Last Updated : April 30, 2021
Details
FilesGeneric 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
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Biosimilar:
No
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:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency 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 |
Files
Last Updated : April 30, 2021