risdiplam

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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

Performance Metric:

Achieved

Biosimilar:

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:

August 26, 2021

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 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