Analisis of budget costs with different treatment efficiencies of newly diagnosed tuberculosis patients with multiple drug resistant pathogen

The article presents the results of predicting the dynamics of the spread of new cases of tuberculosis (TB) with multiple drug resistance (MDR) in the Republic of Karelia, as well as the costs of treating patients with tuberculosis, considering the different effectiveness of treatment. It has been demonstrated that while enhancing efficiency of treatment, due to the rapid determination of drug resistance by the method of polymerase chain reaction and a decrease in treatment gaps (using food kits), the effectiveness of treatment is significantly increased and the prevalence of MDR-TB decreases, which leads to significant budget savings.

Features of the development of the sphere of biomedical cell products in Russia

The successful development of the economy of a modern state is directly related to the entry into the market of new advanced therapy medicinal products. For Russia, the process of developing and implementing biomedical cell products will become the basis for the successful transformation of the pharmaceutical market into a knowledge-intensive market economy. Biomedical cell products can act as one of the main tools of such a promising and capital-intensive direction as regenerative medicine. The field of biomedical cell products therapy is developing rapidly, but there are still questions about the safe use of biomedical cell products therapy. The growing need for effective recommendations for the participants of the biomedical cell products market has determined the relevance of this study. Multivariate analysis of the prospects and barriers to the development of the biomedical cell products market to justify and develop recommendations for investors, pharmaceutical manufacturers and distributors for the production and sale of biomedical cell products in Russia. Materials and methods. The materials were regulatory legal documents of regulatory bodies: the USA, the EU, the Russian Federation, the EAEU, as well as analytical materials of open access. Results. A comparative analysis of the production features and the formation of the cost of autologous and allogeneic biomedical cell products revealed the ways of development of the biomedical cell products market. Further, the key directions of the prospective development of the biomedical cell products market were identified and characterized, risk factors, drivers and barriers were identified. Conclusion. In the direction of regulatory support: – create a general register for monitoring the results of research and the use of biomedical cell products. – to develop an information environment for comparing large sets of biomedical cell products life cycle data obtained from different sources; – to develop regulatory approaches to the circulation of biomedical cell products in the market. In the direction of technological support: – plan the implementation of automation of all stages of the production process; – to provide for the development of technology transfer methods; – to maintain the pharmaceutical quality system in an up-to-date functioning state; – implement a platform for training qualified personnel for this field. In the direction of marketing support: – to create logistics chain systems, with the help of integration technologies, capable of ensuring uninterrupted supply of biomedical cell products with minimal risks to the quality of the supply chain reliability; – supply planning should take into account the stability and storage conditions of the biomedical cell products; – scaling up production leads to a reduction in cost, and an increase in the use of biomedical cell products in routine medical practice leads to an increase in the present value; – conduct training of production employees, distributors and medical personnel. – develop a commercialization strategy for each biomedical cell products separately.

Validation of the pharmacoeconomic model of cost-effectiveness analysis of insulin degludec (Tresiba®) in comparison with the insulin glargine u300 in the treatment of type 2 diabetes mellitus in the Russian Federation

The global pharmacoeconomic model of cost-effectiveness analysis of insulin degludec (Tresiba®) use in comparison with insulin glargine U300 in the treatment of type 2 diabetes mellitus, was validated. As the result, it was found that the model is relevant to local clinical practice, fully complies with the pharmacoeconomics methodology, takes into account the entire spectrum of costs relevant for the pharmacoeconomic evaluation of insulin in Russia, and the computations built in it is correct. Based on the actual cost data entered, the model calculated the ICER of degludec insulin, which was 214,714 rubles, which does not exceed the sum of three GDP per capita – 2,184,562 rubles and corresponds to the willingness to pay threshold in the Russian Federation. Thus, the insulin degludec (Tresiba®) can be considered as cost-effective from the standpoint of the conducted pharmacoeconomic analysis.

SOCIOLOGICAL ASSESSMENT OF THE STUDY OF PATIENTS ‘ OPINIONS ABOUT THE DRUG SUPPLY SYSTEM IN RUSSIA

This article analyzes the results of a sociological survey, which con- firmed the relevance of the issues of accessibility of providing medicines to various categories of citizens. The purpose of this study was to study the attitude of citizens to the existing system, as well as to identify the strengths and weaknesses of preferential security. The main research methods were: the method of studying and generalizing experience; comparative analysis; sociological survey; statistical. According to the presented data, the distribution of answers to questions is determined in % depending on the total number of respondents, including in the dynamics for the analyzed period (2019-2021). This study served as a tool for studying the key problems in obtaining preferential medicines (waiting times for a doctor to issue a prescription, the absence of a prescription in a pharmacy, the refusal of a doctor to issue medicines, etc.). Thus, the results of the conducted sociological survey showed that the LAW system plays a significant role in the structure of healthcare. At the same time, first of all, it is necessary to carry out additional work with various age groups of the popu- lation in the framework of providing information about the possibilities of the additional preferential security system.

DRUG PROVISION MANAGEMENT TO PROVIDE BETTER ACCESS TO THE HIGH COST TREATMENT AND IMPROVE OUTCOMES — EXAMPLE OF MUCOPOLYSACCHARIDOSIS TYPE II

Aim: to conduct a comparative assessment of the efficacy and safety of ERT drugs in MPS II type patients and analyze drug provision organization for pa- tients with this nosology. Methods: to conduct a comparative assessment of the efficacy and safety of ERT drugs, clinical trials data and real clinical practice data, including data from the Hunter outcomes survey register, were used. To assess the drug pro- vision organization were analyzed the current legal framework of the Russian Federation and public procurement data. Results and discussions: provision of pathogenetic therapy to the patients with orphan diseases is attributed to a number of administrative, clinical and eco- nomic constraints. The best example of the management of provision of this patients in Russia is a so-called Federal Program of High-cost nosologies (HCN) that has clear and transparent state regulation and the patient register that is essential for budget planning. The example of mucopolysaccharidosis type II (MPS II) that was included in HCN in 2019 shows noticeable increase in pa- tients’ access to therapy when transferring from regional budgets. Two medical products – idursulfase and idursulfase beta – are available in Russia for life-time pathogenetic treatment of this nosology. These products are produced using different cell lines; they have different INNs and are not interchangeable. Both drugs have registration clinical research, however, unique real world evidence is available for idursulfase only and show the survival rate of the patients with MPS II collected during 15 years of maintaining the international patient register cov- ering more than 1,000 patients from 129 countries, including Russia. According to the analysis, mortality risk in the patients treated with idursulfase is lower by 54% than in those who received no treatment (HR 0.46, 95% CI: 0.29; 0.72). This evidence can be used by health care decision makers to prioritize value of this medicinal product from both clinical and pharmacoeconomic perspectives. Predictability of therapy outcomes and higher prescription frequency according to current standards of care justifies idursulfase as a first choice treatment.

REVIEW OF THE INTERNATIONAL CLASSIFICATION OF RARE DISEASES

The article describes the principles of the international classification of rare diseases, proposed by the organization Orphanet. The supranosological nature of rare diseases predetermined the task of developing their new classification, which is more convenient for coding in the framework of their treatment than ICD-11, but coordinated with it. For these purposes, the international organi- zation Orphanet, formed in France in 1997, together with WHO, is developing an additional classification of rare diseases with the assignment of each noso- logical unit its own unique code based on the collection of information and the formation of its own database of their nomenclature. The Orphanet nomencla- ture includes the following elements: a unique Orpha disease code, a common or most common disease name, synonymous disease names, keywords often used to search for a given disease, if any, and the disease definition itself.

PROBLEMS OF DOMESTIC PRODUCTION OF STRATEGICALLY SIGNIFICANT ANTI-RETROVIRAL DRUGS

Purpose. The aim of the study was to assess the problems of providing patients with HIV in the Russian Federation with antiviral drugs of the ATС group – J05AF (nucleosides and nucleotides - reverse transcriptase inhibitors) included in the list of strategically important drugs, and the prospects for its improvement. Materials and methods. The scientific research was carried out sequentially and included four interrelated stages. The objective of the first stage was to analyze the auctions for public procurement of antiretroviral drugs of the ATС- J05AF group for 6 INNs included in the list of strategically important drugs. The task of the second stage of the work was a comparative analysis of the dynamics of the range of antiretroviral drugs and substances for their production, registered in the Russian Federation, of the ATС group - J05AF by 6 INN. At the third stage, an analysis was made of the availability of interchangeable drugs for each INN. The objective of the fourth stage was to analyze the registered prices for domestic and foreign medicines for each INN. Results. It was found that by 2020 the share of domestic drugs was 63% of the planned 90%. In the Russian Federation, only 4 manufacturers in a limited range produce drugs for the treatment of HIV-infected patients. For individual INNs, domestic substances are completely absent, or are produced in insufficient quantities, which forces manufacturers to purchase pharmaceutical substances from the same enterprises, mainly in China and India. In the State Register of Medicines by 2020, for various INNs, interchangeable medicines appeared, the price of which does not differ statistically significantly, nevertheless, 91% of auctions in 2018 were held with a single supplier. Such a result of the auctions is difficult to explain, since the price of interchangeable drugs in the ATС - J05AF group does not differ statistically significantly between domestic and foreign manufacturers. Conclusion: In order to increase the level of import substitution of strategically important antiretroviral drugs, it is necessary, first of all, to solve the problem of providing Russian manufacturers with domestic pharmaceutical substances.

PHARMACOECONOMIC ANALYSIS IN PARENTERAL AND ENTERAL NUTRITION: METHODOLOGICAL FEATURES IN THE CONDITIONS OF RUSSIAN HEALTHCARE

The presence in Russia of legally approved rules for the pharmacoeconomic assessment of drugs when considering their inclusion in the lists of vital and essential drugs (reimbursement), as well as in the list of medical nutrition for children with disabilities, has features of pharmacoeconomic analysis of parenteral and enteral nutrition. Since parenteral and enteral nutrition can have different legal status - a drug (MP), biologically active additive (BAA) and even medical products, the rules for pharmacoeconomic assessment at the federal level will be different for them.

ASSORTMENT ANALYSIS OF MEDICAL DEVICES FOR MONITORING THE ACTIVITY OF THE CARDIOVASCULAR SYSTEM IN AN OUTPATIENT SETTING

atients with cardiovascular diseases need systematic monitoring of the main parameters of the cardiovascular system on an outpatient basis using special medical devices. The aim of the study is to conduct an assortment analysis of medical devices intended for use at home by patients with cardiovascular diseases. Materials and methods: The objects of the study were clinical recommendations for the treatment of diseases of the cardiovascular system (12); State Register of Medical Devices of the Russian Federation; Internet sites of pharmacy chains of the Republic of Tatarstan (5), sites of Internet pharmacies (1); data of the reference service “003” State Unitary Enterprise “Medical equipment and pharmacy of Tatarstan”. The work uses the methods of content analysis, logical, structural, graphic analysis. Price segmentation was carried out using the Sturgess grouping method. Results. An analysis of clinical guidelines for the prevention and treatment of diseases of the cardiovascular system was carried out to identify the main control parameters required on an outpatient basis. The groups of medical devices used by patients on their own have been determined: tonometers, pulse oximeters and diagnostic tests. The analysis of the State Register of Medical Products and Pharmacy Assortment of the Republic of Tatarstan was carried out in order to identify the availability of medical products to the population. Price segmentation of the studied groups of medical devices was carried out in order to determine consumer opportunities; the indicators of the completeness of the assortment were calculated. A wide range of tonometer models is presented in pharmacies of the Republic of Tatarstan. More than 60% of mechanical and automatic blood pressure monitors are in the low segment; the indicator of the completeness of the assortment Kp = 0.83, which allows satisfying the needs of patients. 50% of the assortment group “pulse oximeters” sold from pharmacies belongs to the low price segment; assortment completeness indicator Kp = 0.29. Diagnostic tests implemented in the Republic of Tatarstan are represented by express tests for the determination of ketones in blood and urine; assortment completeness indicator Kp = 0.31. The price segmentation of test systems is largely determined by the need to use additional instruments (analyzers). 75% of the total number of express tests presented on the pharmaceutical market of the Republic of Tatarstan belong to the middle price segment. Conclusions. As of March 2021, 950 medical devices used in the diagnosis and treatment of cardiovascular diseases were registered on the domestic market. At the same time, 22.6% can be used at home and are sold to the population by pharmacy organizations. For self-monitoring of indicators of the cardiovascular system on an outpatient basis, tonometers, test systems and heart rate monitors are used. Their share of the total number of registered medical devices used in the diagnosis and treatment of cardiovascular diseases is 17%. The price segmentation of the studied groups of medical devices indicates the availability of their purchase by customers with high and medium paying capacity. The prospects for expanding the range of medical products for independent use by patients with cardiovascular diseases in the regional pharmaceutical market have been identified.