Last Updated : November 12, 2021
Details
FilesGeneric Name:
incobotulinumtoxinA
Project Status:
Complete
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
Biosimilar:
No
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.
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 Milestones | |
|---|---|
| Call for patient/clinician input open | 28-Jan-21 |
| Call for patient/clinician input closed | 19-Mar-21 |
| Clarification: - Patient input submission received from Parkinson Québec | |
| Submission received | 26-Feb-21 |
| Submission accepted | 12-Mar-21 |
| Review initiated | 15-Mar-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 01-Jun-21 |
| Deadline for sponsors comments | 10-Jun-21 |
| CADTH responses on draft review report(s) provided to sponsor | 09-Jul-21 |
| Expert committee meeting (initial) | 21-Jul-21 |
| Draft recommendation issued to sponsor | 04-Aug-21 |
| Draft recommendation posted for stakeholder feedback | 12-Aug-21 |
| End of feedback period | 26-Aug-21 |
| Final recommendation issued to sponsor and drug plans | 09-Sep-21 |
| Final recommendation posted | 27-Sep-21 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 23-Sep-21 |
| CADTH review report(s) posted | 12-Nov-21 |
Files
Last Updated : November 12, 2021