Last Updated : January 15, 2025
Details
FilesGeneric Name:
zilucoplan
Project Status:
Active
Therapeutic Area:
Generalized myasthenia gravis (gMG)
Manufacturer:
UCB Canada Inc.
Call for patient/clinician input open:
Brand Name:
Zilbrysq
Project Line:
Reimbursement Review
Project Number:
SR0838-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Not applicable due to external delays - Temporary suspension and/or submission of new information by sponsor
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of refractory 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:
indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. Patients continued to receive standard therapy throughout the pivotal trial.
- 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.
| Call for patient/clinician input open | 12-Jan-24 |
|---|---|
| Call for patient/clinician input closed | 11-Mar-24 |
| Clarification: - Patient input submission received from Muscular Dystrophy Canada | |
| Submission received | 29-Feb-24 |
| Submission accepted | 14-Mar-24 |
| Review initiated | 18-Mar-24 |
| Clarification: - Submission temporarily suspended | |
| Draft CADTH review report(s) provided to sponsor for comment | 11-Oct-24 |
| Clarification: - Additional information has been received and the temporary suspension of the review has been lifted | |
| Deadline for sponsors comments | 23-Oct-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 15-Nov-24 |
| Expert committee meeting (initial) | 27-Nov-24 |
| Draft recommendation issued to sponsor | 10-Dec-24 |
| Draft recommendation posted for stakeholder feedback | 19-Dec-24 |
| End of feedback period | 10-Jan-25 |
| Final recommendation issued to sponsor and drug plans | 23-Jan-25 |
| Final recommendation posted | - |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 07-Feb-25 |
| CADTH review report(s) posted | - |
Files
Last Updated : January 15, 2025