incobotulinumtoxinA


( Last Updated : September 15, 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.
  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 open January 28, 2021
Call for patient/clinician input closed March 19, 2021
Clarification:

- Patient input submission received from Parkinson Québec

Submission received February 26, 2021
Submission accepted March 12, 2021
Review initiated March 15, 2021
Draft CADTH review report(s) provided to sponsor for comment June 01, 2021
Deadline for sponsors comments June 10, 2021
CADTH responses on draft review report(s) provided to sponsor July 09, 2021
Expert committee meeting (initial) July 21, 2021
Draft recommendation issued to sponsor August 04, 2021
Draft recommendation posted for stakeholder feedback August 12, 2021
End of feedback period August 26, 2021
Final recommendation issued to sponsor and drug plans September 09, 2021
Final recommendation posted  
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) September 23, 2021
CADTH review report(s) posted