apomorphine hydrochloride

Details

Files
Generic Name:
apomorphine hydrochloride
Project Status:
Withdrawn
Therapeutic Area:
Parkinson’s Disease
Manufacturer:
Sunovion Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Kynmobi
Project Line:
Reimbursement Review
Project Number:
SR0604-000
Call for patient/clinician input closed:
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Kynmobi (apomorphine hydrochloride) sublingual film is anon-ergoline dopamine agonist indicated for the acute, intermittent treatment of hypomobility, OFF episodes associated with Parkinson’s disease including end-of-dose wearing OFF (including early morning OFF), partial/delayed/No-ON and unpredictable OFF.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Parkinson’s Disease
  1. 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 postedJanuary 25, 2019
Patient group input closedMarch 18, 2019
Clarification:

- Patient input submission received from the David Phinney Foundation for Parkinson's, Parkinson Association of Alberta, Parkinson Canada, Parkinson Society BC and The Michael J. Fox Foundation for Parkinson's Research

Patient input summary sent for review to patient input groupsMarch 27, 2019
Patient group comments on input summary closedApril 02, 2019
Clarification:

- Patient input summary feedback received

Submission receivedFebruary 25, 2019
Submission acceptedMarch 11, 2019
Review initiatedMarch 12, 2019
Draft CADTH review report(s) sent to sponsorMay 27, 2019
Comments from sponsor on draft CADTH review report(s) receivedJune 05, 2019
Redaction requests from sponsor on draft CADTH review report(s) receivedJune 12, 2019
Clarification:

- Voluntarily withdrawn by the manufacturer on 2019-Jun-19