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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">pmedpharm</journal-id><journal-title-group><journal-title xml:lang="ru">Фармация и фармакология</journal-title><trans-title-group xml:lang="en"><trans-title>Pharmacy &amp; Pharmacology</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2307-9266</issn><issn pub-type="epub">2413-2241</issn><publisher><publisher-name>Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical Univer</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.19163/2307-9266-2025-13-3-184-201</article-id><article-id custom-type="elpub" pub-id-type="custom">pmedpharm-1691</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>ОРИГИНАЛЬНАЯ СТАТЬЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>RESEARCH ARTICLE</subject></subj-group></article-categories><title-group><article-title>Клинико-экономические преимущества применения лекарственного препарата сонидегиб в терапии 1 линии пациентов с местно распространённым базальноклеточным раком кожи</article-title><trans-title-group xml:lang="en"><trans-title>Clinical and economic benefits of using sonidegib in the 1-line therapy of patients with locally advanced basal cell carcinoma</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-9483-3171</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ивахненко</surname><given-names>О. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Ivakhnenko</surname><given-names>O. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>ассистент кафедры регуляторных отношений в области обращения лекарственных средств и медицинских изделий ФГАОУ ВО «Первый МГМУ имени И.М. Сеченова» Минздрава России (Сеченовский Университет); магистр права. </p><p>Россия, 119048, г. Москва, ул. Трубецкая, д. 8, стр. 2.</p></bio><bio xml:lang="en"><p>Assistant of the Department of Regulatory Relations in the field of circulation of medicines and medical devices of the Sechenov First Moscow State Medical University (Sechenov University); Master of Law. </p><p>2 Trubetskaya Str., Bldg 8, Moscow, Russia, 119991.</p></bio><email xlink:type="simple">oii@hta-expert.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/0000-0002-1278-5883</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ряженов</surname><given-names>В. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Ryazhenov</surname><given-names>V. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>доктор фармацевтических наук, заведующий кафедрой регуляторных отношений в области обращения лекарственных средств и медицинских изделий ФГАОУ ВО «Первый МГМУ имени И.М. Сеченова» Минздрава России (Сеченовский Университет). </p><p>Россия, 119048, г. Москва, ул. Трубецкая, д. 8, стр. 2.</p></bio><bio xml:lang="en"><p>Doctor of Sciences (Pharmacy), Head of the Department of Regulatory Relations in the Field of Circulation of Drug Products and Medical Devices of the Sechenov First Moscow State Medical University (Sechenov University). </p><p>2 Trubetskaya Str., Bldg 8, Moscow, Russia, 119991.</p></bio><email xlink:type="simple">5052568@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/0000-0002-0389-560X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Фролов</surname><given-names>М. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Frolov</surname><given-names>M. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат медицинских наук, доцент кафедры клинической фармакологии и интенсивной терапии ФГБОУ ВО ВолгГМУ Минздрава России.</p><p>Россия, 400066, г. Волгоград, пл. Павших Борцов, д. 1.</p><p> </p></bio><bio xml:lang="en"><p>Candidate of Sciences (Medicine), Assistant Professor of the Department of Clinical Pharmacology and Intensive Care of the Volgograd State Medical University. </p><p>1 Pavshikh Bortsov Sq., Volgograd, Russia, 400066.</p><p> </p></bio><email xlink:type="simple">clinpharmrussia@yandex.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/0000-0002-2164-2323</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Рогов</surname><given-names>В. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Rogov</surname><given-names>V. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат фармацевтических наук, доцент кафедры организации фармацевтического дела, фармацевтической технологии и биотехнологии ФГБОУ ВО ВолгГМУ Минздрава России.</p><p>Россия, 400066, г. Волгоград, пл. Павших Борцов, д. 1.</p></bio><bio xml:lang="en"><p>Candidate of Sciences (Pharmacy), Assistant Professor of the Department of Pharmaceutical Business Organization, Pharmaceutical Technology and Biotechnology of the Volgograd State Medical University. </p><p>1 Pavshikh Bortsov Sq., Volgograd, Russia, 400066.</p></bio><email xlink:type="simple">var85@ya.ru</email><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет имени И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский университет).</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Sechenov First Moscow State Medical University (Sechenov University).</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное образовательное учреждение высшего образования «Волгоградский государственный медицинский университет» Министерства здравоохранения Российской Федерации.</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Volgograd State Medical University.</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>02</day><month>08</month><year>2025</year></pub-date><volume>13</volume><issue>3</issue><fpage>184</fpage><lpage>201</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Ивахненко О.И., Ряженов В.В., Фролов М.Ю., Рогов В.А., 2025</copyright-statement><copyright-year>2025</copyright-year><copyright-holder xml:lang="ru">Ивахненко О.И., Ряженов В.В., Фролов М.Ю., Рогов В.А.</copyright-holder><copyright-holder xml:lang="en">Ivakhnenko O.I., Ryazhenov V.V., Frolov M.Y., Rogov V.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.pharmpharm.ru/jour/article/view/1691">https://www.pharmpharm.ru/jour/article/view/1691</self-uri><abstract><p>Одним из ключевых факторов доступности современных методов лечения и выбора оптимальной терапии для пациентов являются клинико-экономические характеристики новых медицинских технологий.</p><sec><title>Цель</title><p>Цель. Оценка клинико-экономической целесообразности применения препарата сонидегиб в условиях широкой клинической практики.</p></sec><sec><title>Материалы и методы</title><p>Материалы и методы. В качестве методологической основы применялись общенаучные методы исследования. Для проведения клинико-экономической оценки была разработана модель по типу «дерева решений». Клинико-экономическая оценка применения препарата сонидегиб проведена с позиции системы здравоохранения РФ: учитывались затраты на системную лекарственную терапию 1 линии пациентов с местно распространённым базальноклеточным раком кожи (мрБКРК).</p></sec><sec><title>Результаты</title><p>Результаты. Сравнительный анализ эффективности по критерию «выживаемость без прогрессирования» (ВБП) выявил преимущество сонидегиба над висмодегибом: отношение шансов (ОШ) прогрессии заболевания у пациентов с мрБКРК через 12 мес. с момента начала терапии составило 0,27778 (95% ДИ 0,125–0,618, p=0,0017, Z=3,1423). Снижение риска прогрессирования при использовании сонидегиба по сравнению с висмодегибом составило 59,1% (ОР=0,409; 95% ДИ 0,229–0,732, p=0,0026, Z=3,013). Результаты проверки гипотезы о равенстве долей пациентов с мрБКРК без прогрессии заболевания через 12 мес. после начала терапии также подтвердили наличие статистически значимых различий в эффективности между двумя методами лечения в пользу сонидегиба (χ2=9,2007, df=1, p=0,002419, 95% ДИ 0,09312–0,432132). При использовании сонидегиба в 1 линии терапии потребуется 2,53 млн руб. в год в расчёте на 1 пациента, что на 10,86% ниже, чем при использовании висмодегиба, и соответствует абсолютной экономии в размере 308,55 тыс. руб. Показатель «затраты–эффективность» (CER) для сонидегиба составил 114 627 руб. против 220 295 руб. для висмодегиба. Инкрементальный показатель «затраты–эффективность» (ICER) равен 175 050 руб. за дополнительный месяц ВБП. Анализ чувствительности показал устойчивость результатов при изменении ключевых параметров.</p></sec><sec><title>Заключение</title><p>Заключение. На основании результатов исследования была подтверждена гипотеза о клинико-экономических преимуществах сонидегиба при лечении мрБКРК и получены данные о целесообразности применения сонидегиба в условиях широкой клинической практики.</p></sec></abstract><trans-abstract xml:lang="en"><p>One of the key factors in ensuring the availability of modern treatments and choosing the optimal therapy for patients is the clinical and economic characteristics of new medical technologies.</p><sec><title>The aim</title><p>The aim: to assess the clinical and economic feasibility of using sonidegib in widespread clinical practice.</p></sec><sec><title>Materials and methods</title><p>Materials and methods. General scientific research methods were used as a methodological basis. A "decision tree" model was developed to conduct a clinical and economic assessment. The clinical and economic assessment of the use of sonidegib was carried out from the perspective of the healthcare system of the Russian Federation: the costs of systemic drug therapy for the 1-line of patients with locally advanced basal cell carcinoma (BCC) were taken into account.</p></sec><sec><title>Results</title><p>Results. A comparative analysis of efficacy based on the progression-free survival (PFS) criterion revealed the advantage of sonidegib over vismodegib: the odds ratio (OR) of disease progression in patients with locally advanced BCC 12 months after the start of therapy was 0.27778 (95% CI 0.125–0.618; p=0.0017; Z=3.1423). The reduction in the risk of progression when using sonidegib compared to vismodegib was 59.1% (OR= 0.409; 95% CI 0.229–0.732, p=0.0026, Z=3.013). The results of testing the hypothesis about the equality of the proportion of patients with locally advanced BCC without disease progression 12 months after the start of therapy also confirmed the presence of statistically significant differences in efficacy between the two treatments in favor of sonidegib (χ2=9.2007, df=1, p=0.002419, 95% CI 0.09312–0.432132). The use of sonidegib in the 1-line of therapy, 2.53 million rubles per year will be required per 1 patient, which is 10.86% lower than the use of vismodegib, and corresponds to an absolute saving of 308.55 thousand rubles. The "cost-effectiveness" indicator (CER) for sonidegib was 114,627 rubles versus 220,295 rubles for vismodegib. The incremental cost-effectiveness ratio (ICER) is 175,050 rubles per additional month of PFS. Sensitivity analysis showed the stability of the results when changing key parameters.</p></sec><sec><title>Conclusion</title><p>Conclusion. Based on the results of the study, the hypothesis about the clinical and economic benefits of sonidegib in the treatment of locally advanced BCC was confirmed, and data were obtained on the clinical and economic feasibility of using sonidegib in widespread clinical practice.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>сонидегиб</kwd><kwd>клинико-экономический анализ</kwd><kwd>базальноклеточный рак кожи</kwd><kwd>оценка медицинских технологий</kwd></kwd-group><kwd-group xml:lang="en"><kwd>sonidegib</kwd><kwd>clinical and economic analysis</kwd><kwd>basal cell carcinoma</kwd><kwd>health technology assessment</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Данное исследование проводилось при поддержке компании «Сан Фармасьютикал Лимитед» (Индия). Спонсор не оказывал влияние на выбор материала для публикации, анализ и интерпретацию данных.</funding-statement><funding-statement xml:lang="en">The study was supported by “Sun Pharmaceutical limited” (India). 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