Last Updated : November 15, 2024
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:
Zilbrysq
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:
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 | December 09, 2024 To December 11, 2024 |
| Draft recommendation posted for stakeholder feedback | 19-Dec-24 |
| End of feedback period | 10-Jan-25 |
Last Updated : November 15, 2024