenses was 63 743,8 rubles and 22 233,1 rubles per one case of hospitalization at the expense of budgetary funds and of funds of the compulsory health insurance system accordingly. Entities of the Russian Federation establish, within TPSG frame works, norms of extent and financial expenses for the delivery of health care in hospitals. Actually, the values of such indices can differ from norms, established at the federal level. In this connection, the budgetary part of norm, not like the compulsory health insurance segment, can considerably differ from federal norms as to extent of health care and financial expenditures. Тhe territorial financial norm of the hospitalization case at the expense of compulsory health insurance funds was not lower than the federal norm in any of the analyzed entities of the Russian Federation.

study goal is to prepare a road map for development of price regulation system and system of drug supply at the expense of funds of the healthcare system of the Russian Federation.Study methodology. A structured interview was conducted which involved 11 experts - key participants of the drug price regulation process in the Russian Federation in order to identify current problems and proposals on system reformation; there were analyzed manufacturer’s prices limits, prices of public drug supply contracts, prices for 25 drugs for treatment of malignant neoplasms and cardiovascular diseases, included in the list of vital and essential drugs (VED list) at Russian pharmacies; a road map for development of price regulation system and system of drug supply out of funds of the healthcare system of the Russian Federation for 2015-2017 was prepared.Study results. According to the participants of a structured interview which are the representatives of the Ministry of Health, pharmaceutical companies, distributors and pharmacy organizations,the existing system of drug price regulation requires significant legislative and structural changes aimed at transition from the system of state regulation of prices on drugs from the VED list to the system of public drug supply (comprehensive drug reimbursement system) and reference pricing. The analysis of prices on drugs from the VED list revealed significant (up to 25-fold) price differences for drugs within a single INN, one pack size and one dosage form based on the review of information from all sources.Conclusion. According to the prepared road map, the fundamental changes in the existing system of drug price regulation and public drug supply out of funds of the healthcare system of the Russian Federation shall include the following: transition from the price registration according to the trade names to the registration of drug prices according to international nonproprietary names (reference price) and promulgation of this system for all drugs purchased at public expense; negotiated pricing for drugs, which have no analogues; legislative regulation and introduction of co-payment of the population in case of expansion of public financing programs of drug supply. The initial steps in preparation for the reform of the system should be as follows: transition of the pharmaceutical manufacturers to compliance with the requirements of GMP standards; monitoring of quality, efficacy and safety of drugs circulating on the Russian market with further cancellation of drug registration in case of inefficacy; development of the list of interchangeable drugs and the list of drugs financed out of funds of the healthcare system; pilot implementation of reference pricing for drugs under the current drug reimbursement system.

the article presents the results of cost calculation on the drug supply of the patients with orphan diseases, included in the list of orphan diseases (24 diseases) by the RF Government Regulation of April 26, 2012 № 403. Calculation was performed based on the data of registered patients with orphan diseases (OD) in 83 territorial entities of the Russian Federation in 2013 and based on the average-weighted costs of their drug therapy. Data on registered patients with OD was obtained because of the official request of the Expert Board on Healthcare of the Council of the Federation Committee on Social Policy that was sent to healthcare regulatory bodies of the 83 territorial entities of the Russian Federation. Average-weighted cost calculation of drug treatment (or of specialized nutrition care) of the patients with OD was carried out in accordance with medical care standards and expert assessment. As part of the analysis of the standards the search for pathogenic therapy medications was carried out, in the absence of which – there was a search for supportive care medications that critically affect survivability of the patients with OD. According to the selected list of drugs, information about duration, frequency of prescription, average daily and course dose, was analyzed. In the absence of medical care standards, and in order to verify some questions concerning drug therapy of patients with OD consultations with experts were held. Because of conducted calculation, total average-weighted costs of pharmacotherapy for 24 orphan diseases were 15.73 bln rubles per year (6.36 bln rubles for children and 9.37 bln rubles for adults) for 11 173 registered patients that by 3.3 exceeds current amount of finance. Pathogenetic pharmacotherapy of Mucopolysaccharidoses type VI and II proved to be the most expensive treatment per one patient per year: average-weighted costs per one child with Mucopolysaccharidoses type VI amounted to 40.90 mln rubles, per one adult – to 71.50 mln rubles; for Mucopolysaccharidoses type II costs were 29.60 and 51.83 mln rubles respectively. In order to increase effectiveness of the system of drug supply of the patients with OD and to optimize state expenses for this group of patients it is necessary to approve the entire range of financially balanced and science based medical care standards, to define the legal status of orphan drugs and to carry out state regulation of prices, to ensure increase of regional funding supported by involvement of federal budget funds, to define the list of orphan drugs, to implement state regulation measures to create incentives for pharmaceutical companies to reduce prices for orphan drugs.