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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">10.37489/2588-0519-2025-2-34-45</article-id><article-id custom-type="edn" pub-id-type="custom">FNOVMB</article-id><article-id custom-type="elpub" pub-id-type="custom">clinvest-788</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>ОЦЕНКА ТЕХНОЛОГИЙ ЗДРАВООХРАНЕНИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>HEALTH TECHNOLOGY ASSESSMENT</subject></subj-group></article-categories><title-group><article-title>Анализ влияния на бюджет использования препарата мосунетузумаб при рецидивирующей или рефрактерной фолликулярной лимфоме</article-title><trans-title-group xml:lang="en"><trans-title>Mosunetuzumab budget impact analysis in patients with recurrent or refractory follicular lymphoma</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-3541-1120</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Крысанов</surname><given-names>И. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Krysanov</surname><given-names>I. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Иван Сергеевич Крысанов, к. фарм. н., доцент, зав. курсом фармации, начальник отдела, зав. лаборатории</p><p>отдел клинико-экономического анализа; научно-исследовательскаялаборатория фармации, фармакологии, фармакогнозии, фармацевтической технологии и химии</p><p>Москва; Мытищи</p></bio><bio xml:lang="en"><p>Ivan S. Krysanov, Cand. Sci. (Pharm.), Head of the Pharmacy course, Head of the Department, Head of the Laboratory</p><p>Clinical and Economic Analysis Department; Research Laboratory of Pharmacy, Pharmacology, Pharmacognosy, Pharmaceutical Technology, and Chemistry</p><p>Moscow; Mytishchi</p></bio><email xlink:type="simple">krysanov-ivan@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/0000-0003-3767-8475</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>Екатерина Владимировна Макарова, к. м. н., н. с. лаборатории фармации, фармакологии, фармакогнозии, фармацевтической технологии и химии</p><p>научно-исследовательская лаборатория </p><p>Москва</p></bio><bio xml:lang="en"><p>Ekaterina V. Makarova, Cand. Sci. (Med.), Research Fellow</p><p>Research Laboratory of Pharmacy, Pharmacology, Pharmacognosy, Pharmaceutical Technology, and Chemistry</p><p>Moscow</p></bio><email xlink:type="simple">rue-royal@inbox.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/0000-0002-0547-2088</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>Вера Сергеевна Крысанова, преподаватель</p><p>МИНО; кафедра терапии с курсом фармации и фармакологии</p><p>Москва</p></bio><bio xml:lang="en"><p>Vera S. Krysanova, Lecturer</p><p>Medical Institute of Continuing Education; Department of Therapy with a course in Pharmacology and Pharmacy</p><p>Moscow</p></bio><email xlink:type="simple">v.krysanova@mail.ru</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-4822-7226</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ермакова</surname><given-names>Ю. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Ermakova</surname><given-names>V. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Виктория Юрьевна Ермакова, к. фарм. н., доцент, генеральный директор</p><p>кафедра химии</p><p>Москва; Мытищи</p></bio><bio xml:lang="en"><p>Viktoriya Yu. Ermakova, Cand. Sci. (Pharm.), Associate Professor, general manager</p><p>Department of Chemistry</p><p>Moscow; Mytishchi</p></bio><email xlink:type="simple">ermakova.viktoriya.yurievna@mail.ru</email><xref ref-type="aff" rid="aff-4"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-1116-3425</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Куркин</surname><given-names>Д. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Kurkin</surname><given-names>D. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Денис Владимирович Куркин, д. фарм. н., доцент, директор института</p><p>Научно-образовательный институт фармации им. К. М. Лакина</p><p>Москва</p></bio><bio xml:lang="en"><p>Denis V. Kurkin, Dr. Sci (Pharm.), Associate Professor, Director of the Institute</p><p>KM Lakin Research and Educational Institute of Pharmacy, Chemistry</p><p>Moscow</p></bio><email xlink:type="simple">strannik986@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/0000-0003-1506-2565</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Колосов</surname><given-names>Ю. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Kolosov</surname><given-names>Yu. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Юрий Анатольевич Колосов, к. м. н., доцент, зам. директора института</p><p>Научно-образовательный институт фармации им. К. М. Лакина</p><p>Москва</p></bio><bio xml:lang="en"><p>Yury A. Kolosov, Cand. Sci. (Med), Deputy Director of the Institute</p><p>KM Lakin Research and Education Institute of Pharmacy, Chemistry</p><p>Moscow</p></bio><email xlink:type="simple">tronk79@gmail.com</email><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБОУ ВО «Российский биотехнологический университет (РОСБИОТЕХ)»; ООО «Институт клинико-экономической экспертизы и фармакоэкономики»; ФГБОУ ВО «Российский университет медицины»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>BIOTECH University; Institute of Clinical and Economic Expertise and Pharmacoeconomics LLC; ROSUNIMED</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>ФГБОУ ВО «Российский университет медицины»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>ROSUNIMED</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>ФГБОУ ВО «Российский биотехнологический университет (РОСБИОТЕХ)»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>BIOTECH University</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-4"><aff xml:lang="ru"><institution>ФГБОУ ВО «Российский биотехнологический университет (РОСБИОТЕХ)»; ООО «Институт клинико-экономической экспертизы и фармакоэкономики»; ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» (Сеченовский Университет)</institution><country>Россия</country></aff><aff xml:lang="en"><institution>BIOTECH University; Institute of Clinical and Economic Expertise and Pharmacoeconomics LLC; First Moscow State Medical University named after I.M. Sechenov</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>19</day><month>07</month><year>2025</year></pub-date><volume>0</volume><issue>2</issue><fpage>34</fpage><lpage>45</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Крысанов И.С., Макарова Е.В., Крысанова В.С., Ермакова Ю.В., Куркин Д.В., Колосов Ю.А., 2025</copyright-statement><copyright-year>2025</copyright-year><copyright-holder xml:lang="ru">Крысанов И.С., Макарова Е.В., Крысанова В.С., Ермакова Ю.В., Куркин Д.В., Колосов Ю.А.</copyright-holder><copyright-holder xml:lang="en">Krysanov I.S., Makarova E.V., Krysanova V.S., Ermakova V.Y., Kurkin D.V., Kolosov Y.A.</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/788">https://www.clinvest.ru/jour/article/view/788</self-uri><abstract><sec><title>   Цель</title><p>   Цель. Провести анализ влияния на бюджет применения препарата мосунетузумаб у пациентов с рецидивирующей или рефрактерной фолликулярной лимфомой в рамках 3-й и последующих линий терапии.</p></sec><sec><title>   Материалы и методы</title><p>   Материалы и методы. Анализ влияния на бюджет (АВБ), анализ чувствительности.</p></sec><sec><title>   Результат</title><p>   Результат. Размер целевой популяции составил 340 человек. Анализ затрат на лекарственную терапию вариантов 3-й и последующих линий продемонстрировал высокий разброс затрат: максимальные затраты связаны с применением мосунетузумаба (6 296 060,33 руб., 8 циклов и 11 906 411,12 руб., 17 циклов), минимальные затраты — с применением схемы GDP без ритуксимаба (31 390,80 руб.). Суммарные затраты за 1 год в рамках моделирования текущей практики на все виды терапии составили 891 446 565,79 руб. В рамках текущей практики основная доля затрат приходится на препарат дувелисиб (47,4 %), далее следует схема ибрутиниб+/-R (25,1 %) и RB (6,1 %). Более 70 % затрат в рамках текущей практики расходуется на лекарственные препараты, не имеющие официального показания к применению. Суммарные затраты за 1 год моделирования составили 693 639 708,26 руб. За указанный период моделирования основная доля затрат приходится на следующие схемы: ибрутиниб+/-R (32,3 %) и монотерапия мосунетузумабом (27,2 %). АВБ продемонстрировал, что применение лекарственного препарата мосунетузумаб позволит сэкономить 22,2 % или 197 806 857,54 руб. в течение 1 года и позволит дополнительно пролечить мосунетузумабом 31 нового пациента. Анализ чувствительности результатов АВБ продемонстрировал устойчивость модели к изменению всех исходных параметров, даже в рамках предлагаемого варианта перевода всех пациентов с препарата дувелисиб на монотерапию мосунетузумабом приведёт к экономии — снижению затрат на 2,9 %.</p></sec><sec><title>   Выводы</title><p>   Выводы. Применение мосунетузумаба в качестве терапии 3-й и последующих линий у взрослых пациентов с рецидивирующей или рефрактерной фолликулярной лимфомой является экономически целесообразным подходом в рамках российского здравоохранения.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>   Aim</title><p>   Aim. This study aimed to analyze the budget impact of mosunetuzumab use in patients with relapsed or refractory follicular lymphoma in the third and subsequent lines of therapy.</p></sec><sec><title>   Materials and methods</title><p>   Materials and methods. Budget impact analysis, sensitivity analysis.</p></sec><sec><title>   Results</title><p>   Results. The target population size was 340 people. Analysis of the costs of drug therapy for the third and subsequent lines demonstrated a wide range of costs: the maximum costs are associated with the use of mosunetuzumab (RUB 6,296,060.33, 8 cycles and RUB 11,906,411.12, 17 cycles), and the minimum costs are associated with the use of the GDP regimen without rituximab (RUB 31,390.80). The total costs for 1 year of modeling the current practice for all types of therapy amounted to RUB 891,446,565.79. In current practice, the main share of costs is attributed to the drug duvelisib (47.4 %), followed by the regimen ibrutinib+/-R (25.1 %) and R-B (6.1 %). More than 70 % of the current practice costs are spent on drugs that do not have an official indication for use. The total cost of 1 year of modeling amounted to RUB 693,639,708.26. Over the specified modeling period, the main share of costs was attributed to the following regimens: ibrutinib+/-R (32.3 %) and mosunetuzumab monotherapy (27.2 %). Budget impact analysis demonstrated that the use of mosunetuzumab will save 22.2 % or RUB 197,806,857.54 over 1 year and will allow for additional treatment with mosunetuzumab to 31 new patients. Sensitivity analysis of the budget impact analysis results demonstrated that the model is sustainable to changes in all initial parameters, even within the proposed option of transferring all patients from duvelisib to mosunetuzumab monotherapy will lead to a savings in current costs (2.9 %).</p></sec><sec><title>   Conclusions</title><p>   Conclusions. The use of mosunetuzumab as a 3rd and subsequent line therapy in adult patients with relapsed or refractory follicular lymphoma is an economically feasible approach within the Russian healthcare framework.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>фолликулярная лимфома</kwd><kwd>анализ влияния на бюджет</kwd><kwd>мосунетузумаб</kwd><kwd>фармакоэкономика</kwd><kwd>иммунотерапия</kwd><kwd>затраты на лечение</kwd></kwd-group><kwd-group xml:lang="en"><kwd>follicular lymphoma</kwd><kwd>budget impact analysis</kwd><kwd>mosunetuzumab</kwd><kwd>pharmacoeconomics</kwd><kwd>immunotherapy</kwd><kwd>cost analysis</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">Клинические рекомендации. 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