Generic Name: insulin degludec
Brand Name: Tresiba
Manufacturer: Novo Nordisk Canada Inc.
Therapeutic Area: Diabetes mellitus, Type 1 & 2
Indications: Diabetes mellitus, Type 1 & 2
Submission Type: Initial
Project Status: Complete
Biosimilar: No
Date Recommendation Issued: November 20, 2017
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule A
Key Milestones2 |
|
|---|---|
| Call for patient input posted3 | May 02, 2017 |
| Patient group input closed3 | June 21, 2017 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | July 25, 2017 |
| Patient group comments on input summary closed | August 01, 2017 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | May 31, 2017 |
| Submission accepted for review | June 14, 2017 |
| Review initiated | June 15, 2017 |
| Draft CDR review report(s) sent to applicant | September 01, 2017 |
| Comments from applicant on draft CDR review report(s) received | September 13, 2017 |
| Redaction requests from applicant on draft CDR review report(s) received | September 20, 2017 |
| Clarification:
- No redaction requests from applicant received |
|
| CDR review team's comments on draft CDR review report(s) sent to applicant | October 05, 2017 |
| Canadian Drug Expert Committee (CDEC) meeting | October 18, 2017 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | October 30, 2017 |
| Embargo4 period ended and validation of redacted CDR review report(s) received | November 13, 2017 |
| CDEC Final Recommendation issued to applicant and drug plans | November 20, 2017 |
| CDEC Final Recommendation posted5 | November 22, 2017 |
| Final CDR review report(s) and patient input posted5 | December 15, 2017 |