Last Updated : April 9, 2020
Details
FilesGeneric Name:
vortioxetine hydrobromide
Project Status:
Complete
Therapeutic Area:
Major depressive disorder (MDD), adults.
Manufacturer:
Lundbeck Canada Inc.
Call for patient/clinician input open:
Brand Name:
Trintellix
Project Line:
Reimbursement Review
Project Number:
SR0611-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of major depressive disorder (MDD) in adults.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Major depressive disorder (MDD), adults.
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 Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2 |
|
|---|---|
| Call for patient input posted | April 02, 2019 |
| Patient group input closed | May 23, 2019 |
| Clarification:
- Patient input submission received from Canadian Mental Health Association and Canadian Mental Health Association Alberta, Hope and Me-Mood Disorders Association of Canada, Mood Disorders Society of Canada and Stigma-Free Society |
|
| Patient input summary sent for review to patient input groups | June 06, 2019 |
| Patient group comments on input summary closed | June 13, 2019 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | May 01, 2019 |
| Submission accepted | May 15, 2019 |
| Review initiated | May 16, 2019 |
| Draft CADTH review report(s) sent to sponsor | July 31, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | August 12, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | September 06, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | September 18, 2019 |
| CDEC recommendation sent to sponsor and drug plans | October 01, 2019 |
| Embargo period ended | October 31, 2019 |
| Clarification:
- Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested |
|
| Sponsor's request for reconsideration placed on CDEC agenda | January 15, 2020 |
| CDEC recommendation sent to sponsor and drug plans | January 22, 2020 |
| Embargo period ended | February 05, 2020 |
| CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans | February 12, 2020 |
| CDEC Final Recommendation posted | February 14, 2020 |
| Redaction requests from sponsor on draft CADTH review report(s) received | February 27, 2020 |
| Redacted CADTH review report(s) sent to sponsor and drug plans | March 11, 2020 |
| Validation of redacted CADTH review report(s) received | March 18, 2020 |
| Final CADTH review report(s) posted | April 08, 2020 |
Files
Last Updated : April 9, 2020