Last Updated : June 18, 2019
Details
FilesGeneric 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:
- 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 |
Files
Last Updated : June 18, 2019