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Published in: Clinical Drug Investigation 2/2014

01-02-2014 | Original Research Article

Cost Effectiveness of Adding Dapagliflozin to Insulin for the Treatment of Type 2 Diabetes Mellitus in the Netherlands

Authors: Heleen G. M. van Haalen, Marjolein Pompen, Klas Bergenheim, Phil McEwan, Rebecca Townsend, Marina Roudaut

Published in: Clinical Drug Investigation | Issue 2/2014

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Abstract

Background and Objective

Many patients with type 2 diabetes mellitus (T2DM) on insulin therapy have inadequate glycaemic control. In such cases, Dutch guidelines recommend unlimited up-titration of insulin, yet in practice many patients never reach their glycaemic target. Clinical evidence shows that dapagliflozin—a highly selective sodium–glucose cotransporter 2 inhibitor—meets a need for these patients, i.e. by reducing glycated haemoglobin levels and bodyweight. We estimated the cost effectiveness and cost utility of adding dapagliflozin to insulin compared with not adding dapagliflozin in patients with T2DM who have inadequate glycaemic control while on insulin.

Methods

The cost effectiveness of dapagliflozin was estimated using the Cardiff Diabetes Model, using direct comparative efficacy data from a randomized placebo-controlled trial (ClinicalTrials.gov identifier NCT00673231). In this trial, up-titration of insulin was allowed in case of severe glycaemic imbalance. Risk factor progression and the occurrence of future vascular events were estimated using the United Kingdom Prospective Diabetes Study 68 risk equations. Costs and utilities were derived from the literature. The analysis was conducted from the societal perspective, simulating the remaining lifetime of the patients.

Results

The overall incidence of macro- and microvascular complications was lower, and life expectancy was greater (19.43 versus 19.35 life-years [LYs]) in patients receiving dapagliflozin than in those not receiving dapagliflozin. Patients in the dapagliflozin arm obtained an incremental benefit of 0.42 quality-adjusted life-years (QALYs). The lifetime incremental cost per patient in the dapagliflozin arm was €2,293, resulting in an incremental cost-effectiveness ratio of €27,779 per LY gained and an incremental cost–utility ratio of €5,502 per QALY gained. Sensitivity and scenario analyses showed that the results were insensitive to variations in modelling assumptions and input variables.

Conclusion

Dapagliflozin in combination with insulin was estimated to be a cost-effective treatment option for patients with T2DM whose insulin treatment regimen does not provide adequate glycaemic control in a Dutch healthcare setting.
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Literature
1.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
2.
go back to reference Nationaal Kompas Volksgezondheid, RIVM. http://www.nationaalkompas.nl Nationaal Kompas Volksgezondheid\Gezondheid en ziekte\Ziekten en aandoeningen\Endocriene, voedings- en stofwisselingsziekten en immuniteitsstoornissen\Diabetes mellitus; 2013 (Accessed 15 Aug 2013). Nationaal Kompas Volksgezondheid, RIVM. http://​www.​nationaalkompas.​nl Nationaal Kompas Volksgezondheid\Gezondheid en ziekte\Ziekten en aandoeningen\Endocriene, voedings- en stofwisselingsziekten en immuniteitsstoornissen\Diabetes mellitus; 2013 (Accessed 15 Aug 2013).
3.
go back to reference Baan CA, van Baal PH, Jacobs-van der Bruggen MA, et al. Diabetes mellitus in the Netherlands: estimate of the current disease burden and prognosis for 2025. Ned Tijdschr Geneeskd. 2009;153:1052–8.PubMed Baan CA, van Baal PH, Jacobs-van der Bruggen MA, et al. Diabetes mellitus in the Netherlands: estimate of the current disease burden and prognosis for 2025. Ned Tijdschr Geneeskd. 2009;153:1052–8.PubMed
4.
go back to reference Rutten GEHM, De Grauw WJC, Nijpels G, et al. The NHG guideline diabetes mellitus type 2. Huisarts Wet. 2013;56(10):512–25. Rutten GEHM, De Grauw WJC, Nijpels G, et al. The NHG guideline diabetes mellitus type 2. Huisarts Wet. 2013;56(10):512–25.
5.
go back to reference Gorter K, Van de Laar FA, Janssen PGH et al. Diabetes: glycaemic control in type 2 (drug treatments). Clinical Evid (Online). 2012. pii: 0609. Gorter K, Van de Laar FA, Janssen PGH et al. Diabetes: glycaemic control in type 2 (drug treatments). Clinical Evid (Online). 2012. pii: 0609.
6.
go back to reference Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35:1364–79.PubMedCrossRef Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35:1364–79.PubMedCrossRef
7.
go back to reference Carver C. Insulin treatment and the problem of weight gain in type 2 diabetes. Diabetes Educ. 2006;32:910–7.PubMedCrossRef Carver C. Insulin treatment and the problem of weight gain in type 2 diabetes. Diabetes Educ. 2006;32:910–7.PubMedCrossRef
8.
go back to reference Peyrot M, Rubin RR, Lauritzen T, et al. Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. Diabetes Care. 2005;28:2673–9.PubMedCrossRef Peyrot M, Rubin RR, Lauritzen T, et al. Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. Diabetes Care. 2005;28:2673–9.PubMedCrossRef
9.
go back to reference Logtenberg SJ, Kleefstra N, Ubink-Veltmaat LJ, et al. Intensification of therapy and no increase in body mass index with longer disease duration in type 2 diabetes mellitus (ZODIAC-5). Fam Pract. 2007;24:529–31.PubMedCrossRef Logtenberg SJ, Kleefstra N, Ubink-Veltmaat LJ, et al. Intensification of therapy and no increase in body mass index with longer disease duration in type 2 diabetes mellitus (ZODIAC-5). Fam Pract. 2007;24:529–31.PubMedCrossRef
10.
go back to reference Komoroski B, Vachharajani N, Boulton D, et al. Dapagliflozin, a novel SGLT2 inhibitor, induces dose-dependent glucosuria in healthy subjects. Clin Pharmacol Ther. 2009;85:520–6.PubMedCrossRef Komoroski B, Vachharajani N, Boulton D, et al. Dapagliflozin, a novel SGLT2 inhibitor, induces dose-dependent glucosuria in healthy subjects. Clin Pharmacol Ther. 2009;85:520–6.PubMedCrossRef
11.
go back to reference Wilding JP, Woo V, Soler NG, et al. Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: a randomized trial. Ann Intern Med. 2012;156:405–15.PubMedCrossRef Wilding JP, Woo V, Soler NG, et al. Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: a randomized trial. Ann Intern Med. 2012;156:405–15.PubMedCrossRef
12.
go back to reference McEwan P, Peters JR, Bergenheim K, et al. Evaluation of the costs and outcomes from changes in risk factors in type 2 diabetes using the Cardiff stochastic simulation cost-utility model (DiabForecaster). Curr Med Res Opin. 2006;22:121–9.PubMedCrossRef McEwan P, Peters JR, Bergenheim K, et al. Evaluation of the costs and outcomes from changes in risk factors in type 2 diabetes using the Cardiff stochastic simulation cost-utility model (DiabForecaster). Curr Med Res Opin. 2006;22:121–9.PubMedCrossRef
13.
go back to reference McEwan P, Evans M, Bergenheim K. A population model evaluating the costs and benefits associated with different oral treatment strategies in people with type 2 diabetes. Diabetes Obes Metab. 2010;12:623–30.PubMedCrossRef McEwan P, Evans M, Bergenheim K. A population model evaluating the costs and benefits associated with different oral treatment strategies in people with type 2 diabetes. Diabetes Obes Metab. 2010;12:623–30.PubMedCrossRef
14.
go back to reference McEwan P, Evans M, Kan H, et al. Understanding the inter-relationship between improved glycaemic control, hypoglycaemia and weight change within a long-term economic model. Diabetes Obes Metab. 2010;12:431–6.PubMedCrossRef McEwan P, Evans M, Kan H, et al. Understanding the inter-relationship between improved glycaemic control, hypoglycaemia and weight change within a long-term economic model. Diabetes Obes Metab. 2010;12:431–6.PubMedCrossRef
15.
go back to reference The Mount Hood 4 Modeling Group. Computer modeling of diabetes and its complications: a report on the Fourth Mount Hood Challenge Meeting. Diabetes Care. 2007;30:1638–46.CrossRef The Mount Hood 4 Modeling Group. Computer modeling of diabetes and its complications: a report on the Fourth Mount Hood Challenge Meeting. Diabetes Care. 2007;30:1638–46.CrossRef
16.
go back to reference Erhardt W, Bergenheim K, Duprat-Lomon I, et al. Cost effectiveness of saxagliptin and metformin versus sulfonylurea and metformin in the treatment of type 2 diabetes mellitus in Germany: a Cardiff diabetes model analysis. Clin Drug Investig. 2012;32:189–202.PubMedCrossRef Erhardt W, Bergenheim K, Duprat-Lomon I, et al. Cost effectiveness of saxagliptin and metformin versus sulfonylurea and metformin in the treatment of type 2 diabetes mellitus in Germany: a Cardiff diabetes model analysis. Clin Drug Investig. 2012;32:189–202.PubMedCrossRef
17.
go back to reference Granstrom O, Bergenheim K, McEwan P, et al. Cost-effectiveness of saxagliptin (Onglyza(R)) in type 2 diabetes in Sweden. Prim Care Diabetes. 2012;6:127–36.PubMedCrossRef Granstrom O, Bergenheim K, McEwan P, et al. Cost-effectiveness of saxagliptin (Onglyza(R)) in type 2 diabetes in Sweden. Prim Care Diabetes. 2012;6:127–36.PubMedCrossRef
18.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
19.
go back to reference Wulffele MG, Kooy A, Lehert P, et al. Combination of insulin and metformin in the treatment of type 2 diabetes. Diabetes Care. 2002;25:2133–40.PubMedCrossRef Wulffele MG, Kooy A, Lehert P, et al. Combination of insulin and metformin in the treatment of type 2 diabetes. Diabetes Care. 2002;25:2133–40.PubMedCrossRef
20.
go back to reference Wilding JP, Woo V, Rohwedder K, et al. Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over two years. Diabetes Obes Metab. 2013;. doi:10.1111/dom.12187. Wilding JP, Woo V, Rohwedder K, et al. Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over two years. Diabetes Obes Metab. 2013;. doi:10.​1111/​dom.​12187.
21.
go back to reference Bailey CJ, Wilding JP, Nauck M, et al. Sustained reductions in weight and HbA1c with dapagliflozin: long-term results from phase III clinical studies in type 2 diabetes. Diabetiologica. 2012;55 SUPPL. 1 (S295). Bailey CJ, Wilding JP, Nauck M, et al. Sustained reductions in weight and HbA1c with dapagliflozin: long-term results from phase III clinical studies in type 2 diabetes. Diabetiologica. 2012;55 SUPPL. 1 (S295).
22.
go back to reference Jonsson L, Bolinder B, Lundkvist J. Cost of hypoglycemia in patients with Type 2 diabetes in Sweden. Value Health. 2006;9:193–8.PubMedCrossRef Jonsson L, Bolinder B, Lundkvist J. Cost of hypoglycemia in patients with Type 2 diabetes in Sweden. Value Health. 2006;9:193–8.PubMedCrossRef
23.
go back to reference Hakkaart-van Roijen L, Tan SS, Bouwmans CAM. Handleiding voor kostenonderzoek, methoden en standaard kostprijzen voor economische evaluaties in de gezondheidszorg. [Geactualiseerde versie 2010]. 2010. College voor Zorgverzekeringen. http://www.cvz.nl. Hakkaart-van Roijen L, Tan SS, Bouwmans CAM. Handleiding voor kostenonderzoek, methoden en standaard kostprijzen voor economische evaluaties in de gezondheidszorg. [Geactualiseerde versie 2010]. 2010. College voor Zorgverzekeringen. http://​www.​cvz.​nl.
24.
go back to reference CBS Statline. statline.cbs.nl/statweb/ (Accessed 6 June 2012). CBS Statline. statline.cbs.nl/statweb/ (Accessed 6 June 2012).
25.
go back to reference Erdogan-Ciftci E, Koopmanschap MA. Productivity Costs using Frinction Cost method: New evidence using National Data. Value Health. ISPOR 14th Annual European Congress, vol. 14, Madrid; 2011, pp. A235–A236. Erdogan-Ciftci E, Koopmanschap MA. Productivity Costs using Frinction Cost method: New evidence using National Data. Value Health. ISPOR 14th Annual European Congress, vol. 14, Madrid; 2011, pp. A235–A236.
26.
go back to reference Clarke P, Leal J, Kelman C, et al. Estimating the cost of complications of diabetes in Australia using administrative health-care data. Value Health. 2008;11:199–206.PubMedCrossRef Clarke P, Leal J, Kelman C, et al. Estimating the cost of complications of diabetes in Australia using administrative health-care data. Value Health. 2008;11:199–206.PubMedCrossRef
27.
go back to reference Greving JP, Visseren FL, de Wit GA, et al. Statin treatment for primary prevention of vascular disease: whom to treat? Cost-effectiveness analysis. BMJ. 2011;342:d1672.PubMedCrossRef Greving JP, Visseren FL, de Wit GA, et al. Statin treatment for primary prevention of vascular disease: whom to treat? Cost-effectiveness analysis. BMJ. 2011;342:d1672.PubMedCrossRef
28.
go back to reference Isaaz K, Coudrot M, Sabry MH, et al. Return to work after acute ST-segment elevation myocardial infarction in the modern era of reperfusion by direct percutaneous coronary intervention. Arch Cardiovasc Dis. 2010;103:310–6.PubMedCrossRef Isaaz K, Coudrot M, Sabry MH, et al. Return to work after acute ST-segment elevation myocardial infarction in the modern era of reperfusion by direct percutaneous coronary intervention. Arch Cardiovasc Dis. 2010;103:310–6.PubMedCrossRef
29.
go back to reference Postmus D, Pari AA, Jaarsma T, et al. A trial-based economic evaluation of 2 nurse-led disease management programs in heart failure. Am Heart J. 2011;162:1096–104.PubMedCrossRef Postmus D, Pari AA, Jaarsma T, et al. A trial-based economic evaluation of 2 nurse-led disease management programs in heart failure. Am Heart J. 2011;162:1096–104.PubMedCrossRef
31.
go back to reference Baeten SA, van Exel NJ, Dirks M, et al. Lifetime health effects and medical costs of integrated stroke services—a non-randomized controlled cluster-trial based life table approach. Cost Eff Resour Alloc. 2010;8:21.PubMedCentralPubMedCrossRef Baeten SA, van Exel NJ, Dirks M, et al. Lifetime health effects and medical costs of integrated stroke services—a non-randomized controlled cluster-trial based life table approach. Cost Eff Resour Alloc. 2010;8:21.PubMedCentralPubMedCrossRef
32.
go back to reference Lindgren P, Glader EL, Jonsson B. Utility loss and indirect costs after stroke in Sweden. Eur J Cardiovasc Prev Rehabil. 2008;15:230–3.PubMedCrossRef Lindgren P, Glader EL, Jonsson B. Utility loss and indirect costs after stroke in Sweden. Eur J Cardiovasc Prev Rehabil. 2008;15:230–3.PubMedCrossRef
33.
go back to reference Niessen LW, Dijkstra R, Hutubessy R, et al. Lifetime health effects and costs of diabetes treatment. Neth J Med. 2003;61:355–64.PubMed Niessen LW, Dijkstra R, Hutubessy R, et al. Lifetime health effects and costs of diabetes treatment. Neth J Med. 2003;61:355–64.PubMed
34.
go back to reference Fisher K, Hanspal RS, Marks L. Return to work after lower limb amputation. Int J Rehabil Res. 2003;26:51–6.PubMedCrossRef Fisher K, Hanspal RS, Marks L. Return to work after lower limb amputation. Int J Rehabil Res. 2003;26:51–6.PubMedCrossRef
35.
go back to reference Keeffe JE. Costs of vision impairment: present and future issues. Expert Rev Pharmacoecon Outcomes Res. 2007;7:523–7.PubMedCrossRef Keeffe JE. Costs of vision impairment: present and future issues. Expert Rev Pharmacoecon Outcomes Res. 2007;7:523–7.PubMedCrossRef
36.
go back to reference van der Mei SF, Kuiper D, Groothoff JW, et al. Long-term health and work outcomes of renal transplantation and patterns of work status during the end-stage renal disease trajectory. J Occup Rehabil. 2011;21:325–34.PubMedCentralPubMedCrossRef van der Mei SF, Kuiper D, Groothoff JW, et al. Long-term health and work outcomes of renal transplantation and patterns of work status during the end-stage renal disease trajectory. J Occup Rehabil. 2011;21:325–34.PubMedCentralPubMedCrossRef
37.
go back to reference Clarke P, Gray A, Holman R. Estimating utility values for health states of type 2 diabetic patients using the EQ-5D (UKPDS 62). Med Decis Making. 2002;22:340–9.PubMed Clarke P, Gray A, Holman R. Estimating utility values for health states of type 2 diabetic patients using the EQ-5D (UKPDS 62). Med Decis Making. 2002;22:340–9.PubMed
38.
go back to reference Waugh N, Cummins E, Royle P, et al. Newer agents for blood glucose control in type 2 diabetes: systematic review and economic evaluation. Health Technol Assess. 2010;14:1–248. Waugh N, Cummins E, Royle P, et al. Newer agents for blood glucose control in type 2 diabetes: systematic review and economic evaluation. Health Technol Assess. 2010;14:1–248.
39.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
40.
go back to reference Barry HC, Ebell MH, Hickner J. Evaluation of suspected urinary tract infection in ambulatory women: a cost-utility analysis of office-based strategies. J Fam Pract. 1997;44:49–60.PubMed Barry HC, Ebell MH, Hickner J. Evaluation of suspected urinary tract infection in ambulatory women: a cost-utility analysis of office-based strategies. J Fam Pract. 1997;44:49–60.PubMed
41.
go back to reference Lane S, Levy A, Sambrook J et al.. The impact on utilities of weight loss and weight gain among Canadian patients with type 2 diabetes. Value Health—ISPOR 17th Annual International Meeting, vol. 15, Washington DC; 2012, p. A183. Lane S, Levy A, Sambrook J et al.. The impact on utilities of weight loss and weight gain among Canadian patients with type 2 diabetes. Value Health—ISPOR 17th Annual International Meeting, vol. 15, Washington DC; 2012, p. A183.
43.
go back to reference Woehl A, Evans M, Tetlow AP, et al. Evaluation of the cost effectiveness of exenatide versus insulin glargine in patients with sub-optimally controlled type 2 diabetes in the United Kingdom. Cardiovasc Diabetol. 2008;7:24.PubMedCentralPubMedCrossRef Woehl A, Evans M, Tetlow AP, et al. Evaluation of the cost effectiveness of exenatide versus insulin glargine in patients with sub-optimally controlled type 2 diabetes in the United Kingdom. Cardiovasc Diabetol. 2008;7:24.PubMedCentralPubMedCrossRef
44.
go back to reference 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):S5–26.PubMedCrossRef 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):S5–26.PubMedCrossRef
45.
go back to reference Drummond M, Barbieri M, Cook J, et al. Transferability of economic evaluations across jurisdictions: ISPOR Good Research Practices Task Force report. Value Health. 2009;12:409–18.PubMedCrossRef Drummond M, Barbieri M, Cook J, et al. Transferability of economic evaluations across jurisdictions: ISPOR Good Research Practices Task Force report. Value Health. 2009;12:409–18.PubMedCrossRef
46.
go back to reference Buse JB, Bergenstal RM, Glass LC, et al. Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. Ann Intern Med. 2011;154:103–12.PubMedCrossRef Buse JB, Bergenstal RM, Glass LC, et al. Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. Ann Intern Med. 2011;154:103–12.PubMedCrossRef
47.
go back to reference Vilsboll T, Rosenstock J, Yki-Jarvinen H, et al. Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2010;12:167–77.PubMedCrossRef Vilsboll T, Rosenstock J, Yki-Jarvinen H, et al. Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2010;12:167–77.PubMedCrossRef
Metadata
Title
Cost Effectiveness of Adding Dapagliflozin to Insulin for the Treatment of Type 2 Diabetes Mellitus in the Netherlands
Authors
Heleen G. M. van Haalen
Marjolein Pompen
Klas Bergenheim
Phil McEwan
Rebecca Townsend
Marina Roudaut
Publication date
01-02-2014
Publisher
Springer International Publishing
Published in
Clinical Drug Investigation / Issue 2/2014
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI
https://doi.org/10.1007/s40261-013-0155-0

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