incobotulinumtoxinA


( Last Updated : October 1, 2021)
Generic Name:
incobotulinumtoxinA
Project Status:
Active
Therapeutic Area:
Chronic sialorrhea associated with neurological disorders
Manufacturer:
Merz Pharmaceuticals GMBH
Brand Name:
Xeomin
Project Line:
Reimbursement Review
Project Number:
SR0678-000
NOC Status at Filing:
Post NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For the treatment of chronic sialorrhea associated with neurological disorders in adults.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of chronic sialorrhea associated with neurological disorders in adults.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
  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/clinician input open28-Jan-21
Call for patient/clinician input closed19-Mar-21
Clarification:

- Patient input submission received from Parkinson Québec

Submission received26-Feb-21
Submission accepted12-Mar-21
Review initiated15-Mar-21
Draft CADTH review report(s) provided to sponsor for comment01-Jun-21
Deadline for sponsors comments10-Jun-21
CADTH responses on draft review report(s) provided to sponsor09-Jul-21
Expert committee meeting (initial)21-Jul-21
Draft recommendation issued to sponsor04-Aug-21
Draft recommendation posted for stakeholder feedback12-Aug-21
End of feedback period26-Aug-21
Final recommendation issued to sponsor and drug plans09-Sep-21
Final recommendation posted27-Sep-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)23-Sep-21
CADTH review report(s) posted