Best Practice & Research Clinical Endocrinology & Metabolism
Volume 21, Issue 4 , Pages 657-685 , December 2007

Pharmaco-economic issues for diabetes therapy

  • Julia M. Bottomley, PhD (Managing Director)

      Affiliations

    • Corresponding Author InformationCorresponding author. Tel.: +44 1462 484611; Fax: +44 1462 483534.

References 

  1. In:  Fox-Rushby J,  Cairns J editor. Economic Evaluation. Open University Press; 2005;
  2. Weinstein MC, O'Brien B, Hornberger J, et al. Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR Task Force on Good Research Practices – modeling Studies. Value in Health. 2003;6:9–17
  3. Guidelines for computer modeling of diabetes and its complications. American Diabetes Association Consensus Panel. Diabetes Care. 2004;27(9):2262–2265
  4. Wild S, Roglic G, Green A, et al. Global prevalence of diabetes estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27(5):1047–1053
  5. Centers for Disease Control and Prevention. National Diabetes Surveillance System. Prevalence of Diabetes. Accessed 9 June 2007, at http://www.cdc.gov/diabetes/statistics/prev/national/tnumage.htm.
  6. Centers for Disease Control and Prevention . National Diabetes Fact Sheet: general information and national estimates on diabetes in the United States, 2005. Available at Atlanta, GA: US. Department of Health and Human Services, center for Disease Control and Prevention; 2005;http://www.cdc.gov/diabetes/statisticsAccessed May 2007
  7. The task force on diabetes and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD). Guidelines on diabetes, pre-diabetes and cardiovascular diseases: Full text. www.escardio.org and www.easd.org Accessed May 2007.
  8. Diabetes Atlas. 3rd Edition. Brussels: International Diabetes Federation; 2006;332
  9. Finkelstein EA, Brown DS, Trogdon JG, et al. Age-specific impact of obesity on prevalence and costs of diabetes and dyslipidemia. Value in Health. 2007;10(Supplement 1):S45–S51
  10. Dr Foster's case notes . Obesity and type-2 diabetes in children, 1996-7 to 2003-4. BMJ. 2005;331:1167
  11. Pinhas-Hamiel O, Zeitler P. The global spread of type-2 diabetes mellitus in children and adolescents. The Journal of Pediatrics. 2005;146(5):693–700
  12. Caro JJ, O'Brien JA, Hollnebeak CS, et al. Economic burden and risk of cardiovascular disease and diabetes in patients with different cardiometabolic risk profiles. Value in Health. 2007;10(supplement 1):S12–S20
  13. Roper NA, Bilous RW, Kelly WF, et al. Excess mortality in a population with diabetes and the impact of material deprivation: longitudinal, population based study. BMJ. 2001;322:1389–1393
  14. Almdal T, Scharling H, Jensen JS, et al. The independent effect of type-2 diabetes mellitus on ischaemic heart disease, stroke and death: a population-based study of 13,000 men and women with 20 years of follow-up. Archives of Internal Medicine. 2004;164:1422–1426
  15. Fisher M, Shaw K. Diabetes: a state of premature cardiovascular death. Practical Diabetes International. 2001;18:183–184
  16. American Diabetes Association. Complications of diabetes in the United States. Accessed 12 June 2007, at http://www.diabetes.org/diabetes-statistics/complications.jsp
  17. Koopmanschap M. Coping with type-II diabetes: the patient's perspective. Diabetologia. 2002;45:S18–S22
  18. Bagust A, Beale S. Modelling EuroQol health-related utility values for diabetic complications from CODE-2 data. Health Economics. 2005;14(3):217–230
  19. Clarke P, Gray A, Holman R. Estimating utility values for health states of type-2 diabetic patients using the EQ-5D UKPDS 62. Medical Decision Making. 2002;22:340–349
  20. Coffey JT, Brändle M, Zhou H, et al. Valuing health-related quality of life in diabetes. Diabetes Care. 2002;25(12):2238–2243
  21. Jönsson B. Revealing the cost of Type-II diabetes in Europe. Diabetologia. 2002;45:S5–S12
  22. Williams R, Baxter H, Bottomley J, et al. CODE-2*UK: Our contribution to a European Study of the costs of Type-2 diabetes. Practical Diabetes International. 2001;18:235–238
  23. Currie C, Morgan CL, Peters JR. Patterns and costs of hospital care for coronary heart disease related and not related to diabetes. Heart. 1997;78:544–554
  24. Bagust A, Hopkinson PK, Maier W, et al. An economic model of the long-term health care burden of Type-II diabetes. Diabetologia. 2001;44:2140–2155
  25. Bagust A, Hopkinson PK, Maslove L, et al. The projected health care burden of Type-2 diabetes in the UK from 2000 to 2060. Diabetic Medicine. 2002;19(supplement 4):1–5
  26. Caro JJ, Ward AJ, O'Brien JA. Lifetime costs of complications resulting from type-2 diabetes in the US. Diabetes Care. 2002;25:476–481
  27. Raikou M, McGuire A. The economics of screening and treatment in type-2 diabetes mellitus. Pharmaco-economics. 2003;21(8):543–564
  28. National Diabetes Data Group . Diabetes in America. 2nd Edition. National Institutes of Health. National Institute of Diabetes and Digestive and Kidney Diseases; 1995;NIH Publication No. 95–1468
  29. Williams R, Van Gaal L, Lucioni C. Assessing the impact of complications on the costs of type-II diabetes. Diabetologia. 2002;45:S13–S17
  30. Bottomley JM on behalf of the TARDIS Steering Committee and UK Centres . Managing care of type-2 diabetes. Learnings from T2ARDIS. British Journal of Diabetes and Vascular Disease. 2001;1:68–72
  31. Evans JM, MacDonald TM, Leese GP, et al. Impact of type-1 and type-2 diabetes on patterns and costs of drug prescribing: a population-based study. Diabetes Care. 2000;23:770–774
  32. Holmes J, Gear E, Bottomley J, et al. Do people with type-2 diabetes and their carers lose income? (T2ARDIS-4). Health Policy. 2003;64:291–296
  33. Sullivan PW, Ghushchyan V. Cardiovascular risk factor clusters and employment in the United States. Value in Health. 2007;10(supplement 1):S52–S58
  34. Day C. Diabetes. A new world order?. British Journal of Diabetes and Vascular Disease. 2007;7:3
  35. Economic costs of diabetes in the US in 2002. American Diabetes Association. Diabetes Care. 2003;26:917–932
  36. Gray A, Fenn P, McGuire A. The cost of insulin-dependent diabetes mellitus (IDDM) in England and Wales. Diabet Medicine. 1995;12:1068–1076
  37. Henriksson F, Jonsson B. Diabetes: the cost of illness in Sweden. Journal of Internal Medicine. 1998;244:461–468
  38. Brouwer WBF. Too important to ignore. Informal caregivers and other significant others. Pharmacoeconomics. 2006;24(1):39–41
  39. The UK Prospective Diabetes Study 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
  40. The UK Prospective Diabetes Study Group . Effect of intensive blood glucose control with metformin on complications in overweight patients with type-2 diabetes: UKPDS 34. Lancet. 1998;352:854–865
  41. Gaede P, Vedel P, Larsen N, et al. Multifactorial intervention and cardiovascular disease in patients with type-2 diabetes. The New England Journal of Medicine. 2003;348(5):383–393
  42. 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;317:703–713
  43. Colhoun HM, Betteridge DJ, Durrington PN, et al. Primary prevention of cardiovascular disease with atorvastatin in type-2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet. 2004;364:685–696
  44. The FIELD study investigators . Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type-2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet. 2005;366:1849–1861
  45. Hansson L, Zanchetti A, Carruters SG, et al. Effects of intensive blood pressure lowering and low dose aspirin in patients with hypertension: principle results of the Hypertension Optimal Treatment (HOT) randomised trial. HOT Study Group. Lancet. 1998;351:1755–1762
  46. Pyorala K, Pedersen TR, Kjekshus J, et al. Cholesterol lowering with simvastatin improves prognosis of diabetic patients with coronary heart disease. A subgroup analysis of the Scandinavian Simvastatin Survival Study (4S). Diabetes Care. 1997;20:614–620
  47. Rubins HB, Robins SJ, Collins D, et al. for the Veterans Affairs High Density Lipoprotein Cholesterol Intervention Trial Study Group Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. The New England Journal of Medicine. 1999;341:410–418
  48. Heart Outcomes Prevention Evaluation (HOPE) Study Investigators . Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE and MICRO-HOPE substudy. Lancet. 2000;355:253–259
  49. Heart Protection Study Collaborative Group . MRC/BHF Heart protection Study of cholesterol-lowering with simvastatin in 5953 people with diabetes: a randomised placebo-controlled trial. Lancet. 2003;361:2005–2016
  50. Dormandy JA, Charbonnel B, Eckland DJA, et al. Secondary prevention of macrovascular events in patients with type-2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet. 2005;366:1279–1289
  51. Gray A, Raikou M, McGuire A. Cost effectiveness of an intensive blood glucose control policy in patients with type-2 diabetes: economic analysis alongside randomised controlled trial. UKPDS Group 41. BMJ. 2000;320:1373–1378
  52. UK Prospective Diabetes Study (UKPDS) Group . Cost effectiveness analysis of improved blood pressure control in hypertensive patients with type-2 diabetes. UKPDS 40. BMJ. 1998;317:720–726
  53. Clarke P, Gray A, Adler A, et al. Cost effectiveness analysis of intensive blood glucose control with metformin in overweight patients with Type-II diabetes (UKPDS 51). Diabetologia. 2001;44:298–304
  54. Clarke PM, Gray AM, Briggs A, et al. Cost-utility analyses of intensive blood glucose and tight blood pressure control in type-2 diabetes. UKPDS 72. Diabetologia. 2005;48:868–877
  55. Nyman JA, Martinson MS, Nelson D, et al. Cost-effectiveness of gemfibrozil for coronary heart disease patients with low levels of high-density lipoprotein cholesterol. Archives of Internal Medicine. 2002;162:177–182
  56. Schädlich PK, Brecht JG, Rangoonwala B, et al. Cost effectiveness of Ramipril in patients at high risk for cardiovascular events. Economic evaluation of the HOPE (Heart Outcomes Prevention Evaluation) Study for Germany from the Statutory Health Insurance Perspective. Pharmacoeconomics. 2004;22(15):955–973
  57. Grover SA, Alexander CM, Coupla L, et al. How cost-effective is the treatment of dyslipidemia in patients with diabetes but without cardiovascular disease?. Diabetes Care. 2001;24:45–50
  58. Jönsson B, Cook JR, Pedersen TR. The cost-effectiveness of lipid lowering in patients with diabetes: results from the 4S trial. Diabetologia. 1999;42:1293–1301
  59. Brändle M, Davidson MB, Scriger DL, et al. Cost effectiveness of statin therapy for the primary prevention of major coronary events in individuals with type-2 diabetes. Diabetes Care. 2003;26:1796–1801
  60. Jönsson B, Hansson L, Stålhammer N-O. Health economics in the Hypertension Optimal Treatment (HOT) study: costs and cost-effectiveness of intensive blood pressure lowering and low-dose aspirin in patients with hypertension. Journal of Internal Medicine. 2003;253:472–480
  61. Valentine WJ, Bottomley JM, Palmer AJ, et al. PROactive 06: Cost effectiveness of pioglitazone in type-2 diabetes in the UK. Diabetic Medicine. 2007;
  62. Tilden DP, Mariz S, O'Bryan-Tear G, et al. A lifetime modelled economic evaluation comparing pioglitazone and rosiglitazone for the treatment of type-2 diabetes in the UK. Pharmacoeconomics. 2007;25(1):39–54
  63. Beale S, Baghurst A, Shearer AT, et al. Cost-effectiveness of rosiglitazone combination therapy for the treatment of type-2 diabetes mellitus in the UK. Pharmacoeconomics. 2006;24(supplement 1):21–34
  64. Raikou M, McGuire A, Colhoun HM, et al. Cost effectiveness of primary prevention of cardiovascular disease with atorvastatin in type-2 diabetes: results from the Collaborative Atorvastatin Diabetes Study (CARDS). Diabetologia. 2007;50(4):733–740
  65. Mihaylova B, Briggs A, Armitage J, et al. Heart Protection Study Collaboartive Group. Cost effectiveness of simvastatin in people at different levels of vascular disease risk: economic analysis of a randomized trial in 20,536 individuals. Lancet. 2005;356:1779–1785
  66. UKPDS 37. 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 Study Group. Diabetes Care. 1999;22:1125–1136
  67. The DCCT Research Group . The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The New England Journal of Medicine. 1993;329:977–986
  68. The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications research Group . Retinopathy and nephropathy in patients with type-1 diabetes four years after trial of intensive therapy. The New England Journal of Medicine. 2000;342:381–389
  69. 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. Current Medical Research and Opinion. 2004;20(supplement 1):S5–S26
  70. The Diabetes Control and Complications Trial Research Group . Lifetime benefits and and costs of intensive therapy as practiced in the diabetes control and complications trial. JAMA. 1996;276(17):1409–1415
  71. The DREAM trial investigators . Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomized controlled trial. Lancet. 2006;368:1096–1105
  72. Diabetes Prevention Program Research Group . Prevention of type-2 diabetes with troglitazone in the Diabetes Prevention Program. Diabetes. 2005;54:1150–1156
  73. Tuomilehto J, Lindstrom J, Eriksson JG, et al. Prevention of type-2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. Finnish Diabetes Prevention Study. The New England Journal of Medicine. 2001;344:1343–1350
  74. Chiasson JL, Josse RG, Gomis R, et al. Acarbose for prevention of type-2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet. 2002;359:2072–2077
  75. The Diabetes Prevention Program Research Group , Knowler WC, Barrett-Connor E, et al. Reduction in the incidence of type-2 diabetes with lifestyle intervention or metformin. The New England Journal of Medicine. 2002;346:393–403
  76. Xiang AH, Peters RK, Kjos SL, et al. Effect of pioglitazone on pancreatic beta cell function and diabetes risk in Hispanic women with prior gestational diabetes. Diabetes. 2006;55:517–522
  77. Ramachandran A, Snehalatha C, Mary S, et al. for the Indian Diabetes Prevention Programme (IDPP) The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type-2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia. 2006;49(2):289–297
  78. Kahn SE, Haffner SM, Heise MA, et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. The New England Journal of Medicine. 2006;355:2427–2443
  79. The Diabetes Prevention Program Research Group . Costs associated with the primary prevention of type-2 diabetes in the DPP. Diabetes Care. 2003;26:36–47
  80. Palmer AJ, Roze S, Valentine WJ, et al. Intensive lifestyle changes or metformin in patients with impaired glucose tolerance: modeling the long-term health economic implications of the DPP in Australia, France, Switzerland and the United Kingdom. Clinical Therapeutics. 2004;26:304–321
  81. Herman WH, Hoerger TJ, Brandle M, et al. The cost effectiveness of lifestyle modification or metformin in preventing type-2 diabetes in adults with impaired glucose tolerance. Annals of Internal Medicine. 2005;142:323–332
  82. Eddy DM, Schlessinger L, Kahn R. Clinical outcomes and cost effectiveness of strategies for managing people at high risk for diabetes. Annals of Internal Medicine. 2005;143:251–264
  83. Caro JJ, Getsios D, Caro I, et al. Economic evaluation of therapeutic interventions to prevent type-2 diabetes in Canada. Diabetes Medicine. 2004;21:1229–1236
  84. Klonoff DC, Schwartz DM. An economic analysis of interventions for diabetes. Diabetes Care. 2000;23(3):390–404
  85. Zhang P, Engelgau M, Norris SL. Application of economic analysis to diabetes and diabetes care. Annals of Internal Medicine. 2004;140(11):972–977
  86. Vijgen SMC, Hoogendoorn M, Baan CA, et al. Cost effectiveness of preventative interventions in type-2 diabetes mellitus. A systematic literature review. Pharmacoeconomics. 2006;24(5):425–441
  87. Waugh N, Scotland G, McNamee P, et al. Screening for type-2 diabetes: literature review and economic modeling. Health Technology Assessment. 2007;11(17):
  88. Icks A, Rathmann W, Haastert B, et al. Clinical and cost effectiveness of primary prevention of type-2 diabetes in a ‘real world’ routine healthcare setting: model based on the KORA Survey 2000. Diabetes Medicine. 2007;24:473–480
  89. Nathan DM, Buse JB, Davidson MB, et al. Management of hyperglycaemia in type-2 diabetes: A consensus algorithm for the initiation and adjustment of therapy. A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2006;29(8):1963–1972
  90. Calvert M, McManus RJ, Freemantle N. Management of type-2 diabetes with multiple oral hypoglycaemic agents or insulin in primary care: retrospective cohort study. British Journal of General Practice. 2007;57:455–460
  91. Fox KM, Gerber Pharmd RA, Bolinder B, et al. Prevalence of inadequate glycaemic control among patients with type-2 diabetes in the United Kingdom General Practice Research Database: a series of retrospective analyses of data from 1998 through 2002. Clinical Therapy. 2006;28:388–395
  92. Liebl A, Mata M, Eschwège E. Evaluation of risk factors for development of complications in type-II diabetes in Europe. Diabetologia. 2002;45:S23–S28
  93. Barnett AH. Treating to goal. Challenges of current management. European Journal of Endocrinology. 2004;151(2):T3–T7
  94. Cook MN, Girman CJ, Stein PP, et al. Glycemic control continues to deteriorate after sulfonylureas are added to metformin among patients with type-2 diabetes. Diabetes Care. 2005;28:995–1000
  95. Chuang LM, Tsai ST, Huang BY, et al. for the Diabcare-Asia 1998 Study Group The status of diabetes control in Asia – a cross-sectional survey of 24,317 patients with diabetes mellitus in 1998. Diabetes Medicine. 2002;19:978–985
  96. O'Hare JP, Raymond NT, Mughal S, et al. for the UKADS Study Group Evaluation of delivery of enhanced diabetes care to patients of South Asian ethnicity: The United Kingdom Asian Diabetes Study (UKADS). Diabetes Medicine. 2004;21:1357–1365
  97. Riddle MC. Glycemic management of type-2 diabetes: an emerging strategy with oral agents, insulins, and combinations. Endocrinology and Metabolism Clinics of North America. 2005;34:77–98
  98. Krentz AJ, Bailey CJ. Oral antidiabetic agents. Current role in type-2 diabetes mellitus. Drugs. 2005;65(3):385–411
  99. Nathan DM. Finding new treatments for diabetes – how many, how fast….how good?. The New England Journal of Medicine. 2007;356(5):437–440
  100. Cohen A, Horton ES. Progress in the treatment of type-2 diabetes: new pharmacologic approaches to improve glycemic control. Current Medical Research and Opinion. 2007;23(4):905–917
  101. Palmer AJ, Roze S, Valentine WJ, et al. Cost-effectiveness of detemir-based basal/bolus therapy versus NPH-based basal/bolus therapy for type-1 diabetes in a UK setting: an economic analysis based on meta-analysis results of four clinical trials. Current Medical Research and Opinion. 2004;20:1729–1746
  102. Minshall ME, Twena NS, Nicklasson L, et al. Long-term cost-effectiveness of insulin aspart versus soluble human insulin in patients with type-1 diabetes in the United Kingdom. Value in Health. 2003;8:358–359
  103. 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. Current Medical Research and Opinion. 2007;23(1):S7–S19
  104. McEwan P, Poole CD, Tetlow T, et al. Evaluation of the cost-effectiveness of insulin glargine versus NPH insulin for the treatment of type-2 diabetes in the UK. Current Medical Research and Opinion. 2007;23(1):S21–S31
  105. Palmer AJ, Valentine WJ, Ray JA, et al. An economic assessment of analgue basal-bolus insulin versus human basal-bolus insulin in subjects with type-1 diabetes in the UK. Current Medical Research and Opinion. 2007;23(4):895–901
  106. Hermansen K, Fontaine P, Kukolja KK, et al. Insulin analogues (insulin determir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type-1 diabetes. Diabetologia. 2004;47:622–629
  107. Mueller E, Maxion-Bergemann S, Gultyaev D, et al. Development and validation of the Economic Assessment of Glycaemic control and Long-term Effects of diabetes (EAGLE) Model. Diabetes Technology and Therapeutics. 2006;8(2):219–236
  108. Devlin N, Parkin D. Does NICE have a cost-effectiveness threshold and what other factors influence its decisions? A binary choice analysis. Health Economics. 2004;13(5):437–452
  109. Plun-Favreau J, O'Regan C, Marchant N. Cost-effectiveness of inhaled insulin in patients with diabetes uncontrolled on their current therapy: the UK base case submitted to the National Institute for Health and Clinical Excellence. Value in Health. 2006;9(6):A235
  110. Neovius M, Prüz C. The cost effectiveness of inhaled insulin in Sweden. Value in Health. 2006;9(6):A231
  111. Cvetković RS, Plosker GL. Exenetide. A review of its use in patients with type-2 diabetes mellitus (as an adjunct to metformin and/or a sulfonylurea). Drugs. 2007;67(6):935–954
  112. Byetta[prescribing information] Amylin Pharmaceuticals. Available at http://pi.lilly.com/us/byetta-pi.pdf2006;Accessed on 19 March 2007
  113. Palmer AJ, Roze S, Valentine W, et al. Validation of the CORE Diabetes Model against Epidemiological and Clinical Studies. Current Medical Research and Opinion. 2004;20(supplement 1):S27–S40
  114. Watkins JB, Minshall ME, Sullivan SD. Application of economic analyses in US managed care formulary decisions: a private payer's experience. Journal of Managed Care Pharmacy. 2006;12(9):726–735
  115. Ray JA, Boye KS, Yurgin N, et al. Exenatide versus insulin glargine in patients with type-2 diabetes in the UK: a model of long-term clinical and cost outcomes. Current Medical Research and Opinion. 2007;23(3):609–622
  116. Edwards KL, Irons BK, Xu T. Cost effectiveness of intermediate or long-acting insulin versus Exenatide in type-2 diabetes mellitus patients not optimally controlled on dual oral diabetes medications. Pharmacy Practice. 2006;4(3):129–133
  117. Revicki DA, et al. Recommendations on health-related quality of life research to support labelling and promotional claims in the United States. Quality of Life Research. 2000;9:887–900
  118. Hill S, Garattini S, van Loenhout J, et al. Technology appraisal programme of the national institute for clinical excellence. A review by WHO. Full report available at World Health Organisation; 2003;http://www.nice.org.uk/Docref.asp?d=85797
  119. Warren E, Weatherly-Jones E, Chilcott J, et al. Systematic review of economic evaluation of a long-acting insulin analogue, insulin glargine. Health Technology Assessment. 2004;8(45):1–57iii
  120. Guidance on the use of long-acting insulin analgues for the treatment of diabetes – insulin glargine. Technology Appraisal No. 53. Available at National Institute for Clinical Excellence; December 2002;http://guidance.nice.org.uk/TA53/guidance/pdf/EnglishAccessed June 2007
  121. Currie CJ, Morgan CLI, Poole CD, et al. Multivariate models of health related utility and the fear of hypoglycaemia in people with diabetes. Current Medical Research and Opinion. 2006;22:1523–1534
  122. Insulin glargine (Lantus®) Aventis. No. 11/02, 4 October 2002; Insulin detemir (Lememir®). Novo Nordisk No. 110/04, 9 August 2004; Insulin detemir (Lememir®). Novo Nordisk No. 138/04, 5 November 2004. All available at www.scottishmedicines.org Accessed in June 2007.
  123. Public Summary Document, Insulin detemir (rys) cartridge 3 mL (Penfill®), prefilled device 3 mL (FlexPen®), 100U/mL, Levemir®, March 2006; Insulin glargine, injection, 100 units per mL, 10 mL vials and 3 mL × 5 cartridges, Lantus®, March 2006. Available at http://www.health.gov.au/internet/wcms/publishing.nsf/Content/pbac-outcomes-and-public-summary-documents Accessed June 2007.
  124. Inhaled insulin, 1 mg and 3 mg inhalation powder (Exubera®) No. 254/06. Available at www.scottishmedicines.org7 April 2006;Accessed in June 2007
  125. NICE technology appraisal guidance 113 Inhaled insulin for the treatment of diabetes (types 1 and 2). Available at www.nice.org.uk Accessed in June 2007.
  126. Black C, Cummins E, Royle P, et al. The clinical effectiveness and cost effectiveness of inhaled insulin in diabetes mellitus: a systematic review and economic evaluation. A health technology assessment commissioned by the HTA Programme on behalf of the National Institute for Health and Clinical Excellence. Available at http://guidance.nice.org.uk/page.aspx?o=30551913 April 2006;accessed June 2007
  127. See Exenetide, 5 or 10 micrograms, solution for injection, pre-filled pen (Byetta®). Eli Lilly and Company Limited. No. (376/07). Guidance 9 July 2007. Available at www.scottishmedicines.org.uk
  128. Nauck MA, Duran S, Kim D, et al. A comparison of twice daily exenetide and biphasic insulin aspart in patients with type-2 diabetes who are suboptimally controlled with sulphonylurea and metformin: a non-inferiority study. Diabetologia. 2007;50(2):259–267
  129. Non-Formulary Criteria for use of Sitagliptin (Januvia). See http://www.pbm.va.gov/criteria/sitagliptin.pdfFebruary 2007;Accessed 19 March 2007. Updated versions may be found at www.pbm.va.gov or http://vaww.pbm.va.gov
  130. Rimonabant 20 mg tablet (Acomplia®). No. 341/07 (Sanofi-Aventis). Available at www.scottishmedicines.org12 January 2007;
  131. See series of 2007 Press Releases at http://en.sanofi-aventis.com/press/p_press_2007.asp Accessed 3 July 2007.
  132. Rimonabant for the treatment of overweight and obese patients. Final scope. National Institute for Health and Clinical Excellence. Available at http://guidance.nice.org.uk/page.aspx?o=434918June 2007;
  133. Turner RC, Cull CA, Frighi V, et al. Glycemic control with diet, sulfonylurea, metformin or insulin in patients with type-2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA. 1999;281:2005–2012
  134. National Institute for Clinical Excellence . Management of type-2 diabetes. Management of blood glucose. Guideline G1–27. London: National Institute for Clinical Excellence; 2002;
  135. Clinical Guideline Diabetes – Type-2 (update). Type-2 diabetes: the management of type-2 diabetes (update). National Institute for Health and Clinical Excellence, London. Available at http://guidance.nice.org.uk/page.aspx?o=264875. Accessed June 2007.
  136. Drug Trend Report, 2007. Medco Health Solutions, Inc. Report available at www.drugtrend.com or www.medco.com.
  137. Harbour R, Miller J. A new system for grading recommendations in evidence based guidelines. BMJ. 2001;323:334–336
  138. NICE . The guidelines manual – Chapter 8: incorporating health economics in guidelines and assessing resource impact. London: NICE; 2006;
  139. Rothwell PM. External validity of randomized controlled trials: ‘To whom do the results of this trial apply?’. Lancet. 2005;365:82–93
  140. Peterson GE. Intermediate and long-acting insulins: a review of NPH insulin, insulin glargine and insulin detemir. Current Medical Research and Opinion. 2006;22(12):2613–2619
  141. Currie CJ, Poole CD, Tetlow T, et al. The outcome of care in people with type-1 and type-2 diabetes following switching to treatment with either insulin glargine or insulin detemir in routine general practice in the UK: a retrospective database analysis. Current Medical Research and Opinion. 2007;23(supplement 1):S33–S39
  142. Poole CD, Tetlow T, McEwan P, et al. The prescription cost of managing people with type-1 and type-2 diabetes following initiation of treatment with either insulin glargine or insulin detemir in routine general practice in the UK: a retrospective database analysis. Current Medical Research and Opinion. 2007;23(Supplement 1):S41–S48
  143. Bottomley J, Palmer AJ, Williams R, et al. PROactive03: Pioglitazone, type-2 diabetes and reducing macrovascular events – economic implications?. British Journal of Diabetes and Vascular Disease. 2006;6:63–70
  144. McCallum RW, Fisher M. Comparing cardiovascular outcomes in diabetes studies. British Journal of Diabetes and Vascular Disease. 2006;6:111–118
  145. Urdahl H, Manca A, Sculpher MJ. Assessing generalisability in model-based economic evaluation studies. A structured review in osteoporosis. Phamacoeconomics. 2006;24(12):1181–1197
  146. Manca A, Willan AR. ‘Lost in translation’. Accounting for between-Country differences in the analysis of multinational cost-effectiveness data. Pharmacoeconomics. 2006;24(11):1101–1119
  147. Goeree R, Burke N, O'Reilly DO, et al. Transferability of economic evaluations: approaches and factors to consider when using results from one geographic area for another. Current Medical Research and Opinion. 2007;23(4):671–682
  148. Sculpher MJ, Pang FS, Manca A, et al. Generalisability in economic evaluation studies in health care: a review and case studies. Health Technology Assessment. 2004;8(49):1–206
  149. Office of Fair Trading. The pharmaceutical price regulation scheme. An OFT Market Study. London: OFT. Available at http://www.oft.gov.uk/shared_oft/reports/comp_policy/oft885.pdf2007;Accessed May 2007
  150. Jack A. NICE urged to adjust drug cost rules. Available at Financial Times. 29 June 2007;www.ft.comAccessed on 2 July 2007
  151. Press Release. NICE recommends a scheme to make bortezomib (Velcade) for multiple myeloma accessible to NHS patients. Available at http://www.nice.org.uk/page.aspx?o=4330634 June 2007;
  152. Beta interferon and glatiramir acetate for the treatment of multiple sclerosis. Technology Appraisal No. 32. Available at www.nice.org.ukJanuary 2002;Accessed June 2007
  153. Little R. NHS to fund treatment for 10 000 patients with MS. BMJ. 2002;324:316
  154. Bell CM, Urbach DR, Ray JG, et al. Bias in published cost effectiveness studies: systematic review. BMJ. 2006;332:699–703
  155. Guide to the methods of technology appraisal review process and timelines. GuideToTAMethodsReview[1]pdf available at http://www.nice.org.uk/page.aspx?o=423153 accessed 20 June 2007.

PII: S1521-690X(07)00079-6

doi: 10.1016/j.beem.2007.08.002

Best Practice & Research Clinical Endocrinology & Metabolism
Volume 21, Issue 4 , Pages 657-685 , December 2007

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