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Last Updated: September 17, 2020
Result type: Reports
Project Number: SR0631-000
Product Line: Reimbursement Review

Generic Name: siponimod

Brand Name: Mayzent

Manufacturer: Novartis Pharmaceuticals Canada Inc.

Therapeutic Area: Secondary progressive multiple sclerosis

Indications: Secondary progressive multiple sclerosis

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

Project Status: Complete

Companion Diagnostics: No

Date Recommendation Issued: July 21, 2020

Recommendation Type: Reimburse with clinical criteria and/or conditions

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 postedAugust 28, 2019
Patient group input closedOctober 18, 2019

- Patient input submission received from the Multiple Sclerosis Society of Canada

Patient input summary sent for review to patient input groupsOctober 28, 2019
Patient group comments on input summary closedNovember 04, 2019

- Patient input summary feedback received

Submission receivedSeptember 26, 2019
Submission acceptedOctober 10, 2019
Review initiatedOctober 11, 2019
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 plansJune 29, 2020
Embargo period endedJuly 14, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansJuly 21, 2020
CDEC Final Recommendation postedJuly 23, 2020
Redaction requests from sponsor on draft CADTH review report(s) receivedAugust 05, 2020
Redacted CADTH review report(s) sent to sponsor and drug plansAugust 17, 2020
Validation of redacted CADTH review report(s) receivedAugust 24, 2020
Final CADTH review report(s) postedSeptember 17, 2020