Generic Name: risdiplam
Brand Name: Evrysdi
Manufacturer: Hoffmann La-Roche Ltd.
Therapeutic Area: Spinal muscular atrophy
Indications: For the treatment of spinal muscular atrophy (SMA) in patients 2 months and older.
Manufacturer Requested Reimbursement Criteria1: For the treatment of spinal muscular atrophy (SMA) in patients 2 months and older.
Submission Type: Initial
NOC Status at Filing: Pre NOC
Project Status: Active
Companion Diagnostics: No
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/clinician input open | October 22, 2020 |
| Call for patient/clinician input closed | December 10, 2020 |
| Clarification:
- Patient input submission received from Cure SMA Canada and Muscular Dystrophy Canada |
|
| Submission received | November 19, 2020 |
| Submission accepted | December 03, 2020 |
| Review initiated | December 04, 2020 |
| Draft CADTH review report(s) provided to sponsor for comment | March 08, 2021 |
| Deadline for sponsors comments | March 17, 2021 |
| CADTH responses on draft review report(s) provided to sponsor | April 09, 2021 |
| Expert committee meeting (initial) | April 21, 2021 |
| Draft recommendation issued to sponsor | May 05, 2021 |
| Draft recommendation posted for stakeholder feedback | May 13, 2021 |
| End of feedback period | May 28, 2021 |