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Nusinersen

Last Updated: December 5, 2018
Result type: Reports
Project Number: SR0576-000
Product Line: Common Drug Review

Generic Name: Nusinersen

Brand Name: Spinraza

Manufacturer: Biogen Canada Inc.

Indications: Spinal Muscular Atrophy

Manufacturer Requested Reimbursement Criteria1: That nusinersen be reimbursed for the treatment of 5q SMA across all types (including presymptomatic patients and all ages).

Submission Type: Resubmission

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

Fee Schedule: Schedule B

  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 postedJune 22, 2018
Patient group input closedAugust 14, 2018
Patient input summary sent for review to patient input groupsSeptember 04, 2018
Patient group comments on input summary closedSeptember 11, 2018
Clarification:

- Patient input summary feedback received

Submission receivedJuly 24, 2018
Submission accepted for reviewAugust 08, 2018
Review initiatedAugust 09, 2018
Clarification:

- Selected for participation in CADTH/INESSS Clinical Engagement Pilot

Draft CDR review report(s) sent to applicantOctober 15, 2018
Comments from applicant on draft CDR review report(s) receivedOctober 29, 2018
Redaction requests from applicant on draft CDR review report(s) receivedNovember 20, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantNovember 09, 2018
Canadian Drug Expert Committee (CDEC) meetingNovember 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansDecember 05, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedDecember 19, 2018

Tags

genetics, nervous system, pediatrics, muscular atrophy, spinal, musculoskeletal, spinal muscular atrophy; nusinersen; Spinraza