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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">farmaec</journal-id><journal-title-group><journal-title xml:lang="en">FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology</journal-title><trans-title-group xml:lang="ru"><trans-title>ФАРМАКОЭКОНОМИКА. Современная фармакоэкономика и фармакоэпидемиология</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2070-4909</issn><issn pub-type="epub">2070-4933</issn><publisher><publisher-name>IRBIS LLC</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.17749/2070-4909/farmakoekonomika.2023.220</article-id><article-id custom-type="elpub" pub-id-type="custom">farmaec-946</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>ORIGINAL ARTICLES</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОРИГИНАЛЬНЫЕ ПУБЛИКАЦИИ</subject></subj-group></article-categories><title-group><article-title>Pharmacoeconomic analysis of using empegfilgrastim for the treatment of early and locally advanced HER2+ breast cancer in the Russian Federation</article-title><trans-title-group xml:lang="ru"><trans-title>Фармакоэкономический анализ применения лекарственного препарата эмпэгфилграстим для лечения раннего и местно-распространенного HER2+ рака молочной железы в Российской Федерации</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-9198-8661</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Журавлева</surname><given-names>М. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Zhuravleva</surname><given-names>M. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p> д.м.н., профессор кафедры клинической фармакологии и пропедевтики внутренних болезней; заместитель начальника научного отдела клинической фармакологии Института исследований и разработок </p><p>WoS ResearcherID: AAO-6689-2020; Scopus Author ID:55878917900;  </p><p>ул. Трубецкая, д. 8/2, Москва 119048, Россия</p><p>Петровский б-р, д. 8, стр. 2, Москва 127051, Россия </p></bio><bio xml:lang="en"><p>Dr. Med. Sci., Professor, Chair of Clinical Pharmacology and Propaedeutics of Internal Diseases; Deputy Head ofScientific Department of Clinical Pharmacology, Institute of Research and Development</p><p>Scopus Author ID: 5587891790 </p><p>8 bldg 2 Trubetskaya Str., Moscow 119048, Russia </p><p>8 bldg 2 Petrovsky Bvrd, Moscow 127051, Russia </p></bio><email xlink:type="simple">mvzhuravleva@mail.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/0000-0002-6758-2389</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кокушкин</surname><given-names>К. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Kokushkin</surname><given-names>K. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p> научный руководитель </p><p>ул. Карбышева, д. 4, лит. А, Красногорск 143403, Россия </p></bio><bio xml:lang="en"><p>Scientific Adviser</p><p>4 lit. А Karbyshev Str., Krasnogorsk 143403, Russia </p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-6304-4594</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Лучинин</surname><given-names>Е. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Luchinin</surname><given-names>E. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p> преподаватель кафедры профпатологии, гематологии и клинической фармакологии </p><p>Scopus Author ID: 57220079650</p><p>ул. Большая Казачья, д. 112, Саратов 410012, Россия </p></bio><bio xml:lang="en"><p>Member of Chair of Pathology, Hematology and Clinical Pharmacology</p><p>Scopus Author ID: 57220079650 </p><p>112 Bolshaya Kazachya Str., Saratov 410012, Russia</p></bio><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-3120-8491</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Лучинина</surname><given-names>Е. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Luchinina</surname><given-names>E. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>к.м.н., доцент кафедры профпатологии, гематологии и клинической фармакологии, начальник отдела контроля за обращением лекарственных средств и медицинских изделий клинического центра</p><p>WoS ResearcherID: AAD-4774-2021; Scopus Author ID: 57217133083</p><p>ул. Большая Казачья, д. 112, Саратов 410012, Россия </p></bio><bio xml:lang="en"><p>MD, PhD, Associate Professor, Chair of Pathology,  Hematology and Clinical Pharmacology, Head of  Department of Control over the Circulation of Medicines and Medical Devices, Clinical Center</p><p>WoS ResearcherID: AAD-4774-2021; Scopus Author ID: 57217133083 </p><p> 112 Bolshaya Kazachya Str., Saratov 410012, Russia </p></bio><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-3957-5015</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Каменева</surname><given-names>Т. Р.</given-names></name><name name-style="western" xml:lang="en"><surname>Kameneva</surname><given-names>T. R.</given-names></name></name-alternatives><bio xml:lang="ru"><p>к.м.н., доцент, ведущий специалист организационно-методического отдела по клинической фармакологии;, врач-клинический фармаколог</p><p>ул. Шарикоподшипниковская, д. 9, Москва 115088, Россия</p><p>Каштановая аллея, д. 2, стр. 1, Москва, Зеленоград 124489, Россия </p></bio><bio xml:lang="en"><p>MD, PhD, Associate Professor, Leading Expert, Organizational and Methodological Department of Clinical Pharmacology; Clinical  Pharmacologist</p><p> 9 Sharikopodshipnikovskaya Str., Moscow 115088, Russia </p><p> 2 bldg 1 Kashtanovaya Alley, Moscow, Zelenograd 124489, Russia </p></bio><xref ref-type="aff" rid="aff-4"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-1262-4430</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кузнецова</surname><given-names>Е. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Kuznetsova</surname><given-names>E. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>заведующая организационно-методическим отделом по клинической фармакологии</p><p>ул. Шарикоподшипниковская, д. 9, Москва 115088, Россия </p></bio><bio xml:lang="en"><p>Head of Organizational and Methodological  Department of Clinical Pharmacology</p><p>9 Sharikopodshipnikovskaya Str., Moscow 115088, Russia </p></bio><xref ref-type="aff" rid="aff-5"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-0547-2088</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Крысанова</surname><given-names>В. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Krysanova</surname><given-names>V. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>преподаватель кафедры терапии с курсом фармакологии и фармации Медицинского института непрерывного образования </p><p>WoS ResearcherID: AAE-2346-2019; Scopus Author ID: 57193874403</p><p>Волоколамское ш., д. 11, Москва 125080, Россия </p></bio><bio xml:lang="en"><p>Member of Chair of Therapy with a Course of  Pharmacology and Pharmacy, Medical Institute of Continuing Education</p><p>WoS ResearcherID: AAE-2346-2019; Scopus Author ID:57193874403 </p><p> 11 Volokolamskoe Shosse, Moscow 125080, Russia </p></bio><xref ref-type="aff" rid="aff-6"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-3767-8475</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Макарова</surname><given-names>Е. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Makarova</surname><given-names>E. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p> к.м.н., научный сотрудник </p><p>Scopus Author ID: 57201075018</p><p>ул. Делегатская, д. 20, стр. 1, Москва 127473, Россия </p></bio><bio xml:lang="en"><p>MD, PhD, Researcher</p><p>Scopus Author ID: 57201075018 </p><p> 20 bldg 1 Delegatskaya Str., Moscow 127473, Russia</p></bio><xref ref-type="aff" rid="aff-7"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-4848-6938</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Жукова</surname><given-names>Л. Г.</given-names></name><name name-style="western" xml:lang="en"><surname>Zhukova</surname><given-names>L. G.</given-names></name></name-alternatives><bio xml:lang="ru"><p> д.м.н., чл.-кор. РАН, заместитель директора по онкологии </p><p>Новогиреевская ул., д. 1, корп. 1, Москва 111123,Россия </p></bio><bio xml:lang="en"><p>Dr. Med. Sc., Corresponding Member of RAS, Deputy Director for Oncology</p><p>1 corp. 1 Novogireevskaya Str., Moscow 111123, Russia </p></bio><xref ref-type="aff" rid="aff-8"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru">Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет им. И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет);&#13;
Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации<country>Россия</country></aff><aff xml:lang="en">Sechenov University; &#13;
Scientific Center for Expert Evaluation of Medicinal Products<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru">Государственное бюджетное учреждение Московской области «Научно-практический центр клинико-экономического анализа Министерства здравоохранения Московской области»<country>Россия</country></aff><aff xml:lang="en">Scientific and Practical Center for Clinical and Economic Analysis of the Ministry of Health of the Moscow Region<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru">Федеральное государственное бюджетное образовательное учреждение высшего образования «Саратовский государственный медицинский университет им. В.И. Разумовского» Министерства здравоохранения Российской Федерации<country>Россия</country></aff><aff xml:lang="en">Razumovsky Saratov State Medical University<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-4"><aff xml:lang="ru">Государственное бюджетное учреждение г. Москвы «Научно-исследовательский институт организации здравоохранения и медицинского менеджмента»  Департамента здравоохранения г. Москвы;&#13;
Государственное бюджетное учреждение здравоохранения г. Москвы «Городская клиническая больница им. М.П. Кончаловского Департамента здравоохранения г. Москвы»<country>Россия</country></aff><aff xml:lang="en">Research Institute of Healthcare Organization and Medical Management;&#13;
Konchalovsky City Clinical Hospital<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-5"><aff xml:lang="ru">Государственное бюджетное учреждение г. Москвы «Научно-исследовательский институт организации здравоохранения и медицинского менеджмента» Департамента здравоохранения г. Москвы<country>Россия</country></aff><aff xml:lang="en">Research Institute of Healthcare Organization and Medical Management<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-6"><aff xml:lang="ru">Федеральное государственное бюджетное образовательное учреждение высшего образования «Российский биотехнологический университет»<country>Россия</country></aff><aff xml:lang="en">Russian Biotechnological University<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-7"><aff xml:lang="ru">Федеральное государственное бюджетное образовательное учреждение высшего образования «Московский государственный медико-стоматологический университет им. А.И. Евдокимова» Министерства здравоохранения Российской Федерации<country>Россия</country></aff><aff xml:lang="en">Yevdokimov Moscow State University of Medicine and Dentistry<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-8"><aff xml:lang="ru">Государственное бюджетное учреждение здравоохранения г. Москвы «Московский клинический научно-практический центр им. А.С. Логинова Департамента здравоохранения г. Москвы»<country>Россия</country></aff><aff xml:lang="en">Loginov Moscow Clinical Research and Practical Center<country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2023</year></pub-date><pub-date pub-type="epub"><day>30</day><month>12</month><year>2023</year></pub-date><volume>16</volume><issue>4</issue><fpage>537</fpage><lpage>549</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Zhuravleva M.V., Kokushkin K.A., Luchinin E.A., Luchinina E.V., Kameneva T.R., Kuznetsova E.V., Krysanova V.S., Makarova E.V., Zhukova L.G., 2024</copyright-statement><copyright-year>2024</copyright-year><copyright-holder xml:lang="ru">Журавлева М.В., Кокушкин К.А., Лучинин Е.А., Лучинина Е.В., Каменева Т.Р., Кузнецова Е.В., Крысанова В.С., Макарова Е.В., Жукова Л.Г.</copyright-holder><copyright-holder xml:lang="en">Zhuravleva M.V., Kokushkin K.A., Luchinin E.A., Luchinina E.V., Kameneva T.R., Kuznetsova E.V., Krysanova V.S., Makarova E.V., Zhukova L.G.</copyright-holder><license 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.pharmacoeconomics.ru/jour/article/view/946">https://www.pharmacoeconomics.ru/jour/article/view/946</self-uri><abstract><p>Objective: to assess budget impact of using empegfilgrastim for the prevention of febrile neutropenia in patients with early and locally advanced human epidermal growth factor receptor 2 positive (HER2+) breast cancer who receive neoadjuvant “docetaxel / carboplatin / trastuzumab + pertuzumab” regimen, considering possible subsequent adjuvant therapy with trastuzumab emtansine or trastuzumab within the Russian healthcare system.Material and methods. We searched and analyzed published clinical, epidemiological and pharmacoeconomic studies as well as regulatory and legal documents. A decision tree model was constructed to reflect the probabilities of switching to different adjuvant therapy regimens depending on the achievement of pathomorphological complete response in patients with early and locally advanced HER2+ breast cancer. The budget impact analysis was carried out comparing two primary prophylactic options, empegfilgrastim and filgrastim.Results. Despite the higher costs of prevention with empegfilgrastim compared to filgrastim (249 vs. 134 thousand rubles), due to the higher rate of achieving a pathomorphological complete response and, accordingly, fewer cases requiring adjuvant therapy with the more expensive trastuzumab emtanzine, savings of 916 thousand rubles per 1 patient per 1 year of therapy are possible. In general, prophylaxis in the target population diagnosed with early and locally advanced HER2+ breast cancer using empegfilgrastim will result in a cost reduction of 9.4 billion rubles per 1 year compared to filgrastim.Conclusion. Empegfilgrastim prophylaxis, despite its higher annual cost, is an efficient option within the Russian healthcare system. In addition to reducing the incidence of febrile neutropenia, the frequency and dose of chemotherapy are preserved, resulting in increased efficacy of the primary therapy.</p></abstract><trans-abstract xml:lang="ru"><p>Цель: провести анализ влияния на бюджет применения лекарственного препарата эмпэгфилграстим для первичной профилактики фебрильной нейтропении у пациенток, получающих неоадъювантную терапию по схеме «доцетаксел / карбоплатин / трастузумаб + пертузумаб» при раннем и местно-распространненом раке молочной железы (РМЖ), положительном на рецептор эпидермального фактора роста 2-го типа (англ. human epidermal growth factor receptor 2, HER2+), с учетом возможной последующей адъювантной терапии трастузумаб эмтанзином или трастузумабом в условиях Российской Федерации.Материал и методы. Проведен поиск и анализ опубликованных результатов отечественных клинических, эпидемиологических и фармакоэкономических исследований, а также нормативных правовых актов. Построена модель дерева решений, в которой отражены вероятности перехода на различные схемы адъювантной терапии в зависимости от достижения или недостижения в опухоли полного патоморфологического ответа (ypT0/is, ypN0) у пациенток с ранним и местно-распространенным HER2+ РМЖ. Выполнен анализ влияния на бюджет со сравнением двух опций первичной профилактики: эмпэгфилграстим и филграстим.Результаты. Несмотря на более высокие затраты на профилактику эмпэгфилграстимом по сравнению с филграстимом (249 против 134 тыс. руб.), за счет более высокой частоты достижения полного патоморфологического ответа и, соответственно, меньшего числа случаев, требующих адъювантной терапии более дорогостоящим трастузумаб эмтанзином, возможна экономия 916 тыс. руб. на 1 пациентку за 1 год терапии. В целом профилактика целевой популяции с ранним и местно-распространенным HER2+ РМЖ с применением эмпэгфилграстима позволит снизить затраты на 9,4 млрд руб. за 1 год терапии по сравнению с филграстимом.Заключение. Профилактика эмпэгфилграстимом, несмотря на более высокие затраты за 1 год терапии, является экономически целесообразной опцией сопроводительной терапии в условиях российской системы здравоохранения. В дополнение к снижению частоты развития фебрильной нейтропении сохраняются частота и доза химиотерапии, что приводит к повышению эффективности первичной терапии.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>Рак молочной железы</kwd><kwd>РМЖ</kwd><kwd>неоадъювантная терапия</kwd><kwd>нейтропения</kwd><kwd>эмпэгфилграстим</kwd><kwd>филграстим.</kwd></kwd-group><kwd-group xml:lang="en"><kwd>Breast cancer</kwd><kwd>neoadjuvant therapy</kwd><kwd>neutropenia</kwd><kwd>empegfilgrastim</kwd><kwd>filgrastim</kwd></kwd-group><funding-group xml:lang="ru"><funding-statement>Статья подготовлена при поддержке компании АО «Биокад» (Россия). Спонсор участвовал в разработке проекта исследования и поддержке исследовательской программы, а также в принятии решения о представлении статьи к публикации, что не повлияло на результаты исследования. Авторы несут полную ответственность за содержание окончательной версии рукописи.</funding-statement></funding-group><funding-group xml:lang="en"><funding-statement>The article was prepared with the support of Biocad JSC (Russia). The sponsor participated in the development of the research project and the support of the research program, as well as the decision to submit the article for publication, which did not affect the results of the study. 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