Canada’s Drug Agency | Drugs, Health Technologies and Systems.

teprotumumab

Details

Files
Generic Name:
teprotumumab
Project Status:
Active
Therapeutic Area:
Thyroid Eye Disease (TED), active
Manufacturer:
Amgen Canada Inc.
Call for patient/clinician input open:
Brand Name:
Tepezza
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:
Tepezza (teprotumumab for injection) is indicated in adults for the treatment of moderate to severe active Thyroid Eye Disease (TED).
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
Tepezza (teprotumumab for injection) is indicated in adults for the treatment of moderate to severe active Thyroid Eye Disease (TED).
  1. 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 Milestones2
Call for patient/clinician input open12-Sep-24
Call for patient/clinician input closed04-Nov-24
Submission received25-Oct-24
Submission accepted08-Nov-24
Review initiated12-Nov-24
Draft CADTH review report(s) provided to sponsor for comment07-Feb-25
Deadline for sponsors comments19-Feb-25
CDA-AMC review report(s) and responses to comments provided to sponsor13-Mar-25
Expert committee meeting (initial)26-Mar-25
Draft recommendation issued to sponsor-
Clarification:

- CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements.

Draft recommendation posted for stakeholder feedback-
End of feedback period-

Files

Patient and Clinician Group Input View PDF
Last Updated : April 23, 2025