Value For Money In The Treatment Of Patients With Type 2 Diabetes Mellitus: Assessing The Long-Term Cost-Effectiveness Of IDegLira Versus iGlarLixi In Italy

References

• International Diabetes Federation (IDF). IDF diabetes atlas: Eighth edition 2017. 2017 Available from: http://diabetesatlas.org/resources/2017-atlas.html. Accessed 218, 2019.
   Google Scholar
• Parekh W, Streeton SE, Baker-Knight J, Montagnoli R, Nicoziani P, Marchesini G. The economic burden of insulin-related hypoglycemia in adults with diabetes: an analysis from the perspective of the Italian healthcare system. Diabetes Ther. 2018;9(3):1037–1047. doi:10.1007/s13300-018-0418-029600505
   PubMedGoogle Scholar
• Cryer PE. Glycemic goals in diabetes: trade-off between glycemic control and iatrogenic hypoglycemia. Diabetes. 2014;63(7):2188–2195. doi:10.2337/db14-005924962915
   PubMed Web of Science ®Google Scholar
• Association of Diabetologists and Italian Society for Diabetes (Associazione Medici Diabetologici & Società Italiana di Diabetologia). Italian standards for treatment of diabetes mellitus [Standard Italiani per la cura del diabete mellito]. 2018 Available from: http://aemmedi.it/wp-content/uploads/2009/06/AMD-Standard-unico1.pdf. Accessed 218, 2019.
   Google Scholar
• Apovian CM, Okemah J, O’Neil PM. Body weight considerations in the management of type 2 diabetes. Adv Ther. 2019;36(1):44–58. doi:10.1007/s12325-018-0824-830465123
   PubMed Web of Science ®Google Scholar
• Nuffer W, Guesnier A, Trujillo JM. A review of the new GLP-1 receptor agonist/basal insulin fixed-ratio combination products. Ther Adv Endocrinol Metab. 2018;9(3):69–79. doi:10.1177/204201881775231529492243
   PubMedGoogle Scholar
• Buse JB, Vilsbøll T, Thurman J, et al. Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide (IDegLira). Diabetes Care. 2014;37(11):2926–2933. doi:10.2337/dc14-078525114296
   PubMed Web of Science ®Google Scholar
• Lingvay I, Pérez Manghi F, García-Hernández P, et al. Effect of insulin glargine up-titration vs insulin degludec/liraglutide on glycated hemoglobin levels in patients with uncontrolled type 2 diabetes: the DUAL V randomized clinical trial. Jama. 2016;315(9):898–907. doi:10.1001/jama.2016.125226934259
   PubMed Web of Science ®Google Scholar
• Billings LK, Doshi A, Gouet D, et al. Efficacy and safety of IDegLira versus basal-bolus insulin therapy in patients with type 2 diabetes uncontrolled on metformin and basal insulin: the DUAL VII randomized clinical trial. Diabetes Care. 2018;41(5):1009–1016. doi:10.2337/dc17-111429483185
   PubMed Web of Science ®Google Scholar
• Aroda VR, Rosenstock J, Wysham C, et al. Efficacy and safety of LixiLan, a titratable fixed-ratio combination of insulin glargine plus lixisenatide in type 2 diabetes inadequately controlled on basal insulin and metformin: the LixiLan-L randomized trial. Diabetes Care. 2016;39(11):1972–1980. doi:10.2337/dc16-149527650977
   PubMed Web of Science ®Google Scholar
• Hunt B, Kragh N, McConnachie CC, Valentine WJ, Rossi MC, Montagnoli R. Long-term cost-effectiveness of two GLP-1 receptor agonists for the treatment of type 2 diabetes mellitus in the Italian setting: liraglutide versus lixisenatide. Clin Ther. 2017;39(7):1347–1359. doi:10.1016/j.clinthera.2017.05.35428625506
   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(Suppl 1):S5–S26. doi:10.1185/030079904X1980
   PubMed Web of Science ®Google Scholar
• McEwan P, Foos V, Palmer JL, Lamotte M, Lloyd A, Grant D. Validation of the IMS CORE Diabetes Model. Value Health. 2014;17(6):714–724. doi:10.1016/j.jval.2014.07.00725236995
   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. doi:10.1185/030079904X200615324514
   PubMed Web of Science ®Google Scholar
• Evans M, Billings LK, Håkan-Bloch J, et al. An indirect treatment comparison of the efficacy of insulin degludec/liraglutide (IDegLira) and insulin glargine/lixisenatide (iGlarLixi) in patients with type 2 diabetes uncontrolled on basal insulin. J Med Econ. 2018;21(4):340–347. doi:10.1080/13696998.2017.140922829164973
   PubMed Web of Science ®Google Scholar
• Jansen JP, Fleurence R, Devine B, et al. Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR task force on indirect treatment comparisons good research practices: part 1. Value Health. 2011;14(4):417–428. doi:10.1016/j.jval.2011.04.00221669366
   PubMed Web of Science ®Google Scholar
• Salanti G. Indirect and mixed-treatment comparison, network, or multiple-treatments meta-analysis: many names, many benefits, many concerns for the next generation evidence synthesis tool. Res Synth Methods. 2012;3(2):80–97. doi:10.1002/jrsm.103726062083
   PubMed Web of Science ®Google Scholar
• National Statistics Institute (Istituto Nazionale di Statistica). Aspects of daily life: smoking habits [Aspetti della vita quotidiana: abitudine al fumo]. 2017 Available from: http://dati.istat.it/Index.aspx?QueryId=15513. Accessed 218, 2019.
   Google Scholar
• World Health Organization. Substance abuse: Italy 2014. 2014 Available from: http://www.who.int/substance_abuse/publications/global_alcohol_report/profiles/ita.pdf. Accessed 218, 2019.
   Google Scholar
• World Health Organization. Global health observatory data repository. Life tables by country. 2016 Available from: http://apps.who.int/gho/data/node.main.LIFECOUNTRY?lang=en0. Accessed 218, 2019.
   Google Scholar
• Kotseva K, Wood D, De Backer G, De Bacquer D, Pyörälä K, Keil U. Cardiovascular prevention guidelines in daily practice: a comparison of EUROASPIRE I, II, and III surveys in eight European countries. Lancet. 2009;373(9667):929–940. doi:10.1016/S0140-6736(09)60330-519286092
   PubMed Web of Science ®Google Scholar
• De Berardis G, Pellegrini F, Franciosi M, et al. Quality of care and outcomes in type 2 diabetic patients: a comparison between general practice and diabetes clinics. Diabetes Care. 2004;27(2):398–406. doi:10.2337/diacare.27.2.39814747220
   PubMedGoogle Scholar
• Italian Medicines Agency (Agenzia Italiana del Farmaco). Lista di trasparenza [transparency lists]. 2017 Available from: http://www.agenziafarmaco.gov.it/content/liste-di-trasparenza-aggiornamento-del-15022017. Accessed 218, 2019.
   Google Scholar
• Official Journal (Gazzetta Ufficiale). Decreto 18 Ottobre 2012. GU n.23 del 28-1-2013: suppl. ordinario n.8. Ministero della Salute. 2012 Available from: http://www.gazzettaufficiale.it/eli/gu/2013/01/28/23/so/8/sg/pdf. Accessed 218, 2019.
   Google Scholar
• ARNO Diabetes Observatory (Osservatorio ARNO Diabete). Health profile of the population with diabetes [Il profilo assistenziale della popolazione con diabete]. Rapporto 2015, Vol XXIII. 2015 Available from: http://www.quotidianosanita.it/allegati/allegato272278.pdf. Accessed 218, 2019.
   Google Scholar
• Beaudet A, Grabbi E, Maurel F, Ramos M, Lebioda A. Review of cost of diabetes complications in four European countries. Value Health. 2013;16(7):A443–A444. doi:10.1016/j.jval.2013.08.692
   Web of Science ®Google Scholar
• Ministery of Health (Ministerio della Salute Direzione Generale della Programmazione sanitaria Ufficio VI). Report on hospital treatment: first semester 2014 (Rapporto sull’attività di ricovero ospedaliero – dati SDO: primo semestre 2014). 2015 Available from: http://www.salute.gov.it/imgs/C_17_pubblicazioni_2270_allegato.pdf. Accessed 218, 2019.
   Google Scholar
• Eandi M, Pradelli L, Iannazzo S, Chiroli S, Pontoriero G. Economic evaluation of cinacalcet in the treatment of secondary hyperparathyroidism in Italy. Pharmacoeconomics. 2010;28(11):1041–1054. doi:10.2165/11538600-000000000-0000020936886
   PubMedGoogle Scholar
• Zaniolo O. Costs of diabetes in Italy [Costi del diabete in Italia]. Farmeconomia E Percorsi Terapeutici. 2009;10(2):73–81. doi:10.7175/fe.v10i2.165
   Google Scholar
• Chubb B, Tikkanen CK. The Cost of Non-severe Hypoglycaemia in Europe. Milan: ISPOR 18th Annual European Congress; 2015.
   Google Scholar
• Pagano E, De Rosa M, Rossi E, et al. The relative burden of diabetes complications on healthcare costs: the population-based CINECA-SID ARNO Diabetes Observatory. Nutr Metab Cardiovasc Dis. 2016;26(10):944–950. doi:10.1016/j.numecd.2016.05.00227289165
   PubMedGoogle Scholar
• Veronese G, Marchesini G, Forlani G, et al. Costs associated with emergency care and hospitalization for severe hypoglycemia. Nutr Metab Cardiovasc Dis. 2016;26(4):345–351. doi:10.1016/j.numecd.2016.01.00726897390
   PubMed Web of Science ®Google Scholar
• Beaudet A, Clegg J, Thuresson PO, Lloyd A, McEwan P. Review of utility values for economic modeling in type 2 diabetes. Value Health. 2014;17(4):462–470. doi:10.1016/j.jval.2014.03.00324969008
   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;11:90. doi:10.1186/1477-7525-11-9023731777
   PubMed Web of Science ®Google Scholar
• American Diabetes Association Consensus Panel. Guidelines for computer modeling of diabetes and its complications. Diabetes Care. 2004;27(9):2262–2265. doi:10.2337/diacare.27.9.226215333499
   PubMed Web of Science ®Google Scholar
• Lee AJ, Morgan CL, Morrissey M, Wittrup-Jensen KU, Kennedy-Martin T, Currie CJ. 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. doi:10.1111/j.1464-5491.2005.01657.x16241910
   PubMed Web of Science ®Google Scholar
• Currie CJ, Morgan CL, Poole CD, Sharplin P, Lammert M, McEwan P. Multivariate models of health-related utility and the fear of hypoglycaemia in people with diabetes. Curr Med Res Opin. 2006;22(8):1523–1534. doi:10.1185/030079906X11575716870077
   PubMed Web of Science ®Google Scholar
• Lauridsen JT, Lønborg J, Gundgaard J, Jensen HH. Diminishing marginal disutility of hypoglycaemic events: results from a time trade-off survey in five countries. Qual Life Res. 2014;23(9):2645–2650. doi:10.1007/s11136-014-0712-x24838908
   PubMed Web of Science ®Google Scholar
• Kelly-Hayes M. Influence of age and health behaviors on stroke risk: Lessons from longitudinal studies. J Am Geriatr Soc. 2010;58(Suppl 2):S325–S328. doi:10.1111/j.1532-5415.2010.02915.x21029062
   PubMedGoogle Scholar
• Torre E, Bruno GM, Di Matteo S, et al. Cost-minimization analysis of degludec/liraglutide versus glargine/aspart: Economic implications of the DUAL VII study outcomes. Clinicoecon Outcomes Res. 2018;10:413–421. doi:10.2147/CEOR.S16904530100746
   PubMed Web of Science ®Google Scholar
• Pöhlmann J, Russel-Szymczyk M, Holík P, Rychna K, Hunt B. Treating patients with Type 2 diabetes mellitus uncontrolled on basal insulin in the Czech Republic: Cost-effectiveness of IDegLira versus iGlarLixi. Diabetes Ther. 2019;10(2):493–508. doi:10.1007/s13300-019-0569-730706364
   PubMedGoogle Scholar
• Giugliano D, Maiorino MI, Bellastella G, Esposito K. Clinical inertia, reverse clinical inertia, and medication non-adherence in type 2 diabetes. J Endocrinol Invest. 2018. doi:10.1007/s40618-018-0951-8
   Web of Science ®Google Scholar
• Rossi MC, Lucisano G, Ceriello A, et al. Real-world use of self-monitoring of blood glucose in people with type 2 diabetes: An urgent need for improvement. Acta Diabetol. 2018;55(10):1059–1066. doi:10.1007/s00592-018-1186-z30062588
   PubMedGoogle Scholar
• Shinkins B, Yang Y, Abel L, Fanshawe TR. Evidence synthesis to inform model-based cost-effectiveness evaluations of diagnostic tests: A methodological review of health technology assessments. BMC Med Res Methodol. 2017;17(1):56. doi:10.1186/s12874-017-0331-728410588
   PubMedGoogle Scholar
• Price H, Blüher M, Prager R, Phan TM, Thorsted BL, Schultes B. Use and effectiveness of a fixed-ratio combination of insulin degludec/liraglutide (IDegLira) in a real-world population with type 2 diabetes: Results from a European, multicentre, retrospective chart review study. Diabetes Obes Metab. 2018;20(4):954–962. doi:10.1111/dom.1318229205856
   PubMed Web of Science ®Google Scholar
• Sofra D. Glycemic control in a real-life setting in patients with type 2 diabetes treated with IDegLira at a single Swiss center. Diabetes Ther. 2017;8(2):377–384. doi:10.1007/s13300-017-0234-y28220460
   PubMedGoogle Scholar
• Drummond R, Baru A, Dutkiewicz M, Basse A, Tengmark BO. Physicians’ real-world experience with IDegLira: Results of a European survey. BMJ Open Diabetes Res Care. 2018;6(1):e000531. doi:10.1136/bmjdrc-2018-000531
   PubMed Web of Science ®Google Scholar
• Trifirò G, Parrino F, Pizzimenti V, et al. The management of diabetes mellitus in patients with chronic kidney disease: A population-based study in Southern Italy. Clin Drug Investig. 2016;36(3):203–212. doi:10.1007/s40261-015-0367-6
   PubMed Web of Science ®Google Scholar
• Corrao G, Rea F, Di Martino M, et al. Effectiveness of adherence to recommended clinical examinations of diabetic patients in preventing diabetes-related hospitalizations. Int J Qual Health Care. 2018. doi:10.1093/intqhc/mzy186
   Web of Science ®Google Scholar