Abstract
Objective: To determine the cost effectiveness of fondaparinux sodium compared with enoxaparin sodium for prophylaxis against venous thromboembolism in patients undergoing major orthopaedic surgery.
Methods: Using a cohort simulation model, two primary analyses were conducted from the perspective of the US healthcare payer. Probabilities for a trial-based analysis were obtained from patients participating in the fondaparinux clinical trial programme supplemented with data from published literature. Probabilities for a label-based analysis were estimated for a hypothetical cohort of US patients receiving either fondaparinux or enoxaparin as recommended by US FDA-approved labelling. Resource use and costs were obtained from large US healthcare databases. Outcome measures were rates of symptomatic thromboembolic events and healthcare costs. Costs were in 2003 values.
Results: In the trial-based analysis, fondaparinux was estimated to prevent 15.1 symptomatic venous thromboembolic events (per 1000 patients) at 3 months for patients undergoing major orthopaedic surgery compared with enoxaparin. The cost savings (per patient) of using fondaparinux over enoxaparin are $US61 at 30 days, $US89 at 3 months, and $US155 at 5 years. In the label-based analysis, fondaparinux was estimated to prevent 17.8 venous thromboembolic events (per 1000 patients) at 3 months compared with enoxaparin, producing savings per patient of $US25 at discharge, $US112 over 1 month, $US141 over 3 months and $US234 over 5 years. Results remain robust to clinically plausible variation in input parameters and assumptions.
Conclusions: Our model suggests that fondaparinux, when compared with the current standard regimen of enoxaparin for prophylaxis of venous thromboembolism in major orthopaedic surgery, improves outcomes and is cost saving from a US healthcare-payer perspective over the broad range of assumptions evaluated.
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Notes
The use of trade names is for product identification purposes only and does not imply endorsement.
Calculated using actual numbers of patients enrolled in the fondaparinux clinical trials programme and meeting the criteria previously defined for the specific purpose of our analysis.
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Acknowledgements
We thank the international economic advisory board involved in the construction of this economic model: Chair — Sean Sullivan (health economist, USA), Lars Borris (orthopaedic surgeon, Denmark), Patrick Bossuyt (clinical epidemiologist, The Netherlands), Bruce Davidson (pulmonary and critical care medicine, USA), Bengt Jönsson (health economist, Sweden), Susan Kahn (clinical epidemiologist, Canada), Emile Levy (health economist, France), James E. Muntz (haemato-orthopaedic surgeon, USA), Gerard de Pouvourville (health economist, France), and Gary E. Raskob (clinical epidemiologist, USA). We also thank John Posnett, Adam Gordois and Dan Ollendorf for their assistance in the construction of the economic model.
This study was supported by a grant from Sanofi-Synthelabo, Paris, France and Organon NV, Oss, The Netherlands.
The authors have served as paid consultants for the manufacturer of fondaparinux (Sanofi Synthelabo and Organon NV) and the comparator (enoxaparin) used in the analyses (Aventis).
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Sullivan, S.D., Davidson, B.L., Kahn, S.R. et al. A Cost-Effectiveness Analysis of Fondaparinux Sodium Compared with Enoxaparin Sodium as Prophylaxis Against Venous Thromboembolism. PharmacoEconomics 22, 605–620 (2004). https://doi.org/10.2165/00019053-200422090-00005
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DOI: https://doi.org/10.2165/00019053-200422090-00005