Buprenorphine extended-release injection (BUP-ER; Sublocade) is indicated for the management of moderate-to-severe opioid use disorder (OUD) in adult patients who have been inducted and clinically stabilized on the equivalent of 8 mg per day to 24 mg per day of transmucosal buprenorphine-containing product in combination with counselling and psychosocial support. BUP-ER is available as 100 mg and 300 mg single-use pre-filled syringe at a submitted price of $550 for either dose. The recommended dosage schedule is 300 mg injection per month for the first two months followed by maintenance on monthly 100 mg injections. The monthly maintenance dose may be increased to 300 mg if the patient does not demonstrate satisfactory response and can tolerate the 100 mg dose, although the 300 mg maintenance dose in clinical trials did not provide additional efficacy compared with the 100 mg dose and was associated with a higher incidence of adverse events and study discontinuations.

The manufacturer submitted a cost-utility analysis comparing 100 mg and 300 mg BUP-ER (i.e., 300 mg BUP-ER every four weeks for two doses followed by 100 mg or 300 mg BUP-ER monthly) to oral methadone and generic buprenorphine/naloxone in adults with moderate-to-severe OUD.

Contents

• Abbreviations
• Executive Summary
  • Background
  • Summary of Identified Limitations and Key Results
  • Conclusions
• Information on the Pharmacoeconomic Submission
  • Summary of the Manufacturer’s PE Submission
  • Manufacturer’s Base Case
  • Summary of the 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. Additional Information
• Appendix 3. Summary of Other HTA Reviews of Drug
• Appendix 4. Reviewer Worksheets
• References

Version: Final

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