Diabetic patients without semaglutide: what are the implications?
DOI:
https://doi.org/10.32385/rpmgf.v40i2.13744Keywords:
Semaglutide, Type 2 diabetes mellitus, Obesity, Overweight, Ethics, EconomicsAbstract
A problem with the supply of the medicine Ozempic® (semaglutide) was recently reported, which affects several countries, including Portugal. This drug, a glucagon-like peptide 1 analogue, is approved for the treatment of patients with type 2 diabetes mellitus not satisfactorily controlled, being partially reimbursed only for patients who also have a body mass index equal to, or greater than, 35kg/m2. The drug stock-out seems to have been due to its off-label prescription, carried out with the aim of weight loss in overweight or obese people, but not in diabetic patients. The off-label use of semaglutide in Portugal raises ethical and economic problems. Despite the efforts that have been made to reduce the prevalence of overweight and obese people in our country, namely through the creation of health programs, we consider that there is still significant room for improvement in the field of preventive medicine.
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References
Infarmed. Indisponibilidade de medicamentos contendo semaglutido (Ozempic): circular informativa nº 125/CD/100.20.200. Lisboa: Infarmed; 2021.
Lund A, Knop FK, Vilsbøll T. Glucagon-like peptide-1 receptor agonists for the treatment of type 2 diabetes: differences and similarities. Eur J Intern Med. 2014;25(5):407-14.
Sattar N, Lee MM, Kristensen SL, Branch KR, Del Prato S, Khurmi NS, et al. Cardiovascular, mortality, and kidney outcomes with GLP-1 receptor agonists in patients with type 2 diabetes: a systematic review and meta-analysis of randomised trials. Lancet Diabetes Endocrinol. 2021;9(10):653-62.
Carvalho D, Silva-Nunes J, Raposo JF, Medina JL, de Castro JJ, Carrilho F. Agonistas dos receptores do GLP-1 no tratamento da diabetes tipo 2 [GLP-1 receptor agonists in type 2 diabetes treatment]. Rev Port Diabetes. 2016;11(4):154-66. Portuguese
European Medicines Agency. Ozempic: resumo das características do medicamento [Internet]. Amsterdam: EMA; 2018 Feb 21 [updated 2023 May 03; cited 2022 Dec 31]. Available from: https://www.ema.europa.eu/pt/documents/product-information/ozempic-epar-product-information_pt.pdf
Infarmed. Relatório público de avaliação: Ozempic (semaglutido) [Internet]. Lisboa: Infarmed; 2021 Mar 19 [cited 2022 Dec 31]. Available from: https://www.infarmed.pt/documents/15786/1437513/Relat%C3%B3rio+de+avalia%C3%A7%C3%A3o+de+financiamento+p%C3%BAblico+de+Ozempic+%28semaglutido%29+2021/35b93bad-fd79-a3ed-e5d2-f869a2846c2b
ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, et al. 9. Pharmacologic approaches to glycemic treatment: standards of care in diabetes—2023. Diabetes Care. 2022;46 Suppl 1:S140-57.
U.S. Food & Drug Administration. FDA approves new drug treatment for chronic weight management, first since 2014 [homepage]. FDA; 2021 Jun 04 [cited 2022 Dec 31]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014
Beauchamp TL, Childress JF. Principles of biomedical ethics. 5th ed. Oxford University Press; 2001.
Strech D, Persad G, Marckmann G, Danis M. Are physicians willing to ration health care? Conflicting findings in a systematic review of survey research. Health Policy. 2009;90(2-3):113-24.
Medeiros A. Avaliação económica dos medicamentos [Economic evaluation of medicines]. Rev Port Clin Geral. 2002;18(6):375-80. Portuguese
Infarmed. Meio ambulatório: monitorização do consumo de medicamentos [Internet]. Lisboa: Infarmed; 2022 Oct [cited 2022 Dec 31]. Available from: https://www.infarmed.pt/documents/15786/6353588/outubro/df197087-06d0-bc0a-9db1-db8cce80ca3f?version=1.0
Raposo JF. Diabetes: factos e números 2016, 2017 e 2018. Rev Port Diabetes. 2020;15(1):19-27.
Namorado S, Santos J, Antunes L, Kislaya I, Santos AJ, Castilho E, et al. 1o Inquérito nacional de saúde com exame físico (INSEF 2015): determinantes de saúde [Internet]. Lisboa: Instituto Nacional de Saúde Dr. Ricardo Jorge; 2017. Available from: http://hdl.handle.net/10400.18/4795
Rocha E. A carga global de doença: fonte de informação para a definição de políticas e avaliação de intervenções em saúde [The global burden of disease: an information resource for policy‐making and evaluation of health interventions]. Rev Port Cardiol. 2017;36(4):283-5. Portuguese
GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396(10258):1204-22.
GBD 2019 Risk Factors Collaborators. Global burden of 87 risk factors in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396(10258):1223-49.
Direção-Geral da Saúde. Programa nacional para a promoção da atividade física 2021. Lisboa: DGS; 2021.
Gregório M, Salvador C, Bica M, Graça P, Telo de Arriaga M. The healthy food environment policy index (Food-EPI): relatório de resultados para Portugal [Internet]. Lisboa: Direção-Geral da Saúde; 2022. Available from: https://nutrimento.pt/activeapp/wp-content/uploads/2022/01/FOOD-EPI_Portugal_RelatorioFinal_12Jan-1.pdf
Direção-Geral da Saúde. Programa nacional para a promoção da alimentação saudável 2021. Lisboa: DGS; 2021.
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