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

teplizumab

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Generic 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.
  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 open08-Jan-25
Call for patient/clinician input closed03-Mar-25
Submission received19-Feb-25
Submission accepted05-Mar-25
Review initiated06-Mar-25
Draft CADTH review report(s) provided to sponsor for comment23-May-25
Deadline for sponsors comments03-Jun-25
CADTH review report(s) and responses to comments provided to sponsor11-Jul-25
Expert committee meeting (initial)23-Jul-25
Draft recommendation issued to sponsorAugust 05, 2025
To
August 07, 2025
Draft recommendation posted for stakeholder feedback14-Aug-25
End of feedback period28-Aug-25

Files

Patient and Clinician Group input View PDF
Last Updated : March 6, 2025