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Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice

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No 2 (2017)
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FROM EDITOR

PHARMACOECONOMICS

4-11 1229
Abstract
Aim. To perform health-economic evaluation of trastuzumab emtansine (T-DM1) in patients with HER2+ breast cancer and CNS metastases. Materials and methods. Cost-effectiveness analysis along with sensitivity analysis and budget impact analysis were performed. Direct medical costs and indirect costs (GDP loss) were accounted. Results. At 3 years modeling horizon total cost of trastuzumab emtanzine were higher comparing to lapatinib+capecitabine due to significantly higher overall survival (OS) observed in trastuzumab emtanzine group. CER OS for T-DM1 and lapatinib+capecitabine were 1 686 222 RUR/patient/ year and 1 704 486 RUR/patient/year, consequently. T-DM1 ICER (OS) was lower than cost-effectiveness threshold in Russia in 2016. Conclusions. The study showed T-DM1 is a cost-effective strategy in patient with HER2+ metastatic BC and CNS metastases.
12-24 1057
Abstract
Background. The modern therapies of advanced melanoma include targeted medicines for patients with BRAF mutations. Nowadays, a new perspective on immuno-oncologic medicine pembolizumab became available in Russia. Objective. Assessment of the clinical and economic effectiveness of the use of pembolizumab in the treatment of unrespectable and metastatic melanoma in comparison with targeted medicines in the context of Russian public health. Materials and methods. The Markov model was developed, including the states «without progression», «after progression» and «death», the duration of one Markov cycle is 1 month, the modeling time horizon is 5 years. The probabilities of transitions between states were described using mathematical formulas obtained as a result of digitization and approximation of Kaplan-Mayer survival curves, which were derived from randomized clinical trials KEYNOTE-006, COMBI-v and COMBI-d. Direct medical costs (including drug costs, treatment of adverse events, second-line therapy after disease progression, and palliative care) were analyzed. We did not take into account the costs associated with laboratory-diagnostic procedures and visits to the doctor. The sources of information were: weighted average prices of medicines indicated during public procurement for 2016 (the price of the drug pembolizumab provided by the manufacturer), a program of state guarantees for providing free medical care to Russian citizens for 2016, federal coefficients of relative costs for clinical and statistical groups. The effectiveness criterion for cost-effectiveness analysis was the average number of saved months of a patient’s life. Results. The average number of months saved was 30, 23, 24 and 30 months with pembolizumab, vemurafenib, dabrafenib and dabrafenib plus tramethanib, respectively (calculated using the developed model). Thus, pembolizumab has the same effectiveness as a combination of dabrafenib + tramethanib and is more effective than monotherapy with targeted drugs (dabrafenib or vemurafenib). Direct medical costs per patient over 5 years were approximately 4.06, 5.53, 5.91 and 15.72 million rubles when using pembolizumab, dabrafenib, vemurafenib and a combination of dabrafenib + trametinib, respectively. The health budget saving with pembolizumab instead of dabrafenib, vemurafenib and dabrafenib + trametinib combination may be 26%, 31% and 74%, respectively. Conclusion. Pembolizumab is a rational and economically justified choice for the treatment of unresectable and metastatic melanoma since it leads to cost savings when overall survival is increased.

NON-INTERVENTIONAL STUDY

25-28 1331
Abstract
The article describes the results of retrospective epidemiology (non-interventional study) two-stage study. This study was initiated to reveal and analyze changes occurred in the field of detection and modification of cardiovascular risk factors in patients with stable angina over the five-year period. The study identified some positive shifts in how doctors of outpatient cardiology clinic captured information about risk factors in medical records and how they implemented measures of non-pharmacological modification. However, in general degree of physicians’ attention to cardiovascular risk factors remains low.

DRUGS UTILIZATION RESEARCH

29-34 1204
Abstract
This article analyzes the volume of the Russian pharmaceutical market of antiplatelet drugs in the period 2014-2016. 80% of patients take clopidogrel generics, giving preference to Zilt®. Among the original drugs, the leaders of consumption are Plavix® and Coplavix® - in 2016 year 16%. In the structure of consumption of antiplatelet drugs, the share of original drugs as a whole account for about 60% of consumption in value terms, which is about 25% in packs. Clopidogrel generics (54% in value terms and 85% in natural terms) pass through the state segment, which means that most of the original drugs are purchased by patients through the retail pharmacy network, despite their high cost.

EXPERT OPINIONS

35-42 1434
Abstract
The substitution of one drug for another within one class can be caused by both medical indications, such as low therapeutic efficacy, and by non-medical factors, for example, by choosing a less expensive drug. In this article, the available data on the impact of non-medical switching on the clinical and pharmacoeconomic indices of anti-TNF therapy with drugs are considered.
43-48 846
Abstract
The provision of opioid analgesics for patients suffering from severe chronic pain is still a serious problem. The authors focus on the legislative, service organization and financial problems that impede the adequate provision of opioid analgesics (OA). The problem’s complexity increases with the implementation of the benchmarks specified by “The Russian Government’s Decree on Increasing the Availability of Opioids”. It is stated that there is a clear disbalance between the increasing requirements for OA use and the organizational and financial opportunities for their implementation. The need for introducing at the Federal level some changes in the service organization and financial mechanisms of ensuring patients with OA is emphasized, the one of which should be the allocation of an independent organization/financial programme. In the frame of this programme the provision of OA will be purposefully funded.


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