Last Updated : June 12, 2020
Details
FilesGeneric 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
Biosimilar:
No
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
Last Updated : June 12, 2020