pmedpharmФармация и фармакологияPharmacy & Pharmacology2307-92662413-2241Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical Univer10.19163/2307-9266-2025-13-4-285-296pmedpharm-1708Research ArticleОРИГИНАЛЬНАЯ СТАТЬЯRESEARCH ARTICLEПрименение препарата сонидегиб при лечении пациентов с местно распространённым базальноклеточным раком кожи: анализ влияния на бюджет здравоохранения РоссииThe use of sonidegib in the treatment of patients with locally advanced basal cell carcinoma of the skin: an analysis of the impact on the Russian healthcare budgethttps://orcid.org/0000-0002-0389-560XФроловМ. Ю.FrolovM. Yu.

кандидат медицинских наук, доцент кафедры клинической фармакологии и интенсивной терапии ФГБОУ ВО ВолгГМУ Минздрава России. 

Россия, 400066, г. Волгоград, пл. Павших Борцов, д. 1.

 

Candidate of Sciences (Medicine), Assistant Professor of the Department of Clinical Pharmacology and Intensive Care of the Volgograd State Medical University. 

1 Pavshikh Bortsov Sq., Volgograd, Russia, 400066.

clinpharmrussia@yandex.ruhttps://orcid.org/0000-0002-2164-2323РоговВ. А.RogovV. A.

кандидат фармацевтических наук, доцент кафедры организации фармацевтического дела, фармацевтической технологии и биотехнологии ФГБОУ ВО ВолгГМУ Минздрава России. 

Россия, 400066, г. Волгоград, пл. Павших Борцов, д. 1.

 

Candidate of Sciences (Pharmacy), Assistant Professor of the Department of Pharmaceutical Business Organization, Pharmaceutical Technology and Biotechnology of the Volgograd State Medical University. 

1 Pavshikh Bortsov Sq., Volgograd, Russia, 400066.

var85@ya.ruhttps://orcid.org/0000-0002-9483-3171ИвахненкоО. И.IvakhnenkoO. I.

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. 

Россия, 119048, г. Москва, ул. Трубецкая, д. 8, стр. 2.

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. 

2 Trubetskaya Str., Bldg 8, Moscow, Russia, 119991.

oii@hta-expert.ruhttps://orcid.org/0000-0002-1278-5883РяженовВ. В.RyazhenovV. V.

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). 

Россия, 119048, г. Москва, ул. Трубецкая, д. 8, стр. 2.

 

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). 

2 Trubetskaya Str., Bldg 8, Moscow, Russia, 119991. 

5052568@mail.ruФедеральное государственное бюджетное образовательное учреждение высшего образования «Волгоградский государственный медицинский университет» Министерства здравоохранения Российской Федерации.РоссияVolgograd State Medical University.Russian FederationФедеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет имени И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский университет).РоссияSechenov First Moscow State Medical University (Sechenov University).Russian Federation202504092025134285296Copyright © Фролов М.Ю., Рогов В.А., Ивахненко О.И., Ряженов В.В., 20252025Фролов М.Ю., Рогов В.А., Ивахненко О.И., Ряженов В.В.Frolov M.Y., Rogov V.A., Ivakhnenko O.I., Ryazhenov V.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmpharm.ru/jour/article/view/1708

Анализ влияния на бюджет (АВБ) является ключевым этапом обоснования включения новых лекарственных препаратов в перечень жизненно необходимых и важнейших лекарственных препаратов (ЖНВЛП). Он позволяет прогнозировать финансовые последствия внедрения терапии и оценивать эффективность распределения ресурсов, что имеет особое значение при применении инновационных противоопухолевых средств.

Цель

Цель. Проведение АВБ здравоохранения РФ применения сонидегиба для оценки целесообразности включения в перечень ЖНВЛП для терапии пациентов с местно распространённым базальноклеточным раком кожи (мрБКРК).

Материалы и методы

Материалы и методы. В разработанной для применения в условиях РФ фармакоэкономической модели проведён АВБ для здравоохранения РФ на основе сравнительного моделирования двух сценариев: базового (все пациенты получают висмодегиб) и альтернативного (поэтапное внедрение сонидегиба с ростом доли до 50% к третьему году). Временной горизонт — 3 года. Учтены прямые медицинские затраты, данные о ценах из реестров ЖНВЛП, государственные закупки, нормативные надбавки, демографические и эпидемиологические параметры. Дополнительно выполнен односторонний анализ чувствительности в диапазоне ±10% ключевых переменных

Результаты

Результаты. АВБ здравоохранения РФ показал, что включение сонидегиба в перечень ЖНВЛП приведёт к снижению бюджетных затрат на лечение пациентов с мрБКРК на 3,15% (-37 270 334 руб. или -387 440,81 USD) в рамках моделируемой совокупности пациентов. Представленные результаты АВБ сохраняют устойчивость при изменении цены препаратов сравнения, размеров популяции в сумме и распределения пациентопотока по годам, при отклонении от базового значения ±10%.

Заключение

Заключение. Моделирование показывает, что включение лекарственного препарата сонидегиб в перечень ЖНВЛП приводит к снижению затрат системы здравоохранения при возможном повышении переносимости терапии и расширении терапевтического арсенала для лечения мрБКРК, т.е. является обоснованным с точки зрения клинико-экономических последствий. Полученные результаты подтверждают его фармакоэкономическую обоснованность в качестве альтернативы висмодегибу в терапии мрБКРК.

Budget Impact Analysis (BIA) is a key step in justifying the inclusion of new medicines in the list of vital and essential medicines (VED). It allows you to predict the financial consequences of the introduction of therapy and evaluate the effectiveness of resource allocation, which is of particular importance when using innovative antitumor drugs.

The aim

The aim. Implementation of the BIA of Healthcare of the Russian Federation of the use of sonidegib to assess the feasibility of inclusion in the list of VEDs for the treatment of patients with locally advanced basal cell carcinoma (laBCCs).

Materials and methods

Materials and methods. In the pharmacoeconomic model developed for use in the Russian Federation, the BIA was conducted for healthcare in the Russian Federation based on comparative modeling of two scenarios: basic (all patients receive vismodegib) and alternative (phased introduction of sonidegib with an increase in the share to 50% by the third year). The time horizon is 3 years. Direct medical costs, price data from VED registers, government procurement, regulatory allowances, demographic and epidemiological parameters are taken into account. Additionally, a one-way sensitivity analysis was performed in the range of ±10% of key variables

Results

Results. An analysis of the impact on the healthcare budget of the Russian Federation showed that the inclusion of sonidegib in the list of VED will lead to a 3.15% reduction in budget costs for the treatment of patients with laBCCs (-37,270,334 rubles or -387,440.81 USD) within the modeled patient population. The presented BIA results remain stable with changes in the price of comparison drugs, the total population size and the distribution of patient flow over the years, with a deviation from the baseline value of ±10%.

Conclusion

Conclusion. Modeling shows that the inclusion of the drug sonidegib in the list of VED leads to a reduction in the costs of the healthcare system with a possible increase in the tolerability of therapy and an expansion of the therapeutic arsenal for the treatment of laBCCs, i.e. it is justified from the point of view of clinical and economic consequences. The results obtained confirm its pharmacoeconomic validity as an alternative to vismodegib in the treatment of laBCCs.

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The authors declare that there are no conflicts of interest present.