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vortioxetine hydrobromide

Last Updated: April 8, 2020
Result type: Reports
Project Number: SR0611-000
Product Line: Reimbursement Review

Generic Name: vortioxetine hydrobromide

Brand Name: Trintellix

Manufacturer: Lundbeck Canada Inc.

Indications: Major depressive disorder (MDD), adults.

Manufacturer Requested Reimbursement Criteria1: For the treatment of major depressive disorder (MDD) in adults.

Submission Type: Initial

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: February 12, 2020

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

  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 postedApril 02, 2019
Patient group input closedMay 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 groupsJune 06, 2019
Patient group comments on input summary closedJune 13, 2019
Clarification:

- Patient input summary feedback received

Submission receivedMay 01, 2019
Submission acceptedMay 15, 2019
Review initiatedMay 16, 2019
Draft CADTH review report(s) sent to sponsorJuly 31, 2019
Comments from sponsor on draft CADTH review report(s) receivedAugust 12, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorSeptember 06, 2019
Canadian Drug Expert Committee (CDEC) meetingSeptember 18, 2019
CDEC recommendation sent to sponsor and drug plansOctober 01, 2019
Embargo period endedOctober 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 agendaJanuary 15, 2020
CDEC recommendation sent to sponsor and drug plansJanuary 22, 2020
Embargo period endedFebruary 05, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansFebruary 12, 2020
CDEC Final Recommendation postedFebruary 14, 2020
Redaction requests from sponsor on draft CADTH review report(s) receivedFebruary 27, 2020
Redacted CADTH review report(s) sent to sponsor and drug plansMarch 11, 2020
Validation of redacted CADTH review report(s) receivedMarch 18, 2020
Final CADTH review report(s) postedApril 08, 2020