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Last Updated: April 5, 2019
Result type: Reports
Project Number: SR0576-000
Product Line: Reimbursement Review

Generic Name: Nusinersen

Brand Name: Spinraza

Manufacturer: Biogen Canada Inc.

Therapeutic Area: Spinal Muscular Atrophy

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: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: February 27, 2019

Recommendation Type: Reimburse with clinical criteria and/or conditions

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

- Patient input summary feedback received

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

- Selected for participation in CADTH/INESSS Clinical Engagement Pilot

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

- Reconsideration requested

- Clarification requested by CDR-participating drug plans

Applicant's request for reconsideration placed on CDEC agendaFebruary 20, 2019
Drug plans' request for clarification placed on CDEC agendaFebruary 20, 2019
Response to request for clarification and CDEC Final Recommendation sent to applicant and drug plansFebruary 27, 2019
CDEC Final Recommendation postedMarch 01, 2019
Final CADTH review report(s) postedApril 05, 2019