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:
No
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:
  1. 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
Call for patient/clinician input openFebruary 09, 2022
Call for patient/clinician input closedApril 01, 2022
Clarification:

- Patient input submission received from The ALS Society of Canada

Submission receivedMarch 10, 2022
Submission acceptedMarch 24, 2022
Review initiatedMarch 25, 2022
Draft CADTH review report(s) provided to sponsor for commentJune 09, 2022
Deadline for sponsors commentsJune 20, 2022
CADTH review report(s) and responses to comments provided to sponsorJuly 15, 2022
Expert committee meeting (initial)July 27, 2022
Draft recommendation issued to sponsorNovember 16, 2022
Draft recommendation posted for stakeholder feedbackNovember 24, 2022
End of feedback periodDecember 08, 2022
Final recommendation issued to sponsor and drug plansDecember 22, 2022
Final recommendation postedJanuary 17, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)January 13, 2023
CADTH review report(s) postedFebruary 24, 2023