Evaluation of direct cost in case of insulin GLA-100rgine-100 switching to insulin GLA-100rgine-300 in diabetes mellitus in real clinical practice

Insulin Glargine-300 (GLA-300) is an innovative basal analogue of insulin that has been released into the market in our country and is prescribed to patients with diabetes mellitus (DM). In the real-life practice, GLA-300 is oft en a replacement for the drug of the previous generation - Insulin Glargine-100 (GLA-100) that has been prescribed for more than 10 years and has proved its effi cacy and safety. Government pays for insulins in auctions and tenders, the cost aspects regarding the implementation of GLA-300 in practice are a current problem. According to the aggregated data on patients transferred from GL-100 to GL-300 obtained from the Federal Register of DM of the Russian Federation, the direct costs (DC) for the both types of DM were determined, considering age, complications, and achievement of the target levels of glycated hemoglobin (HbA1c). Th e drugs prices were determined on the basis of the State Register of the Price Ceiling on those medications which are included in the list of the vital and essential medicines (VED). It was found that in case of type 1 diabetes (580 patients), the transfer from GLA-100 to GLA-300 was not accompanied by the transfer from prandial insulin and changes in the total daily dosage of insulins, or HbA1c (59.19 U/day and 59.85 U/day, and HbA1c level was 7.86 % and 7.71 %, respectively). Aft er transferring to GLA-300, the cost of one day of insulin therapy was less by 5.3 %, mainly due to the lower cost of GLA-300 compared to GLA-100 (11.7 % per unit). As for the prandial insulins, insulin aspart (37.4 %) and insulin glulisine (25.5% of prescriptions) were most oft en used. When using GLA-300 + glulisine and GLA-300 + aspart, the levels of HbA1c were similar: 7.71 ± 0.44 % and 7.64 ± 0.48 %, respectively (p< 0.05). Th e cost minimization analysis (CMA) showed the economy cut of 4.5 rubles/day on average when using GLA-300 + insulin glulisine in comparison with GLA-300 + insulin aspart. In type 2 diabetes, 331 patients received monotherapy and 494 patients were given basal + and basal-bolus treatment. In case of monotherapy, daily doses of GLA-100 and GLA-300 did not statistically diff er in both the general study population and in subgroups of patients with and without complications (29.80 U and 30.90 U; 25.61 U and 26.91 U; 30.71 U and 31.63 U, respectively). At the same time, there were no changes in HbA1c levels before and aft er the transfer. CMA showed the reduction in treatment costs by 8.4% when transferring to GLA-300 in the general population and by 9.0% in the group of patients with complications. Th e same dosages of 30.4 U/day of GLA-100 and GLA-300 were used in 42.9% of cases with similar HbA1c levels (7.42 ± 0.33% and 7.42 ± 0.41%, respectively), before and aft er the transfer, and the economy cut upon transferring to GLA-300 in this case amounted to 277.4 thousand rubles/year/100 patients. Th ere were 242 patients aged >60 years (73.1 %). Th e costs of using GLA-300 in this population were 5.2% lower than those when using GLA-100. In a subgroup of patients with complications who reached the target level of HbA1c (153 patients), the dosage of GLA-300 was higher by 1.58 U/day, but the costs for using GLA-300 were 7.2 % lower than those for the therapy with GLA-100. Th e costs for using basal + and basal-bolus schemes in type 2 diabetes decreased by 7.1% aft er the transfer, mainly due to the lower cost of GLA-300 with practically equal dosages of insulins before and aft er the transfer. Conclusion: Th e transfer from GLA-100 to GLA-300 in patients with both types of DM in real-life practice of prescribing these drugs does not require increased dosages, is not accompanied by any changes in HbA1c level, and reduces the direct costs on insulin therapy.

сахарный диабет, инсулин гларгин, фармакоэкономика, анализ минимизации затрат, реальная клиническая практика, исследование потребления лекарств, diabetes mellitus, insulin glargine, pharmacoeconomics Sanofi has supported analysis

1. Дедов И.И., Шестакова М.В., Галстян Г.Р. Распространенность сахарного диабета 2 типа у взрослого населения России (исследование NATION) // Сахарный диабет. 2016; 19 (2): 104-112.

2. Дедов И.И., Концевая А.В., Шестакова М.В. и соавт. Экономические затраты на сахарный диабет 2 типа и его основные сердечно-сосудистые осложнения в Российской Федерации // Сахарный диабет. 2016; 19 (6): 518-527.

3. Kontsevaya A., Karpov O., Shestakova M., Belousov Yu. Economic evaluation of Diabetes Mellitus type 2 and it’s main cardiovascular complications in the Russian Federation // Abstr. ISPOR 22-d International Meeting, May 20-24, 2017, Boston, MA, USA. - Value in Health. - 2017; 20 (5): A374.

4. Омельяновский В.В., Шестакова М.В., Авксентьева М.В. и соавт. Экономические аспекты сахарного диабета в отечественной практике // Медицинские технологии. Оценка и выбор. 2015; 4 (22): 43-60.

5. Белоусов Д.Ю., Афанасьева Е.В. Экономический прогноз применения нового аналога инсулина гларгин при сахарном диабете 2 типа // Качественная клиническая практика. 2016; 2: 5-13.

6. http://grls.rosminzdrav.ru обращение к ресурсу 11.10.2017.

7. Blair H.A., Keating G.M. Insulin glargine 300 U/mL: A Review in Diabetes Mellitus // Drugs. 2016; 76 (3): 363-374.

8. Riddle M.C., Bolli G.B., Ziemen M. et al. New insulin GLA-100rgine 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 (10): 2755-2762.

9. Yki-Jarvinen 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 (12): 3235-3243.

10. Bolli G.B., Riddle M.C., Bergenstal R.M. et al. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulinnaive people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3) // Diabetes Obes. Metab. 2015; 17 (4): 386-394.

11. 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 (4): 637-643.

12. Zhang V., Sauriol L., Glass J. et al. Longitudinal analysis of real-world basal insulin utilization for Type I and Type II diabetes patients transferring to insulin glargine U-300 // SGIM. 2017;32(Suppl. 2):S242.

13. Фармакоэкономика и фармакоэпидемиология - практика приемлемых решений / Ред. В.Б. Герасимов, А.Л. Хохлов, О.И. Карпов. М.: Медицина; 2005; 352.

14. 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; 4: 6-17.

15. Приказ Министерства здравоохранения Российской Федерации от 28 декабря 2012 г. №1581н «Об утверждении стандарта первичной медико-санитарной помощи при инсулиннезависимом сахарном диабете», Зарегистрировано в Минюсте РФ 15 марта 2013 г. Регистрационный № 27719.