lixisenatide + insulin glargine

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

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

lixisenatide + insulin glargine

Key Milestones2

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Key Milestones²