FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology

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Vol 12, No 3 (2019)


169-177 570

The article addresses the model of diagnosis-related groups (DRG) updated according to the new tariffs in the compulsory medical insurance. Especially emphasized are changes made in the DRG model of 2019, which resulted from the previous work on the development and revision of the clinical recommendations in oncology, as well as the regulation changes in the healthcare system. In addition, the article describes the functioning of the DRG model in 2018 and the payment for cancer care and also provides examples from the practice of chemotherapy. The modifications made in the 2019 model are carefully discussed in terms of: expanding the list of oncological diagnoses, creating and characterizing new DRG groups, updating the coding system and the structure of reference books, changing the Guidebook recommendations and the Instruction related to oncological groups. Clarifications are given regarding frequently asked questions on payments for the medical care in oncology within the current DRG model.



Original Article 

178-190 1561

The aim of the review was to analyze the availability of insulin therapy and the ways to improve it in countries with the largest number of patients with diabetes. It was also aimed to assess the medical, social and economic importance of insulin therapy and industrial production of therapeutic recombinant insulin.

Materials and methods. The analysis was based on the data taken from monographs and publications in peer-reviewed journals, reports of companies and medical organizations, and the information available in the Internet. The demand and supply in the market of recombinant therapeutic insulin, the insulin market segmentation, and the costs for insulin replacement therapy in countries with the largest number of patients with diabetes were studied.

Results and discussion. The pro- and contra- arguments regarding the import of insulin and its impact on the national budget are presented. Technological specifics of recombinant insulin production are discussed; the funding and investments in the biopharmaceutical sector are analyzed. The benefits of industrial production of recombinant therapeutic insulin and its impact on the regional and national economy are demonstrated.

Conclusion. The availability of therapeutic insulin in most countries with the largest number of diabetics is unsatisfactory and needs a radical improvement. By analyzing the economic aspects of diabetes and the pharmacoeconomics of insulin, it is advised to develop a modern management system for insulin replacement therapy, especially in countries with large numbers of diabetics. The use of innovative technologies will reduce the production costs of recombinant therapeutic insulin, increase the availability of insulin therapy and thereby improve the quality of life in diabetic patients. Evidence that the production of therapeutic insulin has a positive effect not only on the healthcare, but on the socio-economic situation in the region is also provided. Countries with a number of diabetics exceeding 5 million are encouraged to launch their own production of recombinant therapeutic insulin. The results of the present analysis confirm that half of them are able to manufacture adequate human insulin and/or its analogues.


191-199 630

Objective: to analyze whether comorbidity affects the cost of treatment and medical services in elderly patients with atrial fibrillation (AF).

Materials and methods. We conducted a retrospective analysis of 98 patients with AF. Comorbidity was evaluated using the CIRS-G scale (Cumulative Illness Rating Scale for Geriatrics) and the Charlson criterion. The “cost of illness” calculations included direct costs only.

Results. In elderly patients with AF (mean age 74.7±8.8 years), high rate of comorbidity was typically found. Charlson comorbidity index amounted to 4.0±1.8, and the CIRS-G score – to 8.0±2.8. AF is often associated with heart diseases such as hypertension – 98.9%, coronary heart disease – 27.6%, and congestive heart failure – 76.5%. A patient with AF received on average 7.5±3.8 medications. Direct costs amounted to 18298.2±9440.4 RUB per patient with AF per year. Of this amount, 78.8% were spent for outpatient treatment, 16.5% for hospitalization and 4.7% for ambulance service. Cardiac medications comprised 66.4% of the total direct costs. In patients with high comorbidity, there are high costs of treatment of concomitant diseases, high secondary costs as well as costs for a doctor visit.

Conclusion. An average elderly patient with AF receives 7.5±3.8 permanent medications, which correlates with the severity of comorbidity by the Charlson index (r=0.59; p=0.000) and the CIRS-G score (r=0.29; p=0.004). Management of such patients at the outpatient clinic is by large (66.4%) associated with direct costs of the prescribed medications. However, patients with high comorbidity still need more vital drugs, as the cost of treatment of concomitant diseases increases. Notably, these patients spend 4 times more funds for drugs without proven efficacy.


200-208 785

Aim: to conduct a pharmacoepidemiological analysis of antimicrobial therapy of burn injury in the hospital settings.

Materials and methods. The study was based on medical records of patients with burn injuries hospitalized in the Volga University Hospital (Nizhny Novgorod) in 2018. DDD (Defined Daily Dose) analysis was used to evaluate the actual drug consumption based on the defined daily dose; DU90% (Drug Utilization 90%) analysis allowed us to assess the consumption of drugs based on their representation in the total number of defined daily doses; the “cost of illness” and ABC analyses were also used.

Results and discussion. For antimicrobial agents of interest, the NDDD (Number of DDD) per year, and the NDDD/100 bed-days were determined. Among these antimicrobial agents (AMA), the largest number of prescriptions was noted for vancomycin (18.06% of treatment courses and 92.86% of patients); amikacin (15.28% of treatments and 78.57% of patients); tigecycline (13.89% and 71.43%, respectively); cefoperazone / sulbactam (12.50% and 64.29%) and co-trimoxazole (12.50% and 64.29%). The NDDD/100 bed-days value for vancomycin was 100.73, followed by amikacin and co-trimoxazole: 86.85 and 71.93 NDDD/100 bed days, respectively. Other antimicrobial agents had significantly lower consumption rates. A group containing 90% of NDDD of antimicrobial agents used for burn injury included: vancomycin – 22.30% of total consumption; аmikacin – 19.23%; co-trimoxazole – 15.93%; cefoperazone / sulbactam – 10.72%; tigecycline – 10.54%; cefepime – 6.47%; levofloxacin – 3.04%. These agents accounted for 83.33% of all drug dose prescriptions. The costs of one DDD in segments DU10% and DU90% amounted to 1976.80 rubles and 1282.58 rubles, respectively. In group A, 80% of costs were for tigecycline – 41.98%; vancomycin – 19.06%; cefoperazone / sulbactam – 6.98%; cefepime – 6.82%. The average costs of treatments with AMA from group A were 15112.45 rubles, from group B – 24082.86 rubles, and from group C – 3498.58 rubles.

Implications. The AMAs most commonly used in the treatment of burn injury are vancomycin, amikacin, tigecycline, cefoperazone / sulbactam and co-trimoxazole. The use of vancomycin, tigecycline, cefoperazone / sulbactam and co-trimoxazole is associated with the highest costs of AMA therapy. In the overall spending structure, the cost of amikacin therapy represents an insignificant part (i.e., group C according to the ABC analysis). Notably, amikacin is prescribed more often than other drugs because of its high efficacy in the hospital settings and its low price. We found that more expensive AMA (ertapenem, polymyxin B, linezolid, piperacillin / tazobactam) were used when the starting regimen of antimicrobial therapy produced no adequate clinical effect.

Conclusion. This pharmacoepidemiological analysis made it possible to take a broader look at the cost of AMA consumed by the patients and not only those purchased by the hospital. The results provide for a rational approach to the selection of AMA names and doses.


210-220 741

Clinical / Economic Analysis and the common ABC / VEN analysis are currently used to estimate the qualitative and quantitative indicators of drug supply.

Materials and methods. We used the official information from the national portals and, on the imported medicines and the manufacturing countries related to “The Program for Providing Essential Medicines to Certain Categories of Citizens in the Russian Federation” in two regions of the Far Eastern Federal District.

Results. In Region 1, the highest level of domestically produced drugs (68.7%) was observed in 2014; in 2014-2015 it dropped significantly to 53.8% and 54.1%, respectively. In Region 2, the similar values were 69.6% in 2014, with a trend to decrease to 66.0% in 2015, and 62.4% in 2016. The highest replacement rates were recorded for the moderate and low consumption categories – «B» and «C», and also for essential and non-essential medicines – «E» and «N».

Discussion. The import replacement in the subsidized medicine supply is a complex dynamic process. The authors suggest that the reduced replacement of the imported drugs can be explained by both objective (the actual absence of the respective Russia-made analogues) and subjective (irrational approaches to the procurement of medicines due to the lack of an appropriate algorithm). Therefore, further work is needed to rationalize and advance the priority of the domestic medicines for the subsidized segment of drug supply.

Conclusion. The study shows that the situation with the import replacement in the subsidized segment is satisfactory. However, the reduced number of domestically-produced medicines found in this study, necessitates changes in the procurement policy regarding the medicines fully manufactured in Russia. The present article proposes criteria for the assessment of import replacement and recommends measures for improving the work in this direction.



221-229 920

Introduction. The state guarantee program for provision of free medical care to citizens is a key regulatory document that describes the actual guarantees of citizens for medical care. The standards of the extent and financing of medical care established in it, determine the level of state guarantees throughout the Russian Federation.

The aim is to determine possible limitations of the state guarantee program within the formation of indicators for the extent of medical care provided in the regions of the Russian Federation and the corresponding financial support.

Materials and methods. As part of the study, the federal and regional regulatory legal acts were analyzed, in terms of the methodology for the formation of regional programs of state guarantees, the extent of medical care and financing, as well as the methodology for the formation of these standards.

Results. The existing mechanisms for adapting the federal program of state guarantees at the regional level have been identified, and it has been shown that in most regions of the Russian Federation these methods are not used. Objective criteria for differentiating the standards of medical care exist in 77 regions, these standards correspond to the federal level in the vast majority of the regions of the Russian Federation, however there is a financing gap of the territorial programs in 2017 using the regional budget in 70 regions of the Russian Federation.

Findings. The current recommendations on formation of the territorial program of state guarantees are applied to a limited extent. Calculation of the per capita financing standard for a region of the Russian Federation depends only on the differentiation coefficient; incidence rate, age and gender structure of population in a region are not taken into account while calculating the subvention amount.


230-238 984

The availability of the adequate number of qualified health workforce is an important component of the National Health Program that guarantees affordable and high-quality medical care to the citizens of the Russian Federation. Health workforce planning can be efficient when all its elements are efficient; especially, the methods of assessing the demand for medical personnel and the arrangements for attracting skilled human resources (training programs for specialists, improved work contracts, incentives, and wage regulation).

Aim: to review and analyze the current practice of assessing the demand for medical personnel and the reevant regulations in the Russian Federation.

Materials and Methods. Regulatory documents and other publically available materials regarding the assessment of demand for medical personnel in the Russian Federation were analyzed; our special interest was focused on documents regulating the number of medical doctors. The review included the orders of the Ministry of Health of Russia, which established the methodology for calculating the demand for medical personnel, organizational standards of medical care, and procedures for the provision of medical care.

Results. Two major approaches to the assessment of demand for medical personnel are used in Russia. According to the first approach, the deficit or surplus of the medical personnel is determined by comparing the actual number of employees with the staffing norms. The second approach suggests comparing the actual number of employees with the number calculated in accordance with the recommended methodology. Both approaches have disadvantages that reduce the likelihood of their practical efficiency.

Conclusion. In Russia, the existing approaches to the assessment of the health workforce demand do not allow for long-term strategic planning and should be revised and optimized.



239-245 1073

Introduction. In 2016-2018, the approaches to the development and use of clinical guidelines in the Russian Federation underwent substantial changes. As part of this work, legal aspects of clinical guidelines were modified. The present review, conducted on behalf of the Ministry of Health, is aimed to analyze the international experience regarding the clinical guidelines standards and identify possible obstacles and risks for their implementation.

Materials and methods. We reviewed documents and publications related to the development and implementation of clinical guidelines in 2016-2017 in 12 countries from Europe, Asia and North America known for their well established health care systems. The search for publications has been conducted with the help of the PubMed bibliographic database and the Google search engine, using the following requests: «clinical practice guidelines legal status», «clinical practice guidelines + name of the country». The results were updated to 2019.

Results. In most of the 12 countries, the clinical guideline development process is coordinated at the national level. However, the implementation of these guidelines by medical professionals is not mandatory, although it is often supported by the regulations of the national health system.

Conclusion. The development and implementation of clinical guidelines in the Russian Federation is consistent with the international experience: the development of clinical guidelines is coordinated at the federal level in agreement with the principles of evidence-based medicine; the implementation of guidelines are not mandatory, however, medical organizations and health professionals are expected to provide the medical care by considering the clinical guidelines, approved by the Scientific and Practical Council of the Ministry of Health.




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