Assessing the cost-effectiveness of a once-weekly GLP-1 analogue versus an SGLT-2 inhibitor in the Spanish setting: Once-weekly semaglutide versus empagliflozin

References

• Soriguer F, Goday A, Bosch-Comas A, et al. Prevalence of diabetes mellitus and impaired glucose regulation in Spain: the [email protected] Study. Diabetologia. 2012;55(1):88–93.
   PubMed Web of Science ®Google Scholar
• Ismail-Beigi F, Craven T, Banerji MA, Basile J, et al. ACCORD trial group. Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial. Lancet. 2010;376(9739):419–430.
   PubMed Web of Science ®Google Scholar
• ADVANCE Collaborative Group, Patel A, MacMahon S, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008; 358:2560–2572.
   PubMed Web of Science ®Google Scholar
• UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837–853.
   PubMed Web of Science ®Google Scholar
• Davies MJ, D’Alessio DA, Fradkin J, et al. Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2018;61(12):2461–2498.
   PubMed Web of Science ®Google Scholar
• Gaede P, Lund-Andersen H, Parving H-H, et al. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008;358(6):580–591.
   PubMed Web of Science ®Google Scholar
• Cholesterol Treatment Trialists' (CTT) Collaborators, Kearney PM, Blackwell L, et al. Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet. 2008;371(9607):117–125.
   PubMed Web of Science ®Google Scholar
• UK Prospective Diabetes Study (UKPDS) Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ. 1998;317(7160):703–713.
   PubMed Web of Science ®Google Scholar
• Griffin SJ, Borch-Johnsen K, Davies MJ, et al. Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial. Lancet. 2011; 378(9786):156–167.
   PubMed Web of Science ®Google Scholar
• Williams R, Van Gaal L, Lucioni C. Assessing the impact of complications on the costs of type II diabetes. Diabetologia. 2002;45(S1):S13–S17.
   Google Scholar
• Sorli C, Harashima SI, Tsoukas GM, et al. Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. Lancet Diabetes Endocrinol. 2017;5(4):251–260.
   PubMed Web of Science ®Google Scholar
• Ahrén B, Masmiquel L, Kumar H, et al. Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial. Lancet Diabetes Endocrinol. 2017;5(5):341–354.
   PubMed Web of Science ®Google Scholar
• Ahmann AJ, Capehorn M, Charpentier G, et al. Efficacy and safety of once-weekly semaglutide versus exenatide ER in subjects with type 2 diabetes (SUSTAIN 3): A 56-week, open-label, Randomized Clinical Trial. Dia Care. 2018;41(2):258–266.
   PubMed Web of Science ®Google Scholar
• Aroda VR, Bain SC, Cariou B, et al. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial. Lancet Diabetes Endocrinol. 2017;5(5):355–366.
   PubMed Web of Science ®Google Scholar
• Rodbard HW, Lingvay I, Reed J, et al. Semaglutide added to basal insulin in type 2 diabetes (SUSTAIN 5): A randomized, controlled trial. J Clin Endocrinol Metab. 2018;103(6):2291–2301.
   PubMed Web of Science ®Google Scholar
• Pratley RE, Aroda VR, Lingvay I, et al. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018;6(4):275–286.
   PubMed Web of Science ®Google Scholar
• Häring HU, Merker L, Seewaldt-Becker E, et al. Empagliflozin as add-on to metformin in patients with type 2 diabetes: A 24-week, randomized, double-blind, placebo-controlled trial. Dia Care. 2014;37(6):1650–1659.
   PubMed Web of Science ®Google Scholar
• Häring HU, Merker L, Seewaldt-Becker E, et al. Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Dia Care. 2013;36(11):3396–3404.
   PubMed Web of Science ®Google Scholar
• Kovacs CS, Seshiah V, Merker L, et al. Empagliflozin as add-on therapy to pioglitazone with or without metformin in patients with type 2 diabetes mellitus. Clin Ther. 2015;37(8):1773–1788.e1.
   PubMed Web of Science ®Google Scholar
• Kovacs CS, Seshiah V, Swallow R, et al. Empagliflozin improves glycaemic and weight control as add-on therapy to pioglitazone or pioglitazone plus metformin in patients with type 2 diabetes: a 24-week, randomized, placebo-controlled trial. Diabetes Obes Metab. 2014;16(2):147–158.
   PubMed Web of Science ®Google Scholar
• Ridderstråle M, Andersen KR, Zeller C, et al. Comparison of empagliflozin and glimepiride as add-on to metformin in patients with type 2 diabetes: a 104-week randomised, active-controlled, double-blind, phase 3 trial. Lancet Diabetes Endocrinol. 2014;2(9):691–700.
   PubMed Web of Science ®Google Scholar
• Roden M, Weng J, Eilbracht J, et al. Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2013;1(3):208–219.
   PubMed Web of Science ®Google Scholar
• Sharma R, Wilkinson L, Vrazic H, et al. Comparative efficacy of once-weekly semaglutide and SGLT-2 inhibitors in type 2 diabetic patients inadequately controlled with metformin monotherapy: a systematic literature review and network meta-analysis. Curr Med Res Opin. 2018;34(9):1595–1603.
   PubMed Web of Science ®Google Scholar
• Lingvay I, Catarig AM, Frias JP, et al. Efficacy and safety of once-weekly semaglutide versus daily canagliflozin as add-on to metformin in patients with type 2 diabetes (SUSTAIN 8): a double-blind, phase 3b, randomised controlled trial. Lancet Diabetes Endocrinol. 2019;7(11):P834–P844.
   PubMed Web of Science ®Google Scholar
• Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2016;375(19):1834–1844.
   PubMed Web of Science ®Google Scholar
• Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117–2128.
   PubMed Web of Science ®Google Scholar
• Palmer AJ, Roze S, Valentine WJ, et al. The CORE diabetes model: projecting long-term clinical outcomes, costs and cost-effectiveness of interventions in diabetes mellitus (types 1 and 2) to support clinical and reimbursement decision-making. Curr Med Res Opin. 2004; 20(sup1):S5–S26.
   PubMed Web of Science ®Google Scholar
• Palmer AJ, Roze S, Valentine WJ, et al. Validation of the CORE Diabetes Model against epidemiological and clinical studies. Curr Med Res Opin. 2004; 20(Suppl 1):S27–S40.
   PubMed Web of Science ®Google Scholar
• McEwan P, Foos V, Palmer JL, et al. Validation of the IMS CORE diabetes model. Value Health. 2014; 17(6):714–724.
   PubMed Web of Science ®Google Scholar
• American Diabetes Association Consensus Panel. Guidelines for computer and modeling of diabetes its complications. Diabetes Care. 2004;27(9):2262–2265.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Global Health Observatory data repository: Life tables by country [cited 2018 Dec 4]. Available from: http://apps.who.int/gho/data/view.main.60450?lang=en
   Google Scholar
• Lopez Bastida J, Oliva J, Antonanzas F, et al. A proposed guideline for economic evaluation of health technologies. Gac Sanit. 2010;24(2):154–170.
   PubMed Web of Science ®Google Scholar
• Mezquita-Raya P, Ramírez de Arellano A, Kragh N, et al. Liraglutide versus lixisenatide: long-term cost-effectiveness of GLP-1 receptor agonist therapy for the treatment of type 2 diabetes in Spain. Diabetes Ther. 2017;8(2):401–415.
   PubMed Web of Science ®Google Scholar
• European Central Bank. Statistical Data Warehouse – Inflation rate (HICP). [cited 2018 Mar 21]. Available from: http://sdw.ecb.europa.eu
   Google Scholar
• Beaudet A, Clegg J, Thuresson PO, et al. Review of utility values for economic modeling in type 2 diabetes. Value Health. 2014;17(4):462–470.
   PubMed Web of Science ®Google Scholar
• Evans M, Khunti K, Mamdani M, et al. Health-related quality of life associated with daytime and nocturnal hypoglycaemic events: a time trade-off survey in five countries. Health Qual Life Outcomes. 2013; 11(1):90.
   PubMed Web of Science ®Google Scholar
• Lee AJ, Morgan CL, Morrissey M, et al. Evaluation of the association between the EQ-5D (health-related utility) and body mass index (obesity) in hospital-treated people with type 1 diabetes, type 2 diabetes and with no diagnosed diabetes. Diabet Med. 2005;22(11):1482–1486.
   PubMed Web of Science ®Google Scholar
• Lenters-Westra E, Schindhelm RK, Bilo HJ, et al. Differences in interpretation of haemoglobin A1c values among diabetes care professionals. Neth J Med. 2014;72(9):462–466.
   PubMed Web of Science ®Google Scholar
• Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014;63(25):2985–3023.
   PubMed Web of Science ®Google Scholar
• Viljoen A, Hoxer CS, Johansen P, et al. Evaluation of the long-term cost-effectiveness of once-weekly semaglutide versus dulaglutide for treatment of type 2 diabetes mellitus in the UK. Diabetes Obes Metab. 2019;21(3):611–621.
   PubMed Web of Science ®Google Scholar
• Johansen P, Håkan-Bloch J, Liu AR, et al. Cost effectiveness of once-weekly semaglutide versus once-weekly dulaglutide in the treatment of type 2 diabetes in Canada. Pharmacoecon Open. 2019; [Epub ahead of print]
   PubMedGoogle Scholar
• Ericsson Å, Fridhammar A. Cost-effectiveness of once-weekly semaglutide versus dulaglutide and lixisenatide in patients with type 2 diabetes with inadequate glycemic control in Sweden. J Med Econ. 2019;22(10):997–1005.
   PubMed Web of Science ®Google Scholar
• Malkin SJP, Russel-Szymczyk M, Liidemann G, et al. Once-weekly semaglutide versus once-daily liraglutide for the treatment of type 2 diabetes: a long-term cost-effectiveness analysis in estonia. Diabetes Ther. 2019;10(1):159–176.
   PubMed Web of Science ®Google Scholar
• Green JB, Bethel MA, Armstrong PW, et al. Effect of sitagliptin on cardio- vascular outcomes in type 2 diabetes. N Engl J Med. 2015;373(3):232–242.
   PubMed Web of Science ®Google Scholar
• Scirica BM, Bhatt DL, Braunwald E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369(14):1317–1326.
   PubMed Web of Science ®Google Scholar
• White WB, Cannon CP, Heller SR, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013;369(14):1327–1335.
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Perkovic V, Johansen OE, et al. Effect of linagliptin vs placebo on major cardiovascular events in adults with type 2 diabetes and high cardiovascular and renal risk: the CARMELINA randomized clinical trial. JAMA. 2019;321(1):69–79.
   PubMed Web of Science ®Google Scholar
• Witkowski M, Wilkinson L, Webb N, et al. A systematic literature review and network meta-analysis comparing once-weekly semaglutide with other GLP-1 receptor agonists in patients with type 2 diabetes previously receiving 1-2 oral anti-diabetic drugs. Diabetes Ther. 2018;9(3):1149–1167.
   PubMed Web of Science ®Google Scholar
• Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375(4):311–322.
   PubMed Web of Science ®Google Scholar
• Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019;394(10193):121–130.
   PubMed Web of Science ®Google Scholar
• Hernandez AF, Green JB, Janmohamed S, et al. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Lancet. 2018;392(10157):1519–1529.
   PubMed Web of Science ®Google Scholar
• EUnetHTA. European Network for Health Technology. Guideline—comparators & comparisons: direct and indirect comparisons, 2013; [cited 2018 Dec 1]. Available from: http://www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/Direct%20and%20indirect%20comparisons.pdf.
   Google Scholar
• Dias S,NJ, Sutton AJ, Ades AE. NICE DSU Technical Support Document 1: introduction to evidence synthesis for decision making, 2011; [last updated April 2012; cited 2018 Dec 1]. Available from: http://scharr.dept.shef.ac.uk/nicedsu/wp-content/uploads/sites/7/2016/03/TSD1-Introduction.final_.08.05.12.pdf.
   Google Scholar
• Ministerio de Sanidad, Servicios Sociales e Igualdad. Portal estadístico, 2015. ICD-9-CM: 410 – Infarto agudo miocardio. [cited 2018 Mar 21]. Available from: http://www.pestadistico.inteligenciadegestion.msssi.es.
   Google Scholar
• Nielsen AT, Pitcher A, Lovato E, et al. The Cost-Effectiveness Evaluation of Canagliflozin Versus Dapagliflozin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy in Spain. Poster presented at the 20th Annual Meetiong of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR); May 16–20, 2015; Philadelphia, Pennsylvania. [cited 2018 Mar 21]. Available from: https://www.ispor.org/research_pdfs/49/pdffiles/PDB50.pdf.
   Google Scholar
• Ministerio de Sanidad, Servicios Sociales e Igualdad. Portal estadístico, 2015. ICD-9-CM: 411.1 – Síndrome coronario intermedio; 413 – Angina de pecho. [cited 2018 Mar 21]. Available from: http://www.pestadistico.inteligenciadegestion.msssi.es.
   Google Scholar
• Ministerio de Sanidad, Servicios Sociales e Igualdad. Portal estadístico, 2015. ICD-9-CM: 428.0 – Insuficiencia cardiaca congestiva. [cited 2018 Mar 21]. Available from: http://www.pestadistico.inteligenciadegestion.msssi.es.
   Google Scholar
• Ministerio de Sanidad, Servicios Sociales e Igualdad. Portal estadístico, 2015. ICD-9-CM: 430 – Hemorragia subaracnoidea; 431 – Hemorragia intracerebral; 432 – Otra hemorragia intracraneal y la no especificada; 433 – Oclusión y estenosis de las arterias precerebrales; 434 – Oclusión de las arterias cerebrales; 435 – Isquemia cerebral transitoria; 436 – Enfermedad cerebrovascular aguda mal definida; 437 – Otra enfermedad cerebrovascular y enfermedad cerebrovascular mal definida; 438 – Efectos tardíos de enfermedad cerebrovascular. [cited 2018 Mar 21]. Available from: http://www.pestadistico.inteligenciadegestion.msssi.es.
   Google Scholar
• Ministerio de Sanidad, Servicios Sociales e Igualdad. Portal estadístico, 2015. ICD-9-CM: 443.9 – Enfermedad vascular periférica no especificada. [cited 2018 Mar 21]. Available from: http://www.pestadistico.inteligenciadegestion.msssi.es.
   Google Scholar
• Hemodialysis. Tarifas para facturación de servicios sanitarios y docentes de Osakidetza para el año 2017. Osakidetza-Servicio Vasco de Salud. [cited 2018 Mar 21]. Available from: https://www.osakidetza.euskadi.eus/contenidos/informacion/libro_tarifas/es_libro/adjuntos/Libro_de_Tarifas_2017.pdf.
   Google Scholar
• Peritoneal dialysis. Tarifas para facturación de servicios sanitarios y docentes de Osakidetza para el año 2017. Osakidetza-Servicio Vasco de Salud. [cited 2018 Mar 21]. Available from: https://www.osakidetza.euskadi.eus/contenidos/informacion/libro_tarifas/es_libro/adjuntos/Libro_de_Tarifas_2017.pdf.
   Google Scholar
• Ministerio de Sanidad, Servicios Sociales e Igualdad. Portal estadístico, 2015. GRD-AP: 302 – Transplante renal. [cited 2018 Mar 21]. Available from: http://www.pestadistico.inteligenciadegestion.msssi.es.
   Google Scholar
• Chubb B, Tikkanen C. The cost of non-severe hypoglycaemia in Europe. Value Health. 2015;18(7):A611.
   Web of Science ®Google Scholar
• Jakubczyk M, Lipka I, Pawęska J, et al. Cost of severe hypoglycaemia in nine European countries. J Med Econ. 2016;19(10):973–982.
   PubMed Web of Science ®Google Scholar
• Laser photocoagulation. Tarifas para facturación de servicios sanitarios y docentes de Osakidetza para el año 2017. Osakidetza-Servicio Vasco de Salud. [cited 2018 Mar 21]. Available from: https://www.osakidetza.euskadi.eus/contenidos/informacion/libro_tarifas/es_libro/adjuntos/Libro_de_Tarifas_2017.pdf.
   Google Scholar
• Ministerio de Sanidad, Servicios Sociales e Igualdad. Portal estadístico, 2015. ICD-9-CM: 366.41 – Catarata diabética. [cited 2018 Mar 21]. Available from: http://www.pestadistico.inteligenciadegestion.msssi.es.
   Google Scholar
• SP appointment. Tarifas para facturación de servicios sanitarios y docentes de Osakidetza para el año 2017. Osakidetza-Servicio Vasco de Salud. [cited 2018 Mar 21]. Available from: https://www.osakidetza.euskadi.eus/contenidos/informacion/libro_tarifas/es_libro/adjuntos/Libro_de_Tarifas_2017.pdf.
   Google Scholar
• Ministerio de Sanidad, Servicios Sociales e Igualdad. Portal estadístico, 2015. ICD-9-CM: 369 – Ceguera y baja visión. [cited 2018 Mar 21]. Available from: http://www.pestadistico.inteligenciadegestion.msssi.es.
   Google Scholar
• Ministerio de Sanidad, Servicios Sociales e Igualdad. Portal estadístico, 2015. ICD-9-CM: 249.60 – Diabetes mellitus secundaria con manifestaciones neurológicas no consignada como incontrolada o no especificada. [cited 2018 Mar 21]. Available from: http://www.pestadistico.inteligenciadegestion.msssi.es.
   Google Scholar
• Ministerio de Sanidad, Servicios Sociales e Igualdad. Portal estadístico, 2015. GRD-AP: 114 – Amputación de miembro superior y dedos del pie por transtornos circulatorios. [cited 2018 Mar 21]. Available from: http://www.pestadistico.inteligenciadegestion.msssi.es.
   Google Scholar
• Ministerio de Sanidad, Servicios Sociales e Igualdad. Portal estadístico, 2015. GRD-AP: 462 – Rehabilitación. [cited 2018 Mar 21]. Available from: http://www.pestadistico.inteligenciadegestion.msssi.es.
   Google Scholar
• Ministerio de Sanidad, Servicios Sociales e Igualdad. Portal estadístico, 2015. ICD-9-CM: 785.4 – Gangrena. [cited 2018 Mar 21]. Available from: http://www.pestadistico.inteligenciadegestion.msssi.es.
   Google Scholar
• Ministerio de Sanidad, Servicios Sociales e Igualdad. Portal estadístico, 2015. ICD-9-CM: 707 – Úlcera crónica de la piel. [cited 2018 Mar 21]. Available from: http://www.pestadistico.inteligenciadegestion.msssi.es.
   Google Scholar
• GP appointment. Tarifas para facturación de servicios sanitarios y docentes de Osakidetza para el año 2017. Osakidetza-Servicio Vasco de Salud. [cited 2018 Mar 21]. Available from: https://www.osakidetza.euskadi.eus/contenidos/informacion/libro_tarifas/es_libro/adjuntos/Libro_de_Tarifas_2017.pdf.
   Google Scholar