Soliqua (insulin glargine and lixisenatide; iGlarLixi) is an antidiabetic drug containing a fixedratio combination of insulin glargine (100 units/mL), a basal insulin, and lixisenatide (33 mcg/mL), a glucose-like peptide-1 (GLP-1) receptor agonist. iGlarLixi is indicated as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus (T2DM) inadequately controlled on less than 60 units/day of basal insulin, with or without metformin. It is administered as a once-daily subcutaneous injection via a pre-filled pen injector. The dose is individualized according to clinical response. The starting dose is selected according to the basal insulin dose in the previous regimen but should not exceed the recommend starting dose of lixisenatide (i.e., 10 mcg). At the manufacturer’s submitted price of $37.96 for a 3 mL pre-filled pen (equivalent to 300 units insulin glargine and 100 mcg lixisenatide), the annual treatment cost of iGlarLixi is estimated to vary between $693 and $2,770, depending on the dose administered.

CADTH reviewed lixisenatide in 2017 and recommended reimbursement, provided lixisenatide cost does not exceed the cost of the least costly pharmacotherapy reimbursed for T2DM in combination with basal insulin (with or without metformin). The manufacturer’s insulin glargine formulation (Lantus) was first reviewed by CADTH in September 2005 and was not recommended for reimbursement. A resubmission by the manufacturer resulted in a negative recommendation in March 2006 as well. Since then, several public programs have included insulin glargine in their formulary. In March 2016, a subsequent entry biologic formulation of insulin glargine was recommended by CADTH to be reimbursed in a similar manner as Lantus.

The manufacturer submitted a cost-utility analysis comparing iGlarLixi (47 units), with or without metformin, with a regimen containing basal insulin (47 units) once daily, together with rapid-acting insulin three times daily (88 units daily; basal-prandial three times daily), with or without metformin, from the perspective of the Canadian health care payer.

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. Reviewer Worksheets
• References

Version: Final (with redactions)

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