gms | German Medical Science

15. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie

Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie

20.11. - 21.11.2008, Bonn

Cost advantages and improved patient treatment satisfaction with Insulin Glargine in Typ 2 Diabetes patients. The long-acting Insulin Glargine vs. NPH Insulin cost evaluation study in Germany (LIVE-DE)

Kostenvorteile und verbesserte Behandlungszufriedenheit unter Insulin Glargin im Vergleich zu NPH-Insulin bei Typ 2 Diabetikern, Ergebnisse der LIVE-DE Studie

Meeting Abstract

  • Thomas Kohlmann - Institute of Community Medicine, Univ. of Greifswald, Germany
  • corresponding author Johannes Knollmeyer - sanofi-aventis, Berlin, Germany
  • Wolfgang Landgraf - sanofi-aventis, Berlin, Germany
  • Olaf Pirk - IMS Health HEOR, Nuremberg, Germany
  • Hans Hauner - Center for Nutrition Medicine, TU Munich, Germany

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 15. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. Bonn, 20.-21.11.2008. Düsseldorf: German Medical Science GMS Publishing House; 2008. Doc08gaa04

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter:

Veröffentlicht: 6. November 2008

© 2008 Kohlmann et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen ( Er darf vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.



Background and aim: Rational decisions for reimbursement of innovative drugs can’t be derived appropriately from randomized clinical trials alone but also require real-life data to demonstrate overall effectiveness and benefits of a drug. Since such data from countries with different healthcare systems cannot be easily transferred to German conditions, real-life data from Germany were collected.

Materials and methods: LIVE-DE was a non-interventional, cross-sectional, retrospective study performed between February and May 2007 in 199 randomly selected centres of primary care physicians in Germany. The study enrolled 1602 consecutive type 2 diabetes (T2D) patients with statutory health insurance status who were eligible for documentation when either treated with insulin glargine (GLA) or NPH insulin based regimens for at least 6 months prior to documentation. Primary objective was to assess total direct diabetes treatment costs (DTC) derived from antidiabetic medications (insulins, OADs), blood glucose self-monitoring (test strips, lancets), hypoglycemic treatment (glucagon use) and needles for a 6 months period under real-life conditions. Secondary objectives included patient reported outcomes (PRO) using established (DTSQs, SF-12, PAID) and a newly developed questionnaire (Insulin Treatment Experience Questionnaire, ITEQ).

Results: Mean total DTC were 658 ± 258 € and 685 ± 242 € per patient during 6 months in GLA and NPH patients, respectively (mean diff. -27 €, p = 0.001, Wilcoxon Test). Despite higher drug costs for GLA relevant savings were observed in consumption of short-acting insulins (-62 €), test strips (-52 €), and needles (-6 €). GLA patients had on average also fewer basal insulin injections per day (1.09 vs. 1.47) and required less blood glucose self-measurements. Glucagon use for treatment of severe hypoglycemic events was only documented for NPH (4 pts). SF-12 and ITEQ results showed that GLA patients reported significantly better physical well-being and higher satisfaction with insulin treatment. In addition, DTSQs scores indicated slightly better treatment satisfaction in GLA vs. NPH insulin users. General need of care, number of referrals, hospital admissions, glycemic control and demographics were similar in both groups, but NPH was mainly used in a basal-bolus regimen (79%) whereas GLA was frequently prescribed in a basal/OAD (BOT) regimen (43%). After statistical adjustment of these factors, total DTC per patient during 6 months in GLA users were slightly increased compared to NPH (adjusted mean +73 €, p<0.001, ANCOVA) but improved patient satisfaction with GLA remained significant.

Conclusion: Under real-life conditions total DTC are similar in GLA and NPH T2D patients while patient treatment satisfaction is higher with GLA. LIVE-DE provides new evidence to the German healthcare system demonstrating that treatment preferences and reimbursement decisions should adopt a comprehensive perspective including all relevant cost categories and patient-reported outcomes.