Discussie en Conclusies

In dit rapport wordt de kosteneffectiviteit beschreven van de behandeling met GLP-1 ten opzichte van bolus insuline bij patiënten met diabetes mellitus type 2, waarbij geen glykemische controle bereikt kan worden met basaal insuline en metformine. Het Zorginstituut concludeert na advisering door de WAR dat de

kosteneffectiviteitsanalyse van GLP-1 agonisten bij de behandeling van T2DM niet gereguleerd met basaal insuline en metformine van voldoende methodologische kwaliteit is.

Uit de analyses van de aanvragers blijkt dat behandeling met GLP-1 agonisten van type 2 diabetes mellitus niet gereguleerd met basaal insuline en metformine dominant is ten opzichte van behandeling met bolus insuline (dus meer gezondheidswinst tegen minder kosten).

Zorginstituut Nederland concludeert dat bij een referentiewaarde van €20.000 per QALY de kans dat behandeling met GLP-1 agonisten van type 2 diabetes mellitus niet gereguleerd met basaal insuline en metformine kosteneffectief is ten opzichte van bolus insuline behandeling, 62% is.

DEFINITIEF | Farmaco-Economisch rapport voor GLP-1 agonisten bij de behandeling van T2DM niet gereguleerd met basaal insuline en metformine | 22 augustus 2016

5

Literatuur

1. Samenvatting van de productkenmerken albiglutide (Eperzan®), 2014. 2. Samenvatting van de productkenmerken dulaglutide (Trulicity®), 2014. 3. Samenvatting van de productkenmerken exenatide (Byetta®), 2016 4. Samenvatting van de productkenmerken exenatide (Bydureon®), 2016 5. Samenvatting van de productkenmerken liraglutide (Victoza®), 2015 6. Samenvatting van de productkenmerken degludec/liraglutide (Xultophy®),

2016

7. Samenvatting van de productkenmerken lixisenatide (Lyxumia®), 2015 8. www.gipdatabank.nl 9. http://www.nationaalkompas.nl/gezondheid-en-ziekte/ziekten-en- aandoeningen/endocriene-voedings-en-stofwisselingsziekten-en- immuniteitsstoornissen/diabetes-mellitus/omvang/ 10. http://www.nationaalkompas.nl/algemeen/meta- informatie/modellen/czm/ziektegerelateerde-weegfactoren-voor-de- kwaliteit-van-leven/

11. Stouthard M , Essink-Bot M, Bonsel G, et al. 1997. Disability weights for diseases in the Netherlands . Rotterdam, Department of Public Health, Erasmus University.

12. Bruhn D, Martin AA, Tavares R, et al. Cost-utility of albiglutide versus insulin lispro, insulin glargine, and sitagliptin for the treatment of type 2 diabetes in the US. J Med Econ. 2016;19(7):672-83.

13. Sanchez-Covisa J, Capel M, Baeten S, et al. Comparative Cost-Effectiveness Analysis of Adding Twice-Daily Exenatide To Insulin Glargine Versus Adding Insulin Lispro To Treat Type 2 Diabetes In Spain. Value Health.

2014;17(7):A349-50.

14. Gordon J, McEwan P, Sabale U, et al. The cost-effectiveness of exenatide twice daily (BID) versus insulin lispro three times daily (TID) as add-on therapy to titrated insulin glargine in patients with type 2 diabetes. J Med Econ. 2016:1-26.

15. Huetson P, Palmer JL, Levorsen A, et al. Cost-effectiveness of once daily GLP-1 receptor agonist lixisenatide compared to bolus insulin both in combination with basal insulin for the treatment of patients with type 2 diabetes in Norway. J Med Econ. 2015;18(8):573-85.

16. Diamant M, Nauck MA, Shaginian R, et al. Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care 2014; 37: 2763-73.

17. Budget impact analyse GLP-1 agonisten bij de behandeling van diabetes mellitus type 2 niet gereguleerd met basaal insuline en metformine. Juni 2016

18. Ahrén, B., Johnson, S. L., Stewart, M. et al. HARMONY 3: 104-week randomized, double-blind, placebo-and active-controlled trial assessing the efficacy and safety of albiglutide compared with placebo, sitagliptin, and glimepiride in patients with type 2 diabetes taking metformin. Diabetes care. 2014, 37(8), 2141-2148.

19. Eriksen M, Mackay J, Ross H. The tobacco atlas 4th ed. Beschikbaar op: http://www.tobaccoatlas.org/uploads/Images/PDFs/Tobacco_Atlas_2ndPrint. pdf.

20. World Health Organization (WHO). Global status report on alcohol and health 2014. Beschikbaar op:

http://apps.who.int/iris/bitstream/10665/112736/1/9789240692763_eng.p df.

21. Freemantle N, Mamdani M, Vilsboll T, et al. IDegLira versus alternative intensification strategies in patients with type 2 diabetes inadequately controlled on basal insulin therapy. Diabetes Ther 2015; published online. DOI: 10.1007/s13300-015-0142-y.

22. van Velsen EF, Lamers J, Blok V, et al. A prospective study of concomitant GLP-1 analogue and insulin use in type 2 diabetes in clinical practice. Neth J Med. 2014;72(10):523-7.

23. de Boer SA, Lefrandt JD, Petersen JF, et al. The effects of GLP-1 analogues in obese, insulin-using type 2 diabetes in relation to eating behaviour. Int J Clin Pharm. 2016;38(1):144-51.

24. de Wit HM, Vervoort GM, Jansen HJ, de Grauw WJ, de Galan BE, Tack CJ. Liraglutide reverses pronounced insulin-associated weight gain, improves glycaemic control and decreases insulin dose in patients with type 2 diabetes: a 26 week, randomised clinical trial (ELEGANT). Diabetologia. 2014;57(9):1812-9.

25. Romkens TE, Kusters GC, Netea MG, et al. Prevalence and clinical

characteristics of insulin-treated, anti-GAD-positive, type 2 diabetic subjects in an outpatient clinical department of a Dutch teaching hospital. Neth J Med. 2006;64(4):114-8.

26. Informatie over UKPDS: http://www.dtu.ox.ac.uk/.

27. Palmer, A. J., Roze, S., Valentine, W. J., et al. The CORE Diabetes Model: projecting long-term clinical outcomes, costs and costeffectiveness of interventions in diabetes mellitus (types 1 and 2) to support clinical and reimbursement decision-making. 2004 Current medical research and opinion.

28. 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, 22(4), 2002. 340-349.

29. Beaudet, A., Clegg, J., Thuresson, P. O., et al. Lloyd, A., & McEwan, P. Review of utility values for economic modeling in type 2 diabetes. Value in Health, (2014). 17(4), 462-470.

30. Tengs TO, Wallace A. One thousand health-related quality-of-life estimates. Medical care. 2000;38(6):583-637.

31. Evans M, Khunti K, Mamdani M, Harris S, Galbo-Jorgensen C, Gundaard J, et al. Health-Related Quality of Life Associated with Daytime and Nocturnal Hypoglycemic Events: A Time Trade-Off Survey. American Diabetes Association; June 8 - 12, 2012, Philadelphia, Pennsylvania.

32. Bagust A, Beale S. Modelling EuroQol health-related utility values for

diabetic complications from CODE-2 data. Health Econ. 2005;14(3):217-30. 33. Soekhlal RR, Burgers LT, Redekop WK, Tan SS. Treatment costs of acute

myocardial infarction in the Netherlands. Neth Heart J. 2013;21(5):230-5. 34. Stevanovic J, Denee L, Koenders JM, et al. Incidence description and costs

of acute heart failure in the Netherlands. Value Health. 2014;17:A328. 35. Buisman LR, Tan SS, Nederkoorn PJ, et al. Hospital costs of ischemic stroke

and TIA in the Netherlands. Neurology. 2015;84(22):220815. 36. Cavallo MC, Sepe V, Conte F, et al. Costeffectiveness of kidney

transplantation from DCD in Italy. Transplant Proc. 2014;46(10):3289-96. 37. Hakkaart-van Roijen L, Tan S, Bouwmans C. Handleiding voor

DEFINITIEF | Farmaco-Economisch rapport voor GLP-1 agonisten bij de behandeling van T2DM niet gereguleerd met basaal insuline en metformine | 22 augustus 2016

2016095060 Pagina 47 van 47

impact van niet-ernstige hypoglycemie bij insulinegebruik in Nederland. NTD. 2014;2(12):58-63.

39. Heijink R, Mosca I, Westert G. Effects of regulated competition on key outcomes of care: cataract surgeries in the Netherlands. Health Policy. 2013;113(12):142-50.

40. De Vries NE, Laurendeau C, Lafuma A, et al. Lifetime costs and effectiveness of ReSTOR compared with a monofocal IOL and Array-SA40 in the

Netherlands. Eye (Lond). 2010;24(4):663-72.

41. Koberlein J, Beifus K, Schaffert C, et al. The economic burden of visual impairment and blindness: a systematic review. BMJ Open.

2013;3(11):e003471.

42. Lafuma A, Brezin A, Fagnani F, et al. Nonmedical economic consequences attributable to visual impairment: a nation-wide approach in France. Eur J Health Econ. 2006;7(3):158-64.

43. Redekop WK, McDonnell J, Verboom P, et l. The cost effectiveness of Apligraf treatment of diabetic foot ulcers. Pharmacoeconomics. 2003;21(16):117183

44. Verkooijen L. Gewerkte uren in Nederland in Europees perspectief. ESB. 2012;97(4648):697-98.

45. Freemantle N, Mamdani M, Vilsboll T, et al. IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy. Diabetes Ther. 2015;6(4):573-91. 46. Clarke PM, Gray AM, Briggs A, Farmer AJ, Fenn P, Stevens RJ, 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(10):1747-59.

47. Bilo HJG. T2DM in de eerste lijn en insulinegebruik: transitie van

monotherapie met een (middel)langwerkende insuline naar een mixinsuline of een basis-bolus schema. 2016 31 augustus 2016. Report No.

48. Overbeek J, Houben E, Kring S, Sommer J, Penning-van Beest F, van der Heijden A, et al. Intensification of Basal Insulin Treatment Among Patients With Diabetes Mellitus Type 2 In The Netherlands. Value Health.

2015;18(7):A617.

49. van Giessen A, Boonman-de Winter LJM, Rutten FH, Cramer MJ, Landman MJ, Liem AH, et al. Cost-effectiveness of screening strategies to detect heart failure in patients with type 2 diabetes. Cardiovascular diabetology.

2016;15(1):1-12.

50. Boonman-de Winter LJ, Rutten FH, Cramer MJ. High prevalence of

previously unknown heart failure and left ventricular dysfunction in patients with type 2 diabetes. Diabetologia. 2012;55.

Budget impact analyse GLP-1 agonisten bij de