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Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice

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No 1 (2015)
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PHARMACOECONOMICS

3-8 6477
Abstract
Objective: To conduct a comparative pharmacoeconomic analysis of Cardiomagnyl and Trombo ACC during antiplatelet therapy of cardiac patients. Methodology: Clinical studies have demonstrated equal efficacy of drugs containing acetylsalicylic acid so this analysis model is a «cost-minimization» and consists of a single line therapy, providing short-term economic evaluation (12 months therapy). Results: Antiplatelet therapy with Cardiomagnyl in cardiac elderly patients reduce the cost of the annual rate of pharmacotherapy for 220 rubles in the calculation of per patient compared with therapy Trombo ACC by reducing the cost of correction the side effects. Expenses for correction of side effects when using Cardiomagnyl less on 737 rubles per patient than with Thrombo ACC.
10-16 7989
Abstract
Skeletal-related events - a significant medical and economic problem for women with metastases during the treatment of breast cancer. Clinico-economic evaluation was performed to compare the use of denosumab and zoledronic acid in this category of patients. The recommended pharmacoeconomic methods such as modelling (time horizon - 10 years) with Markov cycles were used. Direct and indirect costs were calculated. Number of skeletal-related events and QALY gained were used as efficacy criteria. As a result, it was shown that denosumab had greater efficacy than zoledronic acid. Using 10 years’ time horizon total costs per patient were less for zoledronic acid than for denosumab. Regardless of efficacy criteria and direct or indirect costs, ICER was below the willingness-to-pay threshold (1,341,308 rubles). The results of the multivariative probabilistic sensitivity analysis confirmed the findings of the basic scenario. Thus, the use of denosumab in patients with breast cancer and bone metastases is cost-effective strategy.
18-31 1502
Abstract
Comparative health technology assessment has been performed for evaluation of hormone resistant prostate cancer 2-d line chemotherapy schemes with cabazitaxel or abiraterone after docetaxel treatment. There were no found the difference between effects of both variations of treatment based on randomized clinical trials results. In the same time, the real world data shown more efficacy of cabazitaxel vs abiraterone based on non-progressive survival rate. Clinical-economic impact of both schemes was equal in relations with clinical trials data. Modelling economic analysis of real world data describes budget saving in case of using cabazitaxel vs abiraterone. Cost of cabazitaxel usage is less vs abiraterone in relations with non-progressive survival rate. Cost saving can use for the treatment of additional 17 patients with cabazitaxel (on each 100 pts.).
32-43 1251
Abstract
We have performed the first-ever comparative pharmacoeconomic analysis in a Russian context of ibrutinib in the first line of therapy of chronic lymphocytic leukemia at patients with a 17p deletion. Research was conducted from a position of the state health system by means of mathematical modeling. It was considered direct and indirect costs. Markov modeling and the sensitivity analysis were used. It was as a result shown that application of Imbruvica® in therapy of chronic lymphocytic leukemia at patients with a 17p deletion is an economically advantageous medical technology from the point of view of a ratio of cost and efficiency in comparing with strategy of an ofatumumab. It was as a result shown that application of Imbruvica® in therapy of chronic lymphocytic leukemia at patients with a 17p deletion is economically expedient medical technology from the point of view of a ratio of cost and efficiency when comparing with strategy of an ofatumumab. Also, this strategy was characterized by high clinical effectiveness and a comparable profile of safety among other medical technologies. As for the budget impact analysis, comparing with strategy of an ofatumumab widespread use of ibrutinib would allow saving up to an additional 80.5 millions rub per 1 000 patients with chronic lymphocytic leukemia, thus the saved means allow to treat with this strategy in addition 16 patients.
44-52 12131
Abstract
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.
53-64 2603
Abstract
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.
66-76 5512
Abstract
Objective: To conduct a comparative cost minimization analysis (CMA) of Movalis with other non-steroidal antiinflammatory drugs (NSAIDs) such as diclofenac, nimesulide, celecoxib and etoricoxib. Methodology: Was conducted search of publications from 1990 to 2014, devoted to randomized controlled clinical trials, a network meta-analysis and systematic reviews (level of evidence: AI) use of NSAIDs in patients with osteoarthritis (OA) and rheumatoid arthritis (RA). The model evaluates economical effectiveness of drugs and the comparison is based on the results of the randomized controlled clinical trials (RCCT), network meta-analyzes and systematic reviews. Since the data RCCT, network meta-analyzes and systematic reviews have shown equal efficacy of NSAIDs, model is a particular drug and CMA consists of one line therapy, providing short-term economic evaluation and impact on the health of patients with OA and RA. Results: The results of used of NSAIDs CMA and treatment of complications in patients with OA and RA showed that the total cost of the Movalis (meloxicam) is lower than another drugs: Voltaren (diclofenac), Nimesil (nimesulide), Celebrex (celecoxib) and Arcoxia (etoricoxib). Costs saving for one patient is favor for Movalis in comparison with the Voltaren was 465 rubles (-8.55%), Celebrex - 1.255 rubles (-23.09%), Arcoxia - 1.274 rubles (-23.43%) for a 1 month of therapy. Sub-analysis of the Movalis compared with the Nimesil (nimesulide) for 15 days of therapy showed that the cost savings per patient is favor for meloxicam will be 1.504 rubles (-117.74%). Sensitivity analysis confirmed these findings: an increase in drug prices Movalis by 25% and reducing the price of the reference drugs by 25%, minimizing the cost figures do not go beyond the parameters of the Movalis that demonstrates the stability of the obtained data in the study.

CLINICAL TRIALS

78-86 1005
Abstract
Clopidogrel remains the main antiplatelet therapy drug for patients after coronary stenting (CS) due to acute coronary syndrome (ACS). The paper contains substantiation and design of an observatory study with the purpose to test the hypothesis that high frequency of of cytochrome CYP2d9*2 polymorphism is associated with coronary stent thrombosis and with paradoxical response to clopidogrel in Siberian residents after CS due to ACS. Response to clopidogrel will be registered by means of light transmission aggregometry (turbidity method) in presence of adenosine diphosphate. Over the period of 30 days after coronary stenting, patients receiving clopidogrel will undergo 4 visits to assess antiplatelet therapy efficacy (end point - early stent thrombosis) and safety (all bleeding events), with consideration of genetic profile. Ethic support of the study

PHARMACOEPIDEMIOLOGY

87-91 1562
Abstract
The article focuses the search of rational drug use (RDU) problem solving ways. The educational level rising on RDU and therapeutic communication skills enhancing of physicians-practitioners are selected as one of the priorities.

QUALITY OF LIFE

92-98 1516
Abstract
Analysis of the results of observational program «Quality of life, symptoms of hypoglycemia and treatment satisfaction in patients with type 2 diabetes receiving basal-bolus insulin therapy» are presented. One thousand patients with type 2 diabetes mellitus (DM2) from ten regions of Russia were included in the above program. The quality of life of DM2 patients with different forms of hypoglycemia on insulin therapy and their distribution according to the grades of quality of life impairment were studied; the health utility index ( Ut) for various forms of hypoglycemia was determined. Quality of life in DM2 patients with hypoglycemia was lower than in those without hypoglycemia. Patients with severe and nocturnal hypoglycemia episodes recorded the expressed disturbances in quality of life; the majority of patients in this group had critical or severe quality of life impairment. On the basis of real-world practice data, the values of health utility index for patients with and without hypoglycemia were determined. The obtained values of health utility index can be used to calculate QALY in pharmacoeconomic analysis.


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ISSN 2588-0519 (Print)
ISSN 2618-8473 (Online)