Clinical and economical results of switching from original valproate - Depakine Chronosphere - to generic tablets of prolong action in adult patients with focal epilepsy has been performed. Methodology: In 127 patients duration of Depakine Chronosphere usage before switching, it’s dosage, efficacy, drug of switching, it’s dosage, dynamic of epilepsy seizures during half of the year after were fixed. Also were calculated total amount of out-patients visits, emergency calls, admission to hospitals, disability days before and after switching. Direct costs, including pharmacotherapy, hospitalization, out-patients visits etc., have been summarized. And total expenditures for one patient were calculated with cost-effective ratio during half of the year before and after switching were ensured. Results: Adult patients with focal epilepsy (127 pts) have been switched by doctors for technical, non medical, reasons to receive valproate Gxs instead previous treatment with Depakine Chronosphere. Patients have switched to Convulex (n=79.), Encorat (n= 27), Valparin ХР (n=21). After Convulex switching the total amount of patients in remission is less than in Depakine treatment. Absolute Risk of seizures is increased on 16,5%, relative risk - on 27,7%. Total amount of out-patients’ visits increased on 47,2% by the less Convulex efficacy as well as necessity in hospitalization has been occurred, and disability days count was 3,35 in average after switching. Total expenditures after switching from Depakine Chronosphere to Convulex were increased, and cost-effective ration for Depakine Chronosphere was less on 80,4% in compare with Convulex. In other cases of switching from original to Gxs valproate results were similar - efficacy was less and cost was increased. Conclusion: Switch from Depakine Chronosphere to valproate Gxs in focal epilepsy in adults is not justified from clinical point of view and more expensive from economic point of view.

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.

Goal: to conduct the pharmacoeconomic analysis of use of pegylated liposomal doxorubicin (PLD) versus doxorubicin in patients with metastatic breast cancer at a high risk of cardiac events with prior adjuvant anthracycline therapy. Materials and methods: Markov model was developed to estimate such outcomes as overall survival, fatal and non-fatal cardiac events in patients treated with PLD compared to doxorubicin. Treatment efficiency data were derived from clinical trials. The analysis was performed from the point of view of Russian health care system - only direct medical cost such as cost of primary therapy, visit to the doctor and treatment of cardiac events were considered. Results: The analysis demonstrated that use of PLD in treatment of metastatic breast cancer compared to doxorubicin was shown to be cost-effective option for patients at high risk of cardiac events in frame of Russian health care system. Resulting incremental cost-effectiveness ratio (ICER) was 549 831 RUB turned out to be significantly lower than willingness-to-pay threshold equal to 1 648 924 RUB in 2015. Sensitivity analyses showed that results were non sensitive to price for medicines (+/-20%), cost of visit to the doctor (+/-20%), but sensitive to time horizon.

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.

We aimed to conduct cost-utility analysis of two different regimens of the oral hypoglycemic therapy in 2 type diabetes mellitus (DM2). Methods. In the whole, 229 patients with DM2, receiving vildagliptin add-on to metformin (group 1) or sulphonylureas add-on to metformin (group 2) were enrolled in the study. Cost-utility ratio (CUR) was identified as a ratio of difference in total costs of treatment in the groups and difference in QALY in corresponding groups. The overall costs included direct costs of treatment as well as costs for treating of DM2 complications (severe hypoglycemia) and the costs related to the loss of GDP due to severe hypoglycemia events. Health utility value was evaluated for each patient on the basis of SF-6D questionnaire. Pharmacoeconomic expediency of treatment regimen was estimated by means of comparing the CUR and wiliness-to-pay ratio (WTP) for Russian Federation (RF). Results. The health utility value was higher in group 1 as compared to group 2: 0,757 vs 0,70 (p>0,05). The overall costs for treating one patient in group 1 during a year were 28 637,34 rubles, in group 2 - 10 231,55 rubles. CUR amounted 328 674,82 rubles and it was 4.4 times lower than upper border of WTP ratio in RF (1 457 400 rub.). Conclusion. The innovation treatment regimen with vildagliptin add-on to metformin is beneficial and may be considered as economically reasonable alternative to traditional treatment regimen with sulphonylureas add-on to metformin for DM2 patients in RF.

We’ve analyzed results of the therapeutic drug monitoring (TDM). TDM is a routine investigation into the compulsory health insurance system and more than 3 000 TDM-tests are performed annually. The most demanded TDM was the monitoring of antiepileptic drugs, cyclosporin, tacrolimus; rarely were monitored digoxin and antibacterial agents. It turned out that more than % of patients with the application of standard doses of antiepileptic drugs do not reach the therapeutic concentrations of these drugs in the blood of patients. In some patients were observed excess of the therapeutic concentration range: for valproate in 15% of cases, for carbamazepine in 7% of cases. Patients treated with cyclosporine in 9%, and tacrolimus in 17% of cases required a dose adjustment. It is found that the application of various drugs containing the same drug substance in the blood concentration may vary considerably.

We developed and embedded in research and clinical practice of the method of quantitative evaluation of adherence to treatment in clinical medicine. Assessment of adherence is investigated by completion of the questionnaire. Analysis of the answers allows us to quantitatively calculate the indicators of adherence to drug therapy, medical support, modification of lifestyle and integral adherence to treatment. In accordance with the obtained results, an adherence can be «high,» «satisfactory» or «unsatisfactory», serving as a basis for making research or treatment decisions. Dynamic quantitative assessment of adherence allows to assess the current efficacy of interventions and to forecast their trends. The questionnaire is recommended for use in clinical practice when treating patients with chronic diseases, as well as at the stages of organization and execution of clinical studies and clinical trials.