FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology

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Vol 13, No 4 (2020)


329-336 540

The study aimed to perform a pharmacoeconomic analysis of antimicrobial drugs (AMDs) prescribed for the treatment of community-acquired pneumonia (CAP) in outpatient conditions.

Materials and methods. 650 medical histories of patients aged 18 to 65 years old with a diagnosis of CAP who received outpatient treatment in a larg Moscow municipal polyclinic in 2018-2019 were selected for pharmacoeconomic analysis. A model of antimicrobial drug consumption was built based on actual Algorithms of Patients’ Management endorsed by the Moscow Department of Healthcare (MDH) in 2018. The analysis of the used AMPs costs in real medical practice and the simulated situation was carried out. To process the obtained results, "Statistica 13.0" software was used

Results. The studied sampling of 650 medical histories included 386 (59.4%) women and 264 (40.6%) men with an average age of 39.8±16.8 years The average real clinical course cost of antimicrobial treatment calculated with a reference to the price and the percentage of total AMDs administered was worth 617.50 rubles. A comparison of the calculated average actual and simulated average AMDs course costs revealed that outpatient treatmen of CAP patients with adherence to the current MDH Algorithms would cost 394.13 rubles what would be 1.6 times more cost-effective than in the current practice.

Conclusions. A course of outpatient treatment of CAP with aminopenicillins and macrolides in accordance with the actual MDH Algorithms regarding the preferences of doctors when choosing antimicrobial drugs within groups would cost on average 394.13 rubles which makes it more cost-effective as compared to real practice expenses.

337-354 735

Introduction. Spinal muscular atrophies (SMA) are clinically and genetically heterogeneous congenital orphan diseases that lead to progressive spinal motoneurons degeneration and loss of their function. There are 4 types of SMA with type I being the most severe. SMA patients need lots of services (medical, social etc.) throughout their life and the cost of the care has never been calculated in Russia before.

Aim. The study aims to calculate the socio-economic burden of SMA in the Russian Federation for direct medical procedures and indirect costs before the introduction of pathogenetic therapy and after its implementation. The assessment of the impact of pathogenetic therapy on the dynamics of the socio-economic burden of SMA in the Russian Federation was performed.

Materials and methods. The data from patient-reported SMA registry, insurance medical companies, epidemiological, and rehabilitation care data were compiled into the model. The authors accounted for direct medical (diagnostics, drugs, surgery, orthopedics, rehabilitation, and family) and nonmedical expenditures including indirect (loss of GDP) costs. Characteristics of the patient population have been taken from the national SMA register. The sources of costs data included governmental healthcare and insurance companies’ tariffs, price lists of commercial companies, clinics, and laboratory services. The modeling time horizon was 5 years. The two following calculation scenarios were evaluated: 1) none of the patients with SMA receive pathogenic therapy 2) the share of pathogenic therapy is stable during the time horizon at the current level.

Results. National SMA register contains the information about 998 patients; 21% of them have SMA I type. In the first scenario, the total social-economic burden of SMA in Russia was 2.37 billion RUR/year (2.38 million RUR/patient/year); the share of in-patient care and rehabilitation were 30.8% and 32.3%, respectively. SMA type I burden was 1.6 billion RUR/year (1.5 million RUR/patient/year). In the second scenario, the total SMA burden was 5.4 billion RUR/year, the highest share of pathogenetic therapy was 43%.

Conclusion. The SMA economic burden in Russia is significant and growing along with the increase in the share of pathogenic therapy, but this growth should be compensated by lowering other direct and indirect costs.

356-365 412

Aim. The study aimed to evaluate the pharmacoeconomic feasibility of propranolol application in the dosage form of the oral solution in the treatment of proliferating infantile hemangioma requiring systemic therapy.

Materials and methods. The study design was a retrospective analysis of the published data. The methods of pharmacoeconomic analysis included a clinical-economic analysis (cost-effectiveness analysis) with a sensitivity analysis; and a "budget impact" analysis with a sensitivity analysis. The authors compared the pharmacoeconomic effectiveness of pharmacotherapy for infant hemangiomas with propranolol and surgical methods of treatment.

Results. The efficacy of propranolol therapy was 39% higher than surgical methods of treatment. The relative increase in the efficacy of propranolol therapy compared to surgical treatments was 68.4%. At the same time, the cost of propranolol therapy was lower than the cost of surgical treatments by 31.7% or 56,486,07 RUR per patient per year. The application of propranolol in the treatment for proliferating infantile hemangioma allowed reducing the burden on the budget of the state guarantee program in comparison with surgical methods of treatment for 3 years by 1,562.0 million RUR with a proportion of 12% of patients with infant hemangiomas requiring systemic therapy (9,694 patients per year). The sensitivity analysis of the cost and effectiveness of the compared medical technologies showed that the obtained results are resistant to the fluctuations in these parameters in the range from − 20% to + 20%.

Conclusion. The application of propranolol preparation in a dosage form of oral solution for the treatment of patients with proliferating infantile hemangioma will significantly increase the efficiency of therapy and reduce costs associated with the application of surgical methods of treatment.

367-376 517

Introduction. Presently, the willingness-to-pay threshold (cost-effectiveness threshold, incremental cost-effectiveness ratio) is used as one of the decision-making criteria for reimbursement in some foreign countries with a developed system of healthcare technologies evaluation (HTE). However, in Russia, the willingness-to-pay threshold (WPT) is undetermined, which complicates the evaluation of clinical-economical effectiveness of medical technologies, including medicines.

Aim. The study aimed to calculate WPT for the Russian healthcare system using the available foreign experience.

Materials and Methods. WPT was calculated with the following methods: the method proposed by the WHO, hemodialysis cost-effectiveness standard, case-based reasoning (CBR), and the evaluation of the shadow cost of the budget.

Results. WPT was calculated for the Russian healthcare system using four different methods of calculation. According to the method proposed by the WHO, WPT was 2,235,201.60 Rub for DALY in the RF; according to the hemodialysis cost-effectiveness standard, it was 1,748,623.36 Rub for QALY; according to the method of the evaluation of the shadow cost of the budget, it was 313,878.21 Rub for DALY and 365,060.31 Rub for QALY; and according to the method of the case-based reasoning, it was 7,494,944.00 Rub for QALY.

Conclusion. The study results showed that the optimal WPT values for the Russian healthcare system were those obtained by the method of the WHO (2,235,201.60 Rub). The authors propose to use this value as one of the decision-making criteria for the reimbursement of medical technologies, including medicinal drugs.

377-387 1060

Aim. The study aimed to assess the economic effect of biological therapy with anti-interleukin (IL)-6 drugs: tocilizumab, olokizumab, and levilimab in patients with severe COVID-19 and cytokine storm.

Materials and Methods. An assessment of the economic consequences of severe COVID-19 therapy was carried out using the cost of illness analysis in a model developed in Microsoft Excel 2016 (Microsoft, USA). The direct medical costs of providing care for COVID-19 were taken into account (ICU service, the cost of biological therapy, and the use of glucocorticosteroids (GC)). Data from a prospective, historical controlled CHIC study conducted in the Netherlands were used as a source of efficacy. A mathematical model has been developed for extrapolating the CHIC study results to clinical outcomes (transfer to mechanical ventilation, discharge from ICU, lethal outcome) and forecasting the costs of managing severe patients with COVID-19 in real clinical practice in the Russian Federation.

Results. The reduction in the cost of therapy when the hypothesis of equal efficacy of tocilizumab, olokizumab, and levilimab is accepted by reducing the cost of drug therapy will be 1,251,698.99 rubles per 72 patients when comparing olokizumab with tocilizumab and 939,718.84 rubles per 72 patients when comparing olokizumab with levilimab.

Conclusion. Anti-interleukin (IL)-6 drugs in combination with GC are an effective treatment option for moderate to severe patients with COVID-19 and cytokine storm symptoms. This group of drugs is indicated as the main one for the treatment of this condition.

388-399 459

Aim. A meta-analysis of 8 controlled studies (n=771, age 53.6±6.2 years) of tie use of tie Chondroguard (100 mg i.m. first 3 injections, from tie 4th injection - 200 mg i.m., EOD, course 20-30 injections) in the complex therapy of osteoarthritis (OA).

Materials and Methods. Tie meta-analysis according to tie fixed-effects model included all published clinical studies on tie efficacy and safety of the CG drug in OA). The effectiveness of therapy was assessed using the VAS, Lequesne, WOMAC scales/indices. For each study, information was collected on 23 features. Data analysis was carried out using the MEDSTUDY and "R" software packages.

Results. Meta-analysis confirmed significant associations between the use of Chondroguard (CG. and pain reduction assessed by the visual analog scale (V)S. - CG: a decrease in pain intensity by -28.3 points, control: -11.6; p=0.042. There was a significant reduction in pain according to VAS at night (CG: -20.1; control: -9.9; p=0.05018., while sitting or lying down (CG: -15.5; control: -7.6; p=0.01656., when walking (CG: -28.2; control: -17.0; p=0.04957). The use of CG led to a significant decrease in the scores of the Lequesne index (CG: -4.3; control: -1.4; p=0.0349., and of the WOMAC index (CG: -338.4; control: -219.8; p=0.004., including WOMAC "function" (CG: -247.8; control: -96; p=0.0027., and WOMAC "stiffness" (CG: -25.4; control: -11.2; p=0.0462.. The incidence of side effects did not differ significantly from the control.

Conclusion. Chondroguard is an effective treatment for osteoarthritis and has a good safety profile.

401-412 294

Introduction. Problems of assessing the healthcare system effectiveness and medical organizations, in particular, are largely associated with the fact that most studies are based on the data approved according to the established procedure in forms of federal statistical observation that do not correspond to the regional characteristics of the medical care organization.

Aim. To assess the effectiveness of personnel management in medical organizations of the Moscow healthcare system which provide primary health care to the adult population, directly involved in the provision of medical services, and the usage of generally accepted statistical indicators for this purpose.

Materials and Methods. The study is based on the analysis of the effectiveness of personnel management in medical organizations of Moscow healthcare system, selected by typological sampling according to the given parameters, carried out in the context of the relevant groups of medical workers (doctors and nurses) in the following areas: number, composition, training level, movement, workload, etc.

Results. Analyzing the effectiveness of personnel management, as the most important element of the resourceful basis in medical organizations, the authors considered the aspects connected with the formation of the staff directly involved in the provision of medical services in accordance with federal regulatory legal acts and regional requirements for primary health care organization. The results of the study confirm that under the circumstances of healthcare system decentralization, current forms of federal statistical observation do not correspond to the regional characteristics of the healthcare organization system and that deficiency of primary data from medical organizations excludes the possibility of forming long-term forecasts in a healthcare system of subjects of the Russian Federation.

Conclusion. The lack of uniform approaches governing the analysis and assessment of the effective resource management processes in medical organizations, the imperfection of existing statistical information for such purposes, and the importance of accounting for regional characteristics of the healthcare organization require searching for tools that can objectively assess the effectiveness of medical organizations, including the organizational specifics of medical care provision.

413-425 468

Introduction. Hemosiderosis is a pathologic condition that accompanies liver, lung, and other organ diseases. Polypeptide-containing drug Laennec contributes to the elimination of excessive iron deposits in tissues.

Aim. The study was aimed to identify peptides contained in the composition of the drug that take part in the regulation of iron homeostasis and correction of hemosiderosis and hyperferritinemia.

Materials and Methods. The study of the drug composition was conducted with hybrid mass-spectrometry and modern methods of analysis of Big Data based on the topological approach to recognition.

Results. The preparation contains 19 peptides that are potentially important for the regulation of iron homeostasis. These peptides help to treat the disorders of iron metabolism by regulating the levels of the main hormone of iron homeostasis hepcidin by reducing the synthesis of ferritin and by exhibiting anti-inflammatory and immunomodulatory effects.

Conclusion. The identified peptides allowed the authors to describe the molecular mechanisms of the iron overload elimination that are known from experimental and clinical studies of the analyzed polypeptide drug.


427-437 370

Aim. The study is aimed to determine and test the approaches to the development of a method for calculation of the demand for medical personnel in the healthcare in the Russian Federation, using a mathematical model of human resource for healthcare HRH balancing.

Materials and methods. As part of the study, the development of a project of the calculation method for the demand for medical personnel in healthcare in the Russian Federation was carried out. The authors based on the foreign experience in the approaches to the calculation of the demand for medical personnel in the economically developed countries that apply socially-oriented healthcare systems (state or social insurance-based) as well as experience of using various approaches to methods of calculation of the demand for medical personnel existing in Russia. To calculate the justified demand for medical personnel in certain specialties, calculations were carried out stagewise and data tables were created, which provided a base for a mathematical model of HRH balancing implemented in the Microsoft Excel environment. The conceptual model was based on a balance of supply and demand modules. As a result of the calculation and comparison of the number of different specialty doctors, this model shows the deficit or surplus of HHR in each module.

Results. This mathematical model of balancing the HRH based on the results of two modules operating to calculate the supply and demand for one specific planning horizon can be used to calculate and compare the following factors: the number of doctors in the simulated period; increase/decrease in demand for HRH; increase/decrease in the number of doctors in the medium and long-term compared to the base year. This model can be supplemented with a block calculating the labor remuneration fund (LRF) for the simulated period and accounting for changes in the consumption (demand) of medical care depending on the implementation of various national projects in the field of healthcare. The presented calculation approach shows that the demand for medical personnel will grow in the next 7-10 years. However, in the long-term perspective, the opposite situation is possible due to an oversupply of personnel in healthcare, which may entail other organizational and social problems and, consequently, other managerial solutions.

Conclusion. The results of this study can be used to reform the existing approaches to the calculation of the demand for medical personnel to increase the organizational and economic efficiency of workforce planning in healthcare, as well as to develop techniques to check the justifiability of funding levels, including those aimed at the provision, maintenance and professional development of health human resources.


438-451 966

This article contains the aims and main principles of the concept of value-based healthcare (VBHC). The relevance of the implementation of this approach into the Russian healthcare system results from the fact that during the control and payment for medical care, the treatment outcomes are evaluated selectively and at separate stages. The medical care payment system considers only its volumes and not achieving the desired treatment outcome significant to a patient. A review of the world’s best practices of introducing VBHC conception and, also new medical care payment methods such as bundled payment and pay-for-performance (P4P) has been conducted. According to international experience, VBHC increases the quality of medical care and provides the optimization of costs. To implement VBHC model in the Russian Federation, it is necessary to ensure the informatization of the providing medical care, development, and improvement of medical quality control systems (development of the resulting criteria for medical care quality for all diseases), and introduction of the rating system for medical organizations. Provided these processes are ensured, further progressing to P4P is possible. Moreover, it would also be feasible to implement VBHC in other healthcare processes including procurement of drugs and medical devices, their pricing, and reimbursement.

452-462 369

The article focuses on the review of a pharmacotherapeutic approach to the therapy of hand osteoarthritis (HO). Apart from non-steroid antiinflammatory drugs (NSAID), promising therapeutic means of HO therapy include steroid drugs, chondroitin sulfate (CS), glucosamine sulfate (GS), and vitamin D. Transdermal application of NSAID and steroid drugs reduces the side effects without a decrease in the effectiveness of the therapy. Reconstructive therapy of cartilaginous and connective tissue of hands includes a long-term application of CS/GS, and in the acute period, injections of CS/GS.

ISSN 2070-4909 (Print)
ISSN 2070-4933 (Online)