Last Updated : April 16, 2025
Details
FilesGeneric Name:
teplizumab
Project Status:
Active
Therapeutic Area:
Delay onset of Stage 3 Type 1 Diabetes
Manufacturer:
sanofi-aventis Canada Inc.
Call for patient/clinician input open:
Brand Name:
Tzield
Project Line:
Reimbursement Review
Project Number:
SR0867-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
The requested reimbursement criteria is for Tzield (teplizumab) to delay the onset of
Stage 3 Type 1 Diabetes in adult and pediatric patients 8 years of age and older with
Stage 2 Type 1 Diabetes.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
The anticipated indication is to delay the onset of Stage 3 Type 1 Diabetes in adult and
pediatric patients 8 years of age and older with Stage 2 Type 1 Diabetes.
- 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 | January 08, 2025 |
|---|---|
| Call for patient/clinician input closed | March 03, 2025 |
| Submission received | February 19, 2025 |
| Submission accepted | March 05, 2025 |
| Review initiated | March 06, 2025 |
| Draft CADTH review report(s) provided to sponsor for comment | May 23, 2025 |
| Deadline for sponsors comments | June 03, 2025 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | July 11, 2025 |
| Expert committee meeting (initial) | July 23, 2025 |
| Draft recommendation issued to sponsor | August 05, 2025 To August 07, 2025 |
| Draft recommendation posted for stakeholder feedback | August 14, 2025 |
| End of feedback period | August 28, 2025 |
Files
Last Updated : April 16, 2025