semaglutide

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Generic Name:
semaglutide
Project Status:
Complete
Therapeutic Area:
Diabetes mellitus, type 2
Manufacturer:
Novo Nordisk Canada Inc.
Call for patient/clinician input open:
Brand Name:
Ozempic
Project Line:
Reimbursement Review
Project Number:
SR0594-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adults patients with type 2 diabetes to improve glycemic control, in combination with metformin (second line treatment) and in combination with metformin and sulfonylurea (third line treatment).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Diabetes mellitus, type 2
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  1. 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 October 26, 2018
Patient group input closed December 14, 2018
Clarification:

- Patient input submission received from Diabetes Canada and Patient Commando

Patient input summary sent for review to patient input groups January 07, 2019
Patient group comments on input summary closed January 14, 2019
Clarification:

- Patient input summary feedback received

Submission received November 23, 2018
Submission accepted for review December 07, 2018
Review initiated December 10, 2018
Draft CADTH review report(s) sent to applicant March 05, 2019
Comments from applicant on draft CADTH review report(s) received March 14, 2019
Redaction requests from applicant on draft CADTH review report(s) received March 21, 2019
CADTH review team's comments on draft CADTH review report(s) sent to applicant March 29, 2019
Canadian Drug Expert Committee (CDEC) meeting April 10, 2019
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans April 24, 2019
Embargo period ended and validation of redacted CADTH review report(s) received May 08, 2019
CDEC Final Recommendation issued to applicant and drug plans May 15, 2019
CDEC Final Recommendation posted May 17, 2019
Final CADTH review report(s) posted June 17, 2019