PharmacoEconomics - Modern pharmacoeconomics and pharmacoepidemiology (E-Journal) / ФАРМАКОЭКОНОМИКА. Современная фармакоэкономика и фармакоэпидемиология
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    ОГРАНИЧИТЕЛЬНЫЕ ПЕРЕЧНИ ЛЕКАРСТВЕННЫХ ПРЕПАРАТОВ. НОРМАТИВНО-ПРАВОВОЕ РЕГУЛИРОВАНИЕ, ВЫПОЛНЯЕМЫЕ ФУНКЦИИ, ИСТОЧНИКИ ФИНАНСИРОВАНИЯ, ПРАВИЛА ФОРМИРОВАНИЯ

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    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. В статье обсуждаются вопросы нормативно-правового регулирования, функции, правила формирования, источники финансирования перечней лекарственных препаратов, оказывающих наиболее существенное влияние на формирование государственной политики в области лекарственного обеспечения населения РФ. Детально рассмотрены действующие в настоящее время перечни лекарственных препаратов: перечень ЖНВЛП, перечень лекарственных препаратов для обеспечения отдельных категорий граждан, перечень «7 нозологий», минимальный ассортимент, перечни региональной льготы, перечни лекарственных препаратов для лечения редких заболеваний в соответствии с перечнем редких (орфанных) заболеваний, перечень стратегически значимых лекарственных средств, перечень лекарственных средств для налогового вычета.

    Распространенность неалкогольной жировой болезни печени в Республике Башкортостан (региональные результаты исследования DIREG 2)

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    Non-alcoholic fatty liver disease (NAFLD) is increasingly recognized as an important problem that can lead to cirrhosis and hepatic failure. It may be the most prevalent liver disease. However, knowledge of the epidemiology is limited. These findings encourage to conduct a larger sample size study to evaluate the real prevalence of NAFLD in the Russian population. It is important to know current prevalence of NAFLD. DIREG 2 study was performed under umbrella of leading Russian professional societies in partnership with Sanofi Russia.Objective: to estimate the prevalence of NAFLD within the general practitioners and gastroenterologist’s patient flow. It is important to know current prevalence of NAFLD in Republic of Bashkortostan and to compare with DIREG 2 results.Materials and methods. Epidemiologic, observational, multicenter study assessing the prevalence of NAFLD among patient’s outpatient practice. A total of 50145 patients (3232 in Republic of Bashkortostan) including those suspected of having NAFLD criteria were enrolled in the Program. The investigators were qualified doctors (GPs/therapist’s/gastroenterologists), providing outpatient care for the population. The epidemiological data were obtained, recorded during two routine patient visits to investigating centers.Results. Percentage of patients with revealed NAFLD within the patient flow primary or consistently coming to selected doctors for any reason including those suspected of having NAFLD was 37,3% in Russia vs 40,8% in Republic of Bashkortostan.Conclusion. Prevalence of NAFLD among patient flow of doctors in Russia is quite high. It has been revealed a high prevalence of NANCFLD within the patient flow primary or consistently coming to selected by doctors for any reason

    Стратегии лекарственного обеспечения пациентов с хроническим вирусным гепатитом С

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    The report reviews the options of drug supply for patients with chronic hepatitis C in the Russian Federation and elsewhere. The results of the Moscow regional program aimed at improving the quality of medical care in such patients are discussed. The proposed measures contribute to the reduced mortality rate in patients suffering from infections. The prospects of further improvements in the availability of antiviral medications for patients with chronic viral hepatitis C are outlined. В статье рассмотрены варианты лекарственного обеспечения пациентов с хроническим вирусным гепатитом С за рубежом и в Российской Федерации. Продемонстрирована эффективность работы целевой региональной программы, направленной на повышение качества оказания медицинской помощи жителям города Москвы, страдающим хроническим вирусным гепатитом С, снижение смертности от инфекционных заболеваний. Определен вектор дальнейшего перспективного развития для повышения доступности лекарственного обеспечения противовирусной терапии (ПВТ) для пациентов с хроническим вирусным гепатитом С.

    Факторы и значение частных расходов в здравоохранении

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    Private health spending in modern developed countries varies considerably depending on the national policy objectives, selected regulatory instruments as well as general socio-economic conditions.The objective of this paper is to analyze key determinants of private health spending.Materials and Methods. To achieve this objective we analyze academic works dealing with theoretical and empirical studies of private health spending.Results. From the analysis the effects of private health spending determining national health financing policy, significant discretionary (breadth and depth of social healthcare system, public health expenditure, regulatory measures on cost sharing, paid medical services, voluntary health insurance) and non-discretionary factors (relative health services price, income and its distribution, age structure, level of education, political preferences) were highlighted.Conclusion. In developed countries priorities of health private spending regulatory policy now are ensuring accessibility of essential health care and preventing consumer’s moral hazard. The most significant discretionary factor influencing the share and amount of private health spending is the management of state guarantees of free medical care; the most significant non-discretionary factor is the income and its distribution

    Предложения и рекомендации по оптимизации Программы государственных гарантий РФ бесплатного оказания гражданам медицинской помощи

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    The article describes questions of medical care regulation and possibility using the mechanisms of concretization for formation of State Guarantees fоr free Medical care for Russian Citizen. The proposed approaches are aimed at the formation of a new system of documentary maintenance of the health system. Inclusion in regulations of mechanisms of concretization allow to control volume, financial resources, quality and availability of medical care.В статье рассмотрены вопросы регламентирования оказания медицинской помощи и возможности применения механизмов конкретизации для формирования Программы государственных гарантий РФ бесплатного оказания гражданам медицинской помощи. Предложенные подходы нацелены на формирование новой системы документального обеспечения системы здравоохранения. Включение в нормативные документы механизмов конкретизации позволяет управлять объемами, финансовым обеспечением, качеством и доступностью медицинской помощи

    КЛИНИКО-ЭКОНОМИЧЕСКАЯ ОЦЕНКА ЭФФЕКТИВНОСТИ ЭРИБУЛИНА ПРИ САРКОМЕ МЯГКИХ ТКАНЕЙ ПО ДАННЫМ МЕТА-АНАЛИЗА

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    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.

    ДИСКУССИЯ О ЛОКАЛИЗАЦИИ ПРОИЗВОДСТВА СУБСТАНЦИЙ И ВЗАИМОЗАМЕНЯЕМОСТИ ЛЕКАРСТВЕННЫХ ПРЕПАРАТОВ

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    .Анна Ярвиц представила позицию Teva по вопросам локализации производства субстанций и взаимозаменяемости препарато

    ОЦЕНКА ЛЕКАРСТВЕННОЙ ТЕРАПИИ ПРОГРЕССИРУЮЩЕГО ДИФФЕРЕНЦИРОВАННОГО РАКА ЩИТОВИДНОЙ ЖЕЛЕЗЫ, РЕФРАКТЕРНОГО К РАДИОАКТИВНОМУ ЙОДУ, У ПАЦИЕНТОВ, ПРОЖИВАЮЩИХ В РОССИЙСКОЙ ФЕДЕРАЦИИ: ФАРМАКОЭКОНОМИЧЕСКИЕ АСПЕКТЫ

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    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

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    PharmacoEconomics - Modern pharmacoeconomics and pharmacoepidemiology (E-Journal) / ФАРМАКОЭКОНОМИКА. Современная фармакоэкономика и фармакоэпидемиология
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