Generic Name: nusinersen
Brand Name: Spinraza
Manufacturer: Biogen Canada Inc.
Therapeutic Area: Spinal Muscular Atrophy
Indications: Spinal Muscular Atrophy
Submission Type: Initial
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 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 |