risdiplam


( Last Updated : November 3, 2021)
Generic Name:
risdiplam
Project Status:
Complete
Therapeutic Area:
Spinal muscular atrophy
Manufacturer:
Hoffmann La-Roche Ltd.
Brand Name:
Evrysdi
Project Line:
Reimbursement Review
Project Number:
SR0661-000
NOC Status at Filing:
Pre NOC

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.
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input open 22-Oct-20
Call for patient/clinician input closed 10-Dec-20
Clarification:

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

Submission received 19-Nov-20
Submission accepted 03-Dec-20
Review initiated 04-Dec-20
Draft CADTH review report(s) provided to sponsor for comment 08-Mar-21
Deadline for sponsors comments 17-Mar-21
CADTH responses on draft review report(s) provided to sponsor 09-Apr-21
Expert committee meeting (initial) 21-Apr-21
Draft recommendation issued to sponsor 05-May-21
Draft recommendation posted for stakeholder feedback 13-May-21
End of feedback period 28-May-21
Clarification:

- Reconsideration: major revisions requested by drug programs

Expert committee meeting 21-Jul-21
Final recommendation issued to sponsor and drug plans 05-Aug-21
Final recommendation posted 26-Aug-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) 19-Aug-21
CADTH review report(s) posted 01-Nov-21