CADTH | Evidence Driven
CADTH | Evidence Driven

cannabidiol

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Generic Name:
cannabidiol
Project Status:
Active
Therapeutic Area:
Lennox-Gastaut Syndrome (LGS)
Manufacturer:
Jazz Pharmaceuticals Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Epidiolex
Project Line:
Reimbursement Review
Project Number:
SR0800-000
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 LGS 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.
  1. 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.
Key Milestones2
Call for patient/clinician input openAugust 10, 2023
Call for patient/clinician input closedSeptember 29, 2023
Clarification:

-Patient input submission received from the Canadian Epilepsy Alliance

Submission receivedSeptember 20, 2023
Submission acceptedOctober 05, 2023
Review initiatedOctober 06, 2023
Draft CADTH review report(s) provided to sponsor for commentDecember 21, 2023
Deadline for sponsors commentsJanuary 09, 2024
CADTH review report(s) and responses to comments provided to sponsorFebruary 15, 2024
Expert committee meeting (initial)February 28, 2024
Draft recommendation issued to sponsorMarch 12, 2024
Draft recommendation posted for stakeholder feedbackMarch 21, 2024
End of feedback periodApril 08, 2024
Final recommendation issued to sponsor and drug plansApril 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

Draft Recommendation View PDF
Last Updated : April 18, 2024