farmaecFARMAKOEKONOMIKA. Modern Pharmacoeconomics and PharmacoepidemiologyФАРМАКОЭКОНОМИКА. Современная фармакоэкономика и фармакоэпидемиология2070-49092070-4933IRBIS LLC10.17749/2070-4909/farmakoekonomika.2026.412farmaec-1489Research ArticleORIGINAL ARTICLESОРИГИНАЛЬНЫЕ ПУБЛИКАЦИИEvaluation of high-technology medicines considering budget impact and societal value: a three-tier approach using incretin-based therapy as an exampleОценка высокотехнологичных лекарственных препаратов с учетом влияния на бюджет и общественной значимости: трехуровневый подход на примере инкретиновой терапииhttps://orcid.org/0009-0001-3341-4248ЛиА. А.LeeА. А.

Ли Артур Анатольевич 

WoS ResearcherID: KIB-6238-2024.

Scopus Author ID: 59260615800.

eLibrary SPIN-code: 3740-8216. 

ул. Вавилова, д. 26, Москва 119334

Arthur A. Lee

WoS ResearcherID: KIB-6238-2024.

Scopus Author ID: 59260615800.

eLibrary SPIN-code: 3740-8216. 

26 Vavilov Str., Moscow 119334

aal1999arth@gmail.comhttps://orcid.org/0009-0001-0944-8413БорисовД. О.BorisovD. О.

Борисов Денис Олегович

WoS ResearcherID: PVE-1383-2026.

ул. Нобеля, д. 3, Инновационный центр Сколково, Москва 121205

Denis O. Borisov

WoS ResearcherID: PVE-1383-2026.

3 Nobel Str., Skolkovo Innovation Center, Moscow 121205

https://orcid.org/0009-0000-0318-3314НовиковаВ. С.NovikovaV. S.

Новикова Виталия Сергеевна

WoS ResearcherID: PVE-1648-2026.

ул. Вавилова, д. 26, Москва 119334

Vitaliya S. Novikova

WoS ResearcherID: PVE-1648-2026.

26 Vavilov Str., Moscow 119334

https://orcid.org/0000-0002-0748-9238КаширскихД. А.KashirskikhD. А.

Каширских Дмитрий Александрович 

WoS ResearcherID: JCE-3357-2023.

Scopus Author ID: 57216539868.

eLibrary SPIN-code: 7765-8502.

ул. Вавилова, д. 26, Москва 119334

Dmitry A. Kashirskikh

WoS ResearcherID: JCE-3357-2023.

Scopus Author ID: 57216539868.

eLibrary SPIN-code: 7765-8502.

26 Vavilov Str., Moscow 119334

https://orcid.org/0000-0003-2096-3237ХотинаВ. А.KhotinaV. А.

Хотина Виктория Александровна, к.б.н. /

WoS ResearcherID: AAD-5232-2019.

Scopus Author ID: 57218608468.

eLibrary SPIN-code: 9030-3267.

ул. Вавилова, д. 26, Москва 119334

Victoria A. Khotina, PhD

WoS ResearcherID: AAD-5232-2019.

Scopus Author ID: 57218608468.

eLibrary SPIN-code: 9030-3267.

26 Vavilov Str., Moscow 119334

https://orcid.org/0000-0001-6311-0838ГасановВ. А.GasanovV. А.

Гасанов Вагиф Али оглы, к.м.н.

WoS ResearcherID: I-9019-2016.

Scopus Author ID: 57211116600.

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ул. Вавилова, д. 26, Москва 119334

Vagif A. Gasanov, PhD

WoS ResearcherID: I-9019-2016.

Scopus Author ID: 57211116600.

eLibrary SPIN-code: 6811-0940.

26 Vavilov Str., Moscow 119334

https://orcid.org/0000-0003-4886-1750ВасильевА. В.VasilyevА. V.

Васильев Андрей Валентинович, д.б.н., чл.-корр. РАН

WoS ResearcherID: G-6495-2019.

Scopus Author ID: 7402045581.

eLibrary SPIN-code: 7050-9087.

ул. Вавилова, д. 26, Москва 119334

Andrey V. Vasiliev, Dr. Biol. Sci., Corr. Member of RAS

WoS ResearcherID: G-6495-2019.

Scopus Author ID: 7402045581.

eLibrary SPIN-code: 7050-9087.

26 Vavilov Str., Moscow 119334

Федеральное государственное бюджетное учреждение науки «Институт биологии развития им. Н.К. Кольцова Российской академии наук»РоссияKoltsov Institute of Developmental Biology of Russian Academy of SciencesRussian FederationНегосударственное образовательное учреждение высшего образования «Российская экономическая школа»РоссияRussian Economic SchoolRussian Federation20230510202600Online First1489Copyright © Lee А.А., Borisov D.О., Novikova V.S., Kashirskikh D.А., Khotina V.А., Gasanov V.А., Vasilyev А.V., 20232023Ли А.А., Борисов Д.О., Новикова В.С., Каширских Д.А., Хотина В.А., Гасанов В.А., Васильев А.В.Lee А.А., Borisov D.О., Novikova V.S., Kashirskikh D.А., Khotina V.А., Gasanov V.А., Vasilyev А.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.pharmacoeconomics.ru/jour/article/view/1489Objective

Objective: To develop a three-tier approach to assessing the value of high-technology medicines, provide a rationale for the approach, and demonstrate its applicability using incretin-based therapy as an example.

Material and methods

Material and methods. A conceptual study was carried out using a descriptive analysis of publicly available clinical, financial, investment, and regulatory data. The theoretical framework was based on approaches to broader health technology value assessment, including the ISPOR Value Flower and recommendations of the Second Panel on Cost-Effectiveness in Health and Medicine. Sources were selected purposively; no systematic review was conducted.

Results

Results. A three-tier approach was proposed, including clinical value, value for the healthcare system, and an extended third tier divided into broader societal impacts of disease and treatment (3A) and the innovation and industrial impacts of pharmaceutical technology development and manufacturing (3B). By using incretin-based therapy as an example, the analysis showed that the expansion of indications and the market was accompanied by changes in corporate revenue structure, investment activity, and manufacturing infrastructure. In 2025, Mounjaro® and Zepbound® accounted for approximately 56% of Eli Lilly’s revenue, while glucagon-like peptide-1-based products for the treatment of type 2 diabetes and products for the treatment of obesity accounted for approximately 75.9% of Novo Nordisk’s revenue. Market capitalization, capital raised, and corporate revenue are not direct measures of clinical or societal value.

Conclusion

Conclusion. A broader assessment of high-technology medicines requires separate consideration of their clinical, pharmacoeconomic, societal, and innovation and industrial impacts. Innovation and industrial impacts should not be incorporated directly into the calculation of the incremental cost-effectiveness ratio; instead, they should be presented as a separate analytical domain to inform industrial and science technology, and innovation policy.

Цель

Цель: разработать и обосновать трехуровневый подход к оценке ценности высокотехнологичных лекарственных препаратов и показать его применимость на примере инкретиновой терапии.

Материал и методы

Материал и методы. Проведено концептуальное исследование с описательным анализом открытых клинических, финансовых, инвестиционных и регуляторных данных. Теоретической основой послужили подходы к расширенной оценке ценности медицинских технологий, включая ISPOR Value Flower и рекомендации Второй экспертной группы по анализу «затраты – эффективность». Источники отбирали целенаправленно, систематический обзор не проводился.

Результаты

Результаты. Предложен трехуровневый подход, включающий клиническую ценность, ценность для системы здравоохранения и расширенный третий уровень, разделенный на общественные последствия заболевания и терапии (3A) и инновационно-промышленные последствия разработки и производства лекарственной технологии (3B). На примере инкретиновой терапии проиллюстрировано, что расширение показаний и рынка сопровождалось изменениями структуры выручки, инвестиционной активности и производственной инфраструктуры. В 2025 г. препараты Mounjaro® и Zepbound® обеспечили около 56% выручки компании Eli Lilly, а препараты на основе глюкагоноподобного пептида-1 для лечения сахарного диабета 2-го типа и препараты для лечения ожирения – около 75,9% выручки компании Novo Nordisk. Рыночная капитализация, привлеченный капитал и корпоративная выручка при этом не являются непосредственными показателями клинической или общественной ценности.

Заключение

Заключение. Расширенная оценка высокотехнологичных лекарственных препаратов требует раздельного учета клинических, фармакоэкономических, общественных и инновационно-промышленных последствий. Инновационно-промышленные последствия не следует непосредственно включать в расчет инкрементального коэффициента «затраты – эффективность», их целесообразно представлять как самостоятельный блок анализа для принятия решений в области промышленной и научно-технологической политики.

высокотехнологичные лекарственные препаратыфармакоэкономикаоценка технологий здравоохраненияценность медицинской технологииобщественные последствияинновационно-промышленные последствияинкретиновая терапиясемаглутидиспользование изобретений без согласия патентообладателятехнологический суверенитетhigh-technology medicinespharmacoeconomicshealth technology assessmenthealth technology valuesocietal impactsinnovation and industrial impactsincretin-based therapysemaglutideuse of inventions without the patent holder’s consenttechnological sovereigntyРабота выполнена при поддержке Программы фундаментальных научных исследований Министерства науки и высшего образования Российской Федерации в 2026 году (проект № 0088-2025-0002 «Лекарственное средство на основе генетически модифицированных клеток, продуцирующих GLP-1 для терапии сахарного диабета 2 типа») в ФГБУН «Институт биологии развития им. Н.К. 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The authors declare that there are no conflicts of interest present.