Canada’s Drug Agency | Drugs, Health Technologies and Systems.
Canada’s Drug Agency | Drugs, Health Technologies and Systems.

cannabidiol

Details

Files
Generic Name:
cannabidiol
Project Status:
Complete
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
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Jazz Pharmaceuticals Canada Inc. are requesting Canada's Drug Agency 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 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 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 Canada's Drug Agency review report(s) provided to sponsor for comment09-Jan-24
Deadline for sponsors comments18-Jan-24
Canada's Drug Agency 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 Canada's Drug Agency review report(s)03-May-24
Canada's Drug Agency review report(s) posted23-Jul-24

Files

Recommendation and Reasons View PDF
Patient and Clinician Group input View PDF
Clinical and Pharmacoeconomic Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : July 23, 2024