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esketamine hydrochloride

Last Updated: November 18, 2020
Result type: Reports
Project Number: SR0621-000
Product Line: Reimbursement Review

Generic Name: esketamine hydrochloride

Brand Name: Spravato

Manufacturer: Janssen Inc.

Therapeutic Area: Major depressive disorder (MDD), adults

Indications: Indicated in combination with a SSRI or SNRI, for the treatment of major depressive disorder in adults who have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current moderate to severe depressive episode.

Manufacturer Requested Reimbursement Criteria1: Indicated in combination with a SSRI or SNRI, for the treatment of major depressive disorder in adults who have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current moderate to severe depressive episode.

Submission Type: Initial

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 plansJuly 02, 2020
Embargo period endedAugust 14, 2020
Clarification:

- Request for extension to embargo period received from the sponsor

- Embargo extension request granted

- Reconsideration requested

Sponsor's request for reconsideration placed on CDEC agendaDecember 09, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans-
CDEC Final Recommendation posted-
Redaction requests from sponsor on draft CADTH review report(s) received-
Redacted CADTH review report(s) sent to sponsor and drug plans-
Validation of redacted CADTH review report(s) received-
Final CADTH review report(s) posted-