Last Updated : September 21, 2020
Details
FilesGeneric Name:
siponimod
Project Status:
Complete
Therapeutic Area:
Secondary progressive multiple sclerosis
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Mayzent
Project Line:
Reimbursement Review
Project Number:
SR0631-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Application held awaiting decision by Health Canada
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features characteristic of multiple sclerosis inflammatory activity, to delay the progression of physical disability.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Secondary progressive multiple sclerosis
Recommendation Type:
Reimburse with clinical criteria and/or conditions
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 | August 28, 2019 |
| Patient group input closed | October 18, 2019 |
| Clarification:
- Patient input submission received from the Multiple Sclerosis Society of Canada |
|
| Patient input summary sent for review to patient input groups | October 28, 2019 |
| Patient group comments on input summary closed | November 04, 2019 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | September 26, 2019 |
| Submission accepted | October 10, 2019 |
| Review initiated | October 11, 2019 |
| 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 | June 29, 2020 |
| Embargo period ended | July 14, 2020 |
| CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans | July 21, 2020 |
| CDEC Final Recommendation posted | July 23, 2020 |
| Redaction requests from sponsor on draft CADTH review report(s) received | August 05, 2020 |
| Redacted CADTH review report(s) sent to sponsor and drug plans | August 17, 2020 |
| Validation of redacted CADTH review report(s) received | August 24, 2020 |
| Final CADTH review report(s) posted | September 17, 2020 |
Files
Last Updated : September 21, 2020