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nusinersen

Last Updated: March 26, 2019
Result type: Reports
Project Number: SR0525-000
Product Line: Common Drug Review

Generic Name: nusinersen

Brand Name: Spinraza

Manufacturer: Biogen Canada Inc.

Indications: Spinal Muscular Atrophy

Submission Type: New

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: December 22, 2017

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

Request for Resubmission: Eligible (May 24, 2018)

Key Milestones2

Call for patient input postedJune 01, 2017
Patient group input closedJuly 21, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsJuly 27, 2017
Patient group comments on input summary closedAugust 04, 2017
Clarification:

- Patient input summary feedback received

Submission receivedJune 28, 2017
Submission accepted for reviewJuly 13, 2017
Review initiatedJuly 14, 2017
Draft CADTH review report(s) sent to applicantOctober 02, 2017
Comments from applicant on draft CADTH review report(s) receivedOctober 12, 2017
Redaction requests from applicant on draft CADTH review report(s) receivedOctober 19, 2017
CADTH review team's comments on draft CADTH review report(s) sent to applicantNovember 03, 2017
Canadian Drug Expert Committee (CDEC) meetingNovember 15, 2017
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plansNovember 29, 2017
Embargo period ended and validation of redacted CADTH review report(s) receivedDecember 13, 2017
CDEC Final Recommendation issued to applicant and drug plansDecember 20, 2017
CDEC Final Recommendation postedDecember 22, 2017
Final CADTH review report(s) and patient input postedJanuary 10, 2018