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lixisenatide + insulin glargine

Last Updated: December 4, 2018
Result type: Reports
Project Number: SR0564-000
Product Line: Common Drug Review

Generic Name: lixisenatide + insulin glargine

Brand Name: Soliqua

Manufacturer: sanofi-aventis Canada Inc.

Indications: Diabetes mellitus, Type 2

Manufacturer Requested Reimbursement Criteria1: Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when oral glucose-lowering medicinal products combined with basal insulin, or basal insulin alone do not provide adequate glycaemic control.

Submission Type: New Combination

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

Fee Schedule: Schedule A

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input postedMarch 21, 2018
Patient group input closedMay 10, 2018
Patient input summary sent for review to patient input groupsJune 21, 2018
Patient group comments on input summary closedJune 29, 2018
Clarification:

- Patient input summary feedback received

Submission receivedMay 18, 2018
Submission accepted for reviewJune 04, 2018
Review initiatedJune 05, 2018
Draft CDR review report(s) sent to applicantAugust 20, 2018
Comments from applicant on draft CDR review report(s) receivedAugust 29, 2018
Redaction requests from applicant on draft CDR review report(s) receivedSeptember 06, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantOctober 04, 2018
Canadian Drug Expert Committee (CDEC) meetingOctober 17, 2018
Clarification:

- Deferred to November 21, 2018 CDEC meeting

CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansDecember 03, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedDecember 17, 2018

Tags

diabetes mellitus, diabetes, Diabetes; Diabetic; soliqua; suliqua; iglarlixi; Lantus; glargine; lixisenatide; Lyxumia