Last Updated : April 1, 2021
Details
FilesGeneric Name:
Levetiracetam
Project Status:
Complete
Therapeutic Area:
Epilepsy
Manufacturer:
Pendopharm, a division of Pharmascience Inc.
Call for patient/clinician input open:
Brand Name:
pdp-levETIRAcetam
Project Line:
Reimbursement Review
Project Number:
SR0653-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For patients on levetiracetam that cannot intake solid oral tablets.
Submission Type:
Initial
Fee Schedule:
Schedule C
Indications:
Adjunctive therapy for: Adults management of patients with epilepsy who are not satisfactorily controlled by conventional therapyPediatrics partial onset seizures with or without secondary generalization in adolescents, children and infants from 1 month of age with epilepsy. myoclonic seizures in adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. primary generalized tonic-clonic seizures in adolescents from 12 years of age with Idiopathic Generalized Epilepsy.
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 input open | June 17, 2020 |
| Call for patient input closed | August 07, 2020 |
| Clarification:
- No patient input submission received |
|
| Submission received | July 17, 2020 |
| Submission accepted | August 05, 2020 |
| Clarification:
- Submission was not accepted for review on 31 Jul 2020 - Revised category 1 requirements received on 31 Jul 2020 |
|
| Review initiated | August 06, 2020 |
| Draft CADTH review report(s) provided to sponsor for comment | October 27, 2020 |
| Deadline for sponsors comments | November 05, 2020 |
| CADTH responses on draft review report(s) provided to sponsor | November 27, 2020 |
| Expert committee meeting (initial) | December 09, 2020 |
| Draft recommendation issued to sponsor | December 22, 2020 |
| End of embargo period | January 13, 2021 |
| Clarification:
- Reconsideration requested - Request for reconsideration was withdrawn by the sponsor |
|
| Final recommendation issued to sponsor and drug plans | February 03, 2021 |
| Final recommendation posted | February 08, 2021 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 18, 2021 |
| CADTH review report(s) posted | March 31, 2021 |
Files
Last Updated : April 1, 2021