nusinersen


( Last Updated : June 12, 2020)
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:
SR0525-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC

Details

Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Spinal Muscular Atrophy
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:

Request for Resubmission: Eligible (Decision Date: May 24, 2018)

Key Milestones2
Call for patient input posted June 01, 2017
Patient group input closed July 21, 2017
Clarification:

- Patient input submission received
Patient input summary sent for review to patient input groups July 27, 2017
Patient group comments on input summary closed August 04, 2017
Clarification:

- Patient input summary feedback received
Submission received June 28, 2017
Submission accepted July 13, 2017
Review initiated July 14, 2017
Draft CADTH review report(s) sent to sponsor October 02, 2017
Comments from sponsor on draft CADTH review report(s) received October 12, 2017
Redaction requests from sponsor on draft CADTH review report(s) received October 19, 2017
CADTH review team's comments on draft CADTH review report(s) sent to sponsor November 03, 2017
Canadian Drug Expert Committee (CDEC) meeting November 15, 2017
CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plans November 29, 2017
Embargo period ended and validation of redacted CADTH review report(s) received December 13, 2017
CDEC Final Recommendation issued to sponsor and drug plans December 20, 2017
CDEC Final Recommendation posted December 22, 2017
Final CADTH review report(s) and patient input posted January 10, 2018

Files

Recommendations and Reasons

Clinical Report

Pharmacoeconomic Report

Patient Input Summary