Edoxaban (Lixiana) is indicated for the treatment of venous thromboembolism (VTE) and the prevention of recurrent VTE.1 The dose is 60 mg once daily. The cost per day of treatment with edoxaban is $2.84.

The manufacturer submitted a cost-utility analysis conducted using a simple Markov model with eight health states: on-treatment after VTE; off-treatment; recurrent VTE; treatment after recurrent VTE; clinically relevant non-major (CRNM) bleed; intracranial hemorrhage (ICH); non-ICH major bleed; and death. In addition, three concomitant events were incorporated to capture complications related to VTE: chronic thromboembolic pulmonary hypertension (CTEPH); severe post-thrombotic syndrome (PTS); and post-ICH. Analysis did not distinguish between deep vein thrombosis (DVT) and pulmonary embolism (PE). Rather, a hybrid state of VTE was used, with results weighted by the proportion of VTE events that were DVT and PE.

There are five comparators considered within the model: edoxaban, warfarin (5 mg once daily), rivaroxaban (60 mg once daily), dabigatran (150 mg twice daily), and apixaban (5 mg twice daily). Analysis comparing edoxaban versus warfarin is conducted through a direct comparison based on the Hokusai–VTE trial. Further comparison with warfarin, rivaroxaban, apixaban, and dabigatran was conducted through a network meta-analysis (NMA) provided by the manufacturer.

Costs for both therapy5 and events were largely obtained from appropriate published articles or relevant databases from Ontario. Utility estimates for health states and events were obtained from relevant published literature.

Contents

• Abbreviations
• Executive Summary
• Informatin on the Pharmacoeconomic Submission
  • 1. Summary of the Manufacturer’s Pharmacoeconomic Submission
  • 2. Manufacturer’s Base Case
  • 3. Summary of Manufacturer’s Sensitivity Analyses
  • 4. Limitations of Manufacturer’s Submission
  • 5. CADTH Common Drug Review Reanalyses
  • 6. Issues for Consideration
  • 7. Patient Input
  • 8. Conclusions
• APPENDIX 1. Cost Comparison
• APPENDIX 2. Summary of Key Outcomes
• APPENDIX 3. Additional Information
• APPENDIX 4. Reviewer Worksheets
• References

This review report was prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH). In addition to CADTH staff, the review team included a clinical expert in hematology who provided input on the conduct of the review and the interpretation of findings.

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