Last Updated : April 18, 2019
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:
SR0576-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
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:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency 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 |
Files
Last Updated : April 18, 2019