Nusinersen

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Generic Name:
Nusinersen
Project Status:
Complete
Therapeutic Area:
Spinal Muscular Atrophy
Manufacturer:
Biogen Canada Inc.
Call for patient/clinician input open:
Brand Name:
Spinraza
Project Line:
Reimbursement Review
Project Number:
SR0576-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
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
Fee Schedule:
Schedule B
Indications:
Spinal Muscular Atrophy
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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 posted June 22, 2018
Patient group input closed August 14, 2018
Patient input summary sent for review to patient input groups September 04, 2018
Patient group comments on input summary closed September 11, 2018
Clarification:

- Patient input summary feedback received

Submission received July 24, 2018
Submission accepted for review August 08, 2018
Review initiated August 09, 2018
Clarification:

- Selected for participation in CADTH/INESSS Clinical Engagement Pilot

Draft CADTH review report(s) sent to applicant October 15, 2018
Comments from applicant on draft CADTH review report(s) received October 29, 2018
Redaction requests from applicant on draft CADTH review report(s) received November 20, 2018
CADTH review team's comments on draft CADTH review report(s) sent to applicant November 09, 2018
Canadian Drug Expert Committee (CDEC) meeting November 21, 2018
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans December 05, 2018
Embargo period ended and validation of redacted CADTH review report(s) received December 19, 2018
Clarification:

- Reconsideration requested

- Clarification requested by CDR-participating drug plans

Applicant's request for reconsideration placed on CDEC agenda February 20, 2019
Drug plans' request for clarification placed on CDEC agenda February 20, 2019
Response to request for clarification and CDEC Final Recommendation sent to applicant and drug plans February 27, 2019
CDEC Final Recommendation posted March 01, 2019
Final CADTH review report(s) posted April 05, 2019