Bronchial asthma (BA) is worldwide lungs’ illness, at least 1,5 mln people are on a dispensary in Russia. Non-control severe BA (SBA) can lead to increasing of direct Health Care System expenditures due to very oft en exacerbations (drugs costs, hospitalizations and out-patient cure etc.) as well as to increasing of non-direct costs because temporary and permanent disability can be a result of a disease progression. Treatment of SBA has difficulties, system steroids with their well-known side effects use often as remedy of choice. Biologicals with high efficacy potential and minimal side effects are used in a clinical practice during few last years.

Aim: evaluation of a comparative influence of two biologicals — dupilumab and omalizumab — on a calculated SBA burden in the Russian Federation.

Materials and methods: Modelling of SBA population size which has needed in biologicals has been prepared based on official statistics and Register of SBA. Direct costs (drugs costs, treatment costs in out-patient departments and in hospitals, visits to doctors etc.) and non-direct costs (payment for temporary and permanent disability, GDP losses) have been modelling and calculated.

Results: Estimated BA patient population size in Russia is 6.94 mln, and non-control SBA amount is 69,7 thousand (31.7 thousand patients in economic active age). The current treatment SBA option (w/o biologicals) has expenditures at least 1 447,2 RUR annually (direct and non-direct in total). Biologicals should decrease total expenditures due to high efficacy — for dupilumab total expenditures could be 495,42 mln RUR/year, for omalizumab — 559,81 mln RUR/year for all patients who are needed in these drugs. Omalizumab has higher weighted average estimated cost in compare with dupilumab (1.19 mln RUR/patient/year and 1.01 mln RUR/patient/year accordingly) and expenditures for omalizumab were higher due to less amount of prevention of exacerbations.

Conclusion: Expenditures for SBA w/o biologicals are higher in compare with biologicals treatment options. Treatment with dupilumab for all patients with non-control SBA could decrease a direct cost on 5,8 %. Dupilumab and omalizumab usage is economically proved in non-control SBA for total cost saving (direct and non-direct).

Aim: a prognosis of clinical-economic efficacy of the fixed combination of insulin glargine and lixisenatide (Soliqua SoloStar®) in comparison with standard therapy with focus on micro- and macrovascular complications of Diabetes Mellitus type 2 (T2DM) in the real practice.

Materials and Methods. Model of Burden of T2DM has been created in Microsoft Excel 2010 program. Direct (costs of medicines, treatment of main T2DM complications — myocardial infarction, stroke, etc.) as well as indirect costs (GPD losses, disability related payments, etc.) were calculated. Complications’ rate was took from Federal Diabetes Register. Influence on Burden of T2DM was tested with the additional model which can calculate expenditures with different drugs including Soliqua SoloStar® usage.

Results. Direct medical costs with Soliqua SoloStar® usage were less in compare with insulin glargine 100 UI/ml on 23,5 % per year due to decreasing level of severe hypoglycemia and possible protective effect on complications of T2DM (better control). Total expenditures for Soliqua SoloStar® were less on 2,5 % annually, in the same time insulin glargine led to total cost increase by 18,4 % per year. So, difference between expenditures in case of Soliqua SoloStar® were less on appr 21 % vs insulin glargine 100 UI/ml. Budget saving is expected as 6,78 ml RUR per year / 1 000 patients in case of Soliqua SoloStar® usage.

Conclusion. Soliqua SoloStar® has economic benefits due to T2DM complications and severe hypoglycemia reduction risks.

Gadolinium-based contrast compounds are paramagnetic chemicals that allow enhancing contrast during magnetic resonance imaging (MRI) tomographic investigation. It`s known that linear gadolinium-based paramagnetic compounds cause permanent accumulation of gadolinium in tissues. This effect is less pronounced in macrocyclic gadolinium-based compounds, which makes them increasingly relevant.

Aim. Evaluate clinical and economic analysis of macrocyclic gadolinium-based contrast gadoteridol compared with gadobutrol for MRI diagnostics.

Methodology. Decision tree model with one-year time horizon was constructed. Model accounted for specific parameters of administration of each of compared contrasts. Only direct medical costs evaluated. The number of detected anomalies selected as effectiveness criterion. We used cost minimization analysis (CMA) because there were no differences in effectiveness. Then we performed the budget impact analysis (BIA), accounting to number of patients receiving MRI of brain in the Russian Federation. Relevant sensitivity analyses carried out.

Result. Gadoteridol was superior both in CMA (cost reduction reached 21.51 %) and BIA (budget burden reduced by 10.31 % which amounts to 15 735 332 rubles). Sensitivity analysis confirms the model robustness.

Conclusion. Clinical and economic analysis of gadoteridol compared with gadobutrol demonstrated that expansion of gadoteridol use in Russian healthcare is economically feasible.

The use of risk-based approach in pharmacovigilance management is due to the strategy of preventive measures to ensure the safe administration of medicines. Now, manufacturers of drugs to ensure the functions of pharmacovigilance provide a set of documents registering the safety of products, including a risk management plan. In the process of preparing a risk management plan, risks are identified and assessed, measures to minimize them are developed and the effectiveness of these measures is further evaluated. The article considers risk factors in relation to pharmacovigilance for a drug and examples of their occurrence. Routine and additional measures to minimize risks are used to ensure risk management. In the case of biotechnological drugs, it is not superfluous to conduct post-registration studies with pharmacoepidemiological design with mandatory publication of both positive and negative results. The article analyzes the domestic and foreign experience of measures to minimize risks. If a particular strategy is found to be ineffective, alternative interventions should be developed and implemented. A possible result of ineffective risk minimization measures is the withdrawal of drugs from the market or the restriction of their use only to the subgroup of patients for whom the benefits outweigh the risks. Manufacturers should not neglect the implementation of measures to minimize risks, as this prevents the application of drastic measures of regulatory authorities in relation to them and allows the drug to exist on the market in a safe application, providing quality medical care for patients.

Success in practical rheumatology of the latest decade achieved mainly due to monoclonal antibodies (MABs) appearance in routine medical practice. At the same time, the experience of practical application of MABs is limited both by observation period and exposure and their clinical and pharmacological properties do not allow to fully characterizing their safety profile with the data from clinical studies. The use of MABs is associated with the risk of delayed adverse drug reactions (ADRs) — types B (immunoallergic reactions), C (new diseases) and D (delayed teratogenic and oncogenic effects). Determination of risk factors in real medical evidence is especially important. The risk factors of ADRs including serious ADRs were studied based on an analysis of the spontaneous reports database of the Federal Service for Supervision in Healthcare and the data from rheumatologic register of patients receiving MABs — the E.E. Eikhvald Clinic in North-Western State Medical University named after I.I. Mechnikov. It was shown that the factors coming from the patient (gender, age group) do not affect the severity of the risk of occurrence of ADR, including serious ADRs, while the risk factor for monoclonal antibodies can be considered the choice of tocilizumab, which increases the risk of serious ADRs.

Background. One of the obligate clinical manifestations of pancreatic cancer is chronic pain syndrome, which is realized in 80 % of patients with a progressive course of the disease. Studying the molecular genetic factors that influence the phenotypic realization of chronic pain syndrome in patients with pancreatic cancer is an important step towards personalizing the roadmap.

Aims. To study the associative effect of single nucleotide polymorphisms (SNPs) of the OPRM1, ABCB1, IL1B, PTGS2, LOC 541472 genes on the interindividual variability of chronic pain syndrome in patients with pancreatic cancer.

Materials and methods. The study included 81 patients aged 18 to 75 years with histological verification, promptly treated for prostate cancer according to the main criterion for inclusion in the study. Molecular genetic studies were performed to determine the allelic variants of rs1799971 of the OPRM1 gene, rs1045642, rs2032582, rs1128503 of the ABCB1 gene, rs1143627 of the IL1B gene, rs5275 of the PTGS2 gene, rs1800795 of the LOC gene 541472. Statistical processing of the results was carried out using the Statistica 10.0 program.

Results. Carriers of the homozygous AA genotype of the OPRM1 gene prevailed among the observed patients of the Krasnoyarsk Territory with pancreatic cancer. Genotype AG IL1B showed an increase in the chances of chronic pain by 18,46 times in patients with pancreatic cancer. Carriers of the GG genotypes of the ABCB1 rs1045642 and AA genes of the ABCB1 rs2032582 gene constituted a risk group for the implementation of chronic pain in patients with pancreatic cancer.

Conclusions. The study showed that the most significant in terms of increasing the chances of chronic pain in patients with pancreatic cancer are the homo- and heterozygous genotypes of the IL1B and LOC 541472 genes encoding IL-6.

Compliance of patients in the drugs preferential provision is considered as the most important component of effectiveness and safety pharmacotherapy.

Aim. Based on the study of patient compliance in the drugs preferential provision program to develop recommendations and proposals to improve adherence to treatment.

Materials and methods. A sociological survey was conducted at 115 patients suffering from chronic diseases in four polyclinics in Vladivostok in 2019. All patients were treated under the «Program of Providing Certain Categories of Citizens with Necessary Drugs». The study used descriptive statistics methods using the Microsoft Office program.

Results. The highest level of adherence was noted in the indicators «compliance with the recommendations of the attending physician for taking medicines» — 78.3 % and «absence of a pass in taking medicines» — 76.5 %. The greatest compliance to drugs treatment (< 50 %) on the majority of indicators of questioning is registered at patients with diagnoses: «diabetes mellitus», «bronchial asthma» and «malignant neoplasms», and also at co-morbid patients. The lowest adherence to pharmacotherapy (> 50 %) was in groups of patients with hypertension and chronic renal failure. Compliance in the field of non-drugs treatment is not sufficient.

Conclusion. The sociological survey showed that adherence to medication and non-medication treatment is insufficient. To improve the compliance it is recommended the introduction of programs of patient education with use of modern interactive educational technologies.