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Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice

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No 4 (2019)
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FROM EDITOR

PHARMACOECONOMICS

4-14 763
Abstract
Atopic dermatitis (AD) is a chronic systemic disease with skin lesion, inflammation caused by mediators plays important role in its pathogenesis. Severe AD characterizes by permanent exacerbations that leads to sufferings and, influences on physical and emotional conditions and losses of patient’s productivity. Modern drugs including biologicals have a good clinical efficacy, but the same time AD burden (cost of illness) in the Russian conditions are not evaluated yet. Direct medical and nonmedical costs, non-direct costs in severe AD in adults based on prevalence data, statistics of finances covering of out-patients and in-patients treatment options, experts’ opinions, reports about temporary disability, losses of GDP etc. have been calculated. Burden of severe AD in local practice can be evaluated as 564 242 RUR/patient/year in working age and 263 230,5 RUR/patient/ year in aged population. Social-economic burden of severe AD in the Russian Federation can reach 13,074 Bln RUR annually (12,031 Bln RUR for working patients and 1,043 Bln RUR for aged population of patients). Direct non-medical and non-direct costs have at least 50 % of all expenditures that highlighting of social importance of severe AD.
15-22 796
Abstract
Cancer-related morbidity and mortality have been increasing worldwide including in Russia. In recent decades, many innovative antineoplastic pharma products have been launched in the international pharmaceutical market; however, their high price has resulted in significant increase in the cost of treatment and in its inaccessibility for a considerable percentage of patients not only in the countries experiencing low economic growth, but also in those with a high level of economic development. One of the most effective ways of reducing the cost of pharmacotherapy is replacement of innovation medications after the expiration of the patent with their generics and biosimilars. In this article the authors discuss the cost of oncopathology pharmacotherapy with original drugs and their generics and also the factors that affect cost-effectiveness of generics and biosimilars in oncology.
23-32 721
Abstract
Purpose. To evaluate pharmacoeconomic efficiency of dapagliflosin application for intensification of hypoglycemic therapy — in comparison with addition to therapy of group of inhibitors of dipeptidyl peptidase 4 (iDPP-4) or basal insulin. Materials and methods. Budget impact analysis was done retrospectively using published clinical research data. The evaluation was carried out according to 2 scenarios of intensification of therapy of patients with diabetes mellitus: using dapagliflozine in comparison with iDP-4 (scenario No. 1) or using dapagliflozine in comparison with basal insulins (scenario No. 2). In the first scenario, both direct and indirect costs were taken into account, and in the second scenario, only direct costs were taken into account. Results. The analysis of influence on the budget showed that when using a dapagliflozin in comparison with medicines of class IDPP-4 it is possible to reach decrease in the total costs on the 2nd year of therapy, at the same time in 5 years economy will make 19.4-24.2 % or 21,985-29,123 rub per 1 patient. In patients who have not previously received insulin, with the same effectiveness in reducing the level of glycated hemoglobin, the use of dapagliflosin in comparison with basal insulin reduces the cost of drug therapy by 9.3 % or by 3,566 rubles per year. If combined «surrogate» endpoint is used as an efficiency criterion, reduction of glycated hemoglobin level and body weight, intensification of therapy using dapagliflosin is dominant scheme: More patients reach the end point on dapagliflozine compared to basal insulin (57 and 37 % respectively), with direct costs associated with using dapagliflozine less by 9.3 % or 1,763 rubles in 180 days. Conclusion. The use of dapagliflosin to intensify therapy in patients with diabetes mellitus is economically viable. From the point of view of pharmacoeconomics, therapy schemes involving dapagliflosin dominate comparison therapy schemes. Dapagliflosin can be recommended for inclusion in medical care standards, drug programs, and formula lists of medical organizations.

HEALTH TECHNOLOGY ASSESSMENT

33-39 732
Abstract
Aim. To evaluate the clinical and economic outcomes associated with cases of Clostridium difficile associated colitis from the standpoint of the Hospital and health care system researcher. Materials and methods. A retrospective case-control observational study was conducted, which included 900 patients (450 in the disease and control group) treated in St. Petersburg state medical institution “St. George Hospital” with an assessment of clinical and economic outcomes (probability of death and hospitalization in the ICU; prolongation of hospitalization, including in the ICU, the cost of the completed case of the disease according to the rates of statutory health insurance). Results. There are significant consequences associated with cases of the disease, both from a clinical and economic point of view: high risks of death (OR 1.52), risks of hospitalization in the ICU (OR 1.57); prolongation of General hospitalization (+8 days) and hospitalization in the ICU (+3 days), as well as significant incremental cost of hospitalization. At the same time, the losses of the State as a payer are significant and amount to about 25.5 thousand rubles for each case of colitis, while the direct costs of the hospital do not exceed 3 thousand rubles. Summary. Efforts to prevent episodes of Clostridium difficile associated colitis, as well as the development of new treatment regimens are important for reducing the burden of the disease, and the resulting calculations can provide useful information when conducting pharmacoeconomical analysis of new treatment regimens for the disease.
40-49 705
Abstract
The problem of rational consumption of resources in situation of limited budgets is extremely relevant for modern health care. Currently, at the state level, there is a procedure for making decisions on the inclusion of new medicines in the restrictive lists (primarily in the List of vital and essential medicines (VED)). It is important to understand that, on the one hand, medicines are not the only medical technology used in the provision of medical care, on the other hand, the existing guidelines are a view of the health system, the State and society on their appearance in real clinical practice. At the same time, conducting clinical and economic research in the hospital allows to take into account the current strategic, organizational, financial, personnel aspects of a particular medical institution. The developed organizational and methodological model of the hospital assessment of health technologies describes the organizational aspects of health technologies assessment in the hospital, as well as the actual methodology of its implementation. The created methodology adapts the world experience of hospital assessment of health care technologies to the existing legislative, administrative, and personnel aspects of the work of medical institutions in the Russian Federation. Testing of the model in hospitals St. Petersburg demonstrated the possibilities and prospects of hospital assessment of health care technologies in Russian institutions, related to information support of management decisions on the introduction of new medical technologies (medicines, medical equipment, medical devices, etc.), taking into account the current strategic, organizational, financial, personnel aspects of a particular medical institution.

PHARMACOEPIDEMIOLOGY

50-54 1011
Abstract
Community-acquired pneumonia (CAP) remains an urgent problem in the structure of infectious diseases worldwide including the Russian Federation. According to medical statistics the incidence rate of CAP increased by 19.1 % by December 2018 as compared to year 2017. The authors addressed the problem of rational choice of antimicrobial agents (AMAs) for outpatient treatment of this disease. The aim was to assess structure and rationality of choice of AMAs for outpatient treatment of CAP by primary care physicians in municipal outpatient clinics in Moscow. A two-stage single-center pharmacoepidemic study was conducted. The survey involved 45 primary care physicians with average age 48.5 ± 13.2 years and medical experience 22.7 ± 13.6 years. Relevant information was also copied out from 650 ambulatory records of patients receiving AMs for CAP. According to the results of our survey the leaders of the respondents’ preferences are beta-lactam antibiotics — amoxicillin/clavulanate (49.0 %) followed by amoxicillin (25.5 %) and cephalosporins (15.7 %). Analysis of real clinical practice brings different picture: cephalosporins become comparable to amoxicillin/clavulanate in terms of frequency of administration, The latter significantly loses popularity, as does amoxicillin as monotherapy These data match with similar survey of 233 Moscow primary care physicians conducted earlier in 2013-2014 by one of the authors where amoxicillin/clavulanate accounted for 43.6 % of total AMAs recommendations. Thus, the initial choice of AMAs for outpatient treatment of CAP in most cases does not comply with current clinical guidelines. Physicians tend to start initial outpatient management of CAP with second-line AMAs (amoxicillin/clavulanate, cephalosporins, less commonly fluoroquinolones), underestimating macrolides and almost neglecting doxycycline. These circumstances result in unwarranted increase in drug load on the patient, decrease in safety of treatment and ineffectiveness of antimicrobial therapy in case if CAP is caused by atypical pathogens.

DRUG SAFETY

55-65 740
Abstract
Cardiovascular toxicity of cancer therapies remains an urgent problem today. The creation of highly effect antitumor drugs also means the appearance of new adverse effects. Immune checkpoint inhibitors (ICI) is a new class of antitumor drugs that is different from traditional chemotherapeutic and targeted drugs. Immunotherapy with ICI (monoclonal antibodies targeting the cytotoxic T-lymphocyte associated antigen 4 (CTLA-4), programmed cell death protein 1 (PD-1) or its ligand (PD-L1)) significantly improved the results of treatment of cancer therapy. These drugs regulate antitumor immunity and promote cancer regression and improve survival, but can also cause a wide range of immunity-related adverse events (AEs). Although cardiotoxicity associated with ICI is rare, it is important because of its high mortality rates. In recent years, cases of myocarditis and fatal heart failure have been recorded more often in patients receiving ICI. This review focuses on the mechanisms of cardiotoxicity, methods for the prevention and treatment of these adverse events. Severe cardiovascular consequences associated with the use of ICI are important issues for oncologists, cardiologists and immunologists.

LITERATURE REVIEW

66-80 905
Abstract
In this article the authors address the problem of poor medication adherence in patients with cardiovascular disease. Poor medication adherence significantly reduces efficacy of pharmacotherapy thus increasing risk of cardiovascular complications and higher treatment costs in routine clinical practice. This problem was first raised by a few foreign scientists in the 90s and then officially recognized by the World Health Organization in 2003. The article presents review on the prevalence of low medication adherence in patients with cardiovascular disease and describes key factors associated with decreased adherence. An overview of widely used indirect methods to measure medication adherence is presented as well. On the way to solve this problem, the development and implementation of various measures and interventions to improve medication adherence is actively carried out in recent years. The results of the most significant studies on the effectiveness of such interventions are also presented in the article. Positive influence on patient adherence was demonstrated, however, only a number of studies reported reduction of the risk of unfavorable clinical outcomes of cardiovascular diseases. This confirms the need to further study the problem of medication adherence focusing on routine clinical practice in Russia.


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ISSN 2588-0519 (Print)
ISSN 2618-8473 (Online)