CADTH | Evidence Driven
CADTH | Evidence Driven

zilucoplan

Details

Generic Name:
zilucoplan
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:
SR0838-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of refractory gMG in adult patients who are AChR antibody positive, and not achieving symptom control after: an adequate trial of two or more immunosuppressive therapies (ISTs), either in combination or as a monotherapy in the previous 12 months, OR at least one IST and chronic plasmapheresis, plasma exchange (PLEX) or intravenous immunoglobulin (IVIg)
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​For the for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
  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 openJanuary 12, 2024
Call for patient/clinician input closedMarch 11, 2024
Clarification:

- Patient input submission received from Muscular Dystrophy Canada

Submission receivedFebruary 29, 2024
Submission acceptedMarch 14, 2024
Review initiatedMarch 18, 2024
Draft CADTH review report(s) provided to sponsor for commentJune 03, 2024
Deadline for sponsors commentsJune 12, 2024
CADTH review report(s) and responses to comments provided to sponsorJuly 12, 2024
Expert committee meeting (initial)July 24, 2024
Draft recommendation issued to sponsorAugust 06, 2024
To
August 08, 2024
Draft recommendation posted for stakeholder feedbackAugust 15, 2024
End of feedback periodAugust 29, 2024
Last Updated : March 20, 2024