CDA | Evidence Driven
CDA | Evidence Driven

rozanolixizumab

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Generic Name:
rozanolixizumab
Project Status:
Active
Therapeutic Area:
Generalized myasthenia gravis (gMG)
Manufacturer:
UCB Canada Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0846-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As an add-on therapy for the treatment of adult patients with gMG who are either acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) antibody positive and for whom symptoms persist despite conventional therapy with acetylcholinesterase inhibitors (AChEIs), corticosteroids, and/or non-steroidal immunosuppressive therapies (NSISTs).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of generalized myasthenia gravis (gMG) in adult patients.
  1. 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 open21-Mar-24
Call for patient/clinician input closed13-May-24
Submission received02-Aug-24
Submission accepted-
Review initiated20-Aug-24
Draft CADTH review report(s) provided to sponsor for comment28-Nov-24
Deadline for sponsors comments09-Dec-24
CADTH review report(s) and responses to comments provided to sponsor10-Jan-25
Expert committee meeting (initial)22-Jan-25
Draft recommendation issued to sponsorFebruary 04, 2025
To
February 06, 2025
Draft recommendation posted for stakeholder feedback13-Feb-25
End of feedback period28-Feb-25

Files

Patient and Clinician Group Input View PDF
Last Updated : September 3, 2024