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lixisenatide + insulin glargine

Last Updated: January 3, 2019
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: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: December 24, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

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 posted March 21, 2018
Patient group input closed May 10, 2018
Patient input summary sent for review to patient input groups June 21, 2018
Patient group comments on input summary closed June 29, 2018
Clarification:

- Patient input summary feedback received

Submission received May 18, 2018
Submission accepted for review June 04, 2018
Review initiated June 05, 2018
Draft CDR review report(s) sent to applicant August 20, 2018
Comments from applicant on draft CDR review report(s) received August 29, 2018
Redaction requests from applicant on draft CDR review report(s) received September 06, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant October 04, 2018
Canadian Drug Expert Committee (CDEC) meeting October 17, 2018
Clarification:

- Deferred to November 21, 2018 CDEC meeting

CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans December 03, 2018
Embargo period ended and validation of redacted CDR review report(s) received December 17, 2018
CDEC Final Recommendation issued to applicant and drug plans December 24, 2018
CDEC Final Recommendation posted January 3, 2019
Final CDR review report(s) and patient input posted January 30, 2019

Tags

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