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nusinersen

Last Updated: January 12, 2018
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

Key Milestones2

Call for patient input posted3June 01, 2017
Patient group input closed3July 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 CDR review report(s) sent to applicantOctober 02, 2017
Comments from applicant on draft CDR review report(s) receivedOctober 12, 2017
Redaction requests from applicant on draft CDR review report(s) receivedOctober 19, 2017
CDR review team's comments on draft CDR review report(s) sent to applicantNovember 03, 2017
Canadian Drug Expert Committee (CDEC) meetingNovember 15, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansNovember 29, 2017
Embargo4 period ended and validation of redacted CDR review report(s) receivedDecember 13, 2017
CDEC Final Recommendation issued to applicant and drug plansDecember 20, 2017
CDEC Final Recommendation posted5December 22, 2017
Final CDR review report(s) and patient input posted5January 10, 2018

Tags

muscular atrophy, spinal, spinal muscular atrophies of childhood, parkinson, Spinraza; nusinersen; spinal muscular atrophy; spinal amyotrophy