CDA | Evidence Driven
CDA | Evidence Driven

cannabidiol

Details

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Generic Name:
cannabidiol
Project Status:
Complete
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.
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 open14-Aug-23
Call for patient/clinician input closed10-Oct-23
Clarification:

- Patient input submission received from the Canadian Epilepsy Alliance

Submission received25-Sep-23
Submission accepted11-Oct-23
Review initiated12-Oct-23
Draft CADTH review report(s) provided to sponsor for comment03-Jan-24
Deadline for sponsors comments12-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) posted27-Jun-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 : June 27, 2024