FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology

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Vol 11, No 4 (2018)
View or download the full issue PDF (Russian)

Original Article 

3-15 813

The aim is to analyze the medical records of patients with malignant lymphoproliferative diseases (LPD) in the Russian Federation in 2016- 2017. Materials and methods. Treating physicians in 75 regions of the Russian Federation were asked to fill the survey questionnaire containing 9 types of malignant LPDs (according to the ICD-10 classification). The questions covered the epidemiology of LPD (prevalence, resistant forms, relapses and mortality), the existence of specialized institutions and beds, the costs of medical care in patients with malignant LPD, and the financial support of pharmacotherapy in these patients during their hospital stay. Results. We found that the most common malignant LPD in 2016-2017 was Hodgkin’s lymphoma (73.5 and 73.4%, respectively). The prevalence of resistant forms and recurrences of malignant LPD over this period accounted for 6.8% of the total patient population. In 2017, the number of patients who died was 7.5% less than that in 2016. There are 815 and 1,763 specialized institutions of the oncology and hematology profiles that provide medical care to children and adult patients, respectively. Among the malignant LPDs, the highest costs of drug therapy in 2016 pertained to lymphosarcoma, and in 2017 – to Hodgkin’s lymphoma. In the system of compulsory health insurance (OMC), the largest spending for both adult and pediatric patients in 2016 and 2017 was accounted for Hodgkin’s lymphoma; a similar result was obtained for the cost of therapy based on high-tech medical care. Conclusion. In 2017, the total number of patients with malignant LPD in the Russian Federation increased by 2.65% as compared to 2016, while the proportion of primary LPD decreased by 1.2%. In 2017, the total costs of drug supply in patients with malignant LPD in the RF increased by 55.35% as compared with 2016.

16-27 811

Introduction. A number of drugs, which improve overall survival and quality of patients’ life, became available for treatment of metastatic castration-resistant prostate cancer (mCRPC). enzalutamide and abiraterone are the only two hormonal drugs increasing survival and approved for the treatment of mCRPC patients in Russia. The aim of the current study was to develop a pharmacoeconomic tool that calculates direct medical costs (price of the drugs) of using enzalutamide or abiraterone for treatment of chemotherapy-naïve patients with mCRPC from the Russian regional healthcare systems perspective. Materials and methods. The calculator is based on a published pharmacoeconomic model of using enzalutamide or abiraterone for the 1st line treatment of mCRPC. Current regional medication prices, which explain the biggest share of direct medical treatment costs, are automatically accounted for 84 Russian regions (except nenetsky AO). The calculator also provides estimates of number of chemotherapy-naïve patients, who are eligible for enzalutamide or abiraterone treatment in each region. Results. Costs of using enzalutamide or abiraterone are almost equal on the federal level, but the differences in the costs between these two medications are higher than 10% in 15 Russian regions. Conclusions. Possible differences in costs of using enzalutamide or abiraterone should be accounted during planning of state procurements on the regional level.

28-37 635

The aim of the study is to determine the limits of using the mathematical-statistical analysis for the evaluation of pharmacotherapy costs in pediatric inpatients diagnosed with community-acquired pneumonia. Materials and methods. The report is based on the assessment of 547 medical records of patients with community-acquired pneumonia, who underwent the treatment in four pediatric hospitals in St. Petersburg. The data array was created from a number of factors that characterize the patients’ profile (gender, duration of hospital stay, cost of therapy, number of prescribed drugs, number of affected lung segments, pathogen location, leukocyte count, and eSR). Results. Correlation analysis allowed us to identify factors contributing to the cost of pharmacotherapy (at a significance of p=0.05); those were: the duration of hospital stay (r=0.34), the number of prescribed drugs (r=0.26), and the number of affected lung segments (r=0.21). Dispersion analysis of qualitative factors (gender, location of pneumonic infiltrate) showed no significant impact of these factors on the costs or the number of prescribed drugs in the total data set. From the regression analysis, we obtained formulas for the dependence of the resulting parameters (cost of pharmacotherapy, number of prescribed drugs) on a set of independent variables. Conclusion. The treatment cost optimization in pediatric patients with community-acquired pneumonia should include the use of antibacterial drugs with proven efficacy and safety, as well as a reduction in non-necessary supporting therapy, e.g., medications aimed to correct morphological and functional changes in the respiratory system.

38-46 921

Fabry disease (FD) is a severe lysosome storage disease caused by congenital deficiency of the enzyme α-galactosidase A and characterized by the risk of renal failure combined with cardiovascular and CNS complications. According to the currently available information, the early start of enzyme replacement therapy (ERT) leads to a significant improvement in patient’s condition.

The aim of the study is to assess whether the timely ERT prevents severe FD complications and to calculate the number of prevented cases as depending on the time of ERT start.

Materials and methods. The proposed model is based on the published results on patients with FD, receiving agalsidase alpha as ERT (no data for agalsidase beta was found). The expected number of cases with life-threatening complications was calculated for different starting timepoints and durations of the ERT.

Results. In patients with FD, continuous ERT during five years reduces the number of serious cardiovascular and renal complications by 25%. An early start of ERT makes it possible to additionally (as compared with a late start) prevent the complications in more than 20% of cases.

Conclusion. The early initiation of RPT in patients with FD can significantly reduce the occurrence of severe lifethreatening complications, increase the patients’ survival and improve their quality of life. 


48-60 974

The aim is to develop a generalized algorithm and methodology for conducting clinical and economic studies (CeS) on medications used in treatment of malignant neoplasms (MnP). Materials and methods. We conducted a literature search and then reviewed the recent reports on similar CeS. In so doing, we paid special attention to the model type, the modeling methodology, information on the effectiveness and cost, the cost elements, performance criteria, the assessment of the CeS final results, as well as the possibility of applying these results to the national healthcare system. We used the methods of generalization, systematization, as well as visual-graphical and mathematical modeling. Results. A general algorithm for conducting a pharmacoeconomic study has been proposed; this includes an effectiveness analysis, a cost analysis and a comparison of costs and effectiveness (cost-effectiveness). The effectiveness analysis includes selection, digitization, and approximation of overall survival (OS) and progression-free survival (PFS) curves followed by their extrapolation. The choice of extrapolation method is discussed. The cost analysis includes calculating the cost of medications in question, the costs associated with the indicated therapy and with adverse events (Ae), as well the costs associated with disease progression (for certain drugs). The possibility of analyzing indirect and non-medical costs is also discussed. A dynamic version of the Markov model pertaining to the first order course of a disease is proposed; this includes the status before progression (first-line therapy), after progression (second-line therapy) and death. Considering the succession of treatments and the availability of additional data, a similar second-order model (and subsequent orders) can be applied to incorporate additional patient’s condition after the first progression to the second progression (second-line therapy) and after the second progression (third-line therapy). Conclusion. A generalized algorithm has been developed and proposed for carrying out CeS of medications
used in MnP.

61-66 801

The article discusses some of the shortcomings in financial statistical reports provided by medical organizations in the healthcare sector, namely: duplication and intersection of indicators in different reporting forms, the inconvenient data format for their presentation and analysis, the lack of correlation between indicators of statistical reporting and internal management accounting. To solve these problems, the authors propose the ways of improving the financial reporting by medical organizations: among them, optimizing the system of indicators, abandoning the statistical reporting forms in favor of creating databases (possibly, with outsourcing assistance), as well as creating the uniform rules for maintaining internal management accounting in medical organizations.

67-72 675

Patient registers are an effective tool for monitoring the disease incidence in the population and the effectiveness of medical care provided to patients. The registers also represent a source of information for making organizational decisions on the healthcare system. The aim of this study is to review the regulatory and legal acts governing the patient registers, and compare them with the registers of compulsory medical insurance (CMI) accounts to assess the possibility of integrating the data into a unified registry based on the CMI accounts.

Foreign Experience 

73-80 1064

The article reviews international methodological guidelines, regulatory documents and existing approaches to the determination of the costeffectiveness threshold (CeT), also known as the willingness-to-pay threshold (WTP), the threshold value of the incremental cost-effectiveness ratio (ICeR), in europe (england and Wales, Scotland, Ireland, France, Belgium, Denmark, the netherlands, Germany, Sweden, Finland, norway, Poland), America (the USA, Canada, Brazil), Asia (Japan, South korea, Taiwan, Thailand), in Australia and new Zealand. The CeT is commonly used to rationalize decision-making in health cost reimbursement. The present review demonstrates that just a few countries (englandandWales,Thailand,Poland,USA) have introduced the explicit value of CeT into their decision making. Some countries (Australia,Canada,new Zealand, thenetherlands,Sweden, andBrazil) use CeT in an implicit manner implying that no specific CeT value is defined by law. In other countries (Finland,Sweden,norway,France,Germany,Denmark,Japan,South korea,Taiwan), the role of the threshold in health reimbursement remains uncertain despite the presence of HTA systems. The CeT is expressed as additional cost per unit of incremental health benefit, which is represented by quality-adjusted life year (QALY) in most counties. However,PolandandBrazilallow using life years gained (LYG) as a measure of additional benefit neglecting the quality of life. In thenetherlandsandengland, different CeT values are applied to the health technology under assessment depending on the severity or rareness of the disease and some other factors.

Review articles 

81-91 608

The review outlines the main legislative aspects of organization and financial support of health services for public institution employees inRussia. Specifically, the review describes the legal framework and regulations of healthcare for servicepersons and other staff within the Ministry of Defense of theRussian Federation. We discuss the financing mechanisms of the departmental health service in the Ministry of Defense. Conclusions are made on the need to improve the legislative base of financial and administrative support of healthcare for the military and associated personnel.

92-96 2029

To reduce maternal mortality, it is important to analyze the clinical conditions posing a potential threat to pregnant women. To characterize such states, the definition was introduced – “maternal morbidity, which almost took the woman’s life” (the near miss maternal morbidity), or the “near miss”. The “near miss” criteria were first defined in 2009. This review article provides a rationale for auditing the “near miss” cases for the purposes of healthcare technologies asessment. The paper also discusses the clinical and economic aspects of “near miss” analysis and the methodology for assessing the “near miss” incidence. Also of scientific and practical interest is the classification of maternal “near miss” cases developed by our colleagues from theRostovPerinatalCenter. Thus, maternal “near miss” cases are divided into obstetric (emergency), extragenital, planned (managed), organizational, and iatrogenic. This differentiated approach to the maternal critical conditions allows us to understand not only their causes, but also to develop a plan of further actions for each specific group. This contributes to the development of rehabilitation and prevention measures to be taken during subsequent pregnancies.

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