Modelling has been performed for evaluation of economic perspectives of new insulin glargine 300 IU/ml usage for diabetes mellitus type 2 (DM2) control based on literature analysis of non-direct comparison with insulin detemir. Evaluation of the reimbursement’s reasonability for insulin glargine 300 IU/ml in clinical practice was the aim of this analysis. Utility cost of insulin glargine 300 IU/ml is higher than insulin detemir for 1 IU on 25,2% (according to Governmental Reestr of maximal manufacturers’ prices). Meanwhile efficacy of insulin glargine on control of DM2 is higher than insulin detemir (61,7% and 42,5% accordingly, Odds Ratio 2,18, 95%CI 1,41-3,34; p=0,01). Besides that, insulin glargine had less amount of hypoglycemic events, less necessity for out-patients visits and hospitalizations. Calculated “cost-effective ratio” (CER), which has included annual insulins’ cost, potential expenditures for severe hypo treatment, cost of medical aid for out-patients and in-patients has been more preferable for insulin glargine (CER for insulin glargine 46 252,40 RUR, for insulin detemir 76 681,01 RUR). Conclusion: Modelling has confirmed the economic rationality of insulin glargine 300 IU/ml usage for effective DM2 control in governmental reimbursement system because budget expenditures will not increase (expert’s conclusion). Prospective comparable trials in the future are important for economic evaluation.

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.

Purpose. Comparative evaluation of the clinical and cost-effectiveness of perioperative antibiotic prophylaxis systemic fluoroquinolones cataract. Methods. A retrospective randomized trial of postoperative infectious complications after 9 314 cataract surgery performed by «small sections» technology from 2012 to 2014. Group 1 patients received 0,5% levofloxacin instillation (4 times a day for three days before surgery), 2nd group patients received additional systemic levofloxacin (oral, 500 mg / day). Relative risk (RR), relative risk reduction (RRR) and absolute risk reduction (ATS) complications, the number of patients needed to treat (NNT) were сalculated. Results. In group of patients receiving antibiotic prophylaxis just as instillation fluoroquinolones, infection rates were 0,25%, while in the group where the patients received an additional fluoroquinolone systems but - 0,02%. RR 0,08, COP - 0,92 CAP - 0,23%, NNT - amounted to 423. The costs of systemic antimicrobial prophylaxis exceeded the cost of a local antibiotic prophylaxis 1,8 times. At the same time the costs of treatment which developed endophthalmitis in 12 group 1 exceeded the value of systemic antibiotic prophylaxis and treatment of endophthalmitis after systemic use of levofloxacin. Conclusions. System use of fluoroquinolones in the perioperative period of cataract surgery is an effective method of preventing infectious tion of postoperative complications as clinical as the economic aspects.

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.

A review on the use of patient-reported outcomes (PRO) in clinical studies: the concept and content of the PRO, methodology enable PRO in clinical studies, the stages of creation and development, basic types and forms of PRO instruments, psychometric characteristics of the instruments PRO (validation, sensitivity, reliability) of PRO assessment technique.

In order to assess the impact of treatment on quality of life of patients with ovarian cancer stage I-III, we have conducted monitoring of 51 patients who were treated in The Primorsky Krai Oncological Clinic from 2014 to 2015, who responded to the overall EQ-5D questionnaire and the special questionnaire EORTC QLQ-C30 before treatment and after 6 cycles of chemotherapy. All patients were subjected to the surgery at the first stage. Laparotomia, hysterectomy with appendages, resection of the greater omentum is made for 41 (80,4%) patients, without resection of the omentum was made for 3 (5,9%) patients. Laparotomia, uppervaginal amputation of uterus with appendages, resection of the greater omentum is made 5 (9,8%), without resection of the omenntum was made for 2 (3,9%) patients. The omentum was not removed owing to a lack of technical capacity for resection. The second stage of the complex treatment is adjuvant chemotherapy scheme TCb (Paclitaxel 175 mg/m² Carboplatin AUC 6) or Paclitaxel 175 mg/m², Cisplatin 75 mg/m² (total 6 cycles). Pronounced changes in the quality of life of patients before treatment was owing to the manifestation of the underlying disease, the lack of «expressed concerns» after treatment indicates the effectiveness of anticancer therapy. The increase of «moderate problem» by the components «daily activity», «anxiety and depression», «health condition», compared with how it was a year ago,» indicates the presence of side effects of chemotherapy. The quality of life assessment via special questionnaire EORTC QLQ-C30 before treatment and after chemotherapy in patients with stage I ovarian cancer shows significant changes in indicators in the growth of dyspeptic symptoms, improvement of the emotional background (decrease anxiety and depression, sleep), reduced performance of significant physical activity. At the stage II ovarian cancer after chemotherapy increase in a general weakness, a limitation in the performance of daily activities and significant physical exertion are marked. At the stage III ovarian cancer substantial significant changes are noticed as the growth of dyspeptic symptoms, emotional depression, but also at the performance of daily activities and physical exercise, in spite of this, patients assessed the overall health status over the last week by 6 points, where 7 points is excellent health condition. Results show the decrease of the quality of life, in the background of the special treatment and the stage of disease.

It was conducted a simple prospective study of the effect of lipid-lowering therapy in the assessment of quality of life using the SF-36 in IHD in men before and after pharmacological intervention. We did not have a statistically significant difference in the dynamics of scales SF-36 questionnaire both before treatment and after in patients with coronary heart disease, stable angina FC I-II with atherogenic GLP-sensitive rosuvastatin treatment, in comparison with a group of patients who switched to bi-component therapy. However, in the analysis of the personal data of patients with coronary artery disease based on genotype found that the original values of quality of life on the scale of SF-36 in media D allele polymorphism ACE I/D is different from that in comparison with the native I allele. Thus, patients are carriers of D allele showed initially a bad score for quality of life and less dynamic values on the scales of SF-36, regardless of the type of pharmacological correction of disorders of lipid metabolism. Therefore, from the point of view of preventive approach is of interest to link genetic and personal-behavioral characteristics considered as psychological factors of CHD risk.

The results of the quality of life (QoL) changes study during fabomotizole treatment in patients with anxiety disorders are presented. The QoL indexes measured with WHOQOL-BREF questionnaire in patients with anxiety disorders are significantly decreased compared to healthy persons. Fabomotizole treatment is associated with both positive changes in QoL and anxiety symptoms reduction. Given the need to treat anxiety disorders in outpatient settings and importance to maintain patient’s optimal social performance and QoL it is reasonable to use fabomotizole as the first line treatment.

In Russia the evaluation of bioequivalence of drugs for more than ten years the main requirement of medical and biological control of generic drugs. Regardless of manufacturer to the generic drugs are exactly the same as the original drug, must meet the following requirements: quality, efficiency and safety. In connection with the increase in recent years of bioequivalence studies of medicinal products requires careful control over the quality of these studies on the territory of the Russian Federation.

The article covers the topics of clinical trial budgeting when applying risk-based monitoring (RBM) model. The problem is that the new monitoring model requires the new model of clinical trail budgeting too, while today, the common practice is to apply an old, traditional fixed-price budgeting.