Objective: to evaluate the pharmacoeconomic feasibility of using monoclonal antibodies or their combinations vs standard therapy in patients with mild and moderate-severe COVID-19 in order to prevent the severe course of the disease.

Material and methods. The decision tree and Markov models for calculation of costs and outcomes were used for patients with COVID-19 and post-COVID-19 syndrome, respectively. The cost-effectiveness of tixagevimab and cilgavimab was evaluated in persons ≥18 years old not vaccinated against COVID-19 with a high risk of progression to severe COVID-19. Effectiveness and safety of tixagevimab and cilgavimab combination was assessed based on TACKLE phase III study results. The quantities of life years gained (LYG) and quality-adjusted life years (QALY) were calculated. Results were compared with the wiliness-to-pay threshold measured as tripled gross domestic product per capita according the World Health Organization recommendations.

Results. Treatment of COVID-19 with tixagevimab and cilgavimab results in additional 0.2657 LIGs or 0.2255 QALYs. The cost of 1 LIG was 213,4 thousand rubles, the cost of 1 QALY was 251,5 thousand rubles. Both costs of LIG and QALY appeared to be significantly less compared to the wiliness-to-pay threshold equal to 3.09 million rubles in 2022.

Conclusion. Treatment of mild and moderate-severe COVID-19 is economically feasible and may be recommended for wide use in the Russian healthcare system.

Objective: analysis of clinical and economic efficiency of various etiotropic chemotherapy regimes in patients with respiratory tuberculosis with multidrug- and extensively drug-resistant (MDR and XDR) pathogen using the pharmacoeconomic modeling method (Markov model).

Material and methods. A single-centre, observational, retrospective, cohort study was performed, which included patients who received treatment in clinics and affiliated organizations of the main Moscow tuberculosis institution during 2014–2019 regarding respiratory tuberculosis with the MDR/XDR pathogen. The data of 1387 patients were analysed, of which 1093 patients received “optimized basic regimen” (OBR) in accordance with the Federal Clinical Recommendations of 2015, 294 patients received etiotropic therapy in accordance with the recommendations of the World Health Organization of 2018–2019. To evaluate economic efficiency, the pharmacoeconomic costeffectiveness analysis and pharmacoeconomic modeling were used. When assessing the economic costs of treatment, the direct costs (medical and non-medical) were taken into account.

Results. The study results showed that 68.4% of patients in the group with bedaquiline-containing chemotherapy regimens reached the outcome of “treatment successfully completed” (patient was cured or transfered into the III group of dispensary follow-up) compared to 51.8% in the OBR group. The use of “new” etiotropic therapy regimens is most economically justified in patients with ХDR-tuberculosis with repeated treatment courses: incremental cost-effectiveness ratios (ICER) were 24,530.20 and 21,526.50 rubles per 1 patient. Markov model was developed, transitions from one state to another were evaluated according to the results of clinical observations during the first 2 years of research.

Conclusion. The use of the dynamic model of the patient state made it possible to refine the estimates of the effectiveness of the compared etiotropic chemotherapy regimens for tuberculosis with MDR/XDR pathogen. Based on the results of modeling the dynamics of patients in the interval of 2 to 10 years of treatment, the use of “new” regimens provides a significant increase in the proportion of treatment success (by 16.1–29.8% in different groups of patients and at different times), a decrease in mortality (by 6.1–11.0%), and in the proportion of those who interrupted treatment (by 8.0–21.8%) in comparison with OBR.

Objective: to perform pharmacoepidemiological and drug interaction analysis of pharmacotherapy for liver/kidney transplantation.

Material and methods. The study was conducted on the basis of multidisciplinary hospital in Nizhny Novgorod, which provides both therapeutic and high-tech surgical care. The object of the study was medical records of 34 patients who had undergone pharmacotherapy for liver/kidney transplantation. We evaluated the particularly dangerous moderate interactions that pose the greatest risk to patient health using Drugs.com electronic resource. Pharmacoepidemiologic assessment was performed using the ATC/DDD methodology (anatomical therapeutic chemical (ATC) classification system – defined daily dose (DDD)) recommended by the World Health Organization. The “average bed occupancy per year” was calculated using DDD per 100 bed-days. ABC analysis was used to estimate the costs of drug groups in therapy for liver/kidney transplantation. Results. In most cases, the third generation cephalosporins were used in the therapy of liver/kidney transplant patients (55.56% of all prescriptions). Antimicrobial drugs were mostly prescribed as monotherapy (61.9%). There were 111 potential major (14.41%) and moderate (72.07%) interactions detected. The largest number of moderate type risks was associated with changes in blood pressure levels (in 23.75% of cases – possible decrease, in 10% – increase), 7.5% of cases were accompanied by headaches, 6.25% – by reduction of drug effectiveness. In antimicrobial therapy, two main interactions were found: moxifloxacin – tacrolimus (arrhythmia), and metipred – moxifloxacin (tendon dystrophy), which is 12.5% of all main interactions for 21 case histories. In the ABC analysis, immunosuppressants were in group A (cost share 85.8%). Tacrolimus accounted for the largest amount of consumption: number of defined daily doses (NDDD) per year was 532.27 mg, NDDD per 100 bed days reached 432.18 (the highest among all drugs).

Conclusion. Pharmacoepidemiologic analysis allows us to systematize data on medication use. The choice of drugs in order to ensure safe and effective use of the registered drug interactions is facilitated by electronic databases.

Background. Due to the significant prevalence of human immunodeficiency virus (HIV) and limited funding in the Syrian Arab Republic (SAR), pharmacoeconomic study of antiretroviral therapy (ART) regimens is relevant, as it allows to choose a rational, pharmacoeconomically reasonable therapy for HIV-infected patients.

Objective: to perform pharmacoeconomic analysis of ART regimens HIV-infected in patients in SAR.

Material and methods. The following algorithm of actions was used: assessment of the cost of prescribed antiretroviral drugs; cost analysis of applied ART regimens. From the auction documentation, information was taken on the total number of purchased drugs and their cost at the end of the auction. To calculate prices in rubles, currency conversion was carried out as of January 1, 2021. To calculate the cost of an assigned regimen, the summation of the costs of its components was carried out. Based on the obtained data, the average cost of combinations of certain antiretroviral drugs classes was calculated. To predict the results of using various ART regimens for 5 years, discounting was used for each year of the time horizon, except for the first year.

Results. It was revealed that the most expensive drugs are the reserve series: Fuzeon^® (enfuvirtide; F. Hoffmann-La Roche Ltd., Switzerland) – 66,492.1 rubles and Isentress^® (raltegravir; Merck Sharp & Dohme, Netherlands) – 31,634.6 rubles, and the lowest price per package was noted for Russian drugs Timazid^® (zidovudine) – 471.0 rubles and Nikavir^® (phosphazide) – 743.8 rubles (both – AZT Pharma K.B. LLC, Russia). The average cost of the first prescribed regimen was 8,970.0 rubles/month, while the most expensive first-line regimens included a protease inhibitors class drug as the third component. As a result of the analysis of the cost of second-line and third-line regimens, it was revealed that the average cost of second-line therapy per month exceeded the average cost of first-line therapy by 4 times (40,154.2 rubles/month). The initial “azidothymidine, zidovudine / lamivudine + efavirenz” group had fewer hospitalizations, lower mortality, and fewer years of life expectancy lost than on “azidothymidine, zidovudine / lamivudine + atazanavir, ritonavir” and “phosphazide + didanosine + efavirenz” regimens.

Conclusion. A pharmacoepidemiological study showed that the cost of second-line therapy per month was 40,154.2 rubles, which exceeded the average cost of first-line therapy by 4 times (9,266.1 rubles). It was revealed that the average cost of the first prescribed ART regimen based on two nucleoside reverse transcriptase inhibitors (NRTIs) and protease inhibitor was 2 times higher than the average cost of regimens based on two NRTIs + non-nucleoside reverse transcriptase inhibitors, which, along with clinical aspects, raised the question of the expediency of their appointment as first-line regimens.

Background. In 2021, new clinical guidelines for the treatment of chronic hepatitis C virus (HCV) in adults were published that did not contain interferon drug therapy regimens. Current therapy of chronic HCV is based on modern drugs of direct-acting antivirals (DAA). In this regard, the model of diagnosis-related groups (DRG) with the use of interferon-containing drugs as etiotropic therapy, which has been in effect until now, has lost its relevance and cannot be used to pay for cases of medical care for chronic HCV within the framework of the Program of State Guarantees of Free Medical Care to Citizens for 2023 and for the planning period of 2024–2025 (PSG). Objective: to improve the DRG model to pay for medical care for chronic HCV in a day hospital based on current clinical recommendations.

Material and methods. Regulatory legal documents on the subject of the study, proposals and expert opinions of specialists, as well as feedback from public organizations, including patients, regarding the payment of medical care for chronic HCV, sent as part of a public discussion of the draft PSG, were studied. For the calculations were used: the current version of the clinical recommendations "Chronic viral hepatitis C"; impersonal personalized information of the database of registers of bills for payment for medical care for 2020–2021; the state register of manufacturers' maximum selling prices for medicines included in the list of vital and essential drugs.

Results. A DRG model was developed to pay for medical care during drug therapy of chronic HCV, including for children. When calculating the model, the cost of medicines, patient days and the principles of accounting for the duration of hospitalization were updated.

Conclusion. The developed DRG model to pay for medical care for chronic HCV in a day hospital with the use of drug therapy regimens with DAA recommended by clinical guidelines, including for children with HCV, contributes to improving the effectiveness of the system of payment for medical care provided as part of the implementation of the PSG and accessibility of medical care for this contingent of patients.

Background. The superficial veins thrombophlebitis (SVT) of lower extremities treatment can include conservative therapy (pharmacotherapy), crossectomy and phlebectomy.  

Objective: рharmacoeconomic evaluation of pharmacotherapy, crossectomy (in combination with pharmacotherapy) and phlebectomy (in combination with pharmacotherapy) in patients with SVT of lower extremities.  

Material and methods. Pharmacoeconomic evaluation was carried out using cost-effectiveness analysis (CEA) by calculating the costeffectiveness ratio (CER). The relapse/progression of the disease within 3 months after the end of treatment, the dynamics of pain, psychological, physical, social factors and the visual analog scale (VAS) indicator were used as parameters of clinical effectiveness. To assess the reliability of the obtained results, a deterministic, multivariate sensitivity analysis was performed.  

Results. Considering part of patients without progression and relapse within 3 months after the end of therapy as an indicator of clinical effectiveness, it was found that median CER for pharmacotherapy (22069,01) was significantly lower than for crossectomy (83353,91) and phlebectomy (95702,96) (p=0,000). Also median CER for crossectomy technique was significantly lower than for phlebectomy (p=0,003). The CER values for the dynamics of pain, psychological, physical, social factors and VAS indicators were significantly lower for pharmacologic treatment than for crossectomy and phlebectomy. There were no statistically significant differences between CER values for crossectomy and phlebectomy.  

Conclusion. It was established that if there are no medical contraindications, it is economically feasible to carry out pharmacotherapy for SVT of lower extremities, which requires the lowest costs to achieve full recovery. The pharmacoeconomic efficiency of crossectomy and phlebectomy are comparable. 

Objective: to conduct a comparative pharmacoeconomic analysis of using follitropin delta for controlled ovarian stimulation in adult women to induce the growth of multiple follicles during cycles of assisted reproductive technology (ART) programs – in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).

Material and methods. The available literature was searched for data on clinical effectiveness and safety of follitropin delta and follitropin alfa. Two large studies were found – ESTHER-1 and ESTHER-2 as well as their combined analysis, based on which a decision tree model was built. Considering the presence of a significant difference between safety profile of analyzed follitropins (the frequency of preventive medical interventions in relation to the development of ovarian hyperstimulation syndrome (OHSS)), the cost-effectiveness analysis was used. The cost analysis included only direct medical costs: drugs (treated separately), ART program cycle, relief of complications. As part of the budget impact analysis (BIA), several options for managing patients with infertility were considered: current practice (in 100% of cases, the use of follitropin alfa), simulated practice (transfer of 50% of patients to follitropin delta). Time horizon was IVF/ICSI cycle 1 within ART program for cost-effectiveness analysis, and 1 year for BIA. Results. Despite the fact that the use of follitropin delta is associated with a higher level of drug costs compared to follitropin alfa, the costs of IVF/ICSI cycles within ART programs and the relief of complications are lower with the use of follitropin delta. The total costs for the Cycle 1 amounted to 132,123.99 rubles with the use of follitropin delta, and 133,392.19 rubles with the use of follitropin alfa. The total costs for three cycles were 200,952.17 rubles with the use of follitropin delta, and 204,296.62 rubles with the use of follitropin alfa (2% difference). The costs per 1 case of no medical interventions due to OHSS for follitropin delta amounted to 135,234.38 rubles, which is 3.2% less compared to the same indicator for follitropin alfa (139,677.69 rubles). BIA demonstrated that the use of follitropin delta will reduce the economic burden on the healthcare system by 49.5 million rubles within 1 year.

Conclusion. According to the results of the study, the use of follitropin delta individual dosing regimen for controlled ovarian stimulation in adult patients as part of IVF/ICSI cycles within ART programs is effective and economically justified approach to organizing medical care for adult patients with infertility in Russia.

Background. The therapy of chronic pain in cancer patients is a highly topical issue for the modern health care system. Intense pain syndrome involves the prescription of strong opioid analgesics (ОА), most of which are classified as narcotic drugs and are under strict governmental control. In this situation, increasing the use of drugs that are equivalent in dosages to morphine and do not require a special narcotic drug prescription may increase the availability of pain relief for cancer patients and will be less associated with drug addiction.

Objective: to analyze the regulatory, organizational, clinical, and economic criteria that determine the choice and influence the prescription of strong ОА for adequate pain relief in cancer patients with chronic pain syndrome (CPS). Material and methods. The article determines legal and regulatory framework regulating the sphere of providing patients with ОА, presents an expert evaluation of existing barriers that limit the availability of adequate pain treatment, and shows ways to solve these issues. We present the results of an original Russian clinical and economic study evaluating the use of prolonged forms of ОА (tapentadol and morphine) for the treatment of moderate and severe CPS in patients with cancer in the Russian healthcare system. The evidence for comparative clinical efficiency and safety of ОА under consideration is analyzed. The costs of therapy with the drugs in equivalent dosages that provide 1 year of adequate analgesia for intensive CPS in oncology patients are compared.

Results. Differences in the regulatory status of opioids, including requirements for prescribing, storage, record keeping, and use, were shown to affect the availability of pain medication. According to a systematic review of the comparative efficiency and safety of prolonged forms of ОА in the therapy of cancer patients with moderate and severe CPS and a meta-analysis of randomized controlled trials, no differences were found for any of the outcomes studied in the tapentadol and morphine groups: frequency of achieving pain control – risk ratio (RR) 0.88 (95% confidence interval (CI) 0.78–1.00), frequency of using emergency (additional) pain relief – RR 1.16 (95% CI 0.95–1.42), frequency of gastrointestinal adverse events – RR 0.82 (95% CI 0.60–1.12). This suggests comparable efficiency and safety of the drugs. The difference in average cost of 1 patient course of therapy for 1 year between tapentadol and morphine was 17,653.02 rubles (–16.8%). Additional funds released in case of treating the cohort of 100 patients with tapentadol instead of morphine made 1,765,301.96 rubles, which means 20 more patients could be treated with tapentadol for 1 year.

Conclusion. The use of modern effective non-invasive forms of ОА (tapentadol in particular) that have no restrictions imposed by regulatory documents on narcotic drugs prescription will increase availability, as well as reduce costs of adequate therapy of moderate and severe CPS in patients with cancer as compared to the use of equivalent daily doses of morphine.

Objective: development of approaches to predict the likelihood of adverse reactions (ARs) when using drugs based on a comprehensive assessment of risk factors.

Material and methods. We used a database containing 1,450 drug-related ARs reports from January through December 2021. A list of antibacterial drugs by international nonproprietary name (INN) with 4 or more ARs reports was selected as a reference group to perform various types of statistical analysis. A cumulative multivariate regression analysis was carried out on a database of 187 ARs notifications for 13 INN of antibacterial drugs. The study was performed in two stages. In the first stage, a statistical method was used (classical multiple regression, linear discriminant analysis, factor analysis, principal component regression, partial least squares regression, estimation of variance accuracy); at the second stage a modeling method was used. As part of the modeling stage, the integral score of the risk of ARs was presented as a sum of values for individual risk factors. Two groups of risks were proposed to be assessed: 1) intrinsic risk value for each factor (attribute), which was equal to the sum of risks of all factors (conditions) in which the drug had been used; 2) intrinsic risk value for antibacterial drugs by each INN. The total risk value was defined as the sum of the risk of the drug and all factors (conditions) in which this drug had been used.

Results. The results were visualized in the form of a two-level risk-based model matrix, with a “heat map” of the risk level overlaid on it. The maximum total risk of ARs was obtained for ceftriaxone – 404.96 points, depending on patient’s gender. The minimum total risk was calculated for azithromycin and cefotaxime depending on the International Classification of Diseases (10th revision) code – 88.46 points. The proposed methodological approach also allows combining all possible combinations of drugs and conditions of their use. For example, for the use of vancomycin in hospital conditions by intravenous administration: intrinsic risk of use – 42.93 points; risk of use in hospital conditions – 183.68 points; risk when administered intravenously – 209.95 points; the total risk value in the designated situation – 436.56 points.

Conclusion. The proposed approach can allow medical organizations to reduce significantly the number of ARs when using drugs by categorizing and preventing risks before they occur. It also has significant prospects of application at the federal level, given its modification on a large volume of data.

Objective: assessment of the information component in the process of consulting visitors to pharmacy organizations during provision of pharmaceutical assistance.

Material and methods. A prospective study involving a simulated secret patient in 100 pharmacy organizations in the city of Khabarovsk was performed. There were no strict criteria for including pharmacies in the study due to the obligation to provide this information service in all organizations, regardless of turnover, form of ownership, availability of a separate service area and other indicators. As criteria for the process information component, a modified (simplified) algorithm from the passport of the “Pharmaceutical consultation” station was used, which is applied for accreditation of specialists. Statistical data processing was carried out using Kruskal–Wallis test.

Results. A high rate of incomplete collection of information about a visitor and his/her current condition was revealed. Pharmacy workers rarely clarify the presence of concomitant complaints, diagnoses, special health conditions, the use of other drugs. For drug care, with the condition indicated by the patient, only 62% of specialists were able to recommend three drugs. Even if the visitor needed information, less than 60% of pharmacy workers were able to explain the possible adverse effects and the course of application. Less than a third of specialists paid the patient's attention to the need of visit to a doctor if the condition worsened or symptoms persisted.

Conclusion. The obtained results allow to confirm the rationality of regular updating the standard operating procedure “Pharmaceutical consultation” in pharmacy organizations and advanced personnel training. 

Background. The implementation of individual methods of high-tech medical care (HTMC) with methods of specialized medical care within the framework of a phased transition to payment methods by diagnostic-related groups (DRGs), on the one hand, significantly expanded the availability of HTMC methods for the population. Still, it created a situation with duplication of individual treatment methods in the list of HTMC types and DRGs. Amendments to the Order of the Ministry of Health of the Russian Federation (MH RF) of August 1, 2017 No. 484n, regulating the revision of HTMC types list in terms of excluding treatment methods and (or) HTMC types in case of their duplication in the context of HTMC groups and/or DRGs, marked the beginning of large-scale work in this area and required methodological ensuring the processes of forming HTMC types list, including in terms of its revision.

Objective: development of a methodological approach to the formation of HTMC types list (using the example of the list for 2023). Material and methods. An analysis of legal documents regulating the HTMC availability in the Russian Federation was carried out, including the list of medical services approved by the Order of the MH RF of October 13, 2017 No. 804n, clinical recommendations for certain nosological entities, the International Classification of Diseases (10th revision), methodological recommendations on ways to pay for medical care at the expense of the compulsory health insurance (CHI) and appendices to them (decoders of DRGs for payment of medical care provided in inpatient and daytime hospital conditions), posted on the official website of the Federal CHI Fund. The frequency of the use of certain HTMC methods and DRGs was analyzed on the basis of impersonalized information from the database of registers of bills for specialized medical care, including HTMC for 2021–2022.

Results. A methodological approach to the revision of HTMC types list was developed. It included its primary analysis, expert discussion of the obtained results, consideration by the Interdepartmental Council of the MH RF of proposals agreed with experts on each HTMC method submitted for discussion, followed by a decision on the appropriateness of the proposed changes, and recalculation of the standard of financial costs for HTMC and/or basic tariff for DRGs.

Conclusion. The proposed methodological approach makes it possible to unify the process of revising the HTMC types list, including the exclusion of duplicate treatment methods and/or HTMC types in the sections of HTMC list types and/or in DRGs, as well as treatment methods missing in clinical recommendations, etc. in order to bring the HTMC types list in accordance with legal documents regulating the provision of medical care in the Russian Federation.

The use of real-world data (RWD) and real-world evidence (RWE) in process of improving public health, their assessment, and use in decision making is a promising area. Discussions are actively underway about the possibility of using RWD and RWE in routine medical practice of doctors and health care organizers, the weaknesses of these matters and ways to overcome them. Taking into account the considerable amount of information, complexity, and inconsistency of issues under consideration, the article presents the basic principles of using RWD and RWE in decision making, classification of health technologies values, classification of RWE sources, position of RWD studies in the hierarchy of clinical study designs, as well as the ways of their use in complex drug assessment.

Today, it is difficult to overestimate the new directions in the pharmacotherapy of peripheral T-cell lymphomas (PTCL): immunotherapy, including adoptive, targeted therapy and chemotherapy. However, there are few biomarkers that predict response to therapy. A big problem is patients with refractory and recurrent PTCL who do not respond to such therapy or demonstrate adverse events, which makes it important to personalize therapy and search for predictive markers, followed by thorough analytical and clinical validation. The literature highlights the importance of using biomarkers obtained from whole exome sequencing and tumor transcriptome sequencing. The review discusses the T cell ontogenesis, as well as the possibilities of personalization of anticancer drugs such as azacitidine, duvelisib, romidepsin, and bortezomib for the treatment of refractory or recurrent PTCL.

Patients who underwent radical antitumor treatment for ovarian cancer, borderline ovarian tumors, often experience a severe range of morphofunctional and psychological disorders. Frequent complications are postovariectomy syndrome, sexual dysfunction, anxiety and depression, and chronic pelvic pain, which reduces the overall quality of life. Numerous studies show that for this category of patients, the preservation of labor activity and social significance is an extremely important aspect. This dictates the need to organize rehabilitation measures that significantly increase the quality of life of oncogynecological patients and contribute to the restoration of their professional and social functioning. 

Osteoarthritis (OA) is a painful and disabling disease that affects millions of people around the world. OA is the most common form of arthritis and is characterized by joint pain and stiffness, leading to a decrease in functional activity and loss of quality of life. Approaches to OA therapy are constantly being revised, as new molecules appear, data on drugs/molecules already in use, including data on adverse events, new randomized controlled trials results, new methods of adjunctive therapy become available. OA therapy and prevention, drugs with chondroprotective properties are prescribed according to the opinion of European experts (2019): chondroitin sulfate (CS), glucosamine sulfate (GS), diacerein, avocado soybean unsaponifiables, hyaluronic acid (HA) for intra-articular administering. Only CS and GS have proven effectiveness and the level of recommendations A1, they are included in clinical recommendations and standards of the Ministry of Health of the Russian Federation (MHRF), and international recommendations according to which CS and GS should be used for a long time (up to 6 months). The article focuses on the analysis of erroneous statements regarding the classification, composition and mechanisms of action of different drugs of this group. Differences in terminology of drug groups are given, such as: chondroprotectors, symptomatic slow acting drugs for osteoarthritis (SYSADOAs), disease-modifying osteoarthritis drugs, between which an equal sign cannot be placed. Based on the analysis, a conclusion was made about erroneous attitudes towards some SYSADOAs: 1) according to the Anatomical Therapeutic Chemical Classification, the active substances CS, GS, diacerein and HA are classified as nonsteroidal anti-inflammatory drugs due to their antiinflammatory activity; 2) quite often, drugs based on bioactive concentrate of small sea fish and glycoaminoglycan-peptide complex do not belong to SYSADOAs according to any of the existing generally recognized classifications, they do not contain a sufficient amount of active substances (CS or peptides), there is no proper level of evidence, they are not included in the recommendations of international medical communities and MHRF clinical recommendations and standards. In Russia, physicians must follow MHRF clinical guidelines and standards for OA therapy.

Objective: to summarize scientific information about the basic principles of modern drug therapy for patients with chronic myeloid leukemia (CML) considering their individual characteristics.

Material and methods. The basis of the study included modern scientific articles and clinical guidelines on CML diagnosis and treatment (2021), State Register of Medicines (SRM) of the Russian Federation, instructions for the use of medicines. The following methods were used: structural analysis, analytical method, content analysis, retrospective analysis, systematic approach, situational-logical and graphical methods of analysis.

Results. The analysis made it possible to summarize scientific information about the basic principles of drug therapy for patients suffering from CML. It was revealed that the problem of CML therapy today is relevant, since every year there is an increase in the incidence of this nosology. Currently, the most significant is the prescription of tyrosine kinase inhibitors (TKIs), since they have pronounced effects and are well tolerated by patients. Therapy for CML in TKIs prescription consists of several lines. Imatinib is the first line therapy because it has better safety profile. There are combinations with imatinib; for example, it is used together with interferon alfa, which allows, in some cases, to increase the response to treatment. The following drugs are used in the second line: nilotinib, dasatinib, bosutinib, ponatinib. If TKI therapy is ineffective, it is possible to prescribe standard chemotherapy, interferon therapy, or bone marrow transplantation in the absence of contraindications. Studies are underway on the possibility of using and including in clinical guidelines such drugs as arsenic trioxide, decitabine, omacetaxime, inhibitors of farnesyl transferases, granulocyte-macrophage factors, antitumor vaccines. The analysis of SRM identified 27 trade names for TKIs, the share of domestic drugs was 60%. There were no Russian analogues for bosutinib and ponatinib in SRM, which are recommended for use in case of ineffective TKI therapy of previous lines.

Conclusion. The study of drug provision for CML patients is an urgent task for pharmaceutical practice and for the healthcare system as a whole. Currently, the acute issues are the individual approach to the treatment of each CML patient considering concomitant diseases, and the search for new, more effective drugs that can increase the life expectancy and quality of life of patients suffering from this disease.

Background. Therapy of hyperlipidemia with synthetic statin drugs is characterized by a number of side effects. In particular, statin-dependent myopathy occurs as a result of statin inhibition of biosynthesis of cofactor coenzyme Q10 (CoQ10), which plays a central role in the electron transport chains during adenosine triphosphate (ATP) synthesis in mitochondria.

Objective: systematic analysis of scientific publications on CoQ10 pharmacology with an emphasis on its effect on the lipid profile.

Material and methods. The analysis included 16,788 articles found by “coenzyme Q10 OR ubiquinone" query in the PubMed/MEDLINE biomedical publications database. Topological and metric big data analysis methods were used developed in the scientific school of Academician of the Russian Academy of Sciences Yu.I. Zhuravlev.

Results. A much wider range of CoQ10 pharmacological effects was established than simply supporting ATP biosynthesis. Coenzyme Q10 exhibits pronounced lipid-lowering, anti-asthenic, and anti-inflammatory effects and can be successfully used in the treatment of asthenic conditions, cardiovascular pathology (including hyperlipidemia and statin-induced myopathy), carbohydrate metabolism disorders (insulin resistance), and diverse neurological diseases. CoQ10 supplements reduce mortality by 50% in patients with cardiovascular diseases, improve glycemic control in insulin resistance, kidney function, and are useful in the treatment of migraine and neurodegenerative pathologies (Parkinson's disease, etc.).

Conclusion. Experimental data and evidence base indicate the potential of using CoQ10 in patients with hyperlipidemia and other cardiovascular system diseases.