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
- 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 posted | May 25, 2018 |
| Patient group input closed | July 16, 2018 |
| Clarification: - Patient input submission received from the ALS Society of Canada | |
| Patient input summary sent for review to patient input groups | July 31, 2018 |
| Patient group comments on input summary closed | August 08, 2018 |
| Clarification: - Patient input summary feedback received | |
| Submission received | July 05, 2018 |
| Submission accepted for review | July 19, 2018 |
| Review initiated | July 20, 2018 |
| Draft CADTH review report(s) sent to applicant | October 04, 2018 |
| Comments from applicant on draft CADTH review report(s) received | October 16, 2018 |
| Redaction requests from applicant on draft CADTH review report(s) received | October 23, 2018 |
| CADTH review team's comments on draft CADTH review report(s) sent to applicant | November 09, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | November 21, 2018 |
| CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans | December 05, 2018 |
| Embargo period ended and validation of redacted CADTH review report(s) received | January 24, 2019 |
| Clarification: - Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested | |
| Applicant's request for reconsideration placed on CDEC agenda | March 20, 2019 |
| CDEC Final Recommendation issued to applicant and drug plans | March 27, 2019 |
| CDEC Final Recommendation posted | March 29, 2019 |
| Final CADTH review report(s) and patient input posted | April 24, 2019 |