Last Updated : May 15, 2020
Details
FilesGeneric Name:
safinamide
Project Status:
Complete
Therapeutic Area:
Parkinson's disease
Manufacturer:
Valeo Pharma Inc.
Call for patient/clinician input open:
Brand Name:
Onstryv
Project Line:
Reimbursement Review
Project Number:
SR0617-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Onstryv (safinamide tablets) is indicated as an add-on therapy to a regimen that includes levodopa for the treatment of the signs and symptoms of idiopathic Parkinson’s disease (PD) in patients experiencing off episodes while on a stable dose of levodopa. Onstryv has not been shown to be effective as monotherapy for the treatment of PD.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Parkinson's disease
Date NOC Issued:
Recommendation Type:
Do not reimburse
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 | April 30, 2019 |
| Patient group input closed | June 19, 2019 |
| Clarification:
- Patient input submission received from Parkinson Canada and Parkinson Society of BC |
|
| Patient input summary sent for review to patient input groups | June 26, 2019 |
| Patient group comments on input summary closed | July 04, 2019 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | May 29, 2019 |
| Submission accepted | June 12, 2019 |
| Review initiated | June 18, 2019 |
| Draft Canada's Drug Agency review report(s) sent to sponsor | September 03, 2019 |
| Comments from sponsor on draft Canada's Drug Agency review report(s) received | September 12, 2019 |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor | October 03, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | October 16, 2019 |
| CDEC recommendation sent to sponsor and drug plans | October 28, 2019 |
| Embargo period ended | December 09, 2019 |
| Clarification:
- Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested |
|
| Sponsor's request for reconsideration placed on CDEC agenda | March 18, 2020 |
| CDEC Final Recommendation & Canada's Drug Agency review report(s) issued to sponsor and drug plans | March 25, 2020 |
| CDEC Final Recommendation posted | March 27, 2020 |
| Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received | April 09, 2020 |
| Redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans | April 21, 2020 |
| Validation of redacted Canada's Drug Agency review report(s) received | April 28, 2020 |
| Final Canada's Drug Agency review report(s) posted | May 15, 2020 |
Files
Last Updated : May 15, 2020