Last Updated : April 18, 2024
Details
FilesGeneric Name:
cannabidiol
Project Status:
Active
Therapeutic Area:
Dravet Syndrome (DS)
Manufacturer:
Jazz Pharmaceuticals Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Epidiolex
Project Line:
Reimbursement Review
Project Number:
SR0799-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As adjunctive therapy for seizures associated with DS in patients two years of age and older.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
EPIDIOLEX® (cannabidiol) is indicated for use as adjunctive therapy for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) or Dravet Syndrome (DS) or Tuberous Sclerosis Complex (TSC) in patients one year of age and older.
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Call for patient/clinician input open | August 14, 2023 |
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Call for patient/clinician input closed | October 10, 2023 |
Clarification: - Patient input submission received from the Canadian Epilepsy Alliance | |
Submission received | September 25, 2023 |
Submission accepted | October 11, 2023 |
Review initiated | October 12, 2023 |
Draft CADTH review report(s) provided to sponsor for comment | January 03, 2024 |
Deadline for sponsors comments | January 12, 2024 |
CADTH review report(s) and responses to comments provided to sponsor | February 15, 2024 |
Expert committee meeting (initial) | February 28, 2024 |
Draft recommendation issued to sponsor | March 12, 2024 |
Draft recommendation posted for stakeholder feedback | March 21, 2024 |
End of feedback period | April 08, 2024 |
Final recommendation issued to sponsor and drug plans | April 18, 2024 |
Final recommendation posted | - |
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | May 03, 2024 |
CADTH review report(s) posted | - |
Files
Last Updated : April 18, 2024