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Last Updated: April 24, 2019
Result type: Reports
Project Number: SR0573-000
Product Line: Reimbursement Review

Generic Name: edaravone

Brand Name: Radicava

Manufacturer: Mitsubishi Tanabe Pharma Corporation

Therapeutic Area: amyotrophic lateral sclerosis

Indications: amyotrophic lateral sclerosis

Manufacturer Requested Reimbursement Criteria1: For the treatment of amyotrophic lateral sclerosis (ALS).

Submission Type: Initial

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: March 27, 2019

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

  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 postedMay 25, 2018
Patient group input closedJuly 16, 2018

- Patient input submission received from the ALS Society of Canada

Patient input summary sent for review to patient input groupsJuly 31, 2018
Patient group comments on input summary closedAugust 08, 2018

- Patient input summary feedback received

Submission receivedJuly 05, 2018
Submission accepted for reviewJuly 19, 2018
Review initiatedJuly 20, 2018
Draft CADTH review report(s) sent to applicantOctober 04, 2018
Comments from applicant on draft CADTH review report(s) receivedOctober 16, 2018
Redaction requests from applicant on draft CADTH review report(s) receivedOctober 23, 2018
CADTH review team's comments on draft CADTH review report(s) sent to applicantNovember 09, 2018
Canadian Drug Expert Committee (CDEC) meetingNovember 21, 2018
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plansDecember 05, 2018
Embargo period ended and validation of redacted CADTH review report(s) receivedJanuary 24, 2019

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested

Applicant's request for reconsideration placed on CDEC agendaMarch 20, 2019
CDEC Final Recommendation issued to applicant and drug plansMarch 27, 2019
CDEC Final Recommendation postedMarch 29, 2019
Final CADTH review report(s) and patient input postedApril 24, 2019