Health economic evaluation of insulin glargine vs NPH insulin in intensified conventional therapy for type 1 diabetes in Germany

Journal of Medical Economics

Volumn 15, Issue SUPPL. 2, 2012, Pages 14-27

  Pfohl, Martin ^a   Schädlich, Peter K ^b   Dippel, Franz Werner ^c   Koltermann, Katharina C ^d  

^a Evangelisches BETHESDA Krankenhaus zu Duisburg GmbH   (Germany)

^b IGES Institut Gmbh   (Germany)

^c SANOFI AVENTIS DEUTSCHLAND GMBH   (Germany)

^d Lychener Strasse   (Germany)

Author keywords

Cost effectiveness; Discrete event simulation; Germany; Insulin glargine; Intensified conventional therapy; NPH insulin; Type 1 diabetes

Indexed keywords

INSULIN GLARGINE; ISOPHANE INSULIN;

ADULT; ARTICLE; COST EFFECTIVENESS ANALYSIS; DATA EXTRACTION; FEMALE; GERMANY; GLYCEMIC CONTROL; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN HYPOGLYCEMIA; MAJOR CLINICAL STUDY; MALE; NOCTURNAL HYPOGLYCEMIA; RISK FACTOR; SENSITIVITY ANALYSIS;

ADULT; COST OF ILLNESS; COST-BENEFIT ANALYSIS; DIABETES MELLITUS, TYPE 1; FEMALE; GERMANY; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN, ISOPHANE; INSULIN, LONG-ACTING; MALE; QUALITY-ADJUSTED LIFE YEARS; YOUNG ADULT;

EID: 84867947691     PISSN: 13696998     EISSN: 1941837X     Source Type: Journal    
DOI: 10.3111/13696998.2012.713879     Document Type: Article

References (63)

1. Häussler B, Klein S, Hagenmeyer EG. Weißbuch Diabetes in Deutschland. Bestandsaufnahme und Zukunftsperspektiven. 2nd edn. Stuttgart: Thieme Verlag, 2010
2. International Diabetes Federation-IDF, editor. IDF Diabetes Atlas. 4th edn. Table 1.12 Prevalence estimates of diabetes mellitus (DM), 2010-European Region. Brussels: IDF, 2009. www.diabetesatlas.org/content/prevalence-estimates- diabetes-mellitus-dm-2010. Accessed December 5, 2010
3. Köster I, von Ferber L, Ihle P, et al. The cost burden of diabetes mellitus: the evidence from Germany-the CoDiM Study. Diabetologia 2006;49:1498-504 (Pubitemid 43848085)
4. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of longterm complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-86
5. Scherbaum WA, Kerner W, editors. Evidenzbasierte Leitlinie der DDG-Therapie des Diabetes mellitus Typ 1 (Publiziert: 05/2003, aktualisiert 05/2007). www.deutsche-diabetes-gesellschaft.de/redaktion/mitteilungen/ leitlinien/EBL-Dm-Typ1-Update-2007.pdf Accessed February 6, 2010
6. Fanelli CG, Porcellati F, Pampanelli S, et al. Insulin therapy and hypoglycaemia: the size of the problem. Diabetes Metab Res Rev 2004;20(2 Suppl):S32-42 (Pubitemid 40029083)
7. Whitmer RA, Karter AJ, Yaffe K, et al. Hypoglycemic episodes and risk of dementia in older patients with type 2 diabetes mellitus. J Am Med Assoc 2009;301:1565-72
8. Desouza CV, Bolli GB, Fonesca V. Hypoglycemia, diabetes, and cardiovascular events. Diabetes Care 2010;33:1389-94
9. Zoungas S, Patel A, Chalmers J, et al. Severe hypoglycemia and risks of vascular events and death. N Engl J Med 2010;363:1410-18
10. Tattersall RB, Gill GV. Unexplained deaths of type 1 diabetic patients. Diabet Med 1991;8:49-58
11. Gill GV, Woodward A, Casson IF, et al. Cardiac arrhythmia and nocturnal hypoglycaemia in type 1 diabetes-the 'dead in bed' syndrome revisited. Diabetologia 2009;52:42-5
12. O'Reilly M, O'Sullivan EP, Davenport C, et al. "Dead in bed": a tragic complication of type 1 diabetes mellitus. Ir J Med Sci 2010;179:585-7
13. Currie CJ, Morgan CL, Poole CD, et al. Multivariate models of health-related utility and the fear of hypoglycaemia in people with diabetes. Curr Med Res Opin 2006;22:1523-34 (Pubitemid 44297431)
14. Cryer PE. Hypoglycemia: still the limiting factor in the glycemic management of diabetes. Endocr Pract 2008;14:750-6
15. Rosak C, Böhm BO. Behandlung mit Insulin. In: Mehnert H, Standl E, Usadel KH, et al, ed. Diabetologie in Klinik und Praxis. Stuttgart: Thieme Verlag, 2003. 235-59
16. Owens DR, Bolli GB. Beyond the era of NPH insulin-Long-acting insulin analogs: chemistry, comparative pharmacology, and clinical application. Diabetes Technol Ther 2008;10:333-49
17. Home PD, Rosskamp R, Forjanic-Klapproth J, et al. A randomized multicentre trial of insulin glargine compared with NPH insulin in people with type 1 diabetes. Diabetes Metab Res Rev 2005;21:545-53 (Pubitemid 41646014)
18. Ratner R, Hirsch IB, Neifing JL, et al. Less hypoglycaemia with Lantus in intensive insulin therapy for type 1 diabetes. U.S. Study Group of Insulin Glargine in Type 1 Diabetes. Diabetes Care 2000;23:639-43 (Pubitemid 30321544)
19. Fulcher GR, Gilbert RE, Yue DK. Glargine is superior to neutral protamine Hagedorn for improving glycated haemoglobin and fasting blood glucose levels during intensive insulin therapy. Intern Med J 2005;35:536-42 (Pubitemid 41291382)
20. Porcellatti F, Rossetti P, Pampanelli S, et al. Better long-term glycaemic control with the basal insulin glargine as compared with NPH in patients with type 1 diabetes mellitus given mealtime lispro insulin. Diabet Med 2004;21:1213-20 (Pubitemid 39472377)
21. Murphy N, Keane S, Ong K, et al. Randomized cross-over trial of insulin glargine plus lispro or NPH insulin plus regular human insulin in adolescents with type 1 diabetes on intensive insulin regimens. Diabetes Care 2003;26:799-804 (Pubitemid 36929346)
22. Ashwell SG, Amiel SA, Bilous RW, et al. Improved glycaemic control with insulin glargine plus insulin lispro: a multicentre, randomized, cross-over trial in people with type 1 diabetes. Diabet Med 2006;23:285-92
23. Grima DT, Thompson MF, Sauriol L. Modelling cost effectiveness of insulin glargine for the treatment of type 1 and 2 diabetes in Canada. Pharmacoeconomics 2007;25:253-66 (Pubitemid 46376834)
24. McEwan P, Poole CD, Tetlow T, et al. Evaluation of the cost-effectiveness of insulin glargine versus NPH insulin for the treatment of type 1 diabetes in the UK. Curr Med Res Opin 2007;23(1 Suppl):S7-S19 (Pubitemid 46456917)
25. Cardiff Research Consortium (CRC) Limited. LANTUS health outcomes model. Model manual. Cardiff, UK: CRC Limited, 2008. Data on file
26. Greiner RA, Azoulay M, Brändle M. Cost-effectiveness of insulin glargine versus NPH insulin for the treatment of type 1 and 2 diabetes modeling the interaction between hypoglycemia and glycemic control in Switzerland. Poster presentation [abstract 2017-PO]. 69th Scientific Sessions of the American Diabetes Association, New Orleans, Louisiana, USA, June 5-9, 2009. http://professional.diabetes.org/Abstracts-Display.aspx?TYP1&CID74137. Accessed June 8, 2009
27. Drummond MF, Sculpher MJ, Torrance GW, et al. Methods for the Economic Evaluation of Health Care Programmes, 3rd edn. Oxford: Oxford University Press, 2005
28. Graf von der Schulenburg JM, Greiner W, Jost F, et al. German recommendations on health care evaluation: third and updated version of the Hanover Consensus. Value Health 2008;11:539-44 (Pubitemid 352032814)
29. Statistisches Bundesamt. Bevölkerung und Erwerbstätigkeit 2008. Fachserie 1, Reihe 1.1. Tabelle 3.14 Sterbetafel 2006/2008. Wiesbaden: Statistisches Bundesamt, 2010
30. Palmer AJ, Weiss C, Sendi PP, et al. The cost-effectiveness of different management strategies for type 1 diabetes: a Swiss perspective. Diabetologia 2000;43:13-26 (Pubitemid 30129298)
31. 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(1 Suppl):S5-S26 (Pubitemid 39349905)
32. Sharplin P, Gordon J, Peters JR, et al. Improved glycaemic control by switching from insulin NPH to insulin glargine: a retrospective observational study. Cardiovasc Diabetol 2009;8:3
33. Mullins P, Sharplin P, Yki-Järvinen H, et al. Negative binomial meta-regression analysis of combined glycosylated hemoglobin and hypoglycemia outcomes across eleven phase III and IV studies of insulin glargine compared with neutral protamine Hagedorn insulin in Type 1 and type 2 diabetes mellitus. Clin Ther 2007;29:1607-19 (Pubitemid 47496243)
34. Stevens RJ, Kothari V, Adler AI, et al. The UKPDS risk engine: a model for the risk of coronary heart disease in type II diabetes (UKPDS 56). Clin Sci 2001;101:671-9 (Pubitemid 33135349)
35. Stevens RJ, Coleman RL, Holman RR. Framingham risk equations underestimate coronary heart disease risk in diabetes. Diabet Med 2005;22:228 (Pubitemid 40204336)
36. Nordrheinische Gemeinsame Einrichtung Disease-Management-Programme GbR. Qualitätsbericht 2008. Disease-Management-Programme in Nordrhein. Kapitel 7. DMP Diabetes mellitus Typ 1. Düsseldorf: Nordrheinische Gemeinsame Einrichtung Disease-Management-Programme GbR, 2009. www.kvno.de/downloads/quali/ qualbe-dmp08.pdf. Accessed July 21, 2010
37. LAUER-FISCHER GmbH. Große Deutsche Spezialitäten-Taxe, Lauer-Taxe mit Apotheken-Ein-und Verkaufspreisen. Fürth: LAUER-FISCHER GmbH, 2010
38. GKV-Spitzenverband. Apotheken-Abschlag sinkt-Mehrkosten für die GKV. Berlin: GKV-Spitzenverband, 2009. www.gkv-spitzenverband.de/Apotheken-Abschlag- sinkt-Mehrkosten-fuer-die-GKV.gkvnet. Accessed December 21, 2009
39. x 61 Sozialgesetzbuch (SGB) Fünftes Buch (V)-Gesetzliche Krankenversicherung. Zuletzt geändert durch Gesetz zur Änderung krankenversicherungsrechtlicher und anderer Vorschriften (GKV- Änderungsgesetz-GKVÄndG) vom 24. Juli 2010. BGBl 2010;I:983-93
40. IMS HEALTH GmbH & Co. OHG. IMS PharmaScope-. Frankfurt/Main: IMS HEALTH GmbH & Co. OHG, 2010. Data on file
41. Molz K, Schober E, Wolf J, et al. Für die DPV-Initiative und das Kompetenzzentrum Diabetes mellitus. Vergleich von Injektionshäufigkeit und Tagesinsulindosis zwischen Detemir, Glargin und NPH bei 29 253 Kindern, Jugendlichen und Erwachsenen mit Typ 1-Diabetes mellitus aus der DPV-Datenbank. [Abstract FV20]. Diabetologie Stoffwe 2010;5:S8
42. Wiesner T, Schädlich PK, Dippel FW, et al. Insulin glargin versus Insulindetemir in der Basal-Bolus-Behandlung von Patienten mit Typ-1-Diabetes mellitus. Ökonomische Evaluation aus Perspektive der Gesetzlichen Krankenversicherung. Perfusion 2010;23:56-65
43. Scherbaum WA, Goodall G, Erny-Albrecht KM, et al. Cost-effectiveness of pioglitazone in type diabetes patients with a history of macrovascular disease: a German perspective. Cost Eff Resour Alloc 2009;7:9
44. Mittendorf T, Smith-Palmer J, Timlin L, et al. Evaluation of exenatide vs. insulin glargine in type 2 diabetes: cost-effectiveness analysis in the German setting. Diabetes Obes Metab 2009;11:1068-79
45. Bundesministerium für Gesundheit (BMG). Kennzahlen der Gesetzlichen Krankenversicherung 1998 bis 2007; 1. bis 4. Quartal 2008. Tabelle KF08Bund. Bonn: BMG, 2009. www.bmg.bund.de/cln-169/nn-1168248/SharedDocs/Downloads/DE/ Statistiken/Gesetzliche-Krankenvers icherung/Kennzahlen-und-Faustformeln/ Kennzahlen-und-Faustformeln, templateId/raw,property/publicationFile.pdf/ Kennzahlen-und-Faustfor meln.pdf. Accessed June 23, 2010
46. Bundesministerium für Gesundheit (BMG). Finanzielle Entwicklung in der Gesetzlichen Krankenversicherung einschl. der landwirtschaftlichen Krankenversicherung im 1. bis 4. Quartal 2009. Veränderungsrate je Versicherten im Vergleich zum 1. bis 4. Quartal 2008 in v.H. GKV Statistik BMG, Vordruck KV 45. Bonn: BMG, 2010. www.bmg.bund.de/SharedDocs/Downloads/DE/Presse/ Presse-2010/pm-10-03-10-kv45-finanzentwicklung, templateId/raw,property/ publicationFile.pdf/pm-10-03-10-kv45-finanzent wicklung.pdf. Accessed June 23, 2010
47. Leese GP, Wang J, Broomhall J, et al. For the DARTS/MEMO Collaboration. Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes: a population-based study of health service resource use. Diabetes Care 2003;26:1176-80 (Pubitemid 36929268)
48. Clarke PM, Gray AM, Briggs A, et al. A model to estimate the lifetime health outcomes of patients with type 2 diabetes: the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model (UKPDS no. 68). Diabetologia 2004;47:1747-59 (Pubitemid 40022410)
49. Morgan CL, McEwan P, Morrissey M, et al. Characterization and comparison of health-related utility in people with diabetes with various single and multiple vascular complications. Diabet Med 2006;23:1100-5 (Pubitemid 44401139)
50. Lee AJ, Morgan CL, Conway P, et al. Characterisation and comparison of health-related quality of life for patients with renal failure. Curr Med Res Opin 2005;21:1777-83 (Pubitemid 41667245)
51. IQWiG-Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care). General methods for the assessment of the relation of benefits to costs. Version 1.0-19/11/2009. Cologne: IQWiG, 2009
52. Fishman G. Monte Carlo: concepts, algorithms, and applications. New York: Springer, 1996
53. Sanofi aventis online Akademie. Neue Packungsgrößen für Lantus-und Apidra-zum 1.7.2010. www.onlineakademie.info/?ID/1. Accessed September 22, 2010
54. Gesetz zur Änderung krankenversicherungsrechtlicher und anderer Vorschriften (GKV-Änderungsgesetz-GKVÄndG) vom 24. Juli 2010. BGBl 2010;I:983-93
55. LAUER-FISCHER GmbH. Große Deutsche Spezialitäten-Taxe, Lauer-Taxe mit Apotheken-Ein-und Verkaufspreisen. Fürth: LAUER-FISCHER GmbH, 2010
56. Towes A, Pritchard C, Devlin N, editors. Cost-effectiveness thresholds: economic and ethical issues. London: King's Fund and Office of Health Economics, 2002
57. Schädlich PK, Schmidt-Lucke C, Huppertz E, et al. Economic evaluation of enoxaparin for anticoagulation in early cardioversion of persisting nonvalvular atrial fibrillation: a Statutory Health Insurance perspective from Germany. Am J Cardiovasc Drugs 2007;7:199-217 (Pubitemid 47047988)
58. Cameron CG, Bennett HA. Cost-effectiveness of insulin analogues for diabetes mellitus. Can Med Assoc J 2009;180:400-7
59. Warren E, Weatherly-Jones E. Chilcott J, et al. Systematic review and economic evaluation of a long-acting insulin analogue, insulin glargine. Health Technol Assess 2004;8:1-57
60. Hagenmeyer EG, Koltermann KC, Dippel FW, et al. Health economic evaluations comparing insulin glargine with NPH insulin in patients with type 1 diabetes: a systematic review. Cost Eff Resour Alloc 2011;9:15
61. Bierwirth R, Kostev K, Dippel FW, et al. Ressourcenverbrauch und Behandlungskosten unter einer intensivierten konventionellen Therapie (ICT) mit Insulin glargin, Insulindetemir oder NPH-Insulin bei Patienten mit Typ-1-Diabetes. Perfusion 2010;23:96-103
62. Pfohl M, Schädlich PK, Dippel FW, et al. Wirtschaftlichkeit von Insulin glargin (GLA) im Vergleich zu NPH-Insulin in der intensivierten konventionellen Insulintherapie (ICT) bei Patienten mit Typ 1 Diabetes in Deutschland-Eine Kosten-Wirksamkeits-und Kosten-Nutzwert-Analyse aus Sicht der Gesetzlichen Krankenversicherung. [Abstract P 107]. Obes Facts 2010;3(1 Suppl):47-8
63. Schädlich PK, Dippel FW, Koltermann KC, et al. Cost-effectiveness of insulin glargine versus NPH insulin in type 1 diabetes using basal bolus treatment in a German setting. [Meeting abstract 10gaa13]. 17th Annual Meeting of the German Drug Utilisation Research Group (GAA), Osnabrück, Germany, November 25-26, 2010. Düsseldorf: German Medical Science GMS Publishing House, 2010:doc10gaa13. www.egms.de/static/en/meetings/gaa2010/10gaa13.shtml. Accessed December 5, 2010