siponimod

Details

Files
Generic 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:
  1. 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