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Economic Evaluation of Enoxaparin for Anticoagulation in Early Cardioversion of Persisting Nonvalvular Atrial Fibrillation

A Statutory Health Insurance Perspective from Germany

  • Original Research Article
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Abstract

Objective

To estimate, from the perspective of Statutory Health Insurance (SHI, third-party payer) in Germany, the economic consequences of using the subcutaneous low-molecular-weight heparin (LMWH) enoxaparin instead of intravenous unfractionated heparin followed by oral phenprocoumon (UFH/PPC) for anticoagulation in patients undergoing transesophageal echocardiography (TEE)-guided early electrical cardioversion (ECV) of persisting nonvalvular atrial fibrillation (AF) without intracardiac clot.

Design and setting

The incremental cost for the enoxaparin-based regimen versus the UFH/PPC-based regimen was chosen as the target variable. A decision-analytic model considering the in- and outpatient sectors was used to quantify the target variable. Resource use during in- and outpatient treatment was taken from the Anticoagulation in Cardioversion using Enoxaparin (ACE) trial and from expert interviews with cardiologists in Germany in order to reflect the day-to-day conditions of clinical practice. Costs were given by SHI expenses for inpatient treatment and for medical services, drugs, disposables, and laboratory tests during outpatient treatment. These costs were determined by multiplying utilized resource items by the price or tariff of each item based on German healthcare regulations for the reference period of 2003/2004. According to the ACE trial, the evaluation encompassed 28 (26–30) treatment days with two consecutive phases. Phase I with 5 (3–12) days comprised diagnostics, start of anticoagulation, and ECV. Phase II with the remaining days consisted of continued anticoagulation and patient monitoring. The dosage of enoxaparin was 1 mg/kg bodyweight twice daily in treatment phase I followed by 40mg twice daily with a bodyweight <65kg or 60mg twice daily with a BW ≥65kg in treatment phase II. The daily dosages of UFH by continuous infusion and overlapping PPC were adjusted to an International Normalized Ratio of 2.0–3.0 in treatment phase I followed by 2.25mg PPC once daily in treatment phase II. Patients with any comorbidity and complication level (CCL) and those with low comorbidity and complications expected to occur in rare cases only (low-risk patients) were analyzed separately. In each base-case analysis, exclusively point estimates of all respective model parameters were applied. Main outcome measures and results: There were savings of €339 and €579 per patient receiving the enoxaparin-based regimen versus the UFH/PPC-based regimen in the case of patients with any CCL and of low-risk patients, respectively (€1 ≈ $US1.25; first quarter 2004 values). In comprehensive sensitivity analyzes, the robustness of the model and its results was shown. First, the impact of the model parameters on the target variable for each patient group was quantified in a deterministic model. Secondly, the dependency of the target variable on random variables was described for each patient group using Monte Carlo simulation. Irrespective of the patient group, the cost weight and the base rate of hospitals for inpatient ECV in phase I turned out to have the greatest impact on the savings obtained by the enoxaparin-based regimen. In the case of patients with any CCL, this impact was about 1.4-fold of that of the probability of enoxaparin patients undergoing outpatient ECV in phase I. In the case of low-risk patients, the impact of the cost weight and the base rate of hospitals for inpatient ECV in phase I was about 4.1-fold of that of the price of enoxaparin 60mg prefilled syringes in the outpatient sector. In 79% and 93% of 10 000 simulated comparisons each versus the UFH/PPC-based regimen, there were savings obtained by the enoxaparin-based regimen in patients with any CCL and in low-risk patients, respectively.

Conclusions

Results of this evaluation showed that an enoxaparin-based regimen for TEE-guided ECV of AF in patients without intracardiac clot offers SHI in Germany a considerable saving potential when used instead of an UFH/PPC-based regimen.

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Acknowledgments

The authors would like to thank Sanofi-Aventis, Berlin, Germany for funding this study and the cardiologists Heyder Omran, MD, Bonn, Germany and Stefan G. Spitzer, MD, Dresden, Germany for providing information on resource use during early electrical cardioversion of atrial fibrillation in the inand outpatient sectors in Germany. Josef Georg Brecht, PhD, and Peter K. Schàdlich, PhD, are the principals of InForMed GmbH, the contractor of this study. Walter Lehmacher, PhD, Uwe Nixdorff, MD, Caroline Schmidt-Lucke, MD, and Christoph Stellbrink, MD, are members of the Anticoagulation in Cardioversion using Enoxaparin Study Group. Eduard Huppertz, MD, was a salaried employee of Sanofi-Aventis at the time this economic evaluation was conducted and the article was written. The views expressed in this paper, however, are solely those of the authors, who have no conflicts of interest directly relevant to the content of this study.

The main author is Peter K. Schàdlich. Uwe Nixdorff, Caroline Schmidt- Lucke, and Christoph Stellbrink have revised the text and checked for the accuracy of the medical aspects. Josef Georg Brecht, Eduard Huppertz, and Walter Lehmacher have revised the text and checked for the accuracy of the health economic and statistical aspects. All authors have revised the manuscript and approved it.

The information contained in this manuscript has been presented in part at the 7th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research, Hamburg, Germany, October 2004;[72] at the 71st Annual Meeting of the German Cardiac Society, Mannheim, Germany, March 2005;[73] at the European Society of Cardiology Congress 2005, Stockholm, Sweden, September 2005;[74] and is published in part in the German language.[57]

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Authors and Affiliations

  1. InForMed GmbH — Outcomes Research and Health Economics, Bureau Itzehoe, Conrad-Roentgen-Strasse 58 C, D-25524, Itzehoe, Germany

    Peter K. Schädlich & Josef Georg Brecht

  2. Molecular Cardiology, University Hospital, Frankfurt/Main, Germany

    Caroline Schmidt-Lucke

  3. Health Outcomes Consultancy, Niedererbach/Ww, Germany

    Eduard Huppertz

  4. Institute for Medical Statistics, Informatics and Epidemiology, University of Cologne, Cologne, Germany

    Walter Lehmacher

  5. European Prevention Center, Medconsult GmbH, Krefeld, Germany

    Uwe Nixdorff

  6. Medical Clinic II, Städtische Kliniken Bielefeld gGmbH, Bielefeld, Germany

    Christoph Stellbrink

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Schädlich, P.K., Schmidt-Lucke, C., Huppertz, E. et al. Economic Evaluation of Enoxaparin for Anticoagulation in Early Cardioversion of Persisting Nonvalvular Atrial Fibrillation. Am J Cardiovasc Drugs 7, 199–217 (2007). https://doi.org/10.2165/00129784-200707030-00006

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