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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher-id">rpcardio</journal-id><journal-title-group><journal-title xml:lang="en">Rational Pharmacotherapy in Cardiology</journal-title><trans-title-group xml:lang="ru"><trans-title>Рациональная Фармакотерапия в Кардиологии</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">1819-6446</issn><issn pub-type="epub">2225-3653</issn><publisher><publisher-name>«SILICEA-POLIGRAF» LLC</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.20996/1819-6446-2015-11-5-496-503</article-id><article-id custom-type="elpub" pub-id-type="custom">rpcardio-323</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>PREVENTIVE CARDIOLOGY AND PUBLIC HEALTH</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ПРОФИЛАКТИЧЕСКАЯ КАРДИОЛОГИЯ И ОБЩЕСТВЕННОЕ ЗДОРОВЬЕ</subject></subj-group></article-categories><title-group><article-title>Cost-effectiveness of new oral anticoagulants in the treatment and secondary prevention of venous thromboembolism</article-title><trans-title-group xml:lang="ru"><trans-title>ЭФФЕКТИВНОСТЬ ЗАТРАТ НА НОВЫЕ ПЕРОРАЛЬНЫЕ АНТИКОАГУЛЯНТЫ ПРИ ТЕРАПИИ И ВТОРИЧНОЙ ПРОФИЛАКТИКЕ ВЕНОЗНОЙ ТРОМБОЭМБОЛИИ</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Рудакова</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Rudakova</surname><given-names>A. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>д.фарм.н., профессор кафедры управления и экономики фармации СПХФА </p></bio><email xlink:type="simple">rudakova_a@mail.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Санкт-Петербургская химико-фармацевтическая академия 197376 Санкт-Петербург, ул. профессора Попова, 14</institution><country>Россия</country></aff><aff xml:lang="en"><institution>St. Petersburg State Chemical Pharmaceutical Academy. Professora Popova ul. 14, St. Petersburg, 197376 Russia</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2015</year></pub-date><pub-date pub-type="epub"><day>05</day><month>11</month><year>2015</year></pub-date><volume>11</volume><issue>5</issue><fpage>496</fpage><lpage>503</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Rudakova A.V., 2015</copyright-statement><copyright-year>2015</copyright-year><copyright-holder xml:lang="ru">Рудакова А.В.</copyright-holder><copyright-holder xml:lang="en">Rudakova A.V.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.rpcardio.online/jour/article/view/323">https://www.rpcardio.online/jour/article/view/323</self-uri><abstract><sec><title>Aim</title><p>Aim. To assess the cost-effectiveness of apixaban in the treatment and secondary prevention of venous thromboembolism (VTE) compared with low molecular weight heparin (LMWH)/warfarin and other new oral anticoagulants (NOACs). Material and methods. Cost-effectiveness analysis was performed using a Markov model, developed on the basis of the results of AMPLIFY AMPLIFY-Ext trials, and network meta-analyzes on the use of antithrombotic drugs in acute VTE and long-term administration after VTE. Markov cycle duration was 3 months. The duration of therapy in the simulation was 6 and 12 months. The time horizon of the study was 5 years. Life expectancy and costs were discounted by 3.5% per year. The costs on drugs were estimated based on the registered marginal cost price. Besides, the analysis was performed to the weighted average auctions prices for NOACs. The costs of monitoring and treatment of complications were calculated on the basis of the collective agreement of compulsory health insurance system (St. Petersburg, 2015). </p></sec><sec><title>Results</title><p>Results. Apixaban provided significant cost savings compared with other modes of anticoagulant therapy for hospital treatment. Apixaban provided cost savings compared with other NOACs with a minimal increase in life expectancy with regard to quality in long-term analysis. Apixaban provided an increase in life expectancy compared with the appointment of LMWH/warfarin, but required some increase in costs. At therapy duration of 6 months, the costs per one additional year of life with regard to quality and to one additional calendar year of life were 309.8-403.7 and 481.6-627.4 thousand rubles, respectively; at therapy duration of 12 months – 1254.4-1476.9 and 649.0-764.1 thousand rubles, respectively. </p></sec><sec><title>Conclusion</title><p>Conclusion. Apixaban provided a reduction in the incidence of bleeding compared with other NOACs and LMWH/warfarin with comparable efficacy in treatment and secondary prevention of VTE. Apixaban therapy costs were lower than these for other NOACs, and the additional cost of apixaban therapy compared with LMWH/warfarin proved to be highly cost effective in the treatment of 6 months duration and economically acceptable in therapy during 12 months. </p></sec></abstract><trans-abstract xml:lang="ru"><sec><title>Цель</title><p>Цель. Оценить эффективность затрат на апиксабан при терапии и вторичной профилактике венозной тромбоэмболии (ВТЭ) по сравнению с низкомолекулярными гепаринами (НМГ)/варфарином и другими новыми пероральными антикоагулянтами (НОАК). Материал и методы. Анализ эффективности затрат осуществляли с помощью марковской модели, разработанной на основе результатов исследований AMPLIFY и AMPLIFY-Ext, а также сетевых мета-анализов по применению антитромботических препаратов в остром периоде ВТЭ и при длительном назначении после ВТЭ. Длительность марковского цикла – 3 мес. Длительность терапии при моделировании составляла 6 и 12 мес. Временной горизонт исследования – 5 лет. Продолжительность жизни и затраты дисконтировали на 3,5% в год. Затраты на препараты рассчитывались на основе зарегистрированной предельной отпускной цены. Также анализ проводили для варианта со средневзвешенными ценами аукционов на НОАК. Затраты на мониторинг и терапию осложнений рассчитывались на основе тарифного соглашения системы обязательного медицинского страхования по г. Санкт-Петербургу на 2015 г. </p></sec><sec><title>Результаты</title><p>Результаты. На этапе стационарного лечения апиксабан обеспечивал существенное снижение затрат по сравнению с другими режимами антикоагулянтной терапии. При долгосрочном анализе апиксабан обеспечивал снижение затрат по сравнению с другими НОАК при минимальном увеличении средней продолжительности жизни с учетом качества. По сравнению с назначением НМГ с переходом на варфарин, апиксабан обеспечивал увеличение средней продолжительности жизни, но при этом требовал некоторого увеличения затрат. При длительности терапии 6 мес затраты в расчете на один дополнительный год жизни с учетом качества составили 309,8403,7 тыс. руб., а на один дополнительный календарный год жизни – 481,6-627,4 тыс. руб., при терапии в течение 12 мес – 649,0-764,1 и 1254,4-1476,9 тыс. руб., соответственно. </p></sec><sec><title>Заключение</title><p>Заключение. При сопоставимой эффективности в отношении терапии и вторичной профилактики ВТЭ, апиксабан обеспечивал снижение частоты кровотечений по сравнению другими НОАК и НМГ с последующим переходом на варфарин. Затраты на терапию апиксабаном ниже, чем на терапию другими НОАК, а дополнительные затраты на апиксабан по сравнению с НМГ с переходом на варфарин оказались экономически высоко эффективными при длительности терапии 6 мес и экономически приемлемыми при терапии в течение 12 мес. </p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>венозная тромбоэмболия</kwd><kwd>антикоагулянты</kwd><kwd>эффективность затрат</kwd></kwd-group><kwd-group xml:lang="en"><kwd>venous thromboembolism</kwd><kwd>anticoagulants</kwd><kwd>cost-effectiveness</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Cohen A.T., Agnelli G., Anderson F.A., et al. Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thrombosis and haemostasis 2007; 98 (4): 75664.</mixed-citation><mixed-citation xml:lang="en">Cohen A.T., Agnelli G., Anderson F.A., et al. Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thrombosis and haemostasis 2007; 98 (4): 75664.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Kachroo S., Boyd D., Bookhart B.K., et al. Quality of life and economic costs associated with postthrombotic syndrome. American journal of health-system pharmacy: AJHP: official journal of the American Society of Health-System Pharmacists 2012; 69 (7): 567-72.</mixed-citation><mixed-citation xml:lang="en">Kachroo S., Boyd D., Bookhart B.K., et al. Quality of life and economic costs associated with postthrombotic syndrome. American journal of health-system pharmacy: AJHP: official journal of the American Society of Health-System Pharmacists 2012; 69 (7): 567-72.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Guanella R. Post-thrombotic syndrome: the forgotten complication of venous thromboembolism. Revue medicale suisse 2013; 9 (372): 321-5.</mixed-citation><mixed-citation xml:lang="en">Guanella R. Post-thrombotic syndrome: the forgotten complication of venous thromboembolism. Revue medicale suisse 2013; 9 (372): 321-5.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Klok F.A., Huisman M.V. Epidemiology and management of chronic thromboembolic pulmonary hypertension. The Netherlands journal of medicine 2010; 68 (9): 347-51.</mixed-citation><mixed-citation xml:lang="en">Klok F.A., Huisman M.V. Epidemiology and management of chronic thromboembolic pulmonary hypertension. The Netherlands journal of medicine 2010; 68 (9): 347-51.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Lang I.M., Klepetko W. Chronic thromboembolic pulmonary hypertension: an updated review. Current opinion in cardiology 2008; 23 (6): 555-9.</mixed-citation><mixed-citation xml:lang="en">Lang I.M., Klepetko W. Chronic thromboembolic pulmonary hypertension: an updated review. Current opinion in cardiology 2008; 23 (6): 555-9.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Agnelli G., Buller H.R., Cohen A., et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med 2013; 369 (9): 799-808.</mixed-citation><mixed-citation xml:lang="en">Agnelli G., Buller H.R., Cohen A., et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med 2013; 369 (9): 799-808.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Agnelli G., Buller H.R., Cohen A., et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med 2013; 368 (8): 699-708.</mixed-citation><mixed-citation xml:lang="en">Agnelli G., Buller H.R., Cohen A., et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med 2013; 368 (8): 699-708.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Covell R. Direct oral anticoagulants: integration into clinical practice. Postgrad Med J 2014; 90: 529-39.</mixed-citation><mixed-citation xml:lang="en">Covell R. Direct oral anticoagulants: integration into clinical practice. Postgrad Med J 2014; 90: 529-39.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Schulman S, Kearon C, Kakkar AK, et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009;361:2342-52.</mixed-citation><mixed-citation xml:lang="en">Schulman S, Kearon C, Kakkar AK, et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009;361:2342-52.</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Schulman S, Kakkar AK, Goldhaber SZ, et al. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation 2014;129:764-72.</mixed-citation><mixed-citation xml:lang="en">Schulman S, Kakkar AK, Goldhaber SZ, et al. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation 2014;129:764-72.</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363:2499-510.</mixed-citation><mixed-citation xml:lang="en">The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363:2499-510.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">The EINSTEIN-PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012;366:1287-97.</mixed-citation><mixed-citation xml:lang="en">The EINSTEIN-PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012;366:1287-97.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Schulman S, Kearon C, Kakkar AK, et al. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med 2013;368:709-18.</mixed-citation><mixed-citation xml:lang="en">Schulman S, Kearon C, Kakkar AK, et al. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med 2013;368:709-18.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Abacus International. Meta-analysis of the clinical evidence for treatment and secondary prevention of thromboembolic events in patients with an index venous thromboembolism (VTE) (OR APIX 023: Acute NMA). 2014.</mixed-citation><mixed-citation xml:lang="en">Abacus International. Meta-analysis of the clinical evidence for treatment and secondary prevention of thromboembolic events in patients with an index venous thromboembolism (VTE) (OR APIX 023: Acute NMA). 2014.</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Abacus International. Meta-analysis of the clinical evidence for extended treatment and secondary prevention of thromboembolic events in patients with an index venous thromboembolism (VTE) (OR APIX 024: Extended NMA). 2014.</mixed-citation><mixed-citation xml:lang="en">Abacus International. Meta-analysis of the clinical evidence for extended treatment and secondary prevention of thromboembolic events in patients with an index venous thromboembolism (VTE) (OR APIX 024: Extended NMA). 2014.</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">Sonnenberg FA, Beck JR. Markov models in medical decision making: a practical guide. Med Decis Making 1993;13(4):322-38.</mixed-citation><mixed-citation xml:lang="en">Sonnenberg FA, Beck JR. Markov models in medical decision making: a practical guide. Med Decis Making 1993;13(4):322-38.</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">World Health Organization. Investing in Health for Economic Development. Report of the Commission on Macroeconomics and Health. Geneva (Switzerland): World Health Organization; 2001.</mixed-citation><mixed-citation xml:lang="en">World Health Organization. Investing in Health for Economic Development. Report of the Commission on Macroeconomics and Health. Geneva (Switzerland): World Health Organization; 2001.</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">Amin A., Bruno A., Trocio J., et al. Real-world medical cost avoidance when new oral anticoagulants are used versus warfarin for venous thromboembolism in the United States. Clin Appl Thromb Hemost. 2015 May 19. pii: 1076029615585991.</mixed-citation><mixed-citation xml:lang="en">Amin A., Bruno A., Trocio J., et al. Real-world medical cost avoidance when new oral anticoagulants are used versus warfarin for venous thromboembolism in the United States. Clin Appl Thromb Hemost. 2015 May 19. pii: 1076029615585991.</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
