CDA | Evidence Driven
CDA | Evidence Driven

trofinetide

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Generic Name:
trofinetide
Project Status:
Active
Therapeutic Area:
Rett syndrome (RTT)
Manufacturer:
Acadia Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Daybue
Project Line:
Reimbursement Review
Project Number:
SR0829-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of Rett syndrome (RTT) in adults and pediatric patients 2 years of age and older and weighing at least 9 kg.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule E
Indications:
For the treatment of Rett syndrome (RTT) in adults and pediatric patients 2 years of age and older and weighing at least 9 kg.
  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 open16-Aug-24
Call for patient/clinician input closed15-Oct-24
Submission received29-Oct-24
Submission accepted13-Nov-24
Review initiated14-Nov-24
Draft CADTH review report(s) provided to sponsor for comment05-Feb-25
Deadline for sponsors comments14-Feb-25
CADTH review report(s) and responses to comments provided to sponsor13-Mar-25
Expert committee meeting (initial)26-Mar-25
Draft recommendation issued to sponsorApril 07, 2025
To
April 09, 2025
Draft recommendation posted for stakeholder feedback17-Apr-25
End of feedback period05-May-25

Files

Patient and Clinician Group Input View PDF
Last Updated : November 14, 2024