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esketamine hydrochloride

Last Updated: March 25, 2020
Result type: Reports
Project Number: SR0621-000
Product Line: Common Drug Review

Generic Name: esketamine hydrochloride

Brand Name: TBC

Manufacturer: Janssen Inc.

Indications: Major depressive disorder (MDD), adults

Manufacturer Requested Reimbursement Criteria1: Esketamine hydrochloride is indicated for the treatment of Major Depressive Disorder in adults who have not responded adequately to at least two different antidepressants of adequate dose and duration in the current depressive episode.

Submission Type: New

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

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 postedMay 27, 2019
Patient group input closedJuly 16, 2019
Clarification:

- Patient input submission received from the Canadian Mental Health Association, National; Canadian Mental Health Association, Alberta Division; Mood Disorders Association of Ontario and the Mood Disorders Society of Canada

Patient input summary sent for review to patient input groupsFebruary 11, 2020
Patient group comments on input summary closedFebruary 19, 2020
Submission receivedJune 24, 2019
Submission acceptedJuly 09, 2019
Review initiatedJuly 10, 2019
Clarification:

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been lifted

Draft CADTH review report(s) sent to sponsorApril 30, 2020
Comments from sponsor on draft CADTH review report(s) receivedMay 11, 2020
CADTH review team's comments on draft CADTH review report(s) sent to sponsorJune 05, 2020
Canadian Drug Expert Committee (CDEC) meetingJune 17, 2020
CDEC recommendation sent to sponsor and drug plansJune 29, 2020
To
July 02, 2020