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
- 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 |