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insulin degludec

Last Updated: January 19, 2018
Result type: Reports
Project Number: SR0521-000
Product Line: Common Drug Review

Generic Name: insulin degludec

Brand Name: Tresiba

Manufacturer: Novo Nordisk Canada Inc.

Indications: Diabetes mellitus, Type 1 & 2

Submission Type: New

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