Last Updated : January 30, 2019
Details
FilesGeneric Name:
lixisenatide + insulin glargine
Project Status:
Complete
Therapeutic Area:
Diabetes mellitus, Type 2
Manufacturer:
sanofi-aventis Canada Inc.
Call for patient/clinician input open:
Brand Name:
Soliqua
Project Line:
Reimbursement Review
Project Number:
SR0564-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Deferral of recommendation by expert committee
Biosimilar:
No
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:
Initial
Fee Schedule:
Schedule A
Indications:
Diabetes mellitus, Type 2
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency 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 |
Files
Last Updated : January 30, 2019