Pharmacoeconomics: theory and practice
Monoclonal antibodies are monospecific in nature and are produced by B-lymphocytes that are cloning of the same cell with exclusive affinity and specificity for a single antigen epitope. Medicines based on monoclonal antibodies are the most common, high-tech, sold and promising segment of the domestic pharmaceutical market. The article considers the possibilities and possibilities of the market for new biosimilar drugs in the dosage form of lyophilisate. The purpose of the work is to study the potential opportunities for localizing the production in the Russian Federation of drugs based on monoclonal antibodies in the dosage form of lyophilisate. The search was carried out by international non-proprietary names (INN) and anatomical-therapeutic-chemical classification (ATC) codes. In the study, methods of marketing analysis and the method of statistical data processing were applied. A study of the market for medicinal products based on monoclonal antibodies in lyophilic form produced in the territory of the Russian Federation showed its significant growth over the period from 2016 to 2020. In monetary terms, production increased from 1.997 to 7589 billion rubles, which amounted to 20% and 45%, respectively. As a result of the analysis, it was found that as of March 2022, the patent protection period for the following INNs has expired: basiliximab, infliximab, omalizumab, trastuzumab. An analysis of the structure of the LP wound based on monoclonal antibodies was carried out. All drugs based on monoclonal antibodies are included in the list of vital and essential drugs, the pricing of which is regulated by the state. The absolute volume of state financing of drugs based on monoclonal antibodies increased from 9,928 to 16,801 million rubles from 2016 to 2020. The dynamics of sales of medicines based on monoclonal antibodies has been studied. There is an increase in sales in physical and monetary terms of localized drugs based on monoclonal antibodies in lyophilic form, however, the potential for localization remains significant. A portfolio of drugs based on monoclonal antibodies in the dosage form «lyophilisate» has been formed, promising for localization of production in the Russian Federation in terms of the criteria for the expiration of patent protection and the level of sales in the Russian Federation.
The main results of the analysis of the structure of consumption of infusion solutions in physical and cost terms in multidisciplinary medical organizations
Objective: to analyze the structure of consumption of infusion solutions in physical and cost terms in multidisciplinary medical organizations of the research base. Materials and methods: calculation of relative and average values, structural and functional analysis, system analysis, retrospective analysis, comparison method, correspondence. Results. As a result of the analysis of the structure of the consumption of infusion solutions by the main groups in multidisciplinary medical organizations of the research base, it was revealed that the largest share in the actual consumption of infusion solutions in kind are the groups of infusion solutions «Regulators of water-electrolyte and acid-base balances» and «Hemodynamic infusion solutions», which is explained by their significance for the provision of medical care in hospital conditions and the need for their appointment for a large number of patients of multidisciplinary medical organizations. As a result of the analysis of the structure of consumption of infusion solutions in value terms, we identified the main groups of infusion solutions that account for the greatest financial burden of multidisciplinary medical organizations of the research base, as well as the rating of the main groups of infusion solutions in the structure of consumption in value terms of multidisciplinary medical organizations. Conclusions. As a result of the analysis of the actual consumption of infusion solutions in kind, a significant predominance of the groups «Regulators of water-electrolyte and acid-base balances» and "Hemodynamic infusion solutions" was revealed. The analysis of the structure of infusion solutions consumption in value terms showed that the largest share in total infusion solutions consumption is also occupied by the groups of infusion solutions «Regulators of water-electrolyte and acid-base balances», "Other infusion solutions" and «infusion solutions for parenteral nutrition».
Comparative analysis of actual and normative consumption of infusion solutions in multidisciplinary medical organizations
Objective: to carry out a comparative analysis of the actual consumption of infusion solutions in multidisciplinary medical organizations and the quantities of infusion solutions calculated on the basis of the generated database to determine the need for infusion solutions of each specific multidisciplinary medical organization. Materials and methods: statistical reports, journals of the movement of medicines and prescribing lists of medical histories of patients examined by multidisciplinary medical organizations, as well as data on standards of medical care and clinical recommendations were used as research materials. In the course of the study, methods of retrospective analysis, comparison, correspondence, etc. were used. Results: a comparative analysis of the data on the actual consumption of infusion solutions and the projected need for infusion solutions in multidisciplinary medical organizations, calculated using the generated database to determine the need for infusion solutions, showed an excess (in some cases, significant) of the actual consumption of 0.9% sodium chloride and 5% dextrose solutions in all surveyed multidisciplinary medical organizations compared to with regulations, regulated standards of medical care and clinical recommendations. Conclusions: in order to optimize the provision of infusion solutions to multidisciplinary medical organizations and, accordingly, to increase the effective- ness of medical care, it is important to use data on the structure of patients of multidisciplinary medical organizations and the most common nosological forms, as well as regulatory and reference information on the drug provision of patients with the most common nosological forms of diseases when predicting the need.
In order to preserve the health of elderly patients, methodological approach- es to the pharmacoeconomic substantiation of the inclusion of drugs for the treatment of dyslipidemia in the list of vital and essential drugs (EDL) were adapted and an appropriate assessment of the drug of cholesterol absorption inhibition was carried out, which showed that from the point of view of the healthcare system, the presence of this drug in the list will have a positive effect: Impact on the budget by increasing the availability of this drug for patients and delaying the prescription of expensive drugs of the PCSK9 inhibitor class. From a clinical point of view, increasing the availability of cholesterol absorption inhibition drugs for patients when it is included in the list of essential drugs will ensure that the correct sequence of the therapeutic line is followed in the treatment of dyslipidemia.
OBJECTIVES. To assess the structure of spending the financial resources of hospital for the purchase of medicines for the treatment of patients with COVID-19 on North-Western State Medical University. I.I. Mechnikov for the period of reprofiling during 2020-2021. Also to conduct a comparative analysis with the costs of treating patients who received treatment in non-reprofiled units. Materials and methods. With the help of ABC/VEN and ATC/DDD analyzes, the consumption of drugs used to treat patients with COVID-19, as well as for non-repurposed units, was estimated. Results. An analysis was made of the consumption of medicines in a medical organization during the period of re-profiling a part of the bed fund for the treatment of patients with COVID-19 in 2020-2021. Based on the results of the assessment of the structure of drug consumption, a significant excess in drug supply (for various pharmacological subgroups) of patients with COVID-19 was revealed in comparison with patients who received treatment in non-reprofiled units. Conclusion. Treatment of patients with COVID-19, subject to the methodological recommendations of the Ministry of Health for the diagnosis and treatment of a new coronavirus infection, is quite financially burdensome for a hospital. Given the shortage of drugs on the market in the conditions of the whole country at the beginning of the COVID-19 pandemic, some purchased drugs were almost completely used to treat patients of the Covid Center.