Generic Name: nusinersen
Brand Name: Spinraza
Manufacturer: Biogen Canada Inc.
Indications: Spinal Muscular Atrophy
Submission Type: New
Project Status: Complete
Biosimilar: No
Date Recommendation Issued: December 22, 2017
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule A
Request for Resubmission: Eligible (May 24, 2018)
Key Milestones2 |
|
|---|---|
| Call for patient input posted3 | June 01, 2017 |
| Patient group input closed3 | 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 for review | July 13, 2017 |
| Review initiated | July 14, 2017 |
| Draft CDR review report(s) sent to applicant | October 02, 2017 |
| Comments from applicant on draft CDR review report(s) received | October 12, 2017 |
| Redaction requests from applicant on draft CDR review report(s) received | October 19, 2017 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | November 03, 2017 |
| Canadian Drug Expert Committee (CDEC) meeting | November 15, 2017 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | November 29, 2017 |
| Embargo4 period ended and validation of redacted CDR review report(s) received | December 13, 2017 |
| CDEC Final Recommendation issued to applicant and drug plans | December 20, 2017 |
| CDEC Final Recommendation posted5 | December 22, 2017 |
| Final CDR review report(s) and patient input posted5 | January 10, 2018 |
Tags
muscular atrophy, spinal, spinal muscular atrophies of childhood, parkinson, nervous system, Spinraza; nusinersen; spinal muscular atrophy; spinal amyotrophy