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apomorphine hydrochloride

Last Updated: March 19, 2019
Result type: Reports
Project Number: SR0604-000
Product Line: Common Drug Review

Generic Name: apomorphine hydrochloride

Brand Name: Kynmobi

Manufacturer: Sunovion Pharmaceuticals Canada Inc.

Indications: Parkinson’s Disease

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: New

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

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 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 groups-
Patient group comments on input summary closed-
Submission receivedFebruary 25, 2019
Submission accepted for reviewMarch 11, 2019
Review initiatedMarch 12, 2019
Draft CDR review report(s) sent to applicantMay 27, 2019
Comments from applicant on draft CDR review report(s) receivedJune 05, 2019
Redaction requests from applicant on draft CDR review report(s) receivedJune 12, 2019
CDR review team's comments on draft CDR review report(s) sent to applicantJuly 05, 2019
Canadian Drug Expert Committee (CDEC) meetingJuly 17, 2019
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJuly 29, 2019
To
July 31, 2019

Tags

nervous system, parkinson