safinamide


( Last Updated : May 15, 2020)
Generic 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:

Details


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:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input postedApril 30, 2019
Patient group input closedJune 19, 2019
Clarification:

- Patient input submission received from Parkinson Canada and Parkinson Society of BC

Patient input summary sent for review to patient input groupsJune 26, 2019
Patient group comments on input summary closedJuly 04, 2019
Clarification:

- Patient input summary feedback received

Submission receivedMay 29, 2019
Submission acceptedJune 12, 2019
Review initiatedJune 18, 2019
Draft CADTH review report(s) sent to sponsorSeptember 03, 2019
Comments from sponsor on draft CADTH review report(s) receivedSeptember 12, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorOctober 03, 2019
Canadian Drug Expert Committee (CDEC) meetingOctober 16, 2019
CDEC recommendation sent to sponsor and drug plansOctober 28, 2019
Embargo period endedDecember 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 agendaMarch 18, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansMarch 25, 2020
CDEC Final Recommendation postedMarch 27, 2020
Redaction requests from sponsor on draft CADTH review report(s) receivedApril 09, 2020
Redacted CADTH review report(s) sent to sponsor and drug plansApril 21, 2020
Validation of redacted CADTH review report(s) receivedApril 28, 2020
Final CADTH review report(s) postedMay 15, 2020