CADTH | Evidence Driven
CADTH | Evidence Driven

cenobamate

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Generic Name:
cenobamate
Project Status:
Complete
Therapeutic Area:
Epilepsy, partial-onset seizures
Manufacturer:
Paladin Labs Inc.
Call for patient/clinician input open:
Brand Name:
Xcopri
Project Line:
Reimbursement Review
Project Number:
SR0770-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As an adjunctive therapy for the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
As an adjunctive therapy for the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy.
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 open05-Jan-23
Call for patient/clinician input closed27-Feb-23
Clarification:

- Patient input submission received from the Canadian Epilepsy Alliance, Epilepsy Association of Calgary, Epilepsy Toronto and Epilepsy South Central Ontario

Submission received07-Feb-23
Submission accepted22-Feb-23
Review initiated23-Feb-23
Draft CADTH review report(s) provided to sponsor for comment11-May-23
Deadline for sponsors comments23-May-23
CADTH review report(s) and responses to comments provided to sponsor16-Jun-23
Expert committee meeting (initial)28-Jun-23
Draft recommendation issued to sponsor13-Jul-23
Draft recommendation posted for stakeholder feedback20-Jul-23
End of feedback period03-Aug-23
Final recommendation issued to sponsor and drug plans17-Aug-23
Final recommendation posted11-Sep-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)31-Aug-23
CADTH review report(s) posted29-Nov-23

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : November 29, 2023