vortioxetine hydrobromide

Details

Files
Generic 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:
  1. 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