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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="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">clinvest</journal-id><journal-title-group><journal-title xml:lang="ru">Качественная клиническая практика</journal-title><trans-title-group xml:lang="en"><trans-title>Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2588-0519</issn><issn pub-type="epub">2618-8473</issn><publisher><publisher-name>ООО «Издательство ОКИ</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.24411/2588-0519-2018-10038</article-id><article-id custom-type="elpub" pub-id-type="custom">clinvest-217</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="ru"><subject>ФАРМАКОЭКОНОМИКА</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>PHARMACOECONOMICS</subject></subj-group></article-categories><title-group><article-title>Фармакоэкономический анализ применения гибкого режима дозирования препарата Ксеомин® для лечения пациентов с фокальной дистонией</article-title><trans-title-group xml:lang="en"><trans-title>Pharmacoeconomic analysis of flexible-dose administration regimen of Xeomine® in patients with focal dystonia</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-8201-7321</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Чеберда</surname><given-names>А. Е.</given-names></name><name name-style="western" xml:lang="en"><surname>Cheberda</surname><given-names>A. E.</given-names></name></name-alternatives><bio xml:lang="ru"><p>к.м.н., MBA, исполнительный директор ООО "Центр фармакоэкономических исследований", Москва</p><p>SPIN-код: 6912-3783</p></bio><bio xml:lang="en"><p>Ph.D., MBA, Executive Director</p><p>SPIN code: 6912-3783</p></bio><email xlink:type="simple">aecheberda@healtheconomics.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-2164-8290</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Белоусов</surname><given-names>Д. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Belousov</surname><given-names>D. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>генеральный директор ООО "Центр фармакоэкономических исследований", Москва</p><p>SPIN-код: 6067-9067</p></bio><bio xml:lang="en"><p>General Director </p><p>SPIN code: 6067-9067</p></bio><email xlink:type="simple">clinvest@mail.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-6348-6867</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Зырянов</surname><given-names>С. К.</given-names></name><name name-style="western" xml:lang="en"><surname>Zyryanov</surname><given-names>S. K.</given-names></name></name-alternatives><bio xml:lang="ru"><p>д.м.н., профессор, зав. кафедрой общей и клинической фармакологии ФГАОУ ВО «Российский университет дружбы народов», Москва</p><p>SPIN-код: 2725-9981</p></bio><bio xml:lang="en"><p>MD, professor, Head of Department of General and Clinical Pharmacology</p><p>SPIN code: 2725-9981</p></bio><email xlink:type="simple">sergey.k.zyryanov@gmail.com</email><xref ref-type="aff" rid="aff-3"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ООО "Центр фармакоэкономических исследований", г. Москва</institution><country>Россия</country></aff><aff xml:lang="en"><institution>LLC "Center for pharmacoeconomics research", Moscow</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>ООО "Центр фармакоэкономических исследований", г. Москва</institution><country>Россия</country></aff><aff xml:lang="en"><institution>LLC "Center for Pharmacoeconomics Research", Moscow</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>ФГАОУ ВО «Российский университет дружбы народов», г. Москва</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Peoples' Friendship University of Russia, Moscow, Russia</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2018</year></pub-date><pub-date pub-type="epub"><day>08</day><month>06</month><year>2018</year></pub-date><volume>0</volume><issue>1</issue><fpage>53</fpage><lpage>65</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Чеберда А.Е., Белоусов Д.Ю., Зырянов С.К., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">Чеберда А.Е., Белоусов Д.Ю., Зырянов С.К.</copyright-holder><copyright-holder xml:lang="en">Cheberda A.E., Belousov D.Y., Zyryanov S.K.</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.clinvest.ru/jour/article/view/217">https://www.clinvest.ru/jour/article/view/217</self-uri><abstract><p>Актуальность. Наиболее эффективным способом терапии фокальных дистоний (блефароспазма (БСП) и цервикальной дистонии (ЦД)) является применение препаратов ботулотоксина: онаботулотоксин А, инкоботулотоксин А, абоботулотоксин А. В 2016 г. стала доступна возможность гибкого дозирования инкоботулотоксина А, что делает актуальным вопрос о фармакоэкономических свойствах данного режима дозирования. Цель. Оценить фармакоэкономические характеристики терапии БСП и ЦД инкоботулотоксином А по сравнению с онаботулотоксином А и абоботулотоксином А с учётом возможности гибкого дозирования препарата инкоботулотоксин А. Методология. Фармакоэкономический анализ (ФЭА) проводится с позиции российской системы здравоохранения в рамках системы обязательного медицинского страхования, а также общественного интереса в целом, включая влияние бремени заболевания на валовой внутренний продукт. Горизонт моделирования составил 5 лет. Разработана комплексная Марковская модель, с использованием которой был проведён расчёт затрат системы здравоохранения и исходов лечения. Критерием клинической эффективности было выбрано число дней в состоянии ремиссии. По результатам моделирования проведены анализ эффективности затрат (CEA), анализ полезности затрат (CUA), анализ влияния на бюджет (BIA), анализ чувствительности (SA). Результат. Инкоботулотоксин А в гибком режиме дозирования обладает фармакоэкономическим превосходством в контексте анализа CEA для показания ЦД и БСП. Учёт непрямых затрат увеличивает превосходство препарата инкоботулотоксин А. Схожие результаты наблюдались и в рамках анализа CUA. Проведённый BIA указывает на то, что применение инкоботулотоксина А с учётом гибкого режима дозирования позволяет добиться снижения бюджетного бремени. SA подтвердил устойчивость полученного результата. Вывод. Использование гибкого режима дозирования инкоботулотоксина А является фармакоэкономически обоснованным.</p></abstract><trans-abstract xml:lang="en"><sec><title>Relevance</title><p>Relevance. The most effective treatment for focal dystonia (blepharospasm (BsP) and cervical dystonia (CD)) is use of botulinum toxin, including onabotulinumtoxinА (BoNTA-Ona), incobotulinumtoxin А (BoNTA-Inco), abobotulinumtoxinА (BoNTA-Abo). In 2016, it became possible to use ­exible-dose regimens of incobotulinumtoxin А, thus necessitating analysis of pharmacoeconomic properties of such regimens. Aim. To determine pharmacoeconomic properties of BsP and CD therapy with incobotulinumtoxin А relative to regimens based on onabotulinumtoxinА (BoNTA-Ona and abobotulinumtoxinА (BoNTA-Abo) accounting for properties of ­exible administration regimen of incobotulinumtoxin А. Methodology. Pharmacoeconomic analysis was performed from the perspective of Russian healthcare system within context of mandatory healthcare insurance, as well as from the perspective of overall social interests of Russian Federation, including impact upon GDP. Modelling horizon was 5 years. A complex Markov model was developed to estimate costs and outcomes. The parameter used for clinical efficacy assessment was number of days patient spend in remission state. Cost effectiveness analysis (CEA), cost utility analysis (CUA) and budget impact analysis (BIA) were performed based on modelling results, and sensitivity analysis (SA) was performed to ascertain model robustness. Result. Incobotulinumtoxin А in fl­exible dose regimen demonstrated pharmacoeconomic superiority during CEA for cervical dystonia and blepharospasm indications. When indirect costs are accounted for, superiority of incobotulinumtoxin А increases. Similar results were obtained during CUA. BIA indicates that use of ­flexible-dose regimen of incobotulinumtoxin А allows to achieve reduction of budgetary burden. SA has conrmed the robustness of these results. Conclusion. Use of incobotulinumtoxin А in a ­flexible-dose regimen is pharmacoeconomically justied.</p></sec><sec><title> </title><p> </p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>блефароспазм</kwd><kwd>цервикальная дистония</kwd><kwd>онаботулотоксин А</kwd><kwd>инкоботулотоксин А</kwd><kwd>абоботулотоксин А</kwd><kwd>гибкий режим дозирования</kwd><kwd>фармакоэкономика</kwd><kwd>анализ эффективности затрат</kwd><kwd>анализ полезности затрат</kwd><kwd>анализ влияния на бюджет</kwd></kwd-group><kwd-group xml:lang="en"><kwd>blepharospasm</kwd><kwd>cervical dystonia</kwd><kwd>incobotulinumtoxinА</kwd><kwd>onabotulinumtoxinА</kwd><kwd>abobotulinumtoxinА</kwd><kwd>­flexible-dose administration regimen</kwd><kwd>pharmacoeconomics</kwd><kwd>cost-effectiveness analysis</kwd><kwd>cost-utility analysis</kwd><kwd>budget impact analysis</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Данное фармакоэкономическое исследование было профинансировано фармацевтической компанией ООО «Мерц Фарма», однако это не оказало влияние на полученные результаты</funding-statement></funding-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Аналитическая информация, DSM Россия, 2017 г. 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