The economic prognosis of the new analog of insulin glargine usage in diabetes mellitus type 2
Abstract
Modelling has been performed for evaluation of economic perspectives of new insulin glargine 300 IU/ml usage for diabetes mellitus type 2 (DM2) control based on literature analysis of non-direct comparison with insulin detemir. Evaluation of the reimbursement’s reasonability for insulin glargine 300 IU/ml in clinical practice was the aim of this analysis. Utility cost of insulin glargine 300 IU/ml is higher than insulin detemir for 1 IU on 25,2% (according to Governmental Reestr of maximal manufacturers’ prices). Meanwhile efficacy of insulin glargine on control of DM2 is higher than insulin detemir (61,7% and 42,5% accordingly, Odds Ratio 2,18, 95%CI 1,41-3,34; p=0,01). Besides that, insulin glargine had less amount of hypoglycemic events, less necessity for out-patients visits and hospitalizations. Calculated “cost-effective ratio” (CER), which has included annual insulins’ cost, potential expenditures for severe hypo treatment, cost of medical aid for out-patients and in-patients has been more preferable for insulin glargine (CER for insulin glargine 46 252,40 RUR, for insulin detemir 76 681,01 RUR). Conclusion: Modelling has confirmed the economic rationality of insulin glargine 300 IU/ml usage for effective DM2 control in governmental reimbursement system because budget expenditures will not increase (expert’s conclusion). Prospective comparable trials in the future are important for economic evaluation.
About the Authors
D. Yu. Belousov
LLC "Center for Pharmacoeconomics Research", Moscow
Russian Federation
Russian Federation
E. V. Afanasyeva
LLC "Center for Pharmacoeconomics Research", Moscow
Russian Federation
Russian Federation
References
1. Колбин А.С. Фармакоэкономическое сравнение базальных аналогов инсулина при сахарном диабете 2 типа. // Качественная Клиническая Практика. 2011;1:92-96.
2. Pscherer S., Dietrich E.S., Dippel F. W., Neilson A.R. Comparison of one-year costs of type 2 diabetes treatment with insulin glargine or insulin detemir in a basal supported oral therapy (BOT) in Germany. // Int. J. Clin. Pharmacol. Ther. 2010;48:129-137.
3. Guisasola A., Llorente C., Rubio-Terres C. Cost analysis of type 2 diabetes mellitus treatment with glargine insulin or detemir insulin in Spain. // Rev Esp Econ Salud. 2007; 6: 304-310.
4. Алгоритмы специализированной медицинской помощи больным сахарным диабетом. Изд. 7-е. Ред. И.И. Дедов, М.В. Шестакова. // Сахарный диабет. 2015; 18 (1S): 1 - 112.
5. Standards of Medical Care in Diabetes-2015 Abridged for Primary Care Providers // Clin. Diabetes. 2015; 33: 97-111.
6. Inzucchi S.E., Bergenstal R.M., Buse J.B. et al. Management of Hyperglycemia in Type 2 Diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes // Diabetes Care. 2015; 38: 140-149.
7. Stratton I.M., Adler A.I., Neil H.A. et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study // BMJ. 2000; 321:405-412.
8. DCCT. Lifetime benefits and costs of intensive therapy as practiced in the Diabetes Control and Complications Trial // JAMA. 1996; 276: 1409-1415.
9. Turner R.C., Cull C.A., Frighi V., Holman R.R. 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.
10. Holman R.R., Paul S.K., Bethel M.A. et al. 10-Year Follow-up of Intensive Glucose Control in Type 2 Diabetes // N.Engl.J.Med. 2008; 359:1577-1589.
11. Riddle M.C., Rosenstock J., Gerich J. The treat-to-target trial randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients // Diabetes Care. 2003; 26: 3080-3086.
12. Owens D.R., Matfin G., Monnier L. Basal insulin analogues in the management of diabetes mellitus: What progress have we made? // Diabetes Metab Res Rev. 2014; 30 (2): 104-119.
13. Porcellati F., Rossetti P., Busciantella N.R. et al. Comparison of pharmacokinetics and dynamics of the long-acting insulin analogs Glargine and Detemir at steady state in Type 1 Diabetes a double-blind, randomized, crossover study // Diabetes Care. 2007; 30: 2447-2452.
14. Abalî S., Turan S., Atay Z. et al. Higher insulin detemir doses are required for the similar glycemic control: comparison of insulin detemir and glargine in children with type 1 diabetes mellitus // Pediatr. Diabetes. 2015; 16: 361-366.
15. Bryant G.A., McDanel D.L., Horner K.E. et al. Evaluation of dosing and clinical outcomes in patients undergoing conversion of insulin glargine to insulin detemir // Pharmacother. J. Hum. Pharmacol. Drug Ther. 2013; 33: 56-62.
16. Инструкция по применению лекарственного препарата для медицинского применения Туджео СолоСтар [http://grls.rosminzdrav.ru, обращение к ресурсу 02.08.2016].
17. Steinstraesser A., Schmidt R., Bergmann K. et al. Investigational new insulin glargine 300 U/ml has the same metabolism as insulin glargine 100 U/ml // Diabetes Obes. Metab. 2014; 16: 873-876.
18. Becker R.H., Dahmen R., Bergmann K. et al. New insulin glargine 300 units- mL- 1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 units- mL- 1 // Diabetes Care. 2015; 38: 637-643.
19. Becker R.H.A., Nowotny I., Teichert L. et al. Low within-and between-day variability in exposure to new insulin glargine 300 U/ml // Diabetes Obes. Metab. 2015; 17: 261-267.
20. Home P.D., Bergenstal R.M., Bolli G.B. et al. New insulin glargine 300 units/ml versus glargine 100 units/mL in people with type 1 diabetes: a randomized, phase 3a, open-label clinical trial (EDITION 4) // Diabetes Care. 2015; 38: 2217-2225.
21. Riddle M.C., Yki-J?rvinen H., Bolli G.B. et al. One-year sustained glycaemic control and less hypoglycaemia with new insulin glargine 300 U/ml compared with 100 U/ml in people with type 2 diabetes using basal plus meal-time insulin: the EDITION 1 12-month randomized trial, including 6-month extension // Diabetes Obes. Metab. 2015; 17: 835-842.
22. Bolli G.B., Riddle M.C., Bergenstal R.M. et al. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naïve people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). // Diabetes Obes. Metab. 2015;17:386-394.
23. Ritzel R., Roussel R., Bolli G.B. et al. Patient-level meta-analysis of the EDITION 1, 2 and 3 studies: glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus glargine 100 U/ml in people with type 2 diabetes // Diabetes Obes. Metab. 2015; 17: 859-867.
24. Yki-Järvinen H., Bergenstal R., Ziemen M. et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2) // Diabetes Care. 2014; 37: 3235-3243.
25. Riddle M.C., Bolli G.B., Home P.D. et al. Efficacy and safety of flexible versus fixed dosing intervals of insulin glargine 300 U/mL in people with Type 2 Diabetes // Diabetes Technology & Therapeutics. 2016; 18 (4): 252-257.
26. Riddle M.C., Bolli G.B., Ziemen M. et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1) // Diabetes Care. 2014; 37: 2755-2762.
27. Frier B.M. How hypoglycaemia can affect the life of a person with diabetes // Diabetes Metab. Res. Rev. 2008; 24: 87-92.
28. The ORIGIN trial investigators et al. Basal insulin glargine and microvascular outcomes in dysglycaemic individuals: results of the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial // Diabetologia. 2014; 57 (7): 1325-1331.
29. Becker R.H., Dahmen R., Bergmann K. et al. New insulin glargine 300 Units • mL-1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 Units • mL-1, Diabetes Care. 2015 Apr; 38 (4): 637-43.
30. Wallace J.P., Wallace J.L., McFarland M.S. Comparing dosing of basal insulin analogues detemir and glargine is it really unit-per-unit and dose-per-dose? // Ann Pharmacother. 2014; 48 (3): 361-368.
31. Rosenstock J., Davies M., Home P.D. et al. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes // Diabetologia. 2008; 51 (3): 408-416.
32. Hollander P., Cooper J., Bregnhoj J. et al. A 52-week, multinational, open-label, parallel group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes // Clin Ther. 2008; 30:1976-1987.
33. Swinnen S.G., Snoek F.J., Dain M.P. et al. Rationale, design, and baseline data of the insulin glargine (Lantus) versus insulin detemir (Levemir) Treat-To-Target (L2T3) study: A multinational, randomized noninferiority trial of basal insulin initiation in type 2 diabetes // Diabetes Technol Ther. 2009; 11 (11): 739-773.
34. Meneghini L., Kesavadev J., Demissie M. et al. Once-daily initiation of basal insulin as add-on to metformin: a 26-week, randomized, treat-to-target trial comparing insulin detemir with insulin glargine in patients with type 2 diabetes // Diabetes Obes Metab. 2013; 15 (8): 729-736.
35. http://grls.rosminzdrav.ru, обращение к ресурсу 10.08.2016
36. Guillermin A.-L., Samyshkin Y., Wright D. et al. Modeling the lifetime costs of insulin glargine and insulin detemir in type 1 and type 2 diabetes patients in Canada: a meta-analysis and a cost-minimization analysis. J. Med. Econ. 2011;14, 207-216.
37. Dailey G., Admane K., Mercier F., Owens D. Comparing Insulin Glargine (GLAR) with Insulin Detemir (DET)-effects of A1c lowering on weight change and insulin dose in patients (pts) with Type 2 Diabetes (T2D) // Diabetes. 2009; 58: A128.
38. Pollock R., Erny-Albrecht K., Kalsekar A. et al. Long-acting insulin analogs: a review of 'real-world’ effectiveness in patients with type 2 diabetes // Curr. Diabetes Rev. 2011:7,61-74.
39. Белоусов Д.Ю., Зырянов С.К. Клинико-экономический анализ базальных аналогов инсулина при сахарном диабете 2 типа в условиях реальной практики // Качественная Клиническая Практика. 2012; 2: 22-32.
40. Дедов И.И., Шестакова М.В., Аметов А.С. и соавт. Консенсус совета экспертов Российской ассоциации эндокринологов по инициации и интенсификации сахароснижающей терапии у больных сахарным диабетом 2 типа // Сахарный Диабет. 2011; 1: 95-105.
41. Колбин А.С., Мосикян А.А., Курылев А.А. и соавт. Клинико-экономический анализ ликсисенатида при сахарном диабете 2 типа // Качественная клиническая практика. 2015; 4: 53-64.
42. Постановление Правительства Российской Федерации №1382 от 19 декабря 2015 г «О Программе государственных гарантий бесплатного оказания гражданам медицинской помощи на 2016 год» [http://consultant.ru]
43. Глинкина И.В. LOTUS2: Наблюдательное исследование эффективности и безопасности терапии инсулином гларгин (лантус) в повседневной клинической практике у пациентов с сахарным диабетом 2-го типа, не достигших целевого гликемического контроля на терапии инсулином детемир // Проблемы Эндокринологии. 2013; 59: 25-31.
44. Дедов И.И., Омельяновский В.В., Шестакова М.В. и соавт. Сахарный диабет как экономическая проблема в Российской Федерации // Сахарный диабет. 2016; 1: 30-43.
Review
For citations:
Belousov D.Yu., Afanasyeva E.V. The economic prognosis of the new analog of insulin glargine usage in diabetes mellitus type 2. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2016;(2):5-13. (In Russ.)
Views:
1301
Email this article 