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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">clinvest</journal-id><journal-title-group><journal-title xml:lang="en">Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice</journal-title><trans-title-group xml:lang="ru"><trans-title>Качественная клиническая практика</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-GCP-0022</article-id><article-id custom-type="edn" pub-id-type="custom">HRLJJQ</article-id><article-id custom-type="elpub" pub-id-type="custom">clinvest-858</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>PHARMACOEPIDEMIOLOGY</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ФАРМАКОЭПИДЕМИОЛОГИЯ</subject></subj-group></article-categories><title-group><article-title>The dynamics of consumption of glucagon-like peptide-1 agonists in the Russian Federation in the period 2010-2025: a pharmacoepidemiological study</article-title><trans-title-group xml:lang="ru"><trans-title>Динамика потребления агонистов глюкогоноподобного пептида-1 в Российской Федерации в период 2010–2025 гг.: фармакоэпидемиологическое исследование</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-7704-9900</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Гомон</surname><given-names>Ю. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Gomon</surname><given-names>Yu. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Гомон Юлия Михайловна — д. м. н., профессор кафедры клинической фармакологии и доказательной медицины</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Yulia M. Gomon — Dr. Sci. (Med.), Professor, Department of Clinical Pharmacology and Evidence-Based Medicine</p><p>Saint Petersburg</p></bio><email xlink:type="simple">gomonmd@yandex.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/0000-0002-1919-2909</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Колбин</surname><given-names>А. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Kolbin</surname><given-names>A. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Колбин Алексей Сергеевич — д. м. н., профессор, зав. кафедрой клинической фармакологии и  доказательной медицины; профессор кафедры фармакологии медицинского факультета</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Alexey S. Kolbin — Dr. Sci. (Med.), Professor, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine; professor of the Department of Pharmacology, Medical Faculty</p><p>Saint Petersburg</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/0000-0003-0587-6258</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Медвенская</surname><given-names>Е. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Medvenskaya</surname><given-names>E. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Медвенская Ева Александровна</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Eva A. Medvenskaya</p><p>Saint Petersburg</p></bio><email xlink:type="simple">79818343988@yandex.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/0000-0002-2776-6239</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Резник</surname><given-names>В. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Reznik</surname><given-names>V. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Резник Виталий Анатольевич — д. м. н., главный врач клиники</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Vitaly A. Reznik — Dr. Sci. (Med.), Chief Physician of the Clinic</p><p>Saint Petersburg</p></bio><email xlink:type="simple">vitaliy-reznik@mail.ru</email><xref ref-type="aff" rid="aff-4"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет имени И.П. Павлова»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Pavlov First Saint Petersburg State Medical University</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>ФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет имени И.П. Павлова»; ФГБОУ ВО «Санкт-Петербургский государственный университет»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Pavlov First Saint Petersburg State Medical University; St. Petersburg State University</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>СПбГБУЗ «Больница Святого Великомученика Георгия»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>St. George the Martyr City Hospital</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-4"><aff xml:lang="ru"><institution>ФГОУ ВО «Санкт-Петербургский государственный педиатрический медицинский университет»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>St. Petersburg State Pediatric Medical University</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2026</year></pub-date><pub-date pub-type="epub"><day>30</day><month>05</month><year>2026</year></pub-date><volume>0</volume><issue>2</issue><fpage>4</fpage><lpage>13</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Gomon Y.M., Kolbin A.S., Medvenskaya E.A., Reznik V.A., 2026</copyright-statement><copyright-year>2026</copyright-year><copyright-holder xml:lang="ru">Гомон Ю.М., Колбин А.С., Медвенская Е.А., Резник В.А.</copyright-holder><copyright-holder xml:lang="en">Gomon Y.M., Kolbin A.S., Medvenskaya E.A., Reznik V.A.</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.clinvest.ru/jour/article/view/858">https://www.clinvest.ru/jour/article/view/858</self-uri><abstract><p>Glucagon-like peptide-1 agonists (aGPP-1) are used in the treatment of type 2 diabetes mellitus (DM2) and obesity.</p><sec><title>Objective</title><p>Objective. To evaluate the dynamics of aGPP-1 consumption in the Russian Federation (RF) in the period from the moment of registration of the first aGPP-1 in 2010 to the present.</p></sec><sec><title>Materials and methods</title><p>Materials and methods. Information about liraglutide, exenatide, lixisenatide, dulaglutide, semaglutide and tirzepatide sales in the period 2010–2025 in RF has been downloaded from the IQVIA database. For each of the years of observation, the consumption indicator “number of DDD per 1000 inhabitants per day” was calculated, the dynamics of consumption in each of the market segments (retail, hospital segment, preferential medical treatment) and consumption in regions of the Russian Federation were estimated.</p></sec><sec><title>Results</title><p>Results. An analysis of the consumption of aGPP-1 in the RF showed that over the past 15 years, their use has increased 733 times — from 0.006 in 2010 to 4.4 DDDs per 1,000 inhabitants per day in 2025. The increase was mainly due to the consumption of semaglutide. So, in 2020, 628.1 thousand DDDs were used, up to 2025 — already 207 million DDDs (an increase of 329 times). In 2025 a double-acting drug, tirzepatide, appeared on the RF market, the consumption of which amounted to 24.5 million DDDs per year. In all the years of observation, with the exception of 2023, retail sales dominated. An analysis of regional consumption patterns (sales for 2025 were analyzed) revealed that the sales level ranged from 0.18 DDDs in the Altai Republic to 10.71 DDDs per 1,000 inhabitants per day in St. Petersburg. Overall, the top 5 regions with the highest consumption of aGPP-1 are St. Petersburg (10.71), Moscow (9.3), Moscow Region (7.42), Yamalo-Nenets Autonomous Okrug (7.35), Magadan Region (7.08 DDDs per 1,000 inhabitants per day). At the same time, retail sales dominated for all regions, with the preferential medical treatment segment accounting for 17, 11, 5, 25, and 20 %, respectively.</p></sec><sec><title>Conclusions</title><p>Conclusions. The expansion of the practice of using glucagon-like peptide-1 agonists, including at the expense of the healthcare system, can help reduce the global burden of disease and the socio-economic burden of T2DM and obesity in RF.</p></sec></abstract><trans-abstract xml:lang="ru"><p>Агонисты глюкагоноподобного пептида-1 (аГПП-1) применяются в  лечении сахарного диабета 2 типа (СД2) и ожирения.</p><sec><title>Цель</title><p>Цель. Оценить динамику потребления аГПП-1 в РФ в период с момента регистрации первого аГПП-1 по настоящее время.</p></sec><sec><title>Материалы и методы</title><p>Материалы и методы. Из базы IQVIA были выгружены сведения о продажах лираглутида, эксенатида, ликсисенатида, дулаглутида, семаглутида и тирзепатида в период 2010–2025 гг. в России. Для каждого из годов наблюдения был рассчитан показатель потребления «количество DDD на 1000 жителей в день», оценена динамика потребления в каждом из сегментов рынка (розница, госпитальный сегмент, ДЛР/РЛО) и в каждом из регионов РФ.</p></sec><sec><title>Результаты</title><p>Результаты. Анализ потребления аГПП-1 в  Российской Федерации продемонстрировал, что за 15 лет их использование выросло в 733 раза — с 0,006 в 2010 г. до 4,4 DDDs на 1000 жителей в день в 2025 г. Рост в основном был обусловлен потреблением семаглутида. Так, в 2020 г. было использовано 628,1 тыс. DDDs, а в 2025 г. — уже 207 млн DDDs (рост в  329 раз). В  2025 г. на российском рынке появилось ЛС двойного действия тирзепатид, потребление которого за год составило 24,5 млн DDDs. Во все годы наблюдения за исключением 2023 г. доминировали розничные продажи, т. е. та доля лекарственных препаратов, которая была приобретена пациентами за собственный счёт. Анализ региональных особенностей потребления выявил, что уровень варьировал от 0,18 DDDs в республике Алтай до 10,71 DDDs на 1000 жителей в день в г. Санкт-Петербург. В топ-5 регионов с максимальным потреблением аГПП-1 вошли Санкт-Петербург (10,71), Москва (9,3), Московская область (7,42), Ямало-Ненецкий автономный округ (7,35), Магаданская область (7,08 DDDs на 1000 жителей в день). При этом, для всех регионов доминировали розничные продажи, доля ДЛО/РЛО сегмента составила 17, 11, 5, 25 и 20 % соответственно.</p></sec><sec><title>Выводы</title><p>Выводы. Расширение практики применения аГПП-1 в том числе за счёт средств системы здравоохранения может способствовать снижению глобального бремени заболевания (Global Burden of Disease) и социально-экономического бремени СД2 и ожирения в России.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>агонисты глюкогоноподобного пептида-1</kwd><kwd>гастроинтестинальный пептид</kwd><kwd>сахарный диабет 2 типа</kwd><kwd>ожирение</kwd><kwd>дополнительное лекарственное обеспечение</kwd><kwd>льготное лекарственное обеспечение</kwd></kwd-group><kwd-group xml:lang="en"><kwd>agonists of glucagon-like peptide-1</kwd><kwd>gastrointestinal peptide</kwd><kwd>type 2 diabetes mellitus</kwd><kwd>obesity</kwd><kwd>additional drug provision</kwd><kwd>preferential drug provision</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Исследование не имело спонсорской поддержки.</funding-statement><funding-statement xml:lang="en">The study had no sponsorship.</funding-statement></funding-group></article-meta></front><body><sec><title>Introduction</title><p>Currently, drugs belonging to the class of glucagon‑like peptide‑1 receptor agonists (GLP‑1 RAs) are used in clinical practice for the treatment of type 2 diabetes mellitus (T2DM) and obesity [<xref ref-type="bibr" rid="cit1">1</xref>]. Glucagon‑like peptide‑1 is an incretin hormone produced mainly by intestinal L‑cells and some brain cells after food intake; its main functions include enhancement of glucose‑dependent insulin secretion, stimulation of insulin biosynthesis, inhibition of glucagon secretion, suppression of gastrointestinal motility, and regulation of appetite [<xref ref-type="bibr" rid="cit2">2</xref>]. Clinically, this allows the achievement of normoglycaemia, body weight reduction, and a decrease in cardiovascular risk, making these agents not merely symptomatic therapies but disease‑modifying treatments for diabetes and obesity [3, 4]. The first GLP‑1 RA, exenatide, was approved in 2005 for the treatment of T2DM [<xref ref-type="bibr" rid="cit5">5</xref>]. Information on GLP‑1 RAs registered in the Russian Federation is presented in Table 1.</p><p>Table 1. Glucagon‑like peptide‑1 receptor agonists registered in the Russian Federation</p><p>INNYear of registration by indication [<xref ref-type="bibr" rid="cit6">6</xref>] (T2DM)Year of registration by indication [<xref ref-type="bibr" rid="cit6">6</xref>] (Obesity)Year of inclusion in Russian clinical guidelines [<xref ref-type="bibr" rid="cit7">7</xref>] (T2DM)Year of inclusion in Russian clinical guidelines [<xref ref-type="bibr" rid="cit7">7</xref>] (Obesity)Liraglutide2010201620152016 (adults), 2021 (children)Exenatide*2011–2015–Semaglutide2019 (injectable), 2021 (oral)202420192024Lixisenatide/insulin glargine2021–2015–Dulaglutide2022–2019–Tirzepatide20252025––</p><p>Notes: * — as of January 2026, no valid registration certificate exists; INN — international nonproprietary name; T2DM — type 2 diabetes mellitus.</p><p>As can be seen from the data presented in Table 1, the future prospects for GLP‑1 RAs are associated with the expansion of their use in patients with obesity, the availability of oral formulations, and the development of fixed‑dose combinations.</p><p>Objective — to evaluate the dynamics of GLP‑1 RA consumption in the Russian Federation from the registration of the first GLP‑1 RA in 2010 to the present.</p></sec><sec><title>Materials and Methods</title><p>A pharmacoepidemiological study, i.e. a quantitative drug utilisation review (DUR) [<xref ref-type="bibr" rid="cit8">8</xref>], was conducted. As the DUR unit of measurement, we used the defined daily dose (DDD) — the assumed average maintenance dose per day for a drug used for its main indication in adults [<xref ref-type="bibr" rid="cit1">1</xref>]. Sales data for liraglutide, exenatide, lixisenatide, dulaglutide, semaglutide and tirzepatide in Russia over the period 2010–2025 were extracted from the IQVIA database (a company specialising in the collection and analysis of pharmaceutical data) [<xref ref-type="bibr" rid="cit1">1</xref>]. The data included information on the international nonproprietary name (INN), trade names, and the number of DDDs sold per year. Several sales segments were distinguished: retail (purchases made with patients’ own funds); additional and regional drug provision (ADP/RDP) — i.e. provision of T2DM patients with medicines at the expense of the healthcare system under the Federal Target Programme “Diabetes Mellitus”; and the hospital segment.</p><p>For each year of observation, the consumption indicator “number of DDDs per 1000 inhabitants per day” was calculated, which reflects the proportion of the population receiving a given drug daily [<xref ref-type="bibr" rid="cit9">9</xref>]. A value of 10 DDDs per 1000 inhabitants per day can be interpreted as follows: in a representative group of 1000 inhabitants, on any analysed day of the year, an average of 10 DDDs of the drug were used, meaning that 1 % (10/1000) of the population takes this drug every day throughout the year. The indicator was calculated using the following formula:</p><p>DDDs per 1000 inhabitants per day=Total annual DDDs×1000Population×365DDDs per 1000 inhabitants per day=Population×365Total annual DDDs×1000​</p><p>where:</p><p>This indicator shows what fraction of the population, on average, takes the drug (or drug class) daily at a dose equivalent to one DDD. For example, a value of 10 DDDs per 1000 inhabitants per day means that on any day of the year, 1 % of the population (10 out of 1000) receives one DDD of this drug; a value of 4.4 means that daily 0.44 % of the population (4.4/1000) receives one DDD of GLP‑1 RAs.</p></sec><sec><title>Results</title><p>Analysis of GLP‑1 RA consumption in the Russian Federation showed that over 15 years, their use increased 733‑fold — from 0.006 in 2010 to 4.4 DDDs per 1000 inhabitants per day in 2025 (Fig. 1).</p><p>Fig. 1. Consumption of glucagon‑like peptide‑1 receptor agonists by year</p><p>As can be seen from Fig. 1, the growth was mainly driven by the consumption of semaglutide. In 2020, 628.1 thousand DDDs were used, while in 2025 this figure reached 207 million DDDs (a 329‑fold increase). In 2025, the dual‑action drug tirzepatide appeared on the Russian market, with annual consumption of 24.5 million DDDs.</p><p>As shown in Fig. 2, the predominant sales channel for liraglutide, semaglutide and tirzepatide was retail, accounting for 86 %, 89 % and 99 %, respectively. For exenatide, the retail share was equal to that of the ADP/RDP segment (44 % each), while lixisenatide and dulaglutide were mainly purchased through the healthcare budget under ADP/RDP (70 % and 56 % of sales, respectively).</p><p>Fig. 2. Sales channels for each glucagon‑like peptide‑1 receptor agonist</p><p>Examining the market segments by year (Fig. 3, 4), it is evident that, with the exception of 2023, patients purchased drugs using their own funds. However, against the backdrop of rapid sales growth in the retail segment, the hospital share fell to 0.33 % by 2025, and the ADP/RDP share fell to 7.9 % of all DDDs, despite an absolute increase in consumption volumes in all market segments.</p><p>Fig. 3. Share of market segments by year</p><p>Analysis of regional consumption patterns revealed that consumption ranged from 0.18 DDDs in the Altai Republic to 10.71 DDDs per 1000 inhabitants per day in St. Petersburg. The top five regions with the highest GLP‑1 RA consumption were St. Petersburg (10.71), Moscow (9.3), the Moscow Region (7.42), the Yamalo‑Nenets Autonomous Okrug (7.35), and the Magadan Region (7.08 DDDs per 1000 inhabitants per day). In all these regions, retail sales dominated, with the ADP/RDP share accounting for 17 %, 11 %, 5 %, 25 %, and 20 %, respectively (Fig. 5).</p><p>The regions with the lowest consumption per 1000 inhabitants per day were the Altai Republic, the North Caucasus Federal District, the Republic of Tyva, the Republic of Dagestan, and the Republic of Buryatia, with consumption levels of 0.18, 0.3, 0.57, 1.17, and 1.24 DDDs per 1000 inhabitants per day, respectively. The corresponding ADP/RDP shares were 100 %, 5.7 %, 1.6 %, 10.5 %, and 29.8 %.</p><p>Fig. 4. Sales in individual market segments by year</p><p>Fig. 5. Distribution of sales by market segment in the top‑5 regions – leaders in GLP‑1 RA sales, taking into account the resident population</p><p>Notes: YaNAO — Yamalo‑Nenets Autonomous Okrug; ADP/RDP — additional and preferential drug provision.</p></sec><sec><title>Discussion</title><p>The multiple increase in GLP‑1 RA consumption in the Russian Federation observed in our study is in line with global trends [11, 12, 13, 15]. In the United States, a survey conducted in May 2024 involving 1,500 respondents showed that at the time of the survey, 6 % of the adult population were taking GLP‑1 RAs or dual‑action drugs, and another 12 % had taken them in the recent past [<xref ref-type="bibr" rid="cit16">16</xref>]. In Denmark, the number of semaglutide users during 2019–2021 was 4 per 1000 adult person‑years, then increased, reaching a peak of 10 per 1000 adult person‑years in the first quarter of 2023 [<xref ref-type="bibr" rid="cit11">11</xref>]. In the United Kingdom, in the first quarter of 2025, 4.9 million adults (one in ten) had either recently taken GLP‑1 RAs or dual‑action agents, or were interested in doing so in the near future [<xref ref-type="bibr" rid="cit17">17</xref>].</p><p>Despite the growth in GLP‑1 RA consumption in Russia, the provision of T2DM patients remains low. According to data from the Federal Diabetes Registry (provided by Aston Consulting JSC) and expert opinion, the proportion of individuals receiving GLP‑1 RAs in Russia in 2022 was only 1 % [<xref ref-type="bibr" rid="cit13">13</xref>]. According to international pharmacoepidemiological studies, the proportion of T2DM patients receiving GLP‑1 RAs during 2013–2017 ranged from 0.6 % to 10 %, increasing to up to 20 % during 2017–2020 [<xref ref-type="bibr" rid="cit18">18</xref>]. Sociocultural factors influencing the prescribing frequency of GLP‑1 RAs have been described: the likelihood of prescribing GLP‑1 RAs is lower when the patient has a lower level of education, lower income, belongs to ethnic minorities, or is elderly or very old [<xref ref-type="bibr" rid="cit19">19</xref>].</p><p>Beyond the low prescribing rate of GLP‑1 RAs to patients with T2DM, there is a well‑known problem of poor adherence to this therapy among patients with T2DM and obesity. In European countries, T2DM patients continuously take GLP‑1 RAs for one year in 80 % of cases, whereas in Israel and the United States this figure is only 50 % [20, 21, 22, 23]. Adherence to therapy when prescribed to patients with obesity is even lower: continuous drug intake over one year is observed in only 32–50 % of prescriptions [24, 25, 26]. Moreover, only 10 % of patients followed the recommended dose escalation of semaglutide every four weeks, and only 12 % achieved the recommended target dose of 2.4 mg, while one in three continued to take a 1.0 mg dose for a prolonged period [<xref ref-type="bibr" rid="cit27">27</xref>].</p><p>Undoubtedly, one of the significant factors for low adherence is the high cost, making the search for strategies to overcome these limitations highly relevant.</p><p>Currently, the development of novel multi‑target agonists continues, which may potentially improve the clinical and economic efficiency of their use. In clinical practice, dual‑action drugs — the GLP‑1 and glucose‑dependent insulinotropic polypeptide (GIP) agonist tirzepatide — are already being used, which is the most effective among its predecessors in terms of body weight reduction [<xref ref-type="bibr" rid="cit28">28</xref>]. Clinical trials of the first triple agonist (GLP‑1, GIP and glucagon) — retatrutide — are ongoing [<xref ref-type="bibr" rid="cit29">29</xref>]. The results of the phase II trial demonstrated its high efficacy in reducing body weight: by week 48, treatment with 8 mg and 12 mg once weekly resulted in body weight reduction exceeding 25 % in 43 % and 48 % of study participants, respectively.</p><p>Alongside increased treatment efficacy, the emergence of generic (reproduced) drugs is of great importance for reducing the cost of therapy and increasing its accessibility to a broader range of patients. Our study demonstrated that the sharp rise in semaglutide consumption was partly driven by a significant decrease in its acquisition cost. The entry of new generics will certainly require a reassessment of the cost‑effectiveness of GLP‑1 RA therapy when making decisions on reimbursement of drug costs for patients with T2DM and obesity under ADP/RDP.</p><p>The high cost of GLP‑1 RAs and the issue of their reimbursement by healthcare systems, especially in patients with T2DM combined with obesity, call for economic evaluations in comparison with other medical technologies, such as bariatric surgery [30, 31, 32]. A recent cost‑effectiveness analysis conducted in Canada showed that, given the current cost and effectiveness of GLP‑1 RAs, Roux‑en‑Y gastric bypass is the most cost‑effective strategy: its incremental cost‑utility ratio (ICUR) was CAD 43 445 per QALY, while the ICUR for the most effective GLP‑1 RA in terms of weight reduction, tirzepatide, was CAD 45 708 per QALY [<xref ref-type="bibr" rid="cit30">30</xref>]. In the United States, the most cost‑effective strategy for the treatment of grade I obesity was sleeve gastrectomy (US  4105/QALY), and for grade II/III obesity — sleeve gastrectomy (US  4105/QALY), and forgrade  II/III obesity —sleeve gastrectomy (US  7821/QALY) [<xref ref-type="bibr" rid="cit31">31</xref>]. By contrast, the cost‑effectiveness of semaglutide in patients with grade I, II and III obesity was US  508 414/QALY,US  508 414/QALY,US  420 483/QALY and US $ 350 637/QALY, respectively. Thus, improving the efficacy of GLP‑1 RAs and reducing their cost remain key factors determining the cost‑effectiveness and accessibility of this therapy for a wide range of patients with T2DM and obesity.</p><p>The WHO guideline on the use of GLP‑1 RAs in adults, published in December 2025, emphasises that although GLP‑1 RAs and dual GIP/GLP‑1 agonists have become promising treatments for obesity and associated diseases over the past decade, there are still substantial knowledge gaps regarding their long‑term clinical efficacy and safety [<xref ref-type="bibr" rid="cit1">1</xref>]. A more complete understanding of these aspects will allow a more precise assessment of the risk‑benefit ratio in their use in routine clinical practice and the development of strategies for broader patient access within multimodal clinical algorithms. 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