risdiplam


( Last Updated : May 6, 2021)
Generic Name:
risdiplam
Project Status:
Active
Therapeutic Area:
Spinal muscular atrophy
Manufacturer:
Hoffmann La-Roche Ltd.
Brand Name:
Evrysdi
Project Line:
Reimbursement Review
Project Number:
SR0661-000

Details


Manufacturer Requested Reimbursement Criteria1:
For the treatment of spinal muscular atrophy (SMA) in patients 2 months and older.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​For the treatment of spinal muscular atrophy (SMA) in patients 2 months and older.
  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/clinician input openOctober 22, 2020
Call for patient/clinician input closedDecember 10, 2020
Clarification:

- Patient input submission received from Cure SMA Canada and Muscular Dystrophy Canada

Submission receivedNovember 19, 2020
Submission acceptedDecember 03, 2020
Review initiatedDecember 04, 2020
Draft CADTH review report(s) provided to sponsor for commentMarch 08, 2021
Deadline for sponsors commentsMarch 17, 2021
CADTH review report(s) and responses to comments provided to sponsorApril 09, 2021
CADTH responses on draft review report(s) provided to sponsorApril 09, 2021
Expert committee meeting (initial)April 21, 2021
Draft recommendation issued to sponsorMay 05, 2021
Draft recommendation posted for stakeholder feedbackMay 13, 2021
End of feedback periodMay 28, 2021
Clarification:

- Reconsideration: major revisions requested by drug programs

Expert committee meetingJuly 21, 2021