The aim of this study was to identify the most effective (in the clinical and pharmacoeconomic aspects) drug for the treatment of widespread progressing differentiated thyroid cancer (DTC) refractory to radioactive iodine in patients – residents of the Russian Federation.

Materials and Methods. The budget impact and the “cost-effectiveness” parameters were analyzed using the MS Excel-model based on a 3-year period. The “cost-effectiveness” analysis was performed to compare the use of lenvatinib 15.28 mg/day, sorafenib 651 mg/day (after dose reduction), and chemotherapeutic agents. As part of the budget impact analysis (BIA), two scenarios were simulated: 1. DTC treatment using sorafenib and the chemotherapeutic agents (CTA);2. In some patients, the sorafenib + CTA therapy has been replaced with lenvatinib. The only parameter analyzed in this model was the drug cost. In the BIA, the impact of scenario 2 on the entire budget reserved for the thyroid cancer treatment was evaluated.

Results. Lenvatinib proved an effective agent (with a manageable safety profile) to be used in monotherapy of DTC refractory to radioactive iodine. According to the BIA, the introduction of lenvatinib had virtually no effect on the cost of thyroid cancer treatment. Using the “progression free survival” parameter, the cost-effectiveness ratio (CER) showed that the annual cost of effective treatment of DTC refractive to radioactive iodine with sorafenib or lenvatinib was 7 285 716.92 rubles or 3 368 077.62 rubles, respectively.

Innovative drugs eribulin and trabectedin are effective in the treatment of soft tissue sarcomas (STS) – rare, but severe malignancies.

Aim of the study. To perform the pharmacoeconomic evaluation of these two agents used with the second and subsequent lines of chemotherapy in common/metastatic STS, in theRussian Federation.

Materials and Methods. Direct, indirect and meta-analytic comparisons were applied to the results of two multicenter, randomized phase III clinical studies, on effectiveness and safety of trabectedin and eribulin as compared with dacarbazine for the treatment of severe anthracyclines-resistant lipoand leiomyosarcoms. The 12-month survival rate and the occurrence of adverse events were the endpoint parameters in this study. The impact on the budget and the “cost-effectiveness” index were also analyzed.

Results. The relative number of patients, who survived for 12 months and continued their treatment with the given drug, was 53% in the eribulin group, and 18% in the trabectedin group. The total number of recorded adverse events was not significantly different between eribulin and dacarbazine. The incidence of adverse events (including haematological) in the trabectedin group was significantly higher than that in the dacarbazine group (lg 95% CI> 1.0). The cost values of different treatment doses of eribulin got into a zone of 1-2 willingness to pay threshold (WPT). The cost of trabectedin treatment was higher than that of eribulin, and even at mid-optimal doses (1.5 mg/m2 ) exceeded 2xWPT. The cost estimating relationship (CER) was 0.69 for trabectedin, and 0.15 for eribulin.

Conclusion. In the Health Care system ofRussia, eribulin has a more favorable pharmaco-economic profile than trabectedin. Since STS is viewed as an orphan disease, both drugs are considered important and promising for the Russian oncological services. 

Aims of the study: to assess health care costs of the use of biological agents (vedolizumab and various TNF-α inhibitors) in adult patients with moderate to severe active ulcerative colitis (UC) and moderate or severe active Crohn’s disease (CT) with an unsatisfactory response, loss of response, or intolerance to one or more chemotherapeutic agents, and TNF-α inhibitors.

Materials and Methods. Statistical analysis, published reports on inflammatory bowel disease (IBD) treatment, the highest quoted prices of drugs from the list of vital and essential drugs (VED), the size of the maximal wholesale mark-ups, and the regulations of financial expenses in the Russian Federation Health system in 2016, were used in this analysis. Since Vedolizumab has been just recently registered in theRussian Federation and it is yet to be included in the VED, for now the drug has no quoted price. Therefore, we used the price suggested by the manufacturer added with the wholesale markup and VAT.

Results. As compared with the biological agents-TNF-α inhibitors currently used in the treatment of adult patients with moderate to severe active UC and moderate to severe active CD who showed an unsatisfactory response, loss of response or intolerance of one or more components of standard therapy, or TNF-α inhibitors, the introduction of Vedolizumab with shares of 3%, 4% and 7% for the first, second and third year is expected to result in cost savings of 26.4 million rubles (0.62%) for UC and 21.5 million rubles (0.63%) for CD.

Perampanel (PER) is a novel drug for treatment of refractory partial epilepsy in patients≥12 y.o. with proven efficacy and safety. PER is registered and may also be used successfully as adjunctive treatment in therapy of primary generalized tonic-clonic seizures (PGTCS).

Objective. To determine the effectiveness of perampanel and it`s clinical stability in patients at different dosing regimens, and evaluate the cost of treatment with perampanel in the Russian Health Care system.

Materials and Methods. Results of open multicenter controlled randomized (phase III) international clinical trials in patients over 12 years of age were used. Modeling of the direct costs was based on (i) the probable treatment outcomes: i.e., no clinical effect, treatment cessation due to adverse events, seizures reduction of 50% and more, complete seizure termination, (ii) the expected number of the above outcomes all overRussia, and (iii) the inflation risks in the period until 2020.

Results. The comparison of different clinical studies on adjunctive perampanel therapy in refractery partial epilepsy with or without secondary generalization as well as in primary generalized tonic-clonic seizures, reveales that the optimal daily dose of perampanel is 8 mg.

Conclusion. Direct costs modeling was performed to estimate annual expenses (per patient) of the adjunctive perampanel therapy. When recalculated for all patients with refractory partial epilepsy and for all patients with PGTCS inRussia, the results indicate that the introduction of perampanel may reduce the costs by more than 40% (up to 4-7 bln. rubles) annually until 2020. 

Objectives. To provide a pharmacoeconomic analysis of brentuximab vetodin therapy in relapsed or refractory CD30+ systemic anaplastic large-cell lymphoma in patients over 18 years of age.

Methods. Recommendations to carry out a budget impact analysis in theRussian Federation (2016) were used.

Results. The analysis covered a period of 3 years. The target population of patients with relapsed or refractory CD30+ systemic anaplastic large cell lymphoma numbered 345 individuals. The results indicate that the introduction of brentuximab vetodin in the List of vital and essential drugs and the Program of state-guaranteed free medical care will not increase the costs of the treatment in patients with relapsed or refractory CD30+ systemic anaplastic large cell lymphoma.

Conclusion. The brentuximab vetodin therapy of relapsed or refractory CD30+ systemic anaplastic large cell lymphoma is an economically reasonable and resource-saving medical modality. 

The present report reviews various aspects of legal regulation, function, guidelines for creation and sources of finance pertaining to the restrictive lists of drugs, which play a substantial role in the drug supply policy in theRussian Federation. The following restrictive lists (currently in effect) are carefully analyzed: the list of VED, the list of medications supplied to certain population groups, the list of “7 medical conditions”, the minimum assortment, the lists of regional benefits, the lists of medicines to treat rare diseases, in accordance with the list of rare (orphan) diseases, the list of strategically important medications, the list of drugs allowed for tax deduction. 

The rapidly growing incidence of obesity and diabetes mellitus, especially in developed countries, stimulates medical experts to closely study the epidemiology of non-alcoholic fatty liver disease (NAFLD). According to the published results of the epidemiological study DIREG 2, the prevalence of NAFLD in outpatients inRussiaincreased over the period from 2007 to 2015 and amounted to 37.3%. In the present report, the population of patients with NAFLD in the Far East Federal District (FEFD) was studied as part of the multicentre epidemiological study DIREG 2.

The aim. To analyze the data on FEFD obtained in the DIREG 2 study and compare those with the DIREG 2 data on the entireRussia.

Materials and Methods. The prospective disease registry study: epidemiological, observational, cross-sectional, multicentre study on the prevalence of NAFLD in outpatients. The total number of participating patients in FEFD was 2500, including 900 males and 1600 females. Epidemiological data were collected within two routine patient visits to the participating research centers.

Results. The major result of this study is that the prevalence of NAFLD in FEFD was significantly lower than that in the entireRussia (21.4% vs 37.3%). Although the rank distribution of the concomitant diseases in FEFD patients was comparable to that in the across-Russia population, the prevalence of metabolic syndrome, menopausal syndrome and hypertriglyceridemia was significantly higher in the FEFD population.

Conclusion. Despite the lower prevalence of NAFLD there is a significantly higher prevalence of disorders associated with NAFLD in the FEFD patients as compared with the acrossRussian patients from DIREG2. A set of measures preventing these risk factors from converting into full-scale disease is needed. 

This report addresses the ways of calculating QALY (Quality-adjusted life-year). OutsideRussia, a standardized methodology to calculate QALY is in use; such an approach makes it possible to apply this universal criterion of effectiveness to the evaluation of new health technologies. Its versatility enables better decision-making on financing the medical treatment within a limited budget. With this algorithm, the financial resources are allocated in such a way as to maximize the levels of QALY. InRussiato date, the use of QALY as a measure of drug effectiveness is not yet possible because of the lack of standardized calculating methods, as well as the absence of uniform tariffs for assessing the medical status of the patient in terms of health utility. Here, we present a number of methods for estimating the health utility, which are used to calculate the QALY, and describe advantages and disadvantages of these methods.