edaravone

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Generic Name:

edaravone

Project Status:

Complete

Therapeutic Area:

Amyotrophic lateral sclerosis

Manufacturer:

Mitsubishi Tanabe Pharma Canada, Inc.

Brand Name:

Radicava

Project Line:

Reimbursement Review

Project Number:

SR0727-000

NOC Status at Filing:

Pre NOC

Performance Metric:

N/A delay outside our control - Application held awaiting decision by Health Canada

Biosimilar:

Manufacturer Requested Reimbursement Criteria¹:

Radicava (injection) and Radicava (oral suspension) are indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).

Submission Type:

Initial

Fee Schedule:

Schedule C

Tumour Type:

N/A

Indications:

Radicava (injection) and Radicava (oral suspension) are indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

December 22, 2022

The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Key Milestones²
Milestones title	Date
Call for patient/clinician input open	February 09, 2022
Call for patient/clinician input closed	April 01, 2022
Clarification: - Patient input submission received from The ALS Society of Canada
Submission received	March 10, 2022
Submission accepted	March 24, 2022
Review initiated	March 25, 2022
Draft CADTH review report(s) provided to sponsor for comment	June 09, 2022
Deadline for sponsors comments	June 20, 2022
CADTH review report(s) and responses to comments provided to sponsor	July 15, 2022
Expert committee meeting (initial)	July 27, 2022
Draft recommendation issued to sponsor	November 16, 2022
Draft recommendation posted for stakeholder feedback	November 24, 2022
End of feedback period	December 08, 2022
Final recommendation issued to sponsor and drug plans	December 22, 2022
Final recommendation posted	January 17, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	January 13, 2023
CADTH review report(s) posted	February 24, 2023

Last Updated : February 24, 2023