Last Updated : February 20, 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
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.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 | January 12, 2024 |
|---|---|
| Call for patient/clinician input closed | March 11, 2024 |
| Clarification: - Patient input submission received from Muscular Dystrophy Canada | |
| Submission received | February 29, 2024 |
| Submission accepted | March 14, 2024 |
| Review initiated | March 18, 2024 |
| Clarification: - Submission temporarily suspended | |
| Draft CADTH review report(s) provided to sponsor for comment | October 11, 2024 |
| Clarification: - Additional information has been received and the temporary suspension of the review has been lifted | |
| Deadline for sponsors comments | October 23, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | November 15, 2024 |
| Expert committee meeting (initial) | November 27, 2024 |
| Draft recommendation issued to sponsor | December 10, 2024 |
| Draft recommendation posted for stakeholder feedback | December 19, 2024 |
| End of feedback period | January 10, 2025 |
| Final recommendation issued to sponsor and drug plans | January 23, 2025 |
| Final recommendation posted | February 11, 2025 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 07, 2025 |
| CADTH review report(s) posted | - |
Files
Last Updated : February 20, 2025