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esketamine hydrochloride

Last Updated: August 9, 2019
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: Suspended

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 groups-
Patient group comments on input summary closed-
Submission receivedJune 24, 2019
Submission accepted for reviewJuly 09, 2019
Review initiatedJuly 10, 2019
Clarification:

- Submission temporarily suspended

Draft CADTH review report(s) sent to applicantSeptember 24, 2019
Comments from applicant on draft CADTH review report(s) receivedOctober 03, 2019
CADTH review team's comments on draft CADTH review report(s) sent to applicantNovember 08, 2019
Canadian Drug Expert Committee (CDEC) meetingNovember 20, 2019
CDEC recommendation sent to applicant and drug plansDecember 02, 2019
To
December 04, 2019