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Purpose of the study. Conducting an assessment of the economic consequences (clinical and economic analysis) when conducting cytogenetic studies before prescribing various first-line treatment regimens for multiple myeloma (MM). Materialsand methods. The pharmacoeconomic study was carried out using the method of cost analysis, “cost-effectiveness” within the framework of the State Guarantee Program (SGP). Results. A review of the literature demonstrated that a limited number of data are currently available on the clinical effectiveness of the analyzed regimens in the first line, both in patients with normal and high cytogenetic risk. The cost-effectiveness analysis showed that among the three studied 1st-line treatment regimens (VMP, Rd, VRd), in terms of PFS (progression-free survival), the coefficient was minimal for the VMP regimen in patients with high cytogenetic risk. Conclusion. The study showed that the choice and prescription of first-line therapy, depending on the results of a cytogenetic study, is a clinically effective and cost-effective approach to organizing medical care for adult patients with multiple myeloma in the Russian Federation. This could be used in the future to formulate.

Background. Mucopolysaccharidosis Type I (MPS I) has clinical heterogeneity without specific symptoms leading to difficulties with diagnostic on time. In-depth screening for MPS I in children has aim of early detection and timely treatment with an enzyme replacement therapy. Aim. The purpose of this study was to conduct a clinical and economic assessment of the feasibility of screening for MPS I in children at group of risks. Materials and methods. Model for evaluation of the social-economic burden of MPS I with calculation of expenditures has been created. Costs of diagnosed and non-diagnosed patients in group of risks were identified, including direct medical costs (pharmacotherapy, out-patient cure, hospital admission, complications treatment, hematopoietic stem cell transplantation; direct non-medical (payments for disability); indirect (expenses related to the reduction or loss of the ability to work of one of the parents performing the duties of caring for a disabled child). Results. The weighted average cost per 1 diagnosed patient with mild forms of MPS I with selective screening, was 405,974.22 rubles, which is 184,421.85 rubles less vs average cost per 1 undiagnosed patient. The management and treatment of patients with mild forms of MPS I after selective screening will allow saving up to 17.7 million rubles/year, which would possible to additionally screen 705 patients. Taking into account the size of the population of patients with undiagnosed MPS I, currently the costs for this group amount to 56.7 million rubles, while the «overspend» of budget funds for untimely diagnosis of MPS I for this cohort of children is about 22.6 million rubles/year. Conclusion. Selective screening for MPS I in children at group of risks is economically proved and can lead to treatment on-time for disability and complications prevention.

Objective: to assess the clinical and economic efficiency and impact on the budget when using the drug Mirabegron in the treatment of an overactive bladder. Materials and methods. Study design — retrospective analysis of published data. Pharmacoeconomic analysis methods — cost analysis, clinical and economic analysis, budget impact analysis. Results. Despite the fact that the drug Mirabegron for the treatment of overactive bladder is less effective in comparison with the use of the botulinum toxin type A-hemagglutinin complex drug, the clinical and economic analysis showed that within the horizon of 12 months the use of the drug Mirabegron will require 66.8 % less costs. Analysis of the impact on the budget showed that when using the drug Mirabegron from the first year in 100 % of patients, the decrease in the burden on the budget will be 66.8 %. Gradual provision of Mirabegron to patients over 3 years instead of Botulinum toxin type A-hemagglutinin complex will reduce the burden on the budget by 44.4 % in 3 years. Sensitivity analysis showed that the results obtained are resistant to changes in prices for compared drugs and a decrease in the volume of therapy with botulinum toxin type A-hemagglutinin complex. Conclusion. The use of the drug Mirabegron in the treatment of patients with an overactive bladder is pharmacoeconomically justified. The inclusion of Mirabegron in the lists of medicines, the costs of which are subject to state reimbursement, is advisable.

Ipragliflozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor that reduce plasma glucose concentrations by inhibiting glucose reabsorption by the kidney through inhibiting SGLT2 sodium-glucose cotransporter and induce glycosuria. SGLT2 inhibitors are a new class of glucose lowering drugs most recently approved for treatment of type 2 diabetes mellitus (T2DM). Unlike other antidiabetic agents, SGLT2 inhibitors improve glycemic control (by HbA1c) and provide multiple additional benefits, including decreased body weight, blood pressure, and other multiple pleiotropic effects. The completed clinical trials and real world data have provided evidence that including of SGLT2 inhibitors in the treatment of T2DM has benefits of reduction of cardiovascular and renal outcomes. Goal. The aim of the study was to conduct a clinical and economic examination of ipragliflozin in comparison with other regimens of glucose-lowering therapy with other SGLT2 inhibitors. Methods. In carrying out the pharmacoeconomic analysis itself, a cost-effectiveness analysis (CEA) was applied with the calculation of the corresponding cost-effectiveness ratio (CER), incremental cost-effectiveness ratio (ICER) according to the formula, as well as an a «budget impact analysis». Multiple one-way sensitivity analysis, check the robustness of the results of the main scenario results to changes in key parameters such as the cost of drugs and complications of diabetes. The time horizon for analyzing the dynamics of economic consequences when using ipragliflozin as a glucose-lowering therapy for T2DM was 5 years. Results. The weighted average cost per patient per year when using the ipragliflozin treatment strategy is 31,182 rubles. The costs of the empagliflozin strategy are 61,291 rubles per patient. In the case of using dapagliflozin, the weighted average costs are 30,032 rubles per patient per year, the total direct medical costs for the current drug therapy option, calculated on the initial number of target practice in 72,143 patients with type 2 diabetes, amounted to 3,068,642,442 rubles. Analysis of the trend of changes in weighted average costs showed that the broader use of ipragliflozin for the treatment of T2DM in the target population leads to reducing in diabetes related direct medical costs by 6.7 %, while the total economic effect of ipragliflozin introduction over five years will be 501,539,327 rubles. Conclusions. Use of ipragliflozin + metformin in T2DM treatment is a cost-effective strategy compared to empagliflozin + metformin. The combination of ipragliflozin with metformin versus dapagliflozin + metformin is economically feasible in terms of cost-effectiveness.

Aim. To assess the pharmacoeconomic feasibility of including the drug upadacitinib in restrictive lists and government funding programs to provide patients with rheumatoid arthritis.Materials and methods. Study Design — Retrospective Analysisof Literary Data. Pharmacoeconomic analysis methods — indirect comparison, clinical-economic analysis (cost-effectiveness analysis) using sensitivity analysis; budget impact analysis using sensitivity analysis. Data on the effectiveness of the analyzed drugs are taken from publications on clinical studies of the compared drugs; on the cost of drugs — the state register of marginal selling prices, data of the manufacturer’s company.Results. According to the results of indirect comparison, with respect to the frequency of achievement of the DAS28 test (CRP)

Purpose. To evaluate pharmacoeconomic efficiency of dapagliflosin application for intensification of hypoglycemic therapy — in comparison with addition to therapy of group of inhibitors of dipeptidyl peptidase 4 (iDPP-4) or basal insulin. Materials and methods. Budget impact analysis was done retrospectively using published clinical research data. The evaluation was carried out according to 2 scenarios of intensification of therapy of patients with diabetes mellitus: using dapagliflozine in comparison with iDP-4 (scenario No. 1) or using dapagliflozine in comparison with basal insulins (scenario No. 2). In the first scenario, both direct and indirect costs were taken into account, and in the second scenario, only direct costs were taken into account. Results. The analysis of influence on the budget showed that when using a dapagliflozin in comparison with medicines of class IDPP-4 it is possible to reach decrease in the total costs on the 2nd year of therapy, at the same time in 5 years economy will make 19.4-24.2 % or 21,985-29,123 rub per 1 patient. In patients who have not previously received insulin, with the same effectiveness in reducing the level of glycated hemoglobin, the use of dapagliflosin in comparison with basal insulin reduces the cost of drug therapy by 9.3 % or by 3,566 rubles per year. If combined «surrogate» endpoint is used as an efficiency criterion, reduction of glycated hemoglobin level and body weight, intensification of therapy using dapagliflosin is dominant scheme: More patients reach the end point on dapagliflozine compared to basal insulin (57 and 37 % respectively), with direct costs associated with using dapagliflozine less by 9.3 % or 1,763 rubles in 180 days. Conclusion. The use of dapagliflosin to intensify therapy in patients with diabetes mellitus is economically viable. From the point of view of pharmacoeconomics, therapy schemes involving dapagliflosin dominate comparison therapy schemes. Dapagliflosin can be recommended for inclusion in medical care standards, drug programs, and formula lists of medical organizations.

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.

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 HbA1c

Actuality. A major problem for rehabilitating patients after a stroke, other major cerebrovascular events or trauma (such as traumatic brain injury (TBI)) is increased muscle tone (spasticity) which in turn causes impairments of mobility and formation of pathological postures (which are oft en painful). In cases when it affects upper limb, the decrease in employment ability, capacity for self-service and overall quality of life of the patient becomes exceptionally pronounced. Botulinum toxin type A preparations (BTA) are first-line drug therapy for this type of disorder. Data indicating that different BTA-based drugs have differences in terms of compensation period (period during which the patient does not require re-administration of botulinum toxin) has become available. The pharmacoeconomic effect of this property within context of treating upper limb spasticity in the Russian healthcare system has not yet been investigated. Given the importance of compensation period both for patient well-being and for the burden upon the healthcare system, performing this pharmacoeconomic analysis represents significant interest. Aim. To assess the respective pharmacoeconomic performances of different botulinum toxin preparations as treatments for upper limb spasticity, specifi cally onabotulinumtoxin А (Botox®), incobotulinumtoxin А (Xeomin®), abobotulinumtoxin А (Dysport®) as well as Relatox®, a Russian botulinum toxin. Methodology. The analysis was performed from the perspective of Russian healthcare system in context of government guarantee program for provision of free medical aid. A Markov model was constructed to carry out this analysis. The following forms of analysis were performed based on modeling results: cost-effectiveness analysis, budget impact analysis, and several sensitivity analyses to assess model’s robustness to a number of assumptions as well as price fluctuations. Model accounted for differences between botulinum toxins in terms of compensation period in context of upper limb spasticity, as well as probability of treatment discontinuation for all causes which included severe adverse events and all other possible discontinuation circumstances. Analysis accounted for direct medical costs associated with botulinum toxin administration. The opportunity to optimize Botox use through utilization of diff erently sized vials was accounted for. Modelling horizon was set at one year (due to the way patient treatment discontinuation obtained from literature sources). This modeling horizon was sufficient to account for the disease’s burden upon the healthcare system. The number of patients in each simulated group for cost-effectiveness analysis was set at 1 000 patients, the number of patients for budget impact analysis was estimated based on epidemiological data for Moscow city. Result. The costs per 1 000 within the scope of one year were lowest for abobotulinumtoxin А (Dysport®) and amounted to 58 947 570 rubles. Other drugs had total costs amounting to 94 954 468 rub., 92 049 480 rub, and 97 143 620 rub for onabotulinumtoxin А (Botox®), incobotulinumtoxin А (Xeomin®) and Relatox® respectively. During cost-effectiveness analysis Dysport demonstrated lowest cost-effectiveness ratio and thus is pharmacoeconomically superior. Cost-effectiveness ratio were 316 752 rub for Dysport, 641 584 rub., 619 028 rub., 656 376 rub. for Botox, Xeomin and Relatox respectively. The Dysport superiority within cost-effectiveness amounted to 48.8 %. During budget impact analysis, Dysport as the drug with superior CEA results was compared to Xeomin. Analysis indicated that moving 25 % of patients from Xeomin to Dysport results in 11.7 % reduction of budget burden (which amounts to more than 23 million rubles when epidemiological data for Moscow city is used). Several sensitivity analysis were carried out and confirmed model robustness to price fluctuations of drugs involved up to 25 % as well as alterations of a number of underlying assumptions related to treatment discontinuation curve parameters and Botox dosing regimens. Conclusion. These results indicate that Dysport has pharmacoeconomic advantages when used for treatment of adult upper limb spasticity resulting from stroke and traumatic brain injury within the context of the Russian healthcare system.

Introduction. Regardless the pharmacoeconomic evaluation of trastuzumab emtanzine (T-DM-1) has been done before new data concerning T-DM1 effectiveness and also costs data require an update of pharmacoeconomic evaluation. Aim. To update pharmacoeconomic evaluation of T-DM1 in patients with HER2+ breast cancer (BC) and CNS metastases. Materials and methods. Cost-effectiveness analysis along with sensitivity analysis were performed. Direct medical costs and indirect costs (GDP loss) were accounted. Results. At 5 years modeling horizon total cost of trastuzumab emtanzine were higher comparing to lapatinib+capecitabine due to significantly higher overall survival (OS) observed in T-DM1 group. CER OS for T-DM1 was by 21% lower comparing to CER lapatinib+capecitabine (2 099 940 RUR/patient/year and 2 541 879 RUR/patient/year, consequently). Conclusions. The study showed T-DM1 is a cost-effective strategy in patient with HER2+ metastatic BC and CNS metastases.

Introduction. Results of both clinical and epidemiological studies demonstrate a high frequency of work incapacity associated with headache, reduced socio-economic activity, low quality of life, greater number of comorbid diseases and mental disorders in patients with chronic migraine (CM) compared to those who suffer from episodic primary headache.Objectives. Te objective of the study was comparative assessment of the disease cost and clinical and economic consequences of using various therapeutic approaches for preventive treatment of CM from the societal perspective in the Russian Federation.Methods. Te following types of pharmacoeconomic analyses were used: disease cost analysis, budget effect analysis. Models based on literature data (Scenario No. 1) and based on expert opinion (Scenario No. 2) were constructed in parallel with subsequent interpretation and discussion of the results obtained. Direct and indirect costs were considered. Efcacy criteria were clinical outcomes of the use of therapeutic options in question — change in the frequency of use of migraine-associated aid: change in the frequency of use of emergency medical care; change in the frequency of inpatient treatment.Results. CM is a disease associated with a signifcant socio-economic burden: the cost of managing a target population of 1 470 840 patients with current distribution of therapeutic approaches can reach up to 402 569 527 778 RUB with clinical and economic modeling based on literature data, and 444 918 119 377 RUB with clinical and economic modeling based on expert opinion surveys. Indirect costs constitute a signifcant proportion of the socio-economic cost of CM, estimated at 61 995 589 503 RUB to 88 794 056 961 RUB. Te use of various therapeutic approaches for treating CM can reduce the cost of the disease for the target population. Te cost of managing one patient with Botox® per year (141 820 RUB) was up to 40 % lower than the cost of preventive treatment of a patient with CM with oral medications (202 894 RUB), up to 192 % lower than the cost of managing patients without preventive treatment (414 305 RUB). Te use of Botox is associated with signifcantly smaller indirect costs in comparison with the use of other therapeutic approaches in managing patients with CM.

Purpose. Comparative economic analysis of complex rehabilitation of children with cerebral palsy (CP) with and without injections of botulinum neurotoxin type A (Dysport®, BoNT-A). Materials and methods. We clinically followed up 149 children with spastic forms of cerebral palsy (GMFCS II-IV) – 78 boys and 71 girls in the age period from 2 to 14 years (108 children who received intramuscular BoNT-A injections and 41 children who underwent similar complex treatment without it). In the budget impact analysis (BIA) only direct medical costs were taken: the cost of pharmacotherapy BoNT-A, rehabilitation care and surgery. Results. Children with CP of the main group needed surgical correction for the first time by 10.5±2.8 years, 4.6 % (5 children) of them needed repeated 95 % (39 children) of the comparison group during the period of active growth from 10 to 12 years. As a result, the BIA found that the use of the treatment scheme for children with CP using abobotulinumtoxinA will save the budget of 24 744 690 RUB per 100 children compared to standard therapy for 12 years of observation. During the CEA it was found that to achieve 1 % efficiency in children with CP with the use of abobotulinumtoxin A requires 1 854 426 RUB, and to achieve a similar result without BoNT-A — 40 702 271 RUB. Including abobotulinumtoxinA injections in the comprehensive rehabilitation of children with CP would allow to treat additional 14 % children (compared to a treatment without BoNT-A ) with the same budget. Conclusion. It was found that the use of treatment regimens for children with cerebral palsy using the BoNT-A is economically justified. Long-term therapy of children with CP with Dysport® during a 12-year-follow-up has considerably improved clinical outcomes and could provide a saving of 24 744 690 rubles compared with a standard therapy per 100 patients. Considering the register of children with CP in the Tyumen region on 01 January, 2018, the budget savings could account for 5,938,726 rubles a year.

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.

Актуальность. Учитывая высокую социальную значимость шизофрении, особенно при ограниченных возможностях реадаптации и ресоциализации пациентов с шизофренией в текущих условиях функционирования психиатрической службы, а также значительную финансовую нагрузку на бюджет системы здравоохранения вследствие высокой доли — до 90 % — прямых затрат на шизофрению в условиях стационара существует необходимость оценить влияние терапии атипичными антипсихотиками (АА) на потребление ресурсов стационара, а также оценить экономический возврат вследствие повышения трудовой занятости пациентов при терапии современными АА. Цели: сравнительная оценка влияния терапии пациентов с шизофренией различными АА на потребление ресурсов стационара психиатрической службы в условиях российской системы здравоохранения; оценка экономического возврата вследствие повышения трудовой занятости пациентов при терапии современными АА, улучшающими уровень социального функционирования пациентов с шизофренией. Методология. Для проведения клинико-экономического анализа была использована модель принятия решений, разработанная для оценки клинических и экономических последствий терапии шизофрении пероральными АА. Результаты. Проведенный анализ показывает экономические преимущества лечения больных с шизофренией палиперидоном за счет меньшей частоты рецидивов, требующих госпитализации, по сравнению с другими препаратами. Большие затраты на амбулаторное лечение по сравнению с кветиапином и рисперидоном компенсируются экономией расходов стационарного звена. Согласно данным официальной статистики, в среднем валовой региональный продукт на душу населения составил в 2008 году 241 767 рублей в год. Таким образом, применение палиперидона у пациентов с шизофренией с высоким потенциалом сохранения или восстановления трудоспособности обеспечит сохранение ВПР в год на уровне 6,2 миллионов рублей в год в расчете на 100 пациентов. Вывод. Внедрение современных инновационных препаратов в психиатрическую практику не только не увеличит расходы службы в целом, но и позволит оптимизировать затраты между амбулаторным и стационарным сегментами, а также обеспечит экономический возврат государству за счет сохранения и восстановления трудоспособности у части пациентов.

The purpose of presented retrospective analysis was to identify retrospectively and estimate the economic benefits that can occur when comparing the costs of using desflurane or sevoflurane for anesthesia during surgery. Formalization and evaluation were carried out in accordance with the industry standard “Health technology assessment”, approved and signed into law June 14, 2014 by Order of the Federal Agency for Technical Regulation and Metrology of the Russian Federation GOST №568-art and ISPOR recommendations, and meet the requirements of statistical significance, allowing to develop recommendation conclusions on the use of each product in any given situation. Pharmacoeconomic evaluation is based on data from official registration licenses and patient information leaflets, randomized controlled clinical trials data and information on value, pricing and costs obtained from the public independent sources. In accordance with the objectives, indications and limitations on the use of these drugs for anesthesia, the target population of this study were patients of diff erent ages, who required the use of inhalation anesthesia during the ongoing surgical procedures: patients with physiological status not higher than Class I (ASA I) on the scale of the American Association of Anesthesiologists. Compared medical technologies were III generation inhalation analgesics Sevorane and Suprane. Th ere was conducted a cost-effectiveness analysis of the inhalation anesthetics, during which cost of achieving the minimum alveolar concentration (MAC) using compared inhaled anesthetic drugs was estimated. The analysis showed that the difference in favor of desflurane is 155.72 rub for a four-hour operation. The most significant influence on the direct medical costs associated with the use of inhalation anesthesia was shown by the cost of inhalation anesthetic (gas) per 1 ml, the concentration of the gas, the flow rate of fresh gas, duration of anesthesia. Sensitivity analysis confirmed the data obtained. In the current situation of the retrospective evaluation the assumed shift from sevoflurane to desflurane in 1 000 patients aged 12 to 60 years that require inhalation anesthesia, will be accompanied by cost savings of 102,907 rub to 155,720 rub, and with the use of induction of anesthesia with propofol up to 162 900 rub. Whereas during anesthesia in newborns and patients older than 60 years shift of desflurane to sevoflurane in 1 000 patients will reduce the cost by 266,354 rub and 225,672 rub respectively. Therefore the economic benefit from the use of a single inhalation anesthetic both as an induction drug and as a drug anesthetic drug has not been proved clinically and from an economic point of view that may require individual assessment of costs on the basis of regions of the Russian Federation or a particular institution.

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.

A health economic study was conducted under the Russian economic conditions to evaluate the feasibility of the use of dexamethasone 0.7 mg as a sustained release intravitreal implant (hereinafter, DEX implant) in the treatment of diabetic macular edema. Cost-effectiveness analyses (CEA) were performed using a decision tree model with calculation of cost effectiveness ratios (CER), as well as incremental cost-effectiveness and cost-utility ratios (ICER and ICUR). Ranibizumab 10 mg/ml, solution for intravitreal administration (hereinafter, ranibizumab), and a­ibercept 40 mg/ml, solution for intravitreal administration (hereinafter, a­ibercept), were used as the comparator drugs; the modeling study covered a three-year period. A probabilistic sensitivity analysis (PSA) was carried out to evaluate the level of uncertainty of the obtained results. A budget impact analysis was also performed. Free scenarios were reviewed for each analysis: the main scenario for phakic and pseudophakic eyes with the weighted average effects of the study drugs; alternative scenario 1 for pseudophakic eyes with the weighted average effects; alternative scenario 2 for pseudophakic eyes with the maximum possible effects of the study drugs. A network meta-analysis of 10 randomized controlled studies (RCT) was performed to evaluate the weighted average effect. e maximum possible effects were determined based on specific studies, including observational studies. e results of the main scenario and alternative scenario 1 demonstrated that the comparator drugs were inferior to the DEX implant with regard to the economic feasibility, since they had higher CER; the ICER and ICUR for the comparator drugs exceeded the social willingness to pay threshold. e results of alternative scenario 2 demonstrated that the DEX implant was dominant with regard to ranibizumab, and it was superior to a­ibercept with regard to the CER, ICER, and ICUR. The budget impact analysis demonstrated that a 3-year use of the DEX implant will allow to save the funds equivalent to an additional treatment of 102–189 patients if it replaces ranibizumab (depending on the scenario) or 72–286 patients if it replaces a­ibercept (depending on the scenario). e sensitivity analysis demonstrated low level of uncertainty of study conclusions.

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.

Health technology assessment has been performed for osteoarthritis treatment. Several technologies were evaluated — NSAIDs, steroid therapy and hyaluronans viscosupplementation for inter joint injection. Expertise based on literature data and modeling evaluated outcomes during 2.5 years in the fourth stage of illness including knee replacement. Only one strategy — with Synvisk® injection has been eff ective in the endpoint of modeling. Expenditures for NSAIDs, steroids and Synvisk® were calculated. Synvisk® usage is more preferable based on budget impact analysis. Th is strategy can save no less than 81 million RUR (on 1000 pts.). Saved money can cover an additional quantity of patients for Synvisk® treatment. Synvisk® technology is delay a necessity of knee replacement surgeon in patients with fourth stage of osteoarthritis following to budget economy during 6-12 months treatment already.

Gadolinium based contrast agents are widely used in MRI in a diagnostic of variety of pathologies. The quality of contrast enhancement depends on the total dose. The aim of the study is to conduct a health economic evaluation of gadoversetamide (OptiMARK, Malickrodt Pharmaceuticals) in contrast enhanced MRI. The cost-effectiveness analysis, costminimizing analysis and sensitivity analysis and budget impact analysis were used modeling contrast enhanced MRI. In results, we can say that OptiMARK is cost-effective comparing to gadopentetic acid and gadobutrol.

Актуальность. Множественная миелома (ММ) составляет приблизительно 1% среди всех злокачественных опухолей, 13% среди гемопоэтических опухолей. Внедрение в клиническую практику ингибитора протеасом бортезомиба привело к увеличению годичной выживаемости пациентов с ММ до 80% в сравнении с дексаметазоном. Цель: провести клинико-экономическое сравнение эффективности бортезомиба при подкожном и внутривенном введении у пациентов с рецидивирующей ММ в условиях РФ. Методология. Были выполнены клинико-экономические анализы минимизации затрат и влияния на бюджет. Результаты. Подкожный способ введения препарата бортезомиб позволяет снизить общие прямые медицинские затраты на 15 108 руб. на 1 больного по сравнению с внутривенной струйной инфузией. Затраты на коррекцию неблагоприятных побочных реакций ниже при подкожном введении на 3 964 руб. на 1 больного. Ожидаемая экономия бюджета при переходе с внутривенной формы на подкожную в 2012 г. составила бы 51,934 млн. руб. и 58,544 млн. руб. в 2013 г. Вывод: подкожное введение бортезомиба представляет собой перспективную альтернативу внутривенной инфузии препарата у всех групп пациентов с ММ за счёт снижения частоты развития периферической нейропатии, удобства введения и, как следствие, сокращения прямых медицинских затрат.

Actuallity. Idiopathic thrombocytopenic purpura (ITP) is an autoimmune disease caused by the production of antibodies to the platelet and megakaryocytes membrane structure, which causes to increase the platelet destruction, but also inadequate thrombocytopoiesis. e disease is characterized by a significant loss of ability to work and decreasing quality of life, higher mortality rate, as well as frequent hospitalizations, re­ecting to health care resources utilization. Therefore, burden of disease assessment is a point of high interest. Methodology. Two pharmacoeconomic models were developed for the "cost-minimization" and "budget impact" analysis on the basis of Microso Excel soware. e modeling hypothesis is comparable efficacy and safety of thrombopoietin receptor agonists (TPO), based on the absence of statistically significant differences from the results of an indirect comparison and the efficacy of romiplostim is assumed to be equal to the efficacy of eltrombopag. Direct medical costs were calculated based on the costs of drugs from the TPO receptor agonist group, the administration of drugs, «rescue therapy», bleeding treatment, and follow-up monitoring of patients with ITP during therapy. Calculations were based on registered limit transfer drug prices from the VED List and standards of the financial expenses per medical care volume unit of Russian Federation in 2018. e reduction in costs per patient per year is 796,967 rubles (33 %). Results. Clinical and economic analysis of drugs from the group of thrombopoietin receptor agonists in the therapy of chronic idiopathic thrombocytopenic purpura in adults has shown that eltrombopag in comparison with romiplostim in patients with chronic ITP at the background of previous treatment failure is more economically expedient being not less clinical effective. It is possible to reduce the budget impact of the healthcare system of the Russian Federation by 1,693 million rubles (8 %) for 5 years with the gradual increasing in eltrombopag share in the purchase of TPO receptor agonists. Conclusion. Eltrombopag with comparable efficacy and safety is more economically sound option of chronic ITP treatment as compared to romiplostim.

Gadolinium based contrast agents are widely used in MRI in a diagnostic of variety of pathologies. The quality of contrast enhancement depends on the total dose (mM per kg body weight) and its relaxivity. Gadobenic acid (MultiHance® , Bracco Imaging S.p.A, Italy) has the highest relaxivity comparing to others gadolinium based contrast agents approved in Russia. The aim of the study is to conduct a health economic evaluation of gadobenic acid in contrast enhanced MRI. The cost effectiveness analysis, sensitivity analysis and budget impact analysis were used to modeling MRI of CNS, MR-angiography and MRI of the liver. In results, we can say that Multihance® is cost-effective comparing to gadopentetic acid, gadobutrol and gadodiamid in CNS MRI.

Percutaneous coronary intervention (PCI — angiography and stent placement) aren’t possible without X-ray contrast agents. Contrast enhancement depends on the iodine concentration, while the safety of particular contrast agents diff ers. Th e aim of the study is to conduct health economic evaluation of Iomeron (Bracco Imaging S.p.A., Italy) in patients with acute coronary artery disease treating with PCI. Th e cost-eff ectiveness analysis, cost-minimization analysis, sensitivity analysis and budget impact analysis were used. In results, we can say that Iomeron is cost-eff ective comparing to iodixanol, iohexol, iopromide and ioversol.

Aim. Conduct a comparative assessment of the pharmacoeconomic ecacy of using the combination Vezomni as compared to a combination of tamsulosin and solifenacin in the form of monopreparations in men with symptoms of the lower urinary tract against a benign prostatic hyperplasia. Methodology. The design of the study is a retrospective analysis of the literature data. Methods of pharmacoeconomic analysis – cost analysis, "budget impact" analysis, cost-effectiveness analysis, sensitivity analysis. Results. The use of Vezomni instead of a combination of monopreparations tamsulosin + solifenacin will reduce the burden on the budget of the state guarantee program by 11.68 % for 3 years. With a target population of 1,000 people, the savings will be 6.28 million rubles. The cost of treatment of symptoms of the lower urinary tract for 1 year will decrease by 2 340.76 rubles for 1 person. At the same cost, the use of a fixed combination will provide therapy with 13.23 % more patients than with monotherapy (1132: 1000 people, respectively). Сonclusion. The use of the combination drug Vezonmi is pharmacoeconomically justified and allows to lower the costs for the treatment of lower urinary tract symptoms that occur against the background of benign prostatic hyperplasia in comparison with the use of a monopreparations of tamsulosin and solifenacin.

Partial epilepsy is the most common type of seizures. Th e prevalence of partial epilepsy in Russia reached 325 thousand patients, with resistant to therapy about 276 thousand. Objective. Pharmacoeconomic analysis (PHe) was conducted for perampanel use in patients older than 14 years with resistance partial epilepsy with or without secondary generalization in Russian Federation. Methodology. Th e perspective of PHe was a Ministry of Health and considers only direct medical costs (DC). Th e time horizont of PHe was adopted for 2 years. Th e data source of the clinical effi cacy was two network meta-analyzes. Th ey included randomized controlled clinical trials. Clinical effi cacy (Ef) criteria: reduction of seizures frequency ≥50%, the frequency of the «free from seizures», the frequency of discontinuation due to adverse events. As a criteria of utility were calculated QALY. In developed Markov model the 2-years time horizont calculation is divided into 6-month cycles. By the standards of primary health care for partial epilepsy in adults, we estimated DC for outpatient care, including diagnostic phase and selection of therapy, and remission phase. We conduct cost-eff ectiveness, cost-utility, budget impact and cost savings analysis. Results. Costeff ectiveness ratio (CER) of perampanel per patient (PP) was 613,968 rubles, lacosamid — 712,533 rubles. Cost-utility ratio (CUR) of perampanel PP was 206,045 rubles, lacosamid — 244, 582 rubles. Neither of comparators do not exceed the «willingness to pay» ratio. Sensitivity analysis confi rmed this fi ndings. Budget impact analysis showed that the overall cost of the therapy will be higher in the group of lacosamid at 15.7% then perampanel. Cost savings in favor of perampanel was 30,752 rubles PP within 2 years of therapy. Conclusion. Perampanel is dominant strategy in terms of CER and CUR, which reduce the DC.

The purpose of this pharmacoeconomic analysis was to determine the drug Nefopam economic feasibility of its use for postoperative pain relief in terms of the health system of the Russian Federation. Target population are Russian patients older than 18 years with moderate to severe pain after surgery, which requires the use of postoperative analgesia. In the context of this pharmacoeconomic analysis of patients treated with the assessment of the physiological status of not higher than class I or II on the scale of the American Association of Anesthesiologists. Clinical utility criterion: change numeric scale pain score (NPS — Numeric Pain Scale). In calculating the cost-utility ratio (CUR) following data were obtained: the cost of therapy at least a separate application ketoprofen — 19.80 rubles; CUR minimum figure in the application of multimodal anesthesia — 13.78 rubles. Budget impact analysis showed that the cost savings when using multimodal analgesia will be 574,662 rubles 1000 patients compared with nefopam; and in a separate application of ketoprofen — 21 538 rubles.

Overactive bladder (OAB) is a chronic disease that correlates with the age of the patient, and occurs in almost one in seven women and men. Pharmacotherapy is one of the main methods for correction of this nosology. Taking into account the absence of additional therapeutic option on the Vital and Essential Drugs List for patients with contraindications for the prescription of solifenacin and BTX-A, patients with intolerance to these drugs conduct, an analysis of the economic consequences of the use of mirabegron under the State Guarantees for Providing Free Medical Care for the OAB treatment. Approved recommendations on carrying out the budget impact analysis were used. Results of the study show, that the expansion of the mirabegron use in the treatment of patients with OAB in the target population leads to the reduction in the cost of medical therapy for this group of patients: with an increase in the share of mirabegron up to 5 %, costs will decrease by 7.8 %; with an increase in the mirabegron share up to 10 % costs will decrease by 12.5 %; when using in 15 % of the target population – by 22.3 %. Trend analysis of changes in the average weighted costs shows the following: an increase in the use of mirabegron leads to a significant reduction in total costs, the total benefit can reach 6 250 002 576 rubles per 3 years of the drug presence in the VED List, which allows attributing the OAB treatment with mirabegron to economically feasible and resource-saving medical technologies.

Актуальность. По экспертным оценкам, ежегодно в РФ осложнённые инфекции кожи и мягких тканей (оИКМТ) наблюдаются примерно у 700 тысяч пациентов. Цель: сравнение препарата цефтаролин с и линезолид у взрослых пациентов с оИКМТ. Методология: анализа эффективности затрат; анализ «влияния на бюджет». Результаты. С точки зрения анализа эффективности затрат применение Зинфоро™ для лечения оИКМТ, является предпочтительным по сравнению с использованием Эдицина™ или Зивокса™. Согласно результатам анализа «влияния на бюджет», переход в лечении оИКМТ с Эдицина™ на Зинфоро™ из расчёта на 1 пациента позволяет сэкономить 819 руб.; показатель упущенных возможностей при этом составляет 0,01. Переход в лечении с Зивокса™ на Зинфоро™ из расчёта на 1 пациента позволяет сэкономить 39 896 руб.; показатель упущенных возможностей при этом составляет 0,34.

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.

Background. Budget impact analyses (BIAs) are an essential part of a comprehensive economic assessment of a health care intervention and are increasingly required by reimbursement authorities as part of a listing or reimbursement submission. Objectives: The objective of this report was to present updated guidance on methods for those undertaking such analyses or for those reviewing the results of such analyses. This update was needed, in part, because of developments in BIA methods as well as a growing interest, particularly in emerging markets, in matters related to affordability and population health impacts of health care interventions. Methods. The Task Force was approved by the International Society for Pharmacoeconomics and Outcomes Research Health Sciences Policy Council and appointed by its Board of Directors. Members were experienced developers or users of BIAs; worked in academia and industry and as advisors to governments; and came from several countries in North America and South America, Oceania, Asia, and Europe. The Task Force solicited comments on the drafts from a core group of external reviewers and, more broadly, from the membership of the International Society for Pharmacoeconomics and Outcomes Research. Results. The Task Force recommends that the design of a BIA for a new health care intervention should take into account relevant features of the health care system, possible access restrictions, the anticipated uptake of the new intervention, and the use and effects of the current and new interventions. The key elements of a BIA include estimating the size of the eligible population, the current mix of treatments and the expected mix after the introduction of the new intervention, the cost of the treatment mixes, and any changes expected in condition-related costs. Where possible, the BIA calculations should be performed by using a simple cost calculator approach because of its ease of use for budget holders. In instances, however, in which the changes in eligible population size, disease severity mix, or treatment patterns cannot be credibly captured by using the cost calculator approach, a cohort or patient-level condition-specific model may be used to estimate the budget impact of the new intervention, accounting appropriately for those entering and leaving the eligible population over time. In either case, the BIA should use data that reflect values specific to a particular decision maker’s population. Sensitivity analysis should be of alternative scenarios chosen from the perspective of the decision maker. The validation of the model should include at least face validity with decision makers and verification of the calculations. Data sources for the BIA should include published clinical trial estimates and comparator studies for the efficacy and safety of the current and new interventions as well as the decision maker’s own population for the other parameter estimates, where possible. Other data sources include the use of published data, well-recognized local or national statistical information, and, in special circumstances, expert opinion. Reporting of the BIA should provide detailed information about the input parameter values and calculations at a level of detail that would allow another modeler to replicate the analysis. The outcomes of the BIA should be presented in the format of interest to health care decision makers. In a computer program, options should be provided for different categories of costs to be included or excluded from the analysis. Conclusions. We recommend a framework for the BIA, provide guidance on the acquisition and use of data, and offer a common reporting format that will promote standardization and transparency. Adherence to these good research practice principles would not necessarily supersede jurisdiction-specific BIA guidelines but may support and enhance local recommendations or serve as a starting point for payers wishing to promulgate methodology guidelines.

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.

Objective: To perform comprehensive pharmacoeconomical assessment of use etravirine and raltegravir in HIV-infected patients. Methodology: Cost-eifectiveness and budget impact analyses of etravirine or raltegravir on the top of optimized background therapy in adult treatment-experienced HIV-infected patients were conducted. Results: Cost to achieve an undetectable viral load (

Goal: to conduct pharmacoeconomic analysis of using the darbepoetin alfa (Aranesp) and other erythropoiesis-stimulating agents for anemia correction in patients on hemodialysis or peritoneal dialysis. Methodology. The study included both original medications: darbepoetin alfa (Aranesp), epoetin alfa (Eprex), methoxy polyethylene glycol-epoetin beta (Mircera), and bioanalog - epoetin alfa (Eralfon). Due to the fact that data are available regarding the discrepancy between the actual dosage of darbepoetin and instructions for drug use (meta Bonafont et al.), to assess the actual practice in a national health system was conduct a retrospective observational study in 11 hospitals of different regions of Russia. Budget Impact Analysis (BIA) was used as the most informative method to identify sources to optimize budget spending allocated for drug coverage this category of patients - only direct medical cost took into account such as cost of the drugs, intravenous administration, the transfusion and the cost of unplanned hospitalization for cardiovascular reasons or due to infection. The same calculation was made changes total cost (savings budget) at a magnification of hospital purchases Aranesp share 15% (± 5% of each of the compared drugs) depending on the target value of the level of hemoglobin. One-way sensitivity analysis of the model to the price of Aranesp ± 10% and reduce the dose of Aranesp by 20% and 47% (based on expert data), as well as to changes in the cost of hospitalization was spend. Results. Data on the efficacy and safety of different types of anemia correction in patients on hemodialysis or peritoneal dialysis have been analyzed. In the literature review was concluded on a similar efficacy and safety of drugs included in the study. Cost analysis showed darbepoetin economic advantage for all the analyzed indicators (total costs per patient attained control, the total annual costs). Sensitivity analysis showed that the results are most sensitive to a change in dose and price of darbepoetin. Despite the fact that these actual practices indicate a possible reduction in the dose of Aranesp by 47%, the economic benefit of the drug Aranesp maintained even at reduction by 30%. Conclusions. Using Aranesp in dosages used in actual practice for correction of anemia in patients undergoing hemodialysis or peritoneal dialysis is more cost-effective way of treatment compared with other alternative erythropoiesis-stimulating drugs.

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.

Purpose. To evaluate the cost effectiveness of use of ustekinumab (Stelara®), infliximab (Remicade®) and adalimumab (Humira®) for treatment of moderate and severe psoriasis. Methods. A cost-effectiveness analysis and budget impact analysis have been conducted. Clinical efficacy was evaluated by reduction in PASI scores by 50, 75 and 90%. The efficacy and safety of compared anti-psoriasis agents were derived from a meta-analysis of efficacy of biologic agents in treatment of moderate and severe plague psoriasis containing all compared drugs. The expenses counted includes costs of anti-psoriasis therapy, cost of drug administration and associated medical services. Results. Ustekinumab (Stelara®) was shown to be the most cost-effective biologic agent with respect to the cost per patient achieving PASI50, PASI75 and PASI90 scores. Total direct medical costs associated with use of ustekinumab for treatment of psoriasis turned to be 2 824 rub. (0.2%) per patient per year less than total cost of treatment associated with adalimumab and 444 315 rub. (27.3%) per patient per year less than total costs associated with infliximab. Thus, treatment of patient with moderate and severe psoriasis with ustekinumab results in optimal health care resource utilization. Conclusion. Prescribing of ustekinumab (Stelara®) was demonstrated to be dominating strategy of treatment of moderate and severe psoriasis being the most effective and less costly strategy among those based on other biologic agents.

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.

Objective: To conduct a comparative pharmacoeconomic analysis Jodantipyrin drugs and Human immunoglobulin against tick-borne encephalitis (TBE) for emergency prevention of tick-borne encephalitis in a health care system of the Russian Federation. Methodology: The study is an analysis of costs, cost-effectiveness and budget impact and consists of a single line of therapy. Results: Cost analysis shows that in the case of the health budget Jodantipyrin costs associated with treatment of established TBE 2.2 times lower than that of the Immunoglobulin against tick-borne encephalitis, and the costs of the use of means of emergency prevention Jodantipyrin - at 11,3 times less.

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.

The objective was to evaluate the cost-effectiveness and budget impact of ceftaroline fosamil compared with other intravenous antibiotics with anti-MRSA activity in the treatment of complicated skin and soft tissue infections (cSSTI). The source of data on the efficacy and safety were randomized controlled trials and meta-analyzes devoted to the study of drugs for the treatment cSSTI. Comparison drugs were daptomycin, tigecycline, vancomycin and linezolid. To “overlap” gram-negative infections for vancomycin, linezolid and daptomycin was taken into account levofloxacin and cefoperazone/sulbactam with the share of each of them at 50%. For the efficacy was taken clinical response at day 7-14 after a course of treatment in ITT-population of patients with cSSTI. We calculated the direct medical and indirect non-medical costs associated with premature mortality. The data obtained are the following types of pharmacoeconomic analysis: cost-effectiveness analysis (CEA), budget impact analysis (BIA) and sensitivity analysis (SA). The results of pharmacoeconomic analyzes have shown that the cost-effectiveness ratio (CER) per patient was lowest in vancomycin - 79.613 rub., further follow: ceftaroline - 94.474 rub., linezolid - 118.049 rub., tigecycline - 122.424 rub. and daptomycin - 127.484 rub. Evaluation of cost-effectiveness threshold demonstrated that CER do not exceed the value of “willingness-to-pay ratio” none of the comparators, i.e., they are subject to state reimbursement under the compulsory health insurance system. Analysis of indirect costs per patient associated with premature mortality and the shortfall in GDP gave the following results: at ceftaroline they accounted for 31.391 rub., daptomycin - 78.458 rub., tigecycline - 105.688 rub., linezolid - 151.880 rub., vancomycin - 187.774 rub. The total costs (direct and indirect) per patient were at least in ceftaroline group - 108.094 rub., further follow: daptomycin - 182.102 rub., tigecycline - 203.493 rub., vancomycin - 251.743 rub. and linezolid - 252.151 rub. BIA shows that the transition from comparators to ceftaroline is costs saving overall of the budget: with linezolid - 144.056 rub., vancomycin - 143.649 rub., tigecycline - 95.399 rub., daptomycin - 74.008 rub. SA confirmed these results. Ceftaroline is the best alternative to daptomycin, tigecycline, vancomycin and linezolid. Active implementation of ceftaroline as a drug for the treatment of cSSTI can contribute both to optimize budget spending at various levels.

Aim. To assess the pharmacoeconomic feasibility of including lenvatinib in the list of vital and essential drugs (VED) and the state program for providing to the necessary drugs to treat patients with differentiated radioiodine-resistant thyroid cancer. Materials and methods. The design of the study is a retrospective analysis of the literature data. Methods of pharmacoeconomic analysis - cost analysis, budget impact analysis, cost-effectiveness analysis. Results. The replacement of sorafenib with lenvatinib when included in the VED list and the state program for providing the necessary medicines for the treatment of patients with differentiated radioiodine-resistant thyroid cancer will reduce the burden on the program budget. At the size of the target group of 100 people for 3 years, the savings will amount to 43.95 million rubles. The total reduction in the load on the budget will be 11.8%. The results obtained are resistant to an increase in the price of lenvatinib by 19.0% and a decrease in the price of sorafenib by 52%. The average cost of therapy for 1 patient with differentiated radioiodine-resistant thyroid cancer for 1 year with the use of lenvatinib in the first line is 36.0% lower than with sorafenib. The savings for 1 year is 334 911 rubles on the patient. In terms of «cost-effectiveness», the drug lenvatinib dominates sorafenib. The CER value per patient for the year using lenvatinib is 48.7% lower than with sorafenib. Conclusion. From the pharmacoeconomic point of view, the use of lenvatinib in the first line of therapy of radioiodide-differentiated thyroid cancer is preferred in comparison with the use of sorafenib. The inclusion of lenvatinib in the list of vital and essential drugs and the state program for providing the necessary drugs is pharmacoeconomically feasible.

We conduct a comparative cost-effectiveness and budget impact analysis of atypical antipsychotics for the treatment of schizophrenia - sertindole versus quetiapine, paliperidone. The primary outcome of interest was rehospitalization rates. The cost of the annual treatment of patients with schizophrenia in the outpatient setting was calculated, costs of hospital readmission and total costs.

Objective. Health economic expertise of pramipexole extended release monotherapy at early stages of Parkinson’s disease. Methods. An economic model was developed based on clinical studies to derive comparative information on the effectiveness, utility and direct medical costs of antiparkinsonian treatment strategies over a year period. Cost-effectiveness, cost-utility and budget impact of comparative therapies were assessed. Results. Mirapex® extended release (ER) has the lowest cost-effectiveness ratio (31 499 rub. per a patient a year responded to antiparkinsonian therapy) and the lowest cost-utility ratio (2 562 rub. for decrease of degree of abnormalities of daily activities and motive abnormalities per a point of UPDRS scale). Budget impact analysis demonstrated that pramipexole ER monotherapy resulted in cost saving of 6 499 rub. (20 %) compared to Pronoran®, 26 918 rub. (51%) compared to Requip Modutab® and 24 966 rub. (49%) compared to Azilect® per a year of therapy. Mirapex® ER was the dominant strategy demonstrating higher effectiveness at lower costs in Parkinson’s disease treatment.

The article presents the results of comparative pharmacoeconomic analysis of treatment of schizophrenia with antipsychotics of the first and second generation in Khabarovsk territory. Regional «portrait» of the patient with schizophrenia is presented. Results of the analysis of experts’ preferences in prescription of psychotropic drugs in treatment of schizophrenia are given. Sociological, pharmacoeconomic and pharmacoepidemiologic methods of the analysis are chosen for carrying out present research. Analysis of «cost-effectiveness» and «budget impact» are used together for pharmacoeconomic method. The results of the conducted researches have allowed to develop the model of optimization of medicines’ provision for patients with schizophrenia taking into account the regional features.

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.

Breast cancer is one of the most wide spread oncological disease and metastatic breast cancer is very severe, because of its high resistance. One of the recent drugs aimed for this group of patients is еribulin, which is microtubules dynamics inhibitor, leading to non-functional tubuline complex formation. Statistically relevant and clinically signifi cant еribulin action according to total survival was approved among HER2-negative and triple negative breast cancer. Eribulin is the only cytostatic approved as a monotherapy that leads to relevant and significant life prolongation among metastatic breast cancer patients, who had several regimens of therapy before.Aim. To determine budget impact and life years saved aft er adding Halaven® (еribulin) to the offi cial lists for metastatic breast cancer treatment.Methodology. Th is PHe was conducted according to standart implemented in the RF. All the breast cancer patients according to the state statics were included. The modelling horizon was 5 years. Drugs comparison are docetaxel, paclitaxel, kapezitabine, gemzitabine, vinorelbine, eribulin. Randomized controlled clinical trials investigating safety and effi cacy of these drugs, as well as performing head-to-head comparisons of some of them, were used as data source on safety and efficacy. A «decision tree» model was then constructed in order to estimate healthcare costs and patients outcomes. Two parameters were chosen as criteria for eff ectiveness assessment — overall survival and survival without progression. The results were used to perform Budget Impact Analysis (BIA) and evaluation of phramacoeconomic expediency and health impact.Results. Eribulin instead of standart therapy prolongs the patients’ life for 76 days. Budget impact analysis was performed to the terms of the treatment and adverse events correction. The profit of the eribulin treatment for every patient was 462858 rubles for 5 years or 5.59% of the budget impact. Sensitivity analysis confirms result stability, however, when price increase reaches 25%, the profit is 321356 rubles or 3.85% of the budget impact.Conclusion. It has been determined that eribulin is the most clinically and economically effective drug for metastatic breast cancer after 2nd line chemotherapy with the lowest budgetary burden.