Efinaconazole topical solution 10% w/w (Jublia) is a triazole antifungal agent indicated for the topical treatment of mild-to-moderate onychomycosis (tinea unguium) of toenails without lunula involvement due to Trichophyton rubrum and T. mentagrohytes in immunocompetent adult patients. Efinaconazole is available in 8 mL bottles at a submitted price of $89.04 per bottle. The product monograph recommends applying one drop of the solution topically to the affected toenail(s) once daily, preferably at bedtime, with a second drop applied to the affected great toenail(s). At the recommended dose, a patient with a single affected great toenail would require two bottles over 48 weeks of therapy, i.e., the duration of therapy in the manufacturer’s pivotal clinical trials, at a cost of $178 per patient. A patient with one affected great toenail and three smaller toenails, which is consistent with the median in the pivotal trials of four affected toenails per patient, would require five bottles over the 48-week period, at a cost of $445.

The manufacturer submitted a cost-utility analysis in the form of a decision-tree model comparing efinaconazole as first-line therapy with no treatment in adults with mild-to-moderate onychomycosis.

Contents

• Abbreviations
• Executive Summary
  • Background
  • Summary of Identified Limitations and Key Results
  • Conclusions
• Information on the Pharmacoeconomic Submission
  • Summary of the Manufacturer’s Pharmacoeconomic Submission
  • Manufacturer’s Base Case
  • Summary of Manufacturer’s Sensitivity Analyses
  • Limitations of Manufacturer’s Submission
  • CADTH Common Drug Review Reanalyses
  • Issues for Consideration
  • Patient Input
  • Conclusions
• Appendix 1. Cost Comparison
• Appendix 2. Summary of Key Outcomes
• Appendix 3. Additional Information
• Appendix 4. Summary of Other Health Technology Assessment Reviews of Drug
• Appendix 5. Reviewer Worksheets
• References

Version: Final

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