insulin degludec

Details

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Generic Name:
insulin degludec
Project Status:
Complete
Therapeutic Area:
Diabetes mellitus, Type 1 & 2
Manufacturer:
Novo Nordisk Canada Inc.
Call for patient/clinician input open:
Brand Name:
Tresiba
Project Line:
Reimbursement Review
Project Number:
SR0521-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Diabetes mellitus, Type 1 & 2
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:

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