Health economic evaluations comparing insulin glargine with NPH insulin in patients with type 1 diabetes: a systematic review

Cost Effectiveness and Resource Allocation

Peter K Schädlich⁴  Franz-Werner Dippel³  Katharina C Koltermann¹  Ernst-Günther Hagenmeyer² 

[1]Lychener Str. 45, 10437 Berlin, Germany

[2]Fischzug 19H, 10245 Berlin, Germany

[3]Sanofi-Aventis Deutschland GmbH, Potsdamer Straße 8, 10785 Berlin, Germany

[4]IGES Institut GmbH, Friedrichstraße 180, 10117 Berlin, Germany

关键词: NPH;    insulin glargine;    basal-bolus therapy;    type 1 diabetes;    health economics;    Systematic review;   

Others  :  811043
DOI  :  10.1186/1478-7547-9-15

 received in 2010-10-27, accepted in 2011-10-06,  发布年份 2011

【 摘 要 】

Background

Compared to conventional human basal insulin (neutral protamine Hagedorn; NPH) the long-acting analogue insulin glargine (GLA) is associated with a number of advantages regarding metabolic control, hypoglycaemic events and convenience. However, the unit costs of GLA exceed those of NPH. This study aims to systematically review the economic evidence comparing GLA with NPH in basal-bolus treatment (intensified conventional therapy; ICT) of type 1 diabetes in order to facilitate informed decision making in clinical practice and health policy.

Methods

A systematic literature search was performed for the period of January 1st 2000 to December 1st 2009 via Embase, Medline, the Cochrane Library, the databases GMS (German Medical Science) and DAHTA (Deutsche Agentur für Health Technology Assessment), and the abstract books of relevant international scientific congresses. Retrieved studies were reviewed based on predefined inclusion criteria, methodological and quality aspects. In order to allow comparison between studies, currencies were converted using purchasing power parities (PPP).

Results

A total of 7 health economic evaluations from 4 different countries fulfilled the predefined criteria: 6 modelling studies, all of them cost-utility analyses, and one claims data analysis with a cost-minimisation design. One cost-utility analysis showed dominance of GLA over NPH. The other 5 cost-utility analyses resulted in additional costs per quality adjusted life year (QALY) gained for GLA, ranging from € 3,859 to € 57,002 (incremental cost effectiveness ratio; ICER). The cost-minimisation analysis revealed lower annual diabetes-specific costs in favour of NPH from the perspective of the German Statutory Health Insurance (SHI).

Conclusions

The incremental cost-utility-ratios (ICER) show favourable values for GLA with considerable variation. If a willingness-to-pay threshold of £ 30,000 (National Institute of Clinical Excellence, UK) is adopted, GLA is cost-effective in 4 of 6 cost utility analyses (CUA) included. Thus insulin glargine (GLA) seems to offer good value for money. Comparability between studies is limited because of methodological and country specific aspects. The results of this review underline that evaluation of insulin therapy should use evidence on efficacy of therapy from information synthesis. The concept of relating utility decrements to fear of hypoglycaemia is a plausible approach but needs further investigation. Also future evaluations of basal-bolus insulin therapy should include costs of consumables such as needles for insulin injection as well as test strips and lancets for blood glucose self monitoring.

【 授权许可】

   
2011 Hagenmeyer et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Hirsch IB: Drug therapy: insulin analogues. N Engl J Med Vol 352 2005, (2):174-183.
• [2]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(5):333-349.
• [3]Heinemann L, Linkeschova R, Rave K, Hompesch B, Sedlak M, Heise T: Time action profile of the long acting insulin analog isnulin glargine (HOE901) in comparison with those of NPH insulin anf placebo. Diabetes Care 2000, 23:644-649.
• [4]Monami M, Marchionni N, Mannucci E: Long-acting insulin analogues vs. NPH human insulin in type 1 diabetes. A meta-analysis. Diabetes Obes Metab 2009, 11(4):372-378.
• [5]Singh SR, Ahmad F, Lal A, Yu C, Bai Z, Bennett H: Efficacy and safety of insulin analogues for the management of diabetes mellitus: a meta-analysis. CMAJ 2009, 180(4):385-397.
• [6]Vardi M, Jacobson E, Nini A, Bitterman H: Intermediate acting versus long acting insulin for type 1 diabetes mellitus. Cochrane Database Syst Rev 2008, (3):CD006297.
• [7]Mullins P, Sharplin P, Yki-Jarvinen H, Riddle MC, Haring HU: 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(8):1607-1619.
• [8]Patterson CC, Dahlquist GG, Gyurus E, Green A, Soltesz G: Incidence trends for childhood type 1 diabetes in Europe during 1989-2003 and predicted new cases 2005-20: a multicentre prospective registration study. Lancet 2009, 373(9680):2027-2033.
• [9]Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, Clarke M, Devereaux PJ, Kleijnen J, Moher D: The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 2009, 339:b2700.
• [10]Higgins JPT, Green S: Cochrane Handbook for Systematic Reviews of Interventions. Chichester: The Cochrane Collaboration and John Wiley & Sons Ltd; 2008.
• [11]Leidl R, Graf von der Schulenburg JM, Wasem J, eds: [Approaches and methods of economic evaluation in health care-an international perspective]. Baden-Baden: Nomos Verlagsgesellschaft; 1999.
• [12]Aidelsburger P, Felder S, Siebert U: [Health economic short HTA-reports-systematic overview of the methods and implementation]. In HTA-Schriftenreihe. Volume 6. Edited by Rüther A, Dauben H, Warda F. Köln: Deutsche Agentur für Health Technology Assessment des Deutschen Instituts für Medizinische Dokumentation und Information; 2003.
• [13]Drummond MF, Jefferson TO: Guidelines for authors and peer reviewers of economic submissions to the BMJ. BMJ 1996, 313:275-283.
• [14]Drummond M, Sculpher M, Torrance G: Methods for the economic evaluation of health care programmes. 3rd edition. Oxford: Oxford University Press; 2005.
• [15]American Diabetes Association Consensus Panel: Consensus statement: Guidelines for computer modeling of diabetes and its complications. Diabetes Care 2004, 27(9):2262-2265.
• [16]von Elm E, Altman DG, Egger M, Pocock S, Gotzsche P, Vancenbroucke J, STROBE Initiative: The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med 2007, 147(8):573-577.
• [17]Welte R, Feenstra T, Jager H, Leidl R: A decision chart for assessing and improving the transferability of economic evaluation results between countries. Pharmacoeconomics 2004, 22(13):857-876.
• [18]Drummond M, Barbieri M, Cook J, Glick HA, Lis J, Malik F, Reed SD, Rutten F, Sculpher M, Severens J: Transferability of economic evaluations across jurisdictions: ISPOR Good Research Practices Task Force report. Value Health 2009, 12(4):409-418.
• [19]Statistisches Bundesamt: [International comparison of consumer prices]. Wiesbaden, Germany: Statistisches Bundesamt; 2009.
• [20]Warren E, Weatherley-Jones E, Chilcott J, Beverley C: The Clinical and Cost-effectiveness of Long-Acting Insulin Analogue, Insulin glargine. Assessment Report. In ScHARR Rapid Reviews Group. School of Health and Related Research. University of Sheffield; 2002.
• [21]Cameron CG, Bennett HA: Cost-effectiveness of insulin analogues for diabetes mellitus. Canadian Medical Association Journal 2009, 180(4):400-407.
• [22]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(3):253-266.
• [23]McEwan P, Poole CD, Tetlow T, Holmes P, Currie CJ: 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, Supplement 2007, 23(1):S7-S19.
• [24]Warren E, Weatherley-Jones E, Chilcott J, Beverley C: Systematic review and economic evaluation of a long-acting insulin analogue, insulin glargine. Health Technol Assess 2004, 8(45):iii. 1-57
• [25]Brändle M, Azoulay M, Greiner R: Cost-effectiveness of insulin glargine versus NPH insulin for the treatment of type 1 and type 2 diabetes in Switzerland. In ADA Scientific Session. Volume 7. New Orleans, Louisiana; 2009::A408-A409.
• [26]Hagenmeyer EG, Gothe H, Kulik M, Schiffhorst G, Höer A, Häussler B: Comparison of Cost and Utilisation among Propensity Score Matched Users of Insulin Glargine and Users of NPH Insulin in Type 1 and Type 2 Diabetes. Berlin: IGES Institut GmbH; 2007.
• [27]Brixner DI, McAdam-Marx C: Cost-effectiveness of insulin analogs. Am J Manag Care 2008, 14(11):766-775.
• [28]Clissold R, Clissold S: Insulin glargine in the management of diabetes mellitus: An evidence-based assessment of its clinical efficacy and economic value. Core Evid 2007, 2(2):89-110.
• [29]Leichter S: Is the use of insulin analogues cost-effective? Adv Ther 2008, 25(4):285-299.
• [30]NICE: Type 1 diabetes in adults: national clinical guideline for diagnosis and management in primary and secondary care. London: Royal College of Physicians; 2004:171.
• [31]Tran K, Banerjee S, Li H, Cimon K, Daneman D, Simpson SH, Campbell K: Long-acting insulin analogues for diabetes mellitus: meta-analysis of clinical outcomes and assessment of cost-effectiveness. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2007.
• [32]National Institute for Clinical Excellence (NICE): Guidance on the use of long-acting insulin analogues for the treatment of diabetes-insulin glargine. In Technology Appraisal No. 53. London: National Institute for Clinical Excellence (NICE); 2002.
• [33]Pieber TR, Eugene-Jolchine I, Derobert E: Efficacy and safety of HOE 901 versus NPH insulin in patients with type 1 diabetes. The European Study Group of HOE 901 in type 1 diabetes. Diabetes Care 2000, 23:157-62.
• [34]Porcellati F, Rossetti P, Pampanelli S, Fanelli CG, Torlone E, Scionti L: Better long-term glycaemic control with the basal insulin glargine as compared with NPH in patients with Type 1 diabetes mellitus given meal-time lispro insulin. Diabet Med 2004, 21(11):1213-1220.
• [35]Ratner RE, Hirsch IB, Neifing JL, Garg SK, Mecca TE, Wilson CA: Less hypoglycemia with insulin glargine in intensive insulin therapy for type 1 diabetes. US Study Group of Insulin Glargine in Type 1 Diabetes. Diabetes care 2000, 23(5):639.
• [36]Hagenmeyer EG, Schädlich PK, Koster AD, Dippel FW, Häussler B: [Quality of life and treatment satisfaction in patients being treated with long-acting insulin analogues]. Dtsch Med Wochenschr 2009, 134(12):565-570.
• [37]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.
• [38]National Institute for Clinical Excellence (NICE): Guide to the methods of technology appraisal. London: National Institute for Clinical Excellence (NICE); 2008.
• [39]Barbieri M, Drummond M, Willke R, Chancellor J, Jolain B, Towse A: Variability of cost-effectiveness estimates for pharmaceuticals in Western Europe: lessons for inferring generalizability. Value Health 2005, 8(1):10-23.
• [40]Siegel JE, Weinstein MC, Russell LB, Gold MR: Recommendations for reporting cost-effectiveness analyses. Panel on Cost-Effectiveness in Health and Medicine. JAMA 1996, 276(16):1339-1341.
• [41]Cooper N, Coyle D, Abrams K, Mugford M, Sutton A: Use of evidence in decision models: an appraisal of health technology assessments in the UK since 1997. J Health Serv Res Policy 2005, 10(4):245-250.