CADTH is committed to supporting Canada’s health care decision-makers through this challenging and uncertain time.
For evidence, tools, and resources related to COVID-19, visit our COVID-19 Evidence Portal.


Begin main content


Last Updated: May 15, 2020
Result type: Reports
Project Number: SR0617-000
Product Line: Reimbursement Review

Generic Name: safinamide

Brand Name: Onstryv

Manufacturer: Valeo Pharma Inc.

Therapeutic Area: Parkinson's disease

Indications: Parkinson's disease

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

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: March 25, 2020

Recommendation Type: Do not reimburse

Fee Schedule: Schedule A

  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

- 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

- 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

- 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