Last Updated : November 14, 2024
Details
FilesGeneric Name:
teprotumumab
Project Status:
Active
Therapeutic Area:
Thyroid Eye Disease (TED), acute
Manufacturer:
Amgen Canada Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0853-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Teprotumumab is indicated in adults for the treatment of moderate to severe Thyroid Eye Disease (TED).
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
Teprotumumab is indicated in adults for the treatment of moderate to severe Thyroid Eye Disease (TED).
- 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.
| Call for patient/clinician input open | 12-Sep-24 |
|---|---|
| Call for patient/clinician input closed | 04-Nov-24 |
| Submission received | 25-Oct-24 |
| Submission accepted | 08-Nov-24 |
| Review initiated | 12-Nov-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 07-Feb-25 |
| Deadline for sponsors comments | 19-Feb-25 |
| CADTH review report(s) and responses to comments provided to sponsor | 13-Mar-25 |
| Expert committee meeting (initial) | 26-Mar-25 |
| Draft recommendation issued to sponsor | April 07, 2025 To April 09, 2025 |
| Draft recommendation posted for stakeholder feedback | 17-Apr-25 |
| End of feedback period | 05-May-25 |
Files
Last Updated : November 14, 2024