Fixed antidiabetic drugs’ combinations have aim to improve Diabetes Mellitus type 2 (DMT2) control as well as a safety treatment increasing. Soliqua SoloStar® is a new registered drug for control fasting and prandial glucose levels, contained insulin glargine 100 Ul/ml and lixisenatide. In the published non-direct comparison, it was more effective for DMT2 control vs insulin glargine 100 Ul/ml and lixisenatide separately, and daily insulin dose was less on 22 UI.

Aim. To evaluate of Soliqua SoloStar® reasonability for inclusion from pharmacoeconomics point of view into the State program of the free medical Aid guarantees.

Materials and methods. Retrospective comparative economic analysis based on published data an new methodology treatment with Soliqua SoloStar® in compare with the current treatment methodology with usage of insulin glargine and lixisenatide separately. Common used methodology of clinical-economic analysis was used, and target group of patients was established based on Federal Diabetes Register. Direct medical cost was defined as a cost of medications. Differentiation between direct medical cost for the proposed methodology and current practice of the separate usage of insulin glargine 100 Ul/ml and lixisenatide was calculated. Discounting at 5% annually used in the calculation of the 3 years’ time horizon. The results of health technology assessment are confirmed by sensitivity analysis. Microsoft Excel was used for calculation.

Results. Calculation has been performed for two pens of Soliqua SoloStar® with different prices (Variation 1 and 2) in compare with different drugs of insulin glargine 100 Ul/ml and lixisenatide. Soliqua SoloStar® had less daily dose (by insulin glargine) on 22 UI vs free combination, and dose of lixisenatide was 20 mkg per day. Amount of patients who have reached HbA_1c<7% was higher in Soliqua group vs free combination group on 29 % (95 % CI: 20,2-30,7; p<0,0001). Cost of daily dose in Variation 1 is 216,15 RUR., for Variation 2 — 172,48 RUR. In the same time cost of the free combination of insulin glargine 100 UI and lixisenatide is depended from trades name of the drug, while cost of lixisenatide per day is the same for free combination and has 158,8 RUR. Soliqua SoloStar® usage can decrease budget impact in comparison with free combination on 27,65-42,26 % (depending on cost of insulin glargine 100 UI from different manufacturers and Soliqua pen cost.

Conclusion. Soliqua SoloStar® has pharmacoeconomics evidences to be included into the Governmental program of free medical Aid in Diabetes Mellitus type 2 patients.

Severe non-control Bronchial Asthma (BA) is a sufficient social problem with decreasing of quality of life, high index of disability and death. New biological drug — dupilumab — would improve the situation.

Materials and methods. Markov’s model has been used for efficacy comparison of dupilumab and omalizumab with cycles between remissions and exacerbations of BA with interval as 4 weeks. Target population was 287naive patients per year which can be treated with dupilumab instead omalizumab. Non-direct comparison has shown that clinical efficacy of dupilumab was higher vs omalizaumab (prevention of 4,2 and 2,4 exacerbations/year accordingly, p<0,05). Horizon of budget impact analysis (BIA) was 3 years, and discounting rate was 5 %. Only direct costs were used (drugs’ costs, expenditures due to hospitalizations and out-patients department treatment).

Results. Cost of dupilumab was 1 013 012 RUR/patient/year, that less on 182,2 thsd RUR than in omalizaumab case (16,04 %). Dupilumab can reduce expenditures in frames of Governmental Guarantees Program on 58,3 mln. RUR for the first year, and 162,2 mln. RUR during 3 —years horizon (16,13 % saving). Direct costs reduction with dupilumab can explain by less expenditures on the cours of therapy as well as decreasing cost of hospitalization and out-patients cure.

Conclusion. Hypothesis about possibilities of dupilumab inclusion into reimbursement programs has been confirmed from clinical-economic point of view.

Insulin therapy is one of the effective methods of effective control of diabetes mellitus type 2 (T2DM) which can manage resistance to insulin. Insulin’s analogs have advantages in compare with human insulins in frames of safety (less amount of hypoglycemia, including severe). Safety profile can be improved with combination of basal insulin and glucagon-like peptide receptor-1 agonist (aGLP-1). Economic aspects of such kind treatment in compare with standard regimen of basal-bolus and basal plus for local conditions are not known yet.

Materials and methods. Economic parameters of the fixed combination of insulin glargine 100 Ul/ml plus lixisenatide (Soliqua SoloStar®) [Regimen 1] were calculated based on prognostic model of risk of T2DM complications, efficacy and safety. Comparison has been made with insulin glargine 100 Ul/ml + insulin glulisine [Regimen 2], insulin glargine 100 Ul/ml + insulin aspart [Regimen 3], insulin detemir + insulin aspart [regimen 4], insulin degludec + insulin aspart [Regimen 5]. Efficacy and safety has been prognosed in different time of model (1-5 years). Direct costs of out-patient treatment, hospitalization cost (complications of T2DM) as well as expenditures on severe hypoglycemia episodes and insulins in DDD were calculated. Published data of clinical trials and real world evidences were used.

Results. Results of T2DM control and prognosis of complications were practically similar in all regimens of therapy. The different rates of hypoglycemia including severe were found for regimens: Regimen 1 — 3,03 и 0,02 events/patient-year; Regimen 2 — 4,1 и 2,3; Regimen 3 — 16,4 и 2,3; Regimen 4 — 9,5 и 2,3 %; Regimen 5 — 11,6 — 0,47 accordingly. Regimen 5 had a highest utilitarian cost based on DDD. Total direct costs, including all expenditures was less in Regimen 1 — 73 956 RUR/patient/year. In the same time expenditures for Regimen 2 were 93 258 RUR, for 3 — 92 289 RUR, for 4 — 87 598 RUR, for 5 — 79 396 RUR.

Conclusion. Fixed dose combination Soliqua SoloStar® is an economic proven strategy for effective control of T2DM in compare with basal-bolus and basal plus regimens of insulin therapy.

In light of rising costs in the health care system and the introduction of innovative but expensive technologies, decision makers are looking for reliable methods to assess their cost-effectiveness. To this end, a comprehensive assessment of medical technology is carried out, including the analysis of information on its comparative clinical efficacy and safety, as well as an assessment of the economic consequences of its implementation. One of the most important features of clinical and economic studies of antimicrobials is the ability of infectious agents to acquire resistance to therapy, which fundamentally changes their effectiveness, and, consequently, the clinical and economic feasibility of use over time. Taking into account the risks of resistance as a criterion of effectiveness in pharmacoeconomical studies of antimicrobial drugs is an important factor affecting the feasibility of inclusion of drugs in the restrictive lists. At the same time, this criterion remains underutilized.

Rationale. Breast cancer (BC) today is the leading oncologic pathology in Russia. The use of new treatments is associated with high healthcare costs. The epidemiological forecast and cost planning are not possible without the building of the mathematical model of BC.

Aim. The perform a literature review of BC models.

Materials and methods. The systematic literature review was performed by searching databases (PubMed). From 547 initially got publications 20 were included in the analysis. Not included publications could be divided into groups: pharmacoeconomic model of particular drug, BC screening models, model of tumor growth, models of ВС imaging (US, MRI).

Results. BC epidemiologic mathematical model should be based on the patient data from national register, the time horizon should be not less than 5 years, it should be based on Markov modelling and be non-homogenous. The model has to differentiate several tumor types and disease stage.

Conclusion. Today in Russia there is no epidemiologic mathematical model of BC.

Objective. To perform the pharmacoeconomic analysis of ceftolosan + tazobactam (Zerbaxa®) compared with the routine practice of antibacterial therapy of complicated intra-abdominal infections (clAI) and ceftazidime + avibactam (Zavicefta®).

Methods. The direct medical costs associated with antibacterial therapy of patients with clAI were calculated using the Markov model. The study horizon of cost-effectiveness analysis was 1 course of patient with clAI therapy and 3 years for the budget impact analysis. A comparative cost-effectiveness analysis was based on the monitoring program of antibiotic resistance, held in the Russian Institute of antimicrobial chemotherapy, the Interregional Association for clinical Microbiology and antimicrobial chemotherapy (AMRmap) and expected frequency sensitivity to ceftolosan + tazobactam, based on the prevalence of producers of metal- β -lactamase (hereinafter MBL) in Russia. The analyzing data considered the sensitivity of more than 40 thousand clinical isolates of microorganisms in 52 cities of the Russian Federation for 1997-2016 in the general population of patients. In the budget impact analysis was evaluated the economic impact of the market introduction of the ceftolosan + tazobactam (Zerbaxa®) compared with the current practice of antibiotic therapy of cIAI.

Results. Using ceftolosan + tazobactam as initial therapy in the general population of patients with cIAI, caused by P. aeruginosa, reduced direct medical costs of 1 completed case of cIAI treatment in comparison with the initial therapy of meropenem by 37 009 RUB (14,1 %), ceftazidime+avibactam — RUB 30 987 (12,1 %). Ceftolosan + tazobactam reduced the cost of life years gained (the coefficient of cost-effectiveness) in comparison with ceftazidime + avibactam by 16 %, meropenem — 28 %. Achieving over three years 12 % rate of the market ceftolosan + tazobactam will reduce the budget impact compared to current practice 291 511 151 RUB (average 1.3 %) for 3 years. This saving will further provide therapy ceftolosan + tazobactam 1296 people for 3 years. The administration ceftolosan + tazobactam leaded to increasing survival in patients with cIAI compared with cefepime — by 2.98 %, ceftazidime — 3.96 %, ceftazidime + avibactam — 1,79 %, meropenem — 7.71 %. The amount of life years gained in terms of 1,000 people increased in comparison with cefepime — on 699 years, ceftazidim — 931, ceftazidime+avibactam — 421, meropenem — 1811. The cost of the empirical drug course (3 days) without sensitivity was: 55 432 RUB for ceftolosan + tazobactam, which is cheaper than therapy ceftazidime+avibactam for 17 801 RUB, and more expensive for 41 563 RUB, 48 444 and 52 775 RUB compared to empirical therapy with meropenem, cefepime and ceftazidime respectively.

Conclusion. Ceftolosan + tazobactam (Zerbaxa®) in the treatment of cIAI caused by P. aeruginosa, is dominant option in comparison with the drugs used in routine practice in the treatment of cIAI in Russia and the drug of a new class of inhibitors of β -lactam/β -lactamase — ceftazidime+avibactam, due to higher efficiency and lower associated direct medical costs.

The article deals the definition, history of development in Russia, the main provisions, problems and prospects of development of pharmacology of extreme ages. The features of the nomenclature of medicines and the applicability of different dosage forms in different age periods are shown. Recommendations on rational use of medicines in patients of special populations — extreme ages are given. The risks of responsible self-treatment and polypharmacology are indicated. The data of international monitoring of drug safety in patients of extreme ages are presented. The article is addressed to pharmacologists, clinical pharmacologists, drug developers and doctors of medical specialties.

Monoclonal antibodies are highly effective medications, which made a breakthrough in medicine. Taking into consideration the properties of monoclonal antibodies safety plays a key role in “risk-benefit” assessment. For monoclonal antibodies this remains studied insufficiently. The article presents a systemic characteristic of safety profile of monoclonal antibodies used in rheumatology, based on the database of spontaneous reports of the Federal Service for the Supervision of Healthcare. Specified greater alertness of Russian practitioners regarding the risk of developing tuberculosis infections in comparison to their foreign counterparts. Spontaneous reports of the development of neoplasms and deviations of laboratory tests, according to our data, on the contrary, are reported less. It is advisable to draw the attention of practitioners to the peculiarities of work with isolated deviations in laboratory tests and keep alert about the safety issues of monoclonal antibodies in general. It is important to continue monitoring to characterize delayed type D adverse drug reactions.

Actuality. The pharmacotherapy practice in elderly and senile patients is characterized by a widespread use of drugs with anticholinergic properties. Available data indicate that the combined anticholinergic cognitive burden correlates with the risk of adverse events and may serve as a factor in increasing the frequency of hospitalization in elderly patients.

Objective. To examine the prevalence of anticholinergic medications and factors associated with anticholinergic cognitive burden in this study population.

Methods. A retrospective pharmacoepidemiological analysis of medical records of 401 patients >65 years of age, hospitalized in Moscow in the period from 1st of June to 30th of December, 2017, was performed. Anticholinergic drugs were identified using Anticholinergic Cognitive Burden Scale (ACB) [Anticholinergic cognitive burden scale. Aging Brain Care. 2012 Update Developed by the Aging Brain Program of the Indiana University Center for Aging Research]. Binary logistic regression was applied to identify significantly the factors associated with anticholinergic medication use in the study population. Data were presented using odds ratios with 95 % confidence intervals.

Results. Four hundred one patients were included in the analysis, with a mean age of 77.4 (±7.2) years, 72.1 % were female, the median (IQR) of comorbidities per patient was 3 (0-5), the median of the number of prescribed medications per patient was 2 (0-4). The most common pathological conditions included chronic heart failure, hypertension, cerebrovascular disease, coronary heart disease. Polypharmacy was observed in 36.7% of patients. according to the ACB scale, 41.9 % of patients were exposed to ACB-contributing medicines (95 % CI: 41.1-42.7). Mean ACB score was 0.71 ± 0.06 (IQR 1-7). The most commonly prescribed ACB- contributing medications were cardiovascular agents — 51.47 %; and oral anticoagulants — 23.4 %. The odds of ACB exposure was 1.47 (CI 95 % = 1.33-1.63). The prescription of drugs with anticholinergic burden was not associated with an increase in the frequency of hospitalization (OR: 0.83, p = 0.089). Patients with ACB>0 had higher levels of potentially inappropriate medications (PIMs) (OR: 1.29, p = 0.02). An association of polypharmacy with high ACB scores was found (p = 0.001). No association was observed between potentially prescribing omission (PPOs), age and gender with Anticholinergic burden (ACB).

Conclusions. Pharmacotherapy analysis of elderly and senile patients showed high prevalence rates of prescribing drugs with potential anticholinergic effects of level 1 according to ACB scale). There was no association between prescribing anticholinergics with an increased risk of hospitalization and the number of concomitant diseases.

The article presents information about innovative drugs for the treatment of primary headaches (in particular, migraine), which are at the stages of clinical or preclinical studies, or were recently introduced to the foreign pharmaceutical market. The classes of these drugs, their mechanism of action, as well as the results of past studies are presents in article.