Abstract

BackgroundThe aim of this study was to project health-economic outcomes relevant to the German setting for the addition of pioglitazone to existing treatment regimens in patients with type 2 diabetes, evidence of macrovascular disease and at high risk of cardiovascular events.MethodsEvent rates corresponding to macrovascular outcomes from the Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive) study of pioglitazone were used with a modified version of the CORE Diabetes Model to simulate outcomes over a 35-year time horizon. Direct medical costs were accounted from a healthcare payer perspective in year 2005 values. Germany specific costs were applied for patient treatment, hospitalization and management. Both costs and clinical benefits were discounted at 5.0% per annum.ResultsOver patient lifetimes pioglitazone treatment improved undiscounted life expectancy by 0.406 years and improved quality-adjusted life expectancy by 0.120 quality-adjusted life years (QALYs) compared to placebo. Direct medical costs (treatment plus complication costs) were marginally higher for pioglitazone treatment and calculation of the incremental cost-effectiveness ratio (ICER) produced a value of €13,294 per QALY gained with the pioglitazone regimen versus placebo. Acceptability curve analysis showed that there was a 78.2% likelihood that pioglitazone would be considered cost-effective in Germany, using a "good value for money" threshold of €50,000 per QALY gained. Sensitivity analyses showed that the results were most sensitive to changes in the simulation time horizon. After adjustment for the potential stabilization of pancreatic β-cell function with pioglitazone treatment, the ICER was €6,667 per QALY gained for pioglitazone versus placebo.ConclusionThe findings of this modelling analysis indicated that, for patients with a history of macrovascular disease, addition of pioglitazone to existing therapy reduces the long-term cumulative incidence of diabetes-complications at a cost that would be considered to represent good value for money in the German setting.

Highlights

  • The direct cost of care for patients with diabetes accounts for 14.2% of total health care costs in Germany, and as the number of diagnosed type 2 diabetes patients continues to rise this is likely to increase substantially in the future [1]

  • Life expectancy and quality-adjusted life expectancy The current health-economic analysis indicated that based on clinical findings for PROactive and long-term projections with a modified version of the CORE Diabetes Model, treatment with pioglitazone was associated with improvements in life expectancy and quality-adjusted life expectancy compared to placebo

  • By reducing the unit cost of pioglitazone by 20%, from €736.15 to €588.92, resulted in a lower incremental cost-effectiveness ratio (ICER) of €424 per quality-adjusted life years (QALYs) gained for pioglitazone versus placebo

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Summary

Introduction

The direct cost of care for patients with diabetes accounts for 14.2% of total health care costs in Germany, and as the number of diagnosed type 2 diabetes patients continues to rise this is likely to increase substantially in the future [1]. The cost of diabetes in Germany is not evenly distributed, with approximately 15% of patients being responsible for almost 60% of all direct costs and the presence of diabetes-related complications being the most important driver of increasing costs [1,2]. Based on data relating to 809 patients, the German arm of the Cost of Diabetes in Europe-type 2 (CODE-2) conducted in 1998 identified complications as the greatest contributor to direct costs of diabetes care [4]. The aim of this study was to project health-economic outcomes relevant to the German setting for the addition of pioglitazone to existing treatment regimens in patients with type 2 diabetes, evidence of macrovascular disease and at high risk of cardiovascular events

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