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Last Updated: December 22, 2020
Result type: Reports
Project Number: SR0653-000
Product Line: Reimbursement Review

Generic Name: Levetiracetam

Brand Name: pdp-levETIRAcetam

Manufacturer: Pendopharm, a division of Pharmascience Inc.

Therapeutic Area: Epilepsy

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.

Manufacturer Requested Reimbursement Criteria1: For patients on levetiracetam that cannot intake solid oral tablets.

Submission Type: Initial

NOC Status at Filing: Post NOC

Project Status: Active

Companion Diagnostics: No

Fee Schedule: Schedule C

  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 input openJune 17, 2020
Call for patient input closedAugust 07, 2020

- No patient input submission received

Submission receivedJuly 17, 2020
Submission acceptedAugust 05, 2020

- Submission was not accepted for review on 31 Jul 2020

- Revised category 1 requirements received on 31 Jul 2020

Review initiatedAugust 06, 2020
Draft CADTH review report(s) provided to sponsor for commentOctober 27, 2020
Deadline for sponsors commentsNovember 05, 2020
CADTH responses on draft review report(s) provided to sponsorNovember 27, 2020
Expert committee meeting (initial)December 09, 2020
Draft recommendation issued to sponsorDecember 22, 2020
End of embargo periodJanuary 13, 2021

- Reconsideration requested

- Reconsideration request under assessment by CADTH