CDA | Evidence Driven
CDA | Evidence Driven

garadacimab

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Generic Name:
garadacimab
Project Status:
Active
Therapeutic Area:
Hereditary angioedema (HAE)
Manufacturer:
CSL Behring Canada Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0860-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Routine prevention of attacks of hereditary angioedema (HAE) in adult and pediatric patients (aged 12 years and older).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Routine prevention of attacks of hereditary angioedema (HAE) in adult and pediatric patients (aged 12 years and older).
  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 open10-Jun-24
Call for patient/clinician input closed02-Aug-24
Submission received31-Jul-24
Submission accepted-
Review initiated16-Aug-24
Draft CADTH review report(s) provided to sponsor for comment01-Nov-24
Deadline for sponsors comments13-Nov-24
CADTH review report(s) and responses to comments provided to sponsor06-Dec-24
Expert committee meeting (initial)18-Dec-24
Draft recommendation issued to sponsorJanuary 07, 2025
To
January 09, 2025
Draft recommendation posted for stakeholder feedback16-Jan-25
End of feedback period31-Jan-25

Files

Patient and Clinician Group input View PDF
Last Updated : August 21, 2024