Generic Name: safinamide
Brand Name: Onstryv
Manufacturer: Valeo Pharma Inc.
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: New
Project Status: Active
Fee Schedule: Schedule A
- 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.
|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 for review||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|
October 30, 2019