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FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology

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FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology

The journal is the first and most reputable in Russia and EurAsEC (Eurasian Economic Community) countries peer-reviewed periodical that publishes materials on new medical technologies, economic optimization of drug therapy, quality-of-life and healthcare problems. 

The journal was founded in 2008.

The impact factor of this journal, as shown in the Russian Science Citation Index (RSCI) is the highest among the periodicals in the areas of pharmacoeconomics, health technology assessment, and epidemiology. According to RSCI, the biennial impact factor (without self-citations) was 0.325 in 2013, 0.411 in 2014, and 0.722 in 2015.

The journal publishes various materials on pharmacoeconomics and pharmaco-epidemiology including the methodology, data analysis and results of studies on public health, medical technologies and economic aspects of drug therapies. The original articles and literature reviews cover Cost-of-Illness Analysis, Cost-Minimization Analysis, Cost-Effectiveness Analysis (CEA), Cost-Utility Analysis (CUA), Cost-Benefit Analysis (CBA), Quality of Life Assessment (QoL), Patients' Preferences & Patients’ Satisfaction indices and related topics. 

Our aims and priorities focus on scientific and information support to the decision-makers and experts in public drug supply, health providers, research and education professionals, as well as pharmaceutic and insurance companies. 

Languages: Russian, English 

Periodicity: 4 issues per year (quarterly). 

Copies of this journal are distributed under the Creative Commons Attribution 4.0 License: full-text materials are freely available to the public in an open access repository.

Distribution of the printed version: Russia, the EurAsian Economic Community countries (Belarus, Kazakhstan, Kyrgyzstan, Tajikistan, Uzbekistan, Armenia, Moldova) 

The editorial board of FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology” includes leading experts in pharmaco-economics, clinical pharmacology, medical technology assessment, epidemiology, and public health from Russia, USA and Spain.

The editorial board maintains the policy of full compliance with all principles of publishing ethics. Our ethical standards and codes conform to those of top international science publishers. 

All submitted materials undergo a mandatory double-blind peer review

Media Certificate of Registration: ПИ №ФС77-32713 of August 01, 2008.
ISSN 2070-4909 (Print)
ISSN 2070-4933 (Online) 

By the decision of the Higher Attestation Commission (HAC) of Russia, FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology is included in the "List of top peer-reviewed scientific journals and publications" where scientists seeking academic degrees are required to publish their results. 

The journal appears in the Russian Universal Scientific Electronic Library (RUNEB) elibrary.ru and is also present in the database of the Russian Science Citation Index (RSCI). Concise versions of major articles from this journal are published by the All-Russian Institute for Scientific and Technical Information (VINITI). The journal is also indexed by "Ulrich's periodicals Directory" – a global information system of periodicals and continued publications.

 

Current issue

Vol 13, No 3 (2020)

ORIGINAL ARTICLES

225-239 52
Abstract

Diagnosis-Related Groups (DRG) for the payment for biological therapy were created at the stage of the pilot project and their coefficients of input intensity were not revised since then. The expansion of the range of genetically-engineered biological drugs (GEBD) and the development of new indications for biological therapy and new groups of expensive drugs (like selective immunodepressants, SI) determine the necessity in the differentiated payment for the therapy with GEBD and SI. However, at the federal level, this will be possible only after the approval of the clinical recommendations.

Aim. The study aimed to identify possible applications of different GEBD and SI within the current provider-payment model of the Russian diagnosis-related group in terms of bronchial asthma (BA) and inflammatory bowel disease (IBD) - Crohn's disease and ulcerative colitis.

Materials and methods. The expenses on GEBD and SI for one case of hospitalization were calculated and compared with the imposed tariffs. For the evaluation of the possibility of the provision of an expensive treatment within the existing DRG model, the authors modeled the distribution of patients with BA and IBD by different pharmaceutical treatment plans in the current practice and cases of an increase in the share of indications of more expensive therapy. The authors identified the number of patients that could have been treated without an increase in the costs of compulsory medical insurance (CHI). The authors proposed the subgroups for the differentiated payment for the treatment of BA and IBD with GEBD and SI.

Results. Few variants of treatment with GEBD and SI were characterized by the costs of drugs that would exceed an average payment rate for DRG st36.003 and ds36.004 in 2020. In the model, an increase in the share of patients that received the most expensive drugs of all the registered GEBD and SI in the RF for the treatment of BA and IBD did not lead to an increase in the costs for CHI. It is possible to maintain the initial volume of the financing and increase the number of patients that receive GEBD and SI due to a decrease in the number of hospitalizations. The authors identified approximate values of the coefficient of input intensity (CII) for the subgroups that can be formed for the differentiated payment for pharmaceutical treatment with GEBD and SI.

Conclusion. Despite the fact that without the recalculation of CII, there were numerous changed introduced into DRGs st36.003 and ds36.004 “Treatment with GEBD and SI” and the spectrum of the associated clinical situations expanded, it was possible to maintain the possibility of the payment for the therapy with different drugs, including the most expensive ones without an increase in the costs for the CHI system. Still, the results of the present study indicate the necessity in the optimization of the system of payment for medical care with genetically-engineered biologic drugs and selective immunodepressants through the implementation of a differentiated approach to the payment at the federal level.

240-250 39
Abstract

Aim. To work out the unified model for description of coloproctological service at the level of federal district.

Material and methods. The study is the summary analysis of data from the annual statistical observation “The Report of the Chief Coloproctologist of the Russian Federal District” in 2016–2018. The analysis included the following stages: the estimation of staff situation; the assessment of the main parameters of out- and inpatient coloproctological care in 2018 in the Far Eastern Federal District (FEFD) and in its federal subjects.

Results. Staff number of doctors in federal subjects of the FEFD did not change significantly in 2016-2018, it was 0.7 per 100 thousand population. An extremely low availability of outpatient consultation of coloproctologist in all federal subjects of FEFD was found (550.2 per 100 thousand population vs 3000 per 100 thousand population in Russian Federation). The incidence of colonoscopy is the lowest among all Federal Districts of Russia as well – 5.5%. A mean number of endoscopists is above 7.0 per 100 thousand population, which can be considered as the minimal threshold parameter. The total average staffing of endoscopists in the far Eastern Federal district was 86.0% in 2016, 87.3% – in 2017, 85.8% – in 2018. The staffing situation improved in Khabarovsk Territory and in Sakhalin Region while other federal subjects showed negative trend.

Conclusion. The analyzed parameters can be considered as an objective tool for the assessment of coloproctological care efficacy. In the FEFD it needs further development.

251-261 62
Abstract

Aim. The study was aimed to perform a comparative retrospective pharmacoepidemiological analysis of antipsychotic drugs (APD) used for inpatient treatment for schizophrenia.

Materials and methods. This retrospective pharmacoepidemiological study included 1077 medical records of patients diagnosed with schizophrenia according to ICD-10 (F20.0-F20.8) selected for the analysis on the base of a psychiatric inpatient hospital in Moscow during 2013-2017. The study design included socio-demographic data (sex, age, education, disability, social status) and clinical-economic data (diagnoses, duration of hospitalization), information on the prescription frequency of drugs and dose regimens were analyzed. The consumption volume of APD was estimated using the WHO ATS/DDD methodology.

Results and discussion. It was found that women prevailed (55-71%) with the mean age ranging from 42.8±14.1 to 47.4±14.7 (±SD – standard deviation). In the studied sampling, paranoid schizophrenia dominated (≥70%). Over the analyzed 5-year period, the consumption volume of APDs was characterized by alternating declines and rises (from 154.49 to 208.09 NDDD/100 bed-days). The consumption of atypical APDs decreased by 7% and typical APDs increased by 25% compared to the base year (2013), respectively. The most significant changes in the consumption were identified for APDs of prolonged action (a decrease by 67% compared to 2013). Haloperidol and clozapine (oral forms), which are included in the DU90% segment, remained the leaders in terms of prescription frequency and consumption volume (49.04 and 45.26 NDDD/100 bed days in 2017, respectively). Moreover, trihexiphenydil (used to correct adverse reactions) also had a high frequency of administration and consumption.

Conclusion. It was found that 1/2 of all prescriptions were antipsychotic drugs used to treat schizophrenia. The total consumption volume of APDs in 2017 decreased by 9.2% compared to 2013. A high consumption volume is typical for drugs from the subgroup of typical APDs, but atypical APDs prevailed in terms of prescription frequency, which may indicate the prescription of typical APDs in doses exceeding the defined daily dose.

262-269 45
Abstract

Aim. Development of a tool for the evaluation of the therapeutic value of anticancer drugs based on multi-criteria analysis of decision making.

Materials and methods. The study included 4 main stages. At the first stage, based on the results of the publications analysis and the EVIDEM system, a list of therapeutic value criteria was formed. At the second stage, for each criterion, a survey of experts was used to develop a scale and to build a value function using the curve-fitting method. At the third stage, the weighing was carried out using the discrete choice experiment method and the statistical package "support.CEs" in R Studio. At the fourth stage, based on the obtained values of the weight coefficients and value functions, a simple linear additive model was constructed.

Results. The authors developed a tool that included 5 criteria for the value of anticancer drugs: efficacy, safety, disease severity, ease of administration, and therapeutic need. For each criterion, a linear value function was built, which allowed the authors to obtain the value of the severity of the criterion in the range from 0 to 1 based on the absolute values of the criterion for a particular drug. As a result of the weighing, two sets of weighting coefficients were obtained by using two different methods of survey results processing. The criterion of efficacy has the most significant contribution to the therapeutic value for the Russian health care system, and the least significant is the severity of the disease. The distribution of the criteria in the intermediate contribution ranks was significantly different between the two sets of weights.

Conclusions. For practical application and implementation of the proposed tool, it is required to conduct the validation using the example of specific antitumor drugs to select a final set of weighting coefficients, check the stability of the results, and form a scale of therapeutic value levels.

270-282 38
Abstract

Introduction. The pharmaceutical drugs used in the treatment of osteoarthritis (OA) differ not only in the mechanisms of anti-inflammatory action but also in the effects on the human microbiome.

Purpose. Evaluation of the influence of some drugs used in the therapy of OA on the human microbiome by the method of chemoinformation analysis.

Materials and methods. Сomparative chemomicrobiome analysis of glucosamine sulfate (GS), diclofenac, acetylsalicylic acid (ASA), and three prebiotics (lactose, lactulose, fructose) as molecules of comparison. For each substance, estimates of the area under the curve (AUC) were obtained for a representative sampling of human microbiota (38 commensal bacteria). The minimum inhibitory concentrations (MIC) were established for more than 120 pathogenic bacteria.

Results. On average, according to a representative sampling of microbiota, the profile of the action of GS on the microbiome was almost identical to the profile of the action of lactose (AUC=0.23±0.18). The most effective growth of the microbiome was provided by fructose and lactulose (AUC=0.58±0.21). The effects of diclofenac and ASA on the commensals of microbiome were comparable to the effects of GS (AUC=0.27±0.22). However, the analysis of the obtained MIC values for pathogenic bacteria showed that diclofenac supported the growth of the pathogenic flora (MIC=35±1.4 μg/ml) to a greater extent than GS (MIC=16±1.5 μg/ml) and ASA (MIC=23±2.2 μg/ml).

Conclusion. The effects of GS on the microbiome are comparable to the effects of the prebiotic lactose whereas the inhibitory effect of GS and ASA on pathogenic bacteria is more pronounced than that of diclofenac. The inhibition of pathogenic bacteria by the GS helps to reduce inflammation.

283-290 46
Abstract

Aim. The evaluation of absolute and relative difference in the growth of standard rates and financing of medical help based on the calculation for Program on State Guarantees to Deliver Free Medical Care to the Citizens of the Russian Federation (PSG) by the parameters approved by the Decree of the Government for 2019 and 2020.

Materials and methods. The evaluation was performed by the methods of mathematic modeling. Mathematic modeling of the calculation of the volumes of medical help (MH) and financial costs in the subjects of the RF was based on the Decrees of the Government for 2019 and 2020 and the method of calculation of the standard rates specified in the Letter on the economic grounds for territorial PSG. Modeling for each region was used to compare the absolute and relative difference in the growth of standard rates for the obtained values in the absolute and relative expression of the calculated planned parameters of PSG for 2019 and 2020 according to the described method in terms of types, conditions, and profiles of medical help.

Results. It was revealed that the existing standard rates for financial costs did not provide a uniform growth of costs by all the conditions and types of MH. The growth of financing by types and conditions varied from 1.43 to 9.59% of the 2019 baseline in the RF. Certain “specialized” (profile) standard rates within the conditions of MH showed a significant growth at a slower growth of financing of the rest of MH types (3.86% for all-day inpatient service and -0.6% (decrease in financing) for day-time inpatient service). The calculation of the model for the subjects of the RF showed even greater fluctuations: from –0.11% to –3.03% for day-time inpatient service and from 1.35% to 7.27% for all-day inpatients service.

Conclusion. Despite the annual growth of the financing of PSG, redistribution of the budget within the conditions of medical service provision is uneven. This situation provides background for the improvement of the mechanisms of planning of MH within PSG using obligatory modeling and balanced standard rates for the subjects of the RF.

REVIEW ARTICLES

291-303 66
Abstract

Background. Systemic sclerosis (SSc) is a severe orphan disease, one of the systemic pathologies of connective tissue. This disease has a significant negative impact on the patient’s quality of life and has a high mortality rate. Treatment of its various complications imposes a great financial burden on the healthcare system. The difficulties of daily functioning and social adaptation and the overall burden of SSc for patients, as well as their caregivers, also contribute to the economic component of the disease.

Aim. To assess the social and economic burden of SSc.

Materials and methods. A systematic review was conducted according to the PRISMA guidelines using predefined PICO(S) criteria. The search was carried out in December 2019 using the MeSH terms in the Embase, MEDLINE / PubMed, Cochrane library databases. The publication date range was 10 years. To identify Russian-language studies, an additional search was conducted in eLIBRARY.ru and the Internet network. The evidence levels of the included studies were determined.

Results. A total of 934 studies were identified from all databases; 53 publications were selected for eligibility; 9 of which were included in the final review. There were no studies identified to assess the burden of SSc in Russia, so the evaluations were based on foreign studies. The estimates of the annual direct costs per patient with SSc for the past decade were almost similar in different countries: 5 038 Canadian dollars in Canada, 11 607 Australian dollars in Australia, 17 365-22 016 US dollars in the USA, and 1 413-17 300 Euros in Europe (an average of about 8 000 euros). The cost structure was dominated by direct medical costs for hospitalization and drug therapy and indirect costs were mostly associated with the loss of productivity and early retirement. The costs associated with the diffuse cutaneous form of SSc were statistically higher if compared to the costs for the limited form of the disease. Among the clinical manifestations of the disease, lung lesions and gastrointestinal problems made the largest contribution to the economic burden.

Conclusion. SSc is associated with significant healthcare resource use compared to the general population. The economic burden of SS has grown significantly in recent years, and this trend is global. At the same time, it is difficult to evaluate the disease costs in Russia due to a lack of information on the patient population.

304-315 67
Abstract

Aim. To conduct an analytical review of the regulatory legal framework on the resources provision required in medical organizations for the provision of oncological medical care based on clinical guidelines.

Materials and methods. Using Russian normative legal and regulative documents on the oncological medical care, the authors studied the normative regulation of the issues of both resources’ provision for medical organizations and resources’ demand assessment, including the need for financial support from various sources of the budgetary system of the Russian Federation. The analysis was carried out in two regulatory areas: financing and organization of the provision of medical care. The authors examined the main legislation acts relating to oncological medical care, including documents of the compulsory medical insurance, the annual decrees of the Government of the Russian Federation on the program of state guarantees of free provision of medical care to citizens for the coming year and the planned period, the decree of the Government of the Russian Federation regulating the provision of medicines and medical products, provisions on the organization of medical care by type of medical care, procedures for the provision of oncological medical care, regulatory documents on clinical guidelines and standards of medical care.

Results. The content analysis of the studied materials showed that certain components of the resources’ provision, including the financial provision of oncological medical care, are regulated by various regulatory documents, and there is no methodology for assessing the resources’ demand based on clinical guidelines.

Conclusion. New approaches to assessing the resources’ demand for the provision of medical care and the required financial support based on clinical guidelines need to be developed.

INTERNATIONAL PRACTICES

316-323 41
Abstract

The article presents a review of the foreign approaches to the mechanisms of financing of medical help and innovative medical technologies with the description of the implemented financial mechanisms of stimulation of innovations in foreign systems of public healthcare. Since the system of payment for diagnosis-related groups (DRG) does not contribute to the implementation of innovations in the medical practice, the majority of countries apply additional mechanisms of financing of innovative technologies in public healthcare such as single and additional payments, and target financing that was initially not associated with a DRG model.