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Last Updated: March 31, 2021
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: Complete

Companion Diagnostics: No

Date Recommendation Issued: February 3, 2021

Recommendation Type: Reimburse with clinical criteria and/or conditions

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 open June 17, 2020
Call for patient input closed August 07, 2020

- No patient input submission received

Submission received July 17, 2020
Submission accepted August 05, 2020

- 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

- 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- Request for reconsideration was withdrawn by the sponsor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