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Aim. To assess the efficacy profiles of different dosing regimens of tofacitinib, baricitinib, and upadacitinib — novel selective oral Janus activated kinase inhibitors, in rheumatoid arthritis (RA). Materials and methods. Randomized controlled trials of tofacitinib, baricitinib and upadacitinib in RA were identified from MEDLINE, and Cochrane databases. Random- effects models were used to estimate pooled mean differences (MD) and relative risks (RRs). American College of Rheumatology 20 % (ACR20), Health Assessment Questionnaire–Disability Index (HAQ-DI) were calculated. Results. Twenty trials with an overall low risk of bias were identified. Tofacitinib, baricitinib, and upadacitinib improved RA control as deter -mined by ACR20 (RR, 2.03; 95 % CI, 1.87 to 2.20) and HAQ-DI (MD, −0.31; 95% CI, −0.34 to −0.28) compared with placebo. Conclusion. Tofacitinib, baricitinib, and upadacitinib significantly improve RA control. To make further decisions, comparative clinical trials of the Janus kinase inhibitors in the real-world clinical practice are necessary.

Diabetes is increasingly widespread in the Russian Federation. It is a severe chronic disease that both independently reduces quality of life and causes exacerbation of other pathologies. This makes evaluation of quality of diabetes management and understanding of clinical and economic properties of various technologies used to screen blood glucose levels, including portable blood glucose meters. Previously there already were clinical-economic evaluations of blood glucose meters within context of Russian Federation but they have not included modern high-precision equipment, thus ensuring attractiveness of current research effort into HTA of modern blood glucose meters that accounts for real life hospital practice. Goal. To assess the clinic-economic properties of modern blood glucose portable measurement systems of OneTouch family and the real-world practics of their use in Russian healthcare facilities. Methodology. The research was performed from the perspective of the Russian healthcare system. Target population was represented by a virtual cohort of 100 patients. Only direct costs were accounted for, specifically all costs caused by consumables involved in operating multifunctional laboratory complexes and all consumables involved in operating portable glucose meters. Employee salaries were also included (accounting for number of personnel involved in different procedures as based on a real clinical practice survey performed as part of this research). Since it is known that modern, standard-compliant portable glucose meters have an accuracy that is more than sufficient for routine screening, cost minimization analysis was used for assessment of economic effects when comparing different approaches to organizing glucose level screening. Research results. The survey during this research effort has indicated that not all medical facilities utilize “tandem usage” of multifunction laboratory complexes and portable glucose meters, however, such “tandem use” is the most widespread approach to organizing blood glucose screening. Cost minimization analysis has demonstrated that “tandem usage” is also the most economically attractive approach and results in cost savings for the medical facility. Conclusions. Current research effort which included cost analysis and cost minimization analysis has demonstrated that “tandem usage” approach which involves combined use of both multifunction laboratory complexes and portable glucose meter systems has substantial economic advantage (over 60 % for analysis with 5 year time horizon). Multiple sensitivity analyses have confirmed robustness of this result. This research further establishes the importance of communicating advantages of modern portable glucose meters to healthcare organizers since this technology is not only clinically rational but also economically optimal.

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 aim. Based on a pharmacoeconomic analysis (PHe) of the use of sodium-glucose cotransporter-2 inhibitors (iSGLT2) and dipeptidyl peptidase-4 (iDPP-4) inhibitors to determine the optimal treatment strategy in patients with type 2 diabetes mellitus (T2DM) with inadequate glycemic control in metformin. Methodology. PE based on the clinical data obtained in the Russian multicenter observational epidemiological study FORSIGHT-T2DM and data obtained by analyzing and synthesizing previously published results of randomized controlled trials. Based on the obtained by Markov modeling outcomes we conduct a cost-eff ectiveness analysis with a calculation of cost-eff ectiveness ratio (CER). The time horizon was 7 years. Results. The highest survival rate observed in patients taking alogliptin and empaglifl ozin. The lowest total direct medical costs was on linagliptin (511,830 rubles) and canaglifl ozin (663,571 rubles). The highest utility index according to the EQ-5D questionnaire in iDPP-4 group was on vildagliptin (0.496), in iSGLT2 group on dapaglifl ozin (0.489) and canaglifl ozin (0.489). The highest life years gained (LYG) in iDPP-4 group was on alogliptin (0.65 years); in iSGLT2 group on empaglifl ozin (0.51 year). The highest quality adjusted life years (QALY) was on alogliptin (0.32) and empaglifl ozin (0.25). The results of PHe showed that the lowest discounted CЕRLYG was on alogliptin (937 921 rubles) and empaglifl ozin (1 645 559 rubles). The lowest discounted CЕRQALY was on alogliptin (1 918 522 rubles) and empaglifl ozin (3 369 349 rubles). The sensitivity analysis confi rmed that increasing the price of empaglifl ozin and alogliptin by 25 % and / or reducing the proportion of patients who reached the target of HbA1c level by 25 % when taking empaglifl ozin or alogliptin did not change the most cost-eff ectiveness strategy. Conclusion. The results of this PE showed that alogliptin and empaglifl ozin have the lowest CЕRLYG and CЕRQALY. In patients with inadequate glycemic control on metformin add-on empaglifl ozin or alogliptin is the most cost-eff ective treatment strategies.

The high prevalence of BRAF V600 gene mutation in the Russian Federation and the cost of treatment the metastatic melanoma (MM) with immuno-oncology and combined targeted drugs make it relevant to assess the clinical and economic feasibility of their use. Objective. Cost-effectiveness analysis (CEA) and budget impact analysis (BIA) of PD-1 inhibitor pembrolizumab was performed in comparison with nivolumab and combinations of BRAF and MEK inhibitors in the 1st line therapy of MM with BRAF v600 gene mutation. Methodology. CEA and BIA was performed using the results of a network meta-analysis and based on the Markov model, which estimated the number of life years saved (LYS), duration of progression-free survival and direct medical costs (DC). Results. The cost of treatment per year in the 1st line therapy on pembrolizumab was 3.32 million RUB, what is 29 % cheaper than combination of dabrafenib + trametinib (4.67 million RUB), 60 % than vemurafenib + cobimetinib (8.30 million RUB), 1.7 % than nivolumab (3.38 million RUB). Total 3 years DC for the 1st line therapy on pembrolizumab (3.80 million RUB) were 43.9%, 68.2% and 1.8 % lower than the cost of dabrafenib + trametinib (6.76 million RUB), vemurafenib + cobimetinib (11.93 million RUB) and nivolumab (3.86 million RUB). CER per 1 LYS for pembrolizumab was 2.43 million RUB, nivolumab – 2.48 million RUB, dabrafenib + trametinib – 4.24 million RUB and vemurafenib + cobimetinib – 7.49 million RUB increase in the use of pembrolizumab to 50 %, by reducing the share of the use of combinations of BRAF and MEK inhibitors, will result in budget savings up to 1 507,5 million RUB (26.4 %). Conclusion. The use of pembrolizumab in the 1st line of MM therapy with BRAF V600 gene mutation allows to save the budget and is economically feasible.

Actuality. Acute cerebral circulation disordersremain an important problem of modern health care. Available evidence suggests that both reperfusion and neuroprotection are important to ensure a favorable outcome of treatment. In the context of neuroprotection, considerable interest are peptideswith neuroprotective properties. A recent randomized controlled trial of the Cellex® showed positive results for treatment of severe patients with acute cerebral circulation disorders with less favorable outcomes and the highest direct medical costs, which makes the question of assessing the pharmacoeconomic properties of this drug relevant in the light of new data. Objective. To conduct a clinical and economic analysis of treatment outcomes for Cellex® and therapeutic alternatives used in patients with Acute cerebral circulation disorders and early rehabilitation period of the disease within the framework of the state guarantee programs of free medical care. Methodology. Pharmacoeconomic modeling, cost-eectiveness analysis, budget impact analysis. Results. Established that the use of Cellex® in the context of Russian practice in patients corresponding to the characteristics of the target population of this pharmacoeconomic study leads to reduce the budget burden by 26 % for 1 year, reaching 46 % at 4 years. e cost-eectiveness analysis indicates that Cellex® leads to greater eciency in the use of health resources. e sensitivity analysis conrms the stability of this result to a change in the market situation, expressed in an increase in the price of Cellex® preparation to 25 % inclusive. This indicates a high pharmacoeconomic feasibility of Cellex® in the context of therapy the ischemic form of acute cerebral circulation disorders in Russian Federation.

Relevance. The most effective treatment for focal dystonia (blepharospasm (BsP) and cervical dystonia (CD)) is use of botulinum toxin, including onabotulinumtoxinА (BoNTA-Ona), incobotulinumtoxin А (BoNTA-Inco), abobotulinumtoxinА (BoNTA-Abo). In 2016, it became possible to use ­exible-dose regimens of incobotulinumtoxin А, thus necessitating analysis of pharmacoeconomic properties of such regimens. Aim. To determine pharmacoeconomic properties of BsP and CD therapy with incobotulinumtoxin А relative to regimens based on onabotulinumtoxinА (BoNTA-Ona and abobotulinumtoxinА (BoNTA-Abo) accounting for properties of ­exible administration regimen of incobotulinumtoxin А. Methodology. Pharmacoeconomic analysis was performed from the perspective of Russian healthcare system within context of mandatory healthcare insurance, as well as from the perspective of overall social interests of Russian Federation, including impact upon GDP. Modelling horizon was 5 years. A complex Markov model was developed to estimate costs and outcomes. The parameter used for clinical efficacy assessment was number of days patient spend in remission state. Cost effectiveness analysis (CEA), cost utility analysis (CUA) and budget impact analysis (BIA) were performed based on modelling results, and sensitivity analysis (SA) was performed to ascertain model robustness. Result. Incobotulinumtoxin А in fl­exible dose regimen demonstrated pharmacoeconomic superiority during CEA for cervical dystonia and blepharospasm indications. When indirect costs are accounted for, superiority of incobotulinumtoxin А increases. Similar results were obtained during CUA. BIA indicates that use of ­flexible-dose regimen of incobotulinumtoxin А allows to achieve reduction of budgetary burden. SA has conrmed the robustness of these results. Conclusion. Use of incobotulinumtoxin А in a ­flexible-dose regimen is pharmacoeconomically justied.

Diabetes mellitus (DM) is a widespread, severe disease that has outpaced many infectious and non-infectious diseases in terms of both incidence increases and economic burden in most developed countries. In addition to the direct threat to the health and well-being of patients, DM is associated with many severe complications. Among the most significant late complications of DM are diabetic retinopathy (DR) and diabetic macular edema (DME) which can lead to slow, persistent vision loss up to blindness. Significant progress in treating DME has been obtained after the role of vascular endothelium growth factor (VEGF) in the disease’s pathophysiology became more understood, with several powerful clinical options emerging as result. Among the anti-VEGF drugs that have proven themselves well in clinical trials and practice with regards to treating DME are ranibizumab and aflibercept. Since there is currently relatively little understanding of their comparative pharmacoeconomic performance within context of Russian healthcare, the current pharmacoeconomic research (PHe) effort was undertaken. Aim. To perform comparative PHe analysis of ranibizumab and aflibercept for treatment of patients with DME in Russian Federation (RF). Methodology. A Markov model with 3 month long cycles, simulating the changes in patient’s vision acuity was designed for this research effort. For each of the compared therapeutic alternative a simulated group of 1000 DME patients was constructed. The PHe analysis was performed from the point of view of Russian healthcare system within context of Mandatory Medical Insurance system and also from point of view of Russian budget as whole. Randomized controlled clinical trials investigating safety and efficacy of analyzed drugs were used as source of efficacy and safety data. Number of patients who avoided stage IV vision loss (blindness) was used as efficacy criterion. Time horizon of PHe analysis was set at 3 years. Costs were accounted based on existing treatment standards, and literature sources were used to link quality of life and vision acuity and then register QALY for various model states. Modelling results were used to carry out cost-effectiveness analysis (CEA), cost-utility analysis (CUA) and budget impact analysis (BIA). Two single-factor sensitivity analyses (SA) were used to ensure the results are robust to changes in market situation, and an additional analysis was undertaken to test for effects of choice of eye being treated (better seeing or worse seeing). Results. CEA indicated that ranibizumab administered using Pro Re Nata (PRN) regimen has best cost-efficacy, with lowest CER of 1 264 rub. Ranibizumab administered in Treat and Extend (T&E) regimen and aflibercept had higher CERs and thus inferior cost-efficacy (1 403 rub and 1667 rub respectively). The advantage of ranibizumab PRN extended to CUA, in which CUR was 554 rub for ranibizumab PRN, 616 rub for ranibizumab T&E and 729 rub for aflibercept. BIA performed per 100 000 population (accounted for prevalence of DM and DME epidemiology) has found that use of ranibizumab PRN instead of aflibercept could result in budget burden reduction of more than 17 million rubles per 3 years. All SA have confirmed result robustness. Conclusion. These results indicate that ranibizumab demonstrates favorable pharmacoeconomic properties and its further introduction into Russian clinical practice would allow to increase the efficacy of healthcare resource utilization in the RF.

Compare the cost effectiveness and budget impact of vortioxetine in monotherapy of depressive disorders with several other important antidepressants using pharmacoeconomic methods within context of Russian healthcare. Agomelatine, fluvoxamine, escitalopram and paroxetine were used as comparators. A «decision tree» model describing probabilities of relevant clinical outcomes and events during the course of therapy with vortioxetine and the comparator drugs (including adverse events) was built using information from available clinical trials. Afterwards, data obtained via modelling, existing Russian documents regarding medical care standards and expert opinion survey data were used to calculate cost of treatment for vortioxetine and for each of the comparators (including costs associated with adverse events). These estimates were used to perform the following types of pharmacoeconomic analysis: cost-effectiveness analysis (CEA), sensitivity analysis (SA) and budget impact analysis (BIA). CEA has demonstrated that vortioxetine definitely dominates among all compounds investigated in the current study with a CER of 41.990 rub., and escitalopram ranks as second with a CER of 77.360 rub. SA confirmed the robustness of this result. BIA indicated that utilization of vortioxetine, as the monotherapy regimen choice is associated with minimum fund expenditure among the compounds compared in the current study. wtP/CER was best for vortioxetine (35,5) according to pharmacoeconomic expediency analysis. The results of this pharmacoeconomic analysis of vortioxetine performance as monotherapy solution for treating depressive disorders in the RF indicate the following: • costs associated with adverse events constitute a significant portion of overall depression treatment costs; • possessing a favorable combination of clinical effectiveness and tolerability parameters, vortioxetine confidently dominates both in terms of raw effectiveness and in terms of CEA; • the aforementioned result is robust - according to sensitivity analysis it remains stable even under considerably unfavorable assumptions; • both complete and incomplete suicide, in addition to having considerable social and clinical consequences, contribute to increasing the budgetary burden; • according to BIA, vortioxetine use is associated with a decreased budgetary burden, which is explained by its low suicidogenic potential and high cost effectiveness; • it is interesting to note that paroxetine use is associated with a very high budgetary burden (which is especially relevant given that paroxetine remains widespread in Russian clinical practice). Compared to vortioxetine, the overall budget spending in case of paroxetine use is 60.3% higher; • among the compounds investigated in this study, vortioxetine is the most attractive from the RF drug reimbursement system point of view.

Diabetes mellitus (DM) is a widespread, severe disease that has outpaced many infectious and non-infectious diseases in terms of both incidence increases and economic burden in most developed countries. In addition to the direct threat to the health and well-being of patients, DM is associated with many severe complications. Among the most significant late complications of DM are diabetic retinopathy (DR) and diabetic macular edema (DME) which can lead to slow, persistent vision loss up to blindness. Significant progress in treating DME has been obtained after the role of vascular endothelium growth factor (VEGF) in the disease’s pathophysiology became more understood, with several powerful clinical options emerging as result. Among the anti-VEGF drugs that have proven themselves well in clinical trials and practice with regards to treating DME are ranibizumab and aflibercept. Since there is currently relatively little understanding of their comparative pharmacoeconomic performance within context of Russian healthcare, the current pharmacoeconomic research (PHe) effort was undertaken. Aim. To perform comparative PHe analysis of ranibizumab and aflibercept for treatment of patients with DME in Russian Federation (RF). Methodology. A Markov model with 3 month long cycles, simulating the changes in patient’s vision acuity was designed for this research effort. For each of the compared therapeutic alternative a simulated group of 1000 DME patients was constructed. The PHe analysis was performed from the point of view of Russian healthcare system within context of Mandatory Medical Insurance system and also from point of view of Russian budget as whole. Randomized controlled clinical trials investigating safety and efficacy of analyzed drugs were used as source of efficacy and safety data. Number of patients who avoided stage IV vision loss (blindness) was used as efficacy criterion. Time horizon of PHe analysis was set at 3 years. Costs were accounted based on existing treatment standards, and literature sources were used to link quality of life and vision acuity and then register QALY for various model states. Modelling results were used to carry out cost-effectiveness analysis (CEA), cost-utility analysis (CUA) and budget impact analysis (BIA). Two single-factor sensitivity analyses (SA) were used to ensure the results are robust to changes in market situation, and an additional analysis was undertaken to test for effects of choice of eye being treated (better seeing or worse seeing). Results. CEA indicated that ranibizumab administered using Pro Re Nata (PRN) regimen has best cost-efficacy, with lowest CER of 1 264 rub. Ranibizumab administered in Treat and Extend (T&E) regimen and aflibercept had higher CERs and thus inferior cost-efficacy (1 403 rub and 1667 rub respectively). The advantage of ranibizumab PRN extended to CUA, in which CUR was 554 rub for ranibizumab PRN, 616 rub for ranibizumab T&E and 729 rub for aflibercept. BIA performed per 100 000 population (accounted for prevalence of DM and DME epidemiology) has found that use of ranibizumab PRN instead of aflibercept could result in budget burden reduction of more than 17 million rubles per 3 years. All SA have confirmed result robustness. Conclusion. These results indicate that ranibizumab demonstrates favorable pharmacoeconomic properties and its further introduction into Russian clinical practice would allow to increase the efficacy of healthcare resource utilization in the RF.

Strokes are one of the most important causes of death and disability both worldwide and in Russian Federation (RF). This disease requires intensive, prolonged treatment and rehabilitation and thus is associated with considerable temporary disability, as well as significant rate of permanent complete disability. Available information indicates that vasodilators affecting peripheral arteries can play a favorable role in treating ischemic strokes, which are the most widespread form of this pathology. However, this type of pharmaceutical is currently not represented in RF standards pertaining to treatment of ischemic strokes. Thus it is expedient to assess the pharmacoeconomics of introducing naftidrofuryl, a member of aforementioned group, into RF treatment and rehabilitation standards for ischemic stroke Aim. To perform the pharmacoeconomic analysis of including naftidrofuryl into the RF standards for treatment and rehabilitation of patients suffering from ischemic stroke by means of performing Cost Minimization Analysis (CMA) and Budget Impact Analysis (BIA). Methodology. The analysis was performed by constructing decision trees for two simulated cohorts. One cohort received only standard treatment and rehabilitation while the other was also receiving naftidrofuryl in addition to standard treatment and rehabilitation. Both direct and indirect costs were accounted. The source of data on the clinical effectiveness was taken from randomized controlled trials and meta-analyzes, which examined the efficacy, safety and tolerability of naftidrofuryl. Analysis of data sources has found that, while there is not enough information to ascertain naftidrofuryl effect on hard clinical endpoints, naftidrofuryl demonstrates an ability to reduce time required to obtain clinical results, thus reducing treatment time and hospital stay. Existing standards were used to calculate expenditures associated with diagnosing, treating, and rehabilitating stroke patients in each simulated group. CMA, BIA and sensitivity analysis were performed. Result. The CMA index for naftidrofuryl was found to be minus 250,630 millions, indicating significant cost reduction. BIA indicated budget savings of 7,59% in the naftidrofuryl group, which amounts to 59,471 mln rubles per 100,000 of population. Sensitivity analysis confirmed these results, indicating stability both in case of price increase and in case of negative alteration of assumptions underlying the model. Conclusion. Including naftidrofuryl in RF national standards for treatment and rehabilitation of patients with ischemic strokes would allow reducing healthcare organization spending as well as overall budgetary burden.

Chronic pain syndrome (CPS) is a complex, hard to treat polyetiological condition. While there is a wide array of possible causes for CPS, it is most important in oncological context, since within oncological setting it may be induced both by the tumor itself and by the treatment modalities used against it. Analgesic therapy is, according to WHO, the primary method of managing CPS, and is effective in approximately 90% of cases. However, patients requiring strong opioids for pain management (III step of WHO’s “analgesic ladder”) face a number of complications associated with adverse events (AE), such as inhibition of respiratory control center, nausea, vomiting, and constipation. While constipation and vomiting are themselves amenable to therapeutic management, they can both significantly reduce quality of life and even require alteration of analgesic medication regime, thus potentially compromising the management of chronic pain. This has necessitated the creation of painkiller medication that would have a more favorable gastrointestinal AE profile while maintaining analgesic efficacy, such as fentanyl transdermal delivery systems (TDS) and oral formulations combining oxycodone and naloxone. The pharmacoeconomic comparison of these two medications in order to determine which of them is more economically rational within context of Russian healthcare is thus justified, and is the subject of this research effort. Aim. To perform evaluation of pharmacoeconomic (PHe) properties of combined naloxone/oxycodone formulation (Targin®) compared to fentanyl TDS (Fendivia®) in Russian oncological patients with CPS. Methodology. This PHe is conducted perspective of public health organizations of the RF at federal and national levels. The modelling horizon was 25 weeks. Comparator drugs were Targin® and Fendivia®. Randomized controlled clinical trials investigating safety and efficacy of these drugs were used as data source on safety and efficacy. A Markov model was constructed in order to estimate healthcare costs and patients outcomes. Each simulated patient group contained 100 patients. Retention of patients with adequate pain management in main treatment regime without dose increase was used as efficacy criterion, since this surrogate endpoint is most clinically relevant, reflecting ability of a given modelled treatment regimen to control chronic pain. These modelling results were used to perform the following types of pharmacoeconomic analysis: carrying out cost-effectiveness analysis (CEA), budget impact analysis (BIA), and evaluation of pharmacoeconomic expediency based on willingness-to-pay ratio (WTP). Result. Naloxone/oxycodone formulation dominates in CEA analysis (direct costs were 2,091 mln. rub. for naloxone/ oxycodone versus 3,747 mln. rub. for fentanyl TDS). The CER indicator for oxycodone/naloxone was 51 218 rub., while fentanyl TDS had CER of 317 409 rub. BIA revealed considerable budgetary burden reduction for oxycodone/naloxone, which was due to considerable reduction of GDP losses and expenses associated with disability and loss of working capacity. The resultant economy of government funds reached 44%. According to PHe analysis, both drugs are attractive for purposes of drug reimbursement system, but oxycodone/naloxone is dominant due to WTP/CER indicator of 32,1 (fentanyl TDS had WTP/CER of 5,1). Sensitivity analysis confirmed the robustness of these findings - CEA and BIA results remained stable even in case of 25% oxycodone/ naloxone price increase. Conclusion. Oxycodone/naloxone combination has been determined to be most pharmacoeconomically attractive due to higher efficiency of healthcare spending (due to domination in terms of CER) and reduction of GDP losses associated with complete disability which resulted in government budgetary savings of up to 44%.

Focal dystonia is a large group of diverse neurological syndromes characterized by significant muscular contractions, spasms, repetitive movements, and persistent pathological poses (which in turn often causes pain syndrome). Blepharospasm (BSP) and cervical dystonia (CD) are two focal dystonias that have a particularly strong impact upon patient’s quality of life (QoL) and work performance. The most effective treatment for these syndromes is injection of botulinum toxin into the affected muscles. Currently there are three notable botulinum toxin drugs on the market - onabotulinumtoxinA (Botox®), incobotulinumtoxinA (Xeomin®), abobotulinumtoxinA (Dysport®). Their notable similarity in terms of safety and effectiveness, as well as severity of impact BSP and CD have on patient’s QoL confer considerable importance to performing proper pharmacoeconomic assessment of the relative benefits of these drugs, which is the subject of current effort. Aim. To perform the pharmacoeconomic analysis (PHe) of therapy using onabotulinumtoxinA, incobotulinumtoxinA, abobotulinumtoxinA of patients suffering from BSP or CD within context of Russian healthcare. Methodology. This PHe research effort is conducted perspective of Russian Healthcare system, as well as generalized budgetary interest (including GDP impact of the disease). The time horizon for this research was 5 years. Comparator drugs were Xeomin®, Dysport®, Botox®. Randomized controlled clinical trials investigating safety and efficacy of these were used as data source on safety and efficacy. Each simulated cohort consisted of 1 000 patients. A complex PHe model consisting of a “decision tree” (break cohorts down into subgroups depending on estimated duration of therapeutic effect) was developed. The subgroups were then directed into a Markov model for evaluating treatment outcomes proper was constructed. Cycle length for the Markov component of the model was set at 1 week. Length of time patients spend in state of clinical remission was chosen as effectiveness criterion because this endpoint is both most clinically relevant and constitutes the main social impact of investigated medical intervention. The results of this modelling effort were used to perform cost-minimization analysis (CMA), budget impact analysis (BIA). Result stability was confirmed by performing sensitivity analysis (SA). Result. Reduction in direct costs by 1 patient on average over 1 year of therapy using Xeomin® has been 26,5% and 19,7% compare Botox® and Dysport® respectively. Xeomin® has demonstrated significant benefit during CMA for both indications (CD and BSP), dominating against Botox® (the savings over 5 years by 1 patient 123 180 rub. (9,7%) and 64 107 rub. (6,1%), respectively) and against Dysport® (84 019 rub. (6,8%) and 43 726 rub. (4,2%), respectively). SA confirms result robustness. To perform BIA a complex analytical scenario was constructed. Within that scenario, market fraction of Dysport® was reduced gradually over the course of 2 years and the patients discontinuing Dysport® were moved to Xeomin® (ratio 3:1). This scenario has indicated that a move to Xeomin® is associated with reduction in budgetary burden, with most significant budget economy happening when patients suffering from CD are moved to Xeomin® (according to BIA the savings from moving to Xeomin® constituted 1,37% thus exceeding 71 million rub.). Conclusion. Use of Xeomin® is associated with reduction in direct costs for Russian healthcare system. Analysis indicates that discontinuing Dysport® in favor of Xeomine within context of governmental healthcare would result in reduction of budgetary burden. These results suggest that Xeomine® is highly pharmacoeconomically expedient within context of Russian healthcare system.

Ovarian cancer is a severe oncological disease, characterized by relatively late detection and unfavorable course leading to significant mortality among affected patients. One of the most well-proven treatment strategies is combination of taxanes such as Paclitaxel with platinum compounds. Unfortunately physicochemical properties of Paclitaxel (Taxol®) necessitate using it with an expensive, highly allergenic and hard to manage emulsifier that requires an extensive premedication regime before administration. A recently developed technology for micronizing Paclitaxel has allowed to create a new drug form, Paclical®, which allows to carry out chemotherapy without a need for complex premedication and specialized infusion systems. Available randomized clinical trial data indicates that Paclical® is not inferior to Taxol® in terms of safety and efficacy. Since taxanes are in high demand in oncology, it appears worthwhile to carry out a pharmacoeconomic comparison of Paclical® and Taxol®, which is the subject of current research effort. Aim. To perform the pharmacoeconomic analysis of Paclical® and Taxol® as adjuvants for Carboplatine for patients with recurrent epithelial ovarian cancer within context of Russian Healthcare. Methodology. This PHe is conducted perspective of public health organizations of the RF at federal and national levels, as well as from general social interest perspective. A complex PHe model consisting of a “decision tree” (to model treatment proper) and a Markov model (to model survival without progression over timespan of 12 months) was constructed. Cycle length for the Markov component of the model was set at 1 month. Two groups composed of 1000 patients each was simulated, each receiving one of the investigated drugs in combination with carboplatine, as well as full set of diagnostic and therapeutic interventions as outlined in relevant Russian standards. Randomized clinical trial dedicated to safety, tolerability and efficacy of the investigated compounds was used as data source. Direct medical costs in each simulated group were estimated using existing standards. Indirect costs including GDP loss and disability payments were also accounted for. Cost-effectiveness analysis, Cost-minimization analysis, Budget impact analysis, pharmacoeconomic expediency assessment and sensitivity analysis were performed. Result. Cost-minimization indicator for Paclical® was determined to be -3 544 819 rub., indicating reduction of direct costs when using this drug. Paclical® also dominated in terms of CER (259 703,5 rub. for Paclical® and 306 852,6 rub. for Taxol®), and since use of Paclical® was associated with both increased effectiveness and cost reduction, ICER calculation was not necessary. Overall number of patients surviving without progression at 12-month mark was used as efficacy criterion. Budget impact analysis has found that Paclical® is associated with reduction of budgetary burden, specifically a 3,6% saving that corresponds to 130 919 rub. per 100 000 of population (adjusted for ovarian cancer incidence). Pharmacoeconomic expediency assessment indicated that both drugs are acceptable for purposes of drug reimbursement system but Paclical® is somewhat more appealing due to wTP/CER indicator of 5,7 (with Taxol® having 4,8). Sensitivity analysis has confirmed the robustness of these findings Conclusion. Use of Paclical® is associated with higher healthcare resources utilization efficiency due to Paclical®’s domination in terms of CER indicator, as well as direct cost reduction of 3 544 819 rub., better absolute progression-free survival at 12-month mark, and reduction of budgetary burden by 3,6% per 100 000 of population. Both drugs being investigated are acceptable as part of drug reimbursement system but Paclical® is slightly more attractive. Thus, use of Paclical® in Russian oncological patients with ovarian cancer appears highly expedient.

Diabetic polyneuropathy (DP) occupies the third place among the most common neurological disorders, affecting a significant portion of diabetes patients, and is characterized by progressive lesions of nervous fibers. While normalizing carbohydrate metabolism is crucial for treating DP, metabolic compounds that integrate into nervous tissue metabolism have received considerable attention. Despite their therapeutic attractiveness and significant spread in clinical practice, the amount of data pertaining to pharmacoeconomic properties of these compounds remains limited. Given significance of this problem and due to availability of new clinical data on comparative effectiveness of two of such drugs, a research effort was undertaken to evaluate the pharmacoeconomic properties of Cocarnit combination drug compared to Milgamma drug, as well as with components of Cocarnit purchased separately. Aim. To evaluate comparative pharmacoeconomic performance of therapy using Cocarnit combination drug, Milgamma, and Cocarnit components purchased and administered separately in the context of Russian healthcare. Methodology. Current analysis was performed from perspective of Russian state healthcare system within context of mandatory medial insurance system. Modelling horizon was 3 years. Randomized clinical trial directly comparing the safety and efficacy of investigated drugs (Cocarnit and Milgamma) as well as long-term randomized clinical trials of other metabolic drugs for treatment of diabetic neuropath and general dynamic of diabetic neuropathy response to metabolic treatment were used as data sources for this PHe. The number of patients in each simulated group was 1000 people. A Markov model was constructed to assess the costs and utility effects of treating diabetic neuropathy with comparator compounds, with simulated treatment protocols being based on existing Russian standards of diabetic neuropathy treatment. The model accounted for existing data regarding long-term outcomes and recurrence rates of diabetic neuropathy undergoing metabolic treatment. Model did not account for mortality resulting from diabetes proper and treatment costs associated with addressing the underlying primary condition (Type I and Type II diabetes). The cycle length was 1 week. QALY improvements were used as surrogate endpoints, since the existing clinical trial data indicates that the only significant difference between the drugs being compared is their quality of life effects. Since clinical trial data contained only SF-36 quality of life data, a widely used mapping algorithm found in peer-reviewed literature was utilized to convert from SF-36 to EQ-5D in order to properly evaluate QALY differences. Upon completion of modelling, the following types of analysis were performed: cost minimization analysis (CMA) for “Cocarnit/Cocarnit components purchased separately” comparator pair (CMA was used here since utility, efficacy and safety values for this case will be strictly equal), budget impact analysis (BIA) for “Cocarnit / Cocarnit components purchased separately” comparator pair, Cost-utility analysis for “Cocarnit / Milgamma” pair. Sensitivity analysis was used to verify the robustness of the results. Discounting was performed at rate of 5%. Results. Cocarnit has demonstrated promising results, showing superiority over separately purchased and administered components in CMA (with CMA factor of -2 752 082 rubles) and budget impact analysis, which indicated that use of Cocarnit instead of separate metabolite components would result in reduction of budget burden totaling 1 458 603 per 100 000 of Russian Federation population (accounting for prevalence of diabetic neuropathy) within 3 years. During cost-utility analysis it was found that Cocarnit is superior to Milgamma demonstrating greater overall quality of life and a CUR of 552,34 rubles (while Milgamma has a less favorable CUR of 555,41 rubles) per patient. It also had ICUR of 208,88 rubles per patient, indicating a low cost per one QALY gained and high pharmacoeconomic expediency within context of pharmacoeconomic expediency analysis. Sensitivity analysis has shown that results remain robust to price increases up to 25%. Conclusion. These results demonstrate that Cocarnit has favorable pharmacoeconomic characteristics and indicates high expediency of using it in Russian healthcare system, and allows us to recommend further research into clinical and pharmacoeconomic properties of this drug.

Rheumatoid arthritis (RA) is a severe, autoimmune disorder characterized by relatively high prevalence among working-age adult population, significant quality of life and work performance impact, as well as high risk of complete disability in case of inadequate or ineffective treatment. The creation of Biologic Disease-modifying anti-rheumatic drugs (bDMARDs) has allowed to significantly improving prognosis for many RA patients, however, the issue of choosing therapy for patients with RA, especially in case of resistance to methotrexate treatment remains problematic, especially in terms of pharmacoeconomic justification of bDMARD choice. Ongoing improvement of clinical understanding of bDMARDs also ensures the significance of further investigating the pharmacoeconomic qualities of these drugs. Aim. To perform the pharmacoeconomic analysis (PHe) of therapy using tocilizumab, adalimumab, as first-line bDMARD therapy in patients with RA receiving standard combination therapy with methotrexate, as well as in patients who require bDMARD monotherapy due to methotrexate resistance, methotrexate nonresponse, or other issues within context of Russian healthcare Methodology. This PHe is conducted from societal perspective which includes interests of Russian healthcare system within context of Obligatory Medical Insurance system and interests of Russian economic system as a whole, including impact on. The time horizon for this research was 2 years. Randomized controlled clinical trials investigating safety and efficacy of these drugs when used in combination with methotrexate and as monotherapy were used as data source on safety and efficacy. A complex PHe model consisting of a «decision tree» (used to form simulated cohorts of patients for each investigated drug, 1 000 simulated patients per cohort) and a Markov model for evaluating treatment outcomes was constructed. Cycle length for the Markov component of the model was 1 week. Clinical improvement of ACR70 was chosen as efficacy end-point because of its high clinical and social relevance. Patients achieving ACR70 can return to workforce. The results of this modelling were used to perform cost-effectiveness analysis (CEA) and budget impact analysis (BIA). Result stability was confirmed by performing sensitivity analyses (SA). Result. During CEA, tocilizumab dominated in terms of cost-effectiveness ratio (CER). CER was 28 525 007 rub. for tocilizumab, 30 898 104 rub. for adalimumab per 1 000 simulated per year in patients receiving standard combination therapy and 21 564 612 rub. for tocilizumab, 30 970 348 rub. for adalimumab per 1 000 simulated per year in patients receiving monotherapy), as well as in terms of clinical effectiveness (as expressed with number of patients achieving ACR70) and with highest healthcare resource utilization effectiveness. BIA indicates that tocilizumab is associated with 4,8% reduction in budget burden compared to adalimumab (estimated per 100 000 per 2 years of Russian population (246 patients), accounted for RA prevalence) in case of standard combination therapy and a 3,98% reduction of budget burden in patients receiving monotherapy. That amounts to 35 575 400 rub. and 28 835 840 rub. respectively (taking into consideration 3,5% discounting factor). SA confirms result robustness to price fluctuations up to 20%.for patients receiving combination therapy and more than 25% for patients receiving monotherapy. Additional sensitivity analysis investigating possible effects of assuming strict safety and efficacy equivalence between the investigated drugs confirms tocilizumab advantage even under such assumption. Conclusion. Modelling results indicate that tocilizumab is pharmacoeconomically rational which is associated with higher effectiveness of healthcare resource utilization. Tocilizumab treatment is also attractive in terms of budget impact as it is associated with up to 4,8% budget burden reduction within scope of 2 years, which is a significant result in context of treating an expensive, potentially debilitating pathology such as RA. Aforementioned results demonstrate that tocilizumab is attractive, pharmacoeconomically effective option for treating patients with in the RF. Prioritization of tocilizumab within context of relevant purchasing channels is thus highly recommended.

This article describes the methodology of pharmacoepidemiological studies that help to research the efficacy and safety of drugs in real clinical practice at the level of a population or large groups of patients, promoting the rational and economically acceptable use of the most effective and safe drugs.

The article describes the methodology for conducting drug utilization researches that study the sales, distribution and use of drugs in the community, with special attention to the medical, social and economic results.

Rheumatoid arthritis (RA) is an autoimmune disease with unknown etiology that is characterized by chronic, erosive arthritis (synovitis), usually affecting more than five joints, and systemic impairment of internal organs. It usually leads to irreversible functional impairment of affected joints, and systemic inflammatory changes. The main goal of therapeutic strategies for RA focuses on preserving quality of life by suppressing the inflammation, preventing structural alteration of joints and other clinical manifestations, normalization of patient’s social functioning. Genetically engineered biological response modifi ers (GEBRM) are a class of drugs that allow the aforementioned results to be attained in patients who have not obtained the required clinical response from other therapeutic approaches. One of the modern GEBRM that have performed well in clinical trials is tocilizumab, which is available in both subcutaneous and intravenous formulation. Currently, not only clinical efficacy and safety, but also pharmacoeconomic expediency of a treatment regimen must be evaluated, which is the goal of current investigation. Aim. To assess the respective pharmacoeconomic performances of subcutaneous and intravenous forms of tocilizumab in Russian patients suff ering from RA. Methodology. A decision-tree model was constructed for this pharmacoeconomic analysis based on Russian healthcare standards and clinical practice. Each modelled group contained 1000 patients. The analysis was performed from the point of view of Russian healthcare system within context of Mandatory Medical Insurance system. Randomized controlled clinical trials investigating safety and effi cacy of analyzed drugs were used as source of efficacy and safety data. Time horizon of pharmacoeconomic analysis was set at 1 year. Clinical response per American college of rheumatology criteria and proportion of patients achieving remission or low activity of RA per DAS28 score were used as efficacy criteria. Safety criteria used were adverse event (AE) frequency and frequency of discontinuation due to AEs. Existing Russian RA treatment standard was used to calculate the healthcare resources utilization parameters. Modelling results were used to carry out Cost Minimization Analysis (CMA) and Budget Impact Analysis (BIA). Single-factor sensitivity analysis (SA) was used to ensure the results are robust to changes in market situation. Result. CMA factor has been determined to be -68 347 289 rubles in favor of subcutaneous tocilizumab, which indicates significant reduction of costs when using this drug form. Furthermore, BIA, when performed for 100 000 of Russian population indicates a 5.4% reduction of budgetary burden (which equals 17 155 170 rubles per 100 000 of population or 68 347 per patient). SA has proven that results are robust to price fl uctuations of up to 5%, which is a good result for a high-cost pharmaceutical. Conclusion. Use of subcutaneous form of tocilizumab results in cost reduction of 68 347 289 rubles, decreases the budgetary burden by 5,4% (17 155 170 rubles per 100 000 of Russian population). This indicates that use of subcutaneous tocilizumab for therapy of RA in Russian Federation is pharmacoeconomically justified.

Chronic obliterating diseases of lower limb arteries is a large group of socially significant diseases, characterized by persistent chronic progress, high probability of disabling complications as well as the emergence needs for expensive surgical treatment. This disease characterized by the association with other diseases of the cardiovascular system, making the conservative therapy especially relevant. Aim. To perform the pharmacoeconomic analysis (PHe) of the naft idrofuryl in the Russian Federation (RF) in patients aged 66 years and older with peripheral vascular disease, including atherosclerosis of the lower limbs arteries and the clinical picture, corresponding to Stage II of Fontaine. Methodology. Th is PHe is conducted perspective of public health organizations of the RF and considers only direct medical costs. Horizon of PHe adopted for 240 weeks (4.6 years). The source of data on the clinical eff ectiveness was taken from randomized controlled trials and meta-analyzes, which examined the efficacy, safety and tolerability comparable drugs. For criteria of clinical efficacy has been chosen the mean log expression of the maximum distance walk. As a criterion of utility were calculated the quality adjusted life years (QALY). In developed Markov model, the time horizon was broken down into a cycle of length for 1 week. On the basis of existing government standard of care was the assessment of costs in health care system for diagnosis and treatment in simulated groups, taking into consideration the cost of angioplasty. It was conducted cost-eff ectiveness (CEA), cost-utility (CUA), budget impact (BIA) and sensitivity analysis (SA), calculated cost-eff ectiveness threshold. Result. CER per patient at naft idrofuryl was 2,061 rubl., at pentoxifylline — 4,764 rubl. Since naft idrofuryl is not only superior to pentoxifylline in clinical effectiveness, but also was associated with a lower cost, the calculation of the ICER not needed. PHe show that CER per patient did not exceed the «willingness-to-pay ratio» none of the drugs, thus both of the drugs is relevant to reimbursement system. CUA demonstrated superiority naft idrofuryl both in terms of the net impact on the QALY, and in terms of utility costs (CUR), CUR of naft idrofuryl per patient totaled 144,992 rubl., pentoxifylline — 213,854 rubl. SA confi rmed the stability of these results. Analysis of BIA shows that the fi scal burden associated with naft idrofuryl, is lower by 183,9 million rubl. per year for every 3,000 treated patients on pentoxifylline, which can allow one to treat 1,321 patients more via a naft idrofuryl based therapeutic strategy. Conclusion. Excellence naft idrofuryl over pentoxifylline confi rmed in this pharmacoeconomic study. Naft idrofuryl dominates in terms of CER, CUR and reduce budget impact.

Aim. To perform pharmacoeconomic analysis of CHF therapy with supramolecular sacubitril/valsartan complex compared to routine therapy in patients with diabetes type 2 and ACE inhibitor intolerance within context of Russian healthcare system.Material and methods. A Markov model based on Russian Standards of treatment and clinical practice results was built. Cost-effectiveness analysis was done by comparing two patient groups of 1000 people each. Budget impact analysis required 27,451 simulated patients. Randomized controlled clinical trials results of sacubitril/valsartan vs. routine practice were used as source of efficacy and safety data. Time horizon was set at 3 years. Quality Adjusted Life Years (QALY) were used as effectiveness. Single-factor sensitivity analysis (SA) was used to ensure the results are robust to changes in market situation.Results. Cost-effectiveness ratio for sacubitril/valsartan is 301,145.7 rub. per QALY while cost-effectiveness ratio for routine practice is 510,621 rub. Budget impact analysis results indicate that during three years, in case of sacubitril/valsartan usage budgetary burden can be reduced by more than 220,000 rubles per patient and leads to savings of more than six billion rubles in terms of the whole population. Sensitivity analysis has confirmed the robustness of results.Conclusion. These results indicate benefits of sacubitril/valsartan using for CHF patients with type 2 diabetes and ACE inhibitor intolerance and justify inclusion of this drug into reimbursement lists that allow to reduce risk of hospitalization, lethal outcomes and budget of healthcare system.

Sevoflurane is one of the widely used inhalation anesthetics as well as desflurane, which started to be used in Russia in 2012. These drugs possess similar properties; however, desflurane provides faster restoration of cognitive functions and reduces the time to extubation. This study was aimed to investigate the impact of properties of these medications on pharmacoeconomic parameters. The objective is to evaluate pharmacoeconomic parameters of anesthesia with desflurane and sevoflurane in a medical unit, investigating their impact on the performance of surgical teams and opportunity to introduce Fast-track surgery in the Russian Federation. Methods. For the purpose of cost-effectiveness analysis (CEA), the time period for simulation of the compared regimens made 1 year. And the time period for budget impact analysis (BIA) and additional analysis of Fast-Track surgery made 3 years. Results of randomized clinical trials were used as a source of data on safety and clinical efficiency. The simulated groups (100 patients each) were formed for the purpose of analysis. The decision tree was used, including all direct medical costs of anesthesia, and surgery in general (dextral hemicolectomy was analyzed). The number of surgeries performed in case of the maximum load in a medical unit was used as an efficiency criterion for CEA, and the full scope of costs for additional surgeries was also included. Result: Desflurane demonstrated maximum absolute efficiency, expressed as the number of surgeries in case of the maximum load in a medical unit, i.e. the best rate of cost-effectiveness (CER). CER for the regimen with desflurane made 63,251 RUR and CER for the one with sevoflurane made 63,841 RUR, The budget impact analysis showed that use of desflurane reduced the budget costs by 153,467 RUR during 3 years (provided that there are 247 surgeries per year and 3 surgeries per day). Sensitivity analysis confirmed the invariance of the obtained results. Analysis of potential introduction of Fast-Track surgeries showed that its use was associated with reduction of budget costs by 8,013,182 RUR. Conclusion: Use of anesthesia with desflurane resulted in higher effectiveness and was the most cost-effective providing reduction of budget costs.

Lately, in Russia, the number of patients with severe stage of acute renal failure requiring renal replacement therapy is increasing. Intermittent hemodialysis is the most common type of this therapy, however, the continuous methods of renal replacement therapy also started to be more often used in clinical practice despite of their high basic cost. The subject of this study is to investigate of pharmaco-economic results reflecting direct medical and indirect non-medical costs when using these technologies versus the maximum effective use of funds while treating patients with severe renal dysfunctions. Objective: to perform comparative clinical and economic analysis of intermittent and continuous renal replacement therapy in the intensive care wards of medical units in Russia. Methods. The study was conducted in compliance with acting Standards on Clinical Economic Studies used in Russian Federation. The study methods included evaluation of existing randomized clinical studies and trials which included data from network meta-analyses and systematic reviews of the investigated technologies. The direct medical and indirect non-medical costs were calculated and analyzed in respect of cost-effectiveness and costs-utility and budget impact analyses, utility, expressed in the number of saved quality-adjusted life years. Result: Simulation and comparative healtheconomic analysis of intermittent (IRRT) and continuous (CRRT) renal replacement therapy showed that the use continuous (CRRT) renal replacement therapy resulted in reduction of direct medical and indirect non-medical costs even within the first year. By the end of the third year savings can achieve 341,129.5 RUR per patient, and of this amount, savings in direct medical costs show 279,646.3 RUR and savings of indirect non-medical costs show 61,483.1 RUR. Budget impact analysis identified that using continuous renal replacement therapy (CRRT) allowed to save more than 230 million RUR for the whole country during 3 years per 1,740 patients with acute renal failure. Conclusion: Despite its high initial costs, the use of CRRT results in the reduction of costs and maximum efficient use of funds, and thus CRRT can be recommended for wider use in the Russian practice.

The study objective is to conduct a pharmacoeconomic analysis of naftidrofuryl effectiveness in patients with ischemic stroke.Materials and methods. The work is based on the results of clinical studies of effectiveness, tolerability, and safety of naftidrofuryl in patients who suffered an ischemic stroke. The study design included data on 1000 patients of 45 and older with first-time acute cerebrovascular disease of ischemic type.Results. Direct medical costs for the chosen patient cohort per the Standard of stroke treatment current at the time of the study were 730 575 189 rubles, in case of naftidrofuryl inclusion they were 476 467 620 rubles. Cost minimization is 254 107 569 rubles. Indirect nonmedical costs associated with temporary incapacity for work for treatment per the Standard of stroke treatment were 124 156 950 rubles, and 64 559 180 rubles for naftidrofuryl use which demonstrates the drug’s economic benefit. Budget impact analysis has shown that the possible savings constitute 7.59 %.Conclusion. Inclusion of naftidrofuryl into treatment of patients with ischemic stroke is justified as it decreases duration of rehabilitation. This leads to a positive economic effect expressed as decreased direct and non-direct medical costs.

Background: Cost-of-Illness Analysis (COI) constitutes the basis for the decision-making process on the budget and allocation in a modern health care system. Considering the wide prevalence of type 2 diabetes mellitus (Т2DM), it is important to perform COI in the Russian Federation (RF). Aim: The aim of the secondary objective FORSIGHT-Т2DM study was to conduct Cost-of-Illness Analysis (COI) of Т2DM in the Russian Federation in relation to taking into consideration the presence of complications and concomitant diseases. Materials and methods: COI of Т2DM was performed using the data obtained in Russian multicenter observational, pharmacoepidemiologic cross-sectional study of diabetes care for assessing routine healthcare pattern of T2DM in the Russian Federation (FORSIGHT-Т2DM). Information for each patient was collected from primary medical records and By asking patients to fill out a questionnaire. Total costs were calculated as the sum of direct medical costs (DCm), direct non-medical costs (DCn) and indirect costs (IC). Results: The final analysis included data from 2014 patients with T2DM residing in 45 cities of RF. Total direct medical costs (DCm) of treating Т2DM and its complications and comorbidities amounted to 105 337 rubles ($2742) per patient per year; direct non-medical costs (DCn) amounted to 24 518 rubles ($638) per patient per year; indirect costs (IC) amounted to 149 754 rubles ($3898) per patient per year. The total cost of T2DM in RF in 2014 year amounted to 279 609 rubles ($7278) per patient. The total cost of T2DM in RF in 2014 amounted to 279 609 rubles per patient. Conclusions: More than half (53,5%) of the total cost of T2DM is the loss of GDP due to patients’ disability. The DCm constitute 37,7% of the total cost of the disease, of which 57% is spent on treatment of T2DM complications and concomitant diseases, while only 10% is spent on glucose-lowering therapies.