esketamine hydrochloride


( Last Updated : April 30, 2021)
Generic Name:
esketamine hydrochloride
Project Status:
Complete
Therapeutic Area:
Major depressive disorder (MDD), adults
Manufacturer:
Janssen Inc.
Call for patient/clinician input open:
Brand Name:
Spravato
Project Line:
Reimbursement Review
Project Number:
SR0621-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC

Details


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
Fee Schedule:
Schedule A
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.
Recommendation Type:
Do not reimburse
Final Recommendation:
  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 posted May 27, 2019
Patient group input closed July 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 February 11, 2020
Patient group comments on input summary closed February 19, 2020
Submission received June 24, 2019
Submission accepted July 09, 2019
Review initiated July 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 sponsor April 30, 2020
Comments from sponsor on draft CADTH review report(s) received May 11, 2020
CADTH review team's comments on draft CADTH review report(s) sent to sponsor June 05, 2020
Canadian Drug Expert Committee (CDEC) meeting June 17, 2020
CDEC recommendation sent to sponsor and drug plans July 02, 2020
Embargo period ended August 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 agenda December 09, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans December 16, 2020
CDEC Final Recommendation posted December 18, 2020
Redaction requests from sponsor on draft CADTH review report(s) received January 07, 2021
Redacted CADTH review report(s) sent to sponsor and drug plans January 19, 2021
Validation of redacted CADTH review report(s) received January 26, 2021
Final CADTH review report(s) posted April 29, 2021