CDA | Evidence Driven
CDA | Evidence Driven

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.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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 open18-Aug-23
Call for patient/clinician input closed17-Oct-23
Clarification:

- Patient input submission received from the Canadian Epilepsy Alliance

Submission received29-Sep-23
Submission accepted17-Oct-23
Review initiated18-Oct-23
Draft CADTH review report(s) provided to sponsor for comment09-Jan-24
Deadline for sponsors comments18-Jan-24
CADTH review report(s) and responses to comments provided to sponsor15-Feb-24
Expert committee meeting (initial)28-Feb-24
Draft recommendation issued to sponsor12-Mar-24
Draft recommendation posted for stakeholder feedback21-Mar-24
End of feedback period08-Apr-24
Final recommendation issued to sponsor and drug plans18-Apr-24
Final recommendation posted07-May-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)03-May-24
CADTH review report(s) posted-

Files

Recommendation and Reasons View PDF
Patient and Clinician Group input View PDF
Last Updated : May 10, 2024