Generic Name:
Project Status:
Therapeutic Area:
Parkinson's disease
Valeo Pharma Inc.
Call for patient/clinician input open:
Brand Name:
Project Line:
Reimbursement Review
Project Number:
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
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:
Fee Schedule:
Schedule A
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 posted April 30, 2019
Patient group input closed June 19, 2019

- 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

- Patient input summary feedback received

Submission received May 29, 2019
Submission accepted June 12, 2019
Review initiated June 18, 2019
Draft CADTH review report(s) sent to sponsor September 03, 2019
Comments from sponsor on draft CADTH review report(s) received September 12, 2019
CADTH review team's comments on draft CADTH 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

- 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 & CADTH 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 CADTH review report(s) received April 09, 2020
Redacted CADTH review report(s) sent to sponsor and drug plans April 21, 2020
Validation of redacted CADTH review report(s) received April 28, 2020
Final CADTH review report(s) posted May 15, 2020