Cost-effectiveness of insulin degludec compared with insulin glargine in a basal-bolus regimen in patients with type 1 diabetes mellitus in the UK

Journal of Medical Economics

Volumn 18, Issue 1, 2015, Pages 56-68

  Evans, M ^a   Wolden, M ^b   Gundgaard, J ^b   Chubb, B ^c   Christensen, T ^b  

^a LLANDOUGH HOSPITAL   (United Kingdom)

^b NOVO NORDISK A S   (Denmark)

^c Novo Nordisk Ltd   (United Kingdom)

Author keywords

Cost effectiveness; Insulin analogs; Insulin therapy; Nocturnal hypoglycemia; Pharmaco economics; Type 1 diabetes

Indexed keywords

HEMOGLOBIN A1C; INSULIN DEGLUDEC; INSULIN GLARGINE; ANTIDIABETIC AGENT; GLARGINE; GLYCOSYLATED HEMOGLOBIN; LONG ACTING INSULIN;

ARTICLE; BLOOD GLUCOSE MONITORING; BOLUS INJECTION; COMPARATIVE STUDY; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DIABETIC PATIENT; GLYCEMIC CONTROL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN INJECTION PEN; INSULIN TREATMENT; MAJOR CLINICAL STUDY; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL (TOPIC); QUALITY ADJUSTED LIFE YEAR; TEST STRIP; COST BENEFIT ANALYSIS; DIABETES MELLITUS, TYPE 1; ECONOMICS; NEEDLE; PUBLIC HEALTH; STATISTICAL MODEL; UNITED KINGDOM;

BLOOD GLUCOSE SELF-MONITORING; CLINICAL TRIALS, PHASE III AS TOPIC; COST-BENEFIT ANALYSIS; DIABETES MELLITUS, TYPE 1; GREAT BRITAIN; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN, LONG-ACTING; MODELS, ECONOMETRIC; NATIONAL HEALTH PROGRAMS; NEEDLES; QUALITY-ADJUSTED LIFE YEARS;

EID: 84918822078     PISSN: 13696998     EISSN: 1941837X     Source Type: Journal    
DOI: 10.3111/13696998.2014.971160     Document Type: Article

References (58)

1. Campbell RK, Martin TM. The chronic burden of diabetes. Am J Manag Care 2009;15(Suppl 9):S248-54
2. Diabetes UK. Diabetes: facts and stats. 2014. http://www.diabetes.org.uk/Documents/About%20Us/Statistics/Diabetes-key-stats-guidelines-April2014.pdf. Accessed June 11, 2014
3. U.K. Prospective Diabetes Study Group. Quality of life in type 2 diabetic patients is affected by complications but not by intensive policies to improve blood glucose or blood pressure control (UKPDS 37). Diabetes Care 1999;22:1125-36
4. Rubin RR, Peyrot M. Quality of life and diabetes. Diabetes Metab Res Rev 1999;15:205-18
5. Hex N, Bartlett C, Wright D, et al. Estimating the current and future costs of Type 1 and Type 2 diabetes in the UK, including direct health costs and indirect societal and productivity costs. Diabet Med 2012;29:855-62
6. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000;321:405-12
7. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med 1993;329:977-86
8. International Diabetes Federation (IDF). Diabetes Atlas, Sixth Edition. 2013. http://www.idf.org/sites/default/files/EN-6E-Atlas-Full-0.pdf. Accessed January 20, 2014
9. National Institute for Health and Clinical Excellence. Clinical Guideline 15: type 1 diabetes: diagnosis and management of type 1 diabetes in children, young people and adults. 2004. http://www.nice.org.uk/guidance/CG15. Accessed July 31, 2014
10. American Diabetes Association Workgroup on Hypoglycemia. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care 2005;28:1245-9
11. Cryer PE, Davis SN, Shamoon H. Hypoglycemia in diabetes. Diabetes Care 2003;26:1902-12
12. Graveling AJ, Frier BM. Impaired awareness of hypoglycaemia: a review. Diabetes Metab 2010;36(3 Suppl):S64-74
13. Brod M, Wolden M, Christensen T, et al. A nine country study of the burden of non-severe nocturnal hypoglycaemic events on diabetes management and daily function. Diabetes Obes Metab 2013;15:546-57
14. Frier BM. How hypoglycaemia can affect the life of a person with diabetes. Diabetes Metab Res Rev 2008;24:87-92
15. Devries JH, Nattrass M, Pieber TR. Refining basal insulin therapy: what have we learned in the age of analogues? Diabetes Metab Res Rev 2007;23:441-54
16. Heise T, Hermanski L, Nosek L, et al. Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab 2012;14:859-64
17. Heise T, Nosek L, Bottcher SG, et al. Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect in type 2 diabetes. Diabetes Obes Metab 2012;14:944-50
18. Heller S, Buse J, Fisher M, et al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet 2012; 379:1489-97
19. Mathieu C, Hollander P, Miranda-Palma B, et al. Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: Flex T1): a 26-week randomized, treat-totarget trial with a 26-week extension. J Clin Endocrinol Metab 2013;98:1154-62
20. Vora J, Christensen T, Rana A, et al. Insulin degludec versus insulin glargine in type 1 and type 2 diabetes mellitus: a meta-analysis of endpoints in phase 3a trials. Diabetes Ther 2014. Epub ahead of print. DOI: 10.1007/s13300-014-0076-9.
21. Evans M, Wolden M, Gundgaard J, et al. Cost-effectiveness of insulin degludec compared with insulin glargine for patients with type 2 diabetes treated with basal insulin - from the UK health care cost perspective. Diabetes Obes Metab 2014;16:366-75
22. Sassi F. Calculating QALYs, comparing QALY and DALY calculations. Health Policy Plan 2006;21:402-8
23. National Institute for Health and Care Excellence. Technology appraisal 94: statins for the prevention of cardiovascular events, Appendix B. 2006. http://www.nice.org.uk/guidance/TA94. Accessed July 31, 2014
24. National Institute for Health and Care Excellence. The guidelines manual 2012. 2012 http://www.nice.org.uk/article/PMG6/chapter/1%20 Introduction. Accessed July 31, 2014
25. European Medicines Agency. Lantus EPAR - Assessment report. 2012. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Assessment-Report-Variation/human/000284/WC500130938.pdf. Accessed July 31, 2014
26. Food and Drug Administration. Guidance for industry. Diabetes mellitus: developing drugs and therapeutic biologics for treatment and prevention - Draft Guidance. 2008. Center for Drug Evaluation and Research. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071624.pdf. Accessed July 31, 2014
27. The Forum for Injection Technique (FIT). Diabetes care in the UK: the first UK injection technique recommendations. 2nd edn. 2011. http://www.fit4diabetes.com/files/2613/3102/3031/FIT-Recommendations-Document.pdf. Accessed July 31, 2014
28. Sanofi-Aventis. Lantus (insulin glargine): structure titration to target fasting glucose. http://www.lantus.com/hcp/dosing-titration/titration-guide.aspx. Accessed July 31, 2014
29. Meneghini L, Miranda-Palma B. Insulin degludec: a novel ultra-long-acting basal insulin for use in Type 1 and Type 2 diabetes. Exp Rev Endocrinol Metab 2012;7:9-14
30. Donnelly LA, Morris AD, Frier BM, et al. Frequency and predictors of hypoglycaemia in Type 1 and insulin-treated Type 2 diabetes: a population-based study. Diabet Med 2005;22:749-55
31. Ostenson CG, Geelhoed-Duijvestijn P, Lahtela J, et al. Self-reported nonsevere hypoglycaemic events in Europe. Diabet Med 2014;31:92-101
32. Brod M, Christensen T, Thomsen TL, et al. The impact of non-severe hypoglycemic events on work productivity and diabetes management. Value Health 2011;14:665-71
33. ISD Scotland. Scottish Ambulance Service, expenditure and statistics, by board area, 2010-2011. http://www.isdscotland.org/Health-Topics/Finance/Publications/2011-11-29/Costs-R910-2011.xls. Accessed September 6, 2012
34. Department of Health. Payment by results tariffs 2011-2012. http://www.dh. gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH-124356. Accessed January 11, 2013
35. Personal Social Services Research Unit. Unit costs of health and social care 2011. http://www.pssru.ac.uk/archive/pdf/uc/uc2011/uc2011.pdf. Accessed November 14, 2012
36. 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
37. Harris SB, Khunti K, Landin-Olsson M, et al. Descriptions of health states associated with increasing severity and frequency of hypoglycemia: a patientlevel perspective. Patient Prefer Adher 2013;7:925-36
38. UK Hypoglycaemia Study Group. Risk of hypoglycaemia in types 1 and 2 diabetes: effects of treatment modalities and their duration. Diabetologia 2007;50:1140-7
39. 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
40. European Medicines Agency. Tresiba-(insulin degludec) summary of product characteristics. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/002498/WC500138940.pdf. Accessed July 8, 2014
41. Boye KS, Matza LS, Walter KN, et al. Utilities and disutilities for attributes of injectable treatments for type 2 diabetes. Eur J Health Econ 2011;12:219-30
42. Evans M, Jensen HH, Bogelund M, et al. Flexible insulin dosing improves health-related quality-of-life (HRQoL): a time trade-off survey. J Med Econ 2013;16:1357-65
43. Garg SK, Gottlieb PA, Hisatomi ME, et al. Improved glycemic control without an increase in severe hypoglycemic episodes in intensively treated patients with type 1 diabetes receiving morning, evening, or split dose insulin glargine. Diabetes Res Clin Pract 2004;66:49-56
44. Allbright E, Desmond R, Bell D. Efficacy of conversion from bedtime NPH insulin injection to once- or twice-daily injections of insulin glargine in type 1 diabetic patients using Basal/Bolus Therapy. Diabetes Care 2004;27:632-3
45. Luddeke HJ, Sreenan S, Aczel S, et al. PREDICTIVE- a global, prospective observational study to evaluate insulin detemir treatment in types 1 and 2 diabetes: baseline characteristics and predictors of hypoglycaemia from the European cohort. Diabetes Obes Metab 2007;9:428-34
46. Bode BW, Buse JB, Fisher M, et al. Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basalbolus treatment with mealtime insulin aspart in Type 1 diabetes (BEGIN Basal- Bolus Type 1): 2-year results of a randomized clinical trial. Diabet Med 2013;30:1293-7
47. Heller S, Koenen C, Bode B. Comparison of insulin detemir and insulin glargine in a basal-bolus regimen, with insulin aspart as the mealtime insulin, in patients with type 1 diabetes: a 52-week, multinational, randomized, open-label, parallel-group, treat-to-target noninferiority trial. Clin Ther 2009;31:2086-97
48. Wild D, von Maltzahn R, Brohan E, et al. A critical review of the literature on fear of hypoglycemia in diabetes: implications for diabetes management and patient education. Patient Educ Couns 2007;68:10-15
49. Brod M, Wolden M, Christensen T, et al. Understanding the economic burden of nonsevere nocturnal hypoglycaemic events: impact on work productivity, disease management, and resource utilization. Value Health 2013;16:1140-9
50. Gold AE, MacLeod KM, Frier BM. Frequency of severe hypoglycemia in patients with type I diabetes with impaired awareness of hypoglycemia. Diabetes Care 1994;17:697-703
51. Smith CB, Choudhary P, Pernet A, et al. Hypoglycemia unawareness is associated with reduced adherence to therapeutic decisions in patients with type 1 diabetes: evidence from a clinical audit. Diabetes Care 2009;32:1196-8
52. Heller SR. Hypoglycaemia: its pathophysiology in insulin treated diabetes and hypoglycaemia unawareness. Br J Diabetes Vasc Dis 2011;11 (1 Suppl):6-9
53. Ratner R, Gough SC, Mathieu C, et al. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab 2013;15:175-84
54. Davis RE, Morrissey M, Peters JR, et al. Impact of hypoglycaemia on quality of life and productivity in type 1 and type 2 diabetes. Curr Med Res Opin 2005;21:1477-83
55. Brod M, Pohlman B, Wolden M, et al. Non-severe nocturnal hypoglycemic events: experience and impacts on patient functioning and well-being. Qual Life Res 2013;22:997-1004
56. Brod M, Christensen T, Bushnell DM. Impact of nocturnal hypoglycemic events on diabetes management, sleep quality, and next-day function: results from a four-country survey. J Med Econ 2012;15:77-86
57. Geddes J, Schopman JE, Zammitt NN, et al. Prevalence of impaired awareness of hypoglycaemia in adults with Type 1 diabetes. Diabet Med 2008;25:501-4
58. Fontaine P, Gin H, Pinget M, et al. Effect of insulin detemir dose frequency on clinical outcomes in patients with diabetes in PREDICTIVE. Adv Ther 2009;26:535-51