cannabidiol

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Generic Name:
cannabidiol
Project Status:
Active
Therapeutic Area:
Seizures associated with Tuberous Sclerosis Complex (TSC)
Manufacturer:
Jazz Pharmaceuticals Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Epidiolex
Project Line:
Reimbursement Review
Project Number:
SR0798-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Jazz Pharmaceuticals Canada Inc. are requesting CADTH review this for: the adjunctive therapy with other anti-seizure medications for the treatment of seizures associated with TSC in patients two years of age and older.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Epidiolex is indicated as adjunctive therapy with other anti-seizure medications for the treatment of seizures associated with Tuberous Sclerosis Complex (TSC) in patients 2 years 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 18, 2023
Call for patient/clinician input closedOctober 17, 2023
Clarification:

- Patient input submission received from the Canadian Epilepsy Alliance

Submission receivedSeptember 29, 2023
Submission acceptedOctober 17, 2023
Review initiatedOctober 18, 2023
Draft CADTH review report(s) provided to sponsor for commentJanuary 09, 2024
Deadline for sponsors commentsJanuary 18, 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-