Canada’s Drug Agency | Drugs, Health Technologies and Systems.
Canada’s Drug Agency | Drugs, Health Technologies and Systems.

nusinersen

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Generic Name:
nusinersen
Project Status:
Complete
Therapeutic Area:
Spinal Muscular Atrophy
Manufacturer:
Biogen Canada Inc.
Brand Name:
Spinraza
Project Line:
Reimbursement Review
Project Number:
SR0713-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Biogen Canada Inc. requests that the previous Canada's Drug Agency-recommended criteria (see project SR0576-000) for Spinraza be expanded to include adult type II & type III patients older than 18 years of age regardless of ambulatory status.
Submission Type:
Reassessment
Fee Schedule:
Schedule A
Indications:
Spinraza (nusinersen) is indicated for the treatment of 5q Spinal Muscular Atrophy (SMA).
Recommendation Type:
Do not reimburse
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input open04-Nov-21
Call for patient/clinician input closed05-Jan-22
Clarification:

- Patient input submission received from Cure SMA Canada, Muscular Dystrophy Canada and The Love for Lewiston Foundation

Submission received02-Dec-21
Submission accepted16-Dec-21
Review initiated17-Dec-21
Draft Canada's Drug Agency review report(s) provided to sponsor for comment15-Mar-22
Deadline for sponsors comments24-Mar-22
Canada's Drug Agency review report(s) and responses to comments provided to sponsor14-Apr-22
Expert committee meeting (initial)27-Apr-22
Draft recommendation issued to sponsor10-May-22
Draft recommendation posted for stakeholder feedback19-May-22
End of feedback period03-Jun-22
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting27-Jul-22
Final recommendation issued to sponsor and drug plans11-Aug-22
Final recommendation posted29-Aug-22
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)25-Aug-22
Canada's Drug Agency review report(s) posted08-Nov-22

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, and Stakeholder Input combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : November 8, 2022