Last Updated : November 21, 2024
Details
FilesGeneric Name:
ravulizumab
Project Status:
Active
Therapeutic Area:
Generalized Myasthenia Gravis
Manufacturer:
Alexion Pharma GmbH
Call for patient/clinician input open:
Brand Name:
Ultomiris
Project Line:
Reimbursement Review
Project Number:
SR0855-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Add-on therapy for acetylcholine receptor antibody-positive (AChR-Ab+) adult gMG patients whose symptoms persist despite adequate treatment with acetylcholinesterase inhibitors (AChEIs), corticosteroids (CS), and/or non-steroidal immunosuppressants (NSISTs).
Submission Type:
Resubmission
Fee Schedule:
Schedule A
Indications:
Ultomiris (ravulizumab for injection) is indicated for the treatment of adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalized Myasthenia Gravis (gMG). Ultomiris was studied in adult gMG patients with a Myasthenia Gravis Foundation of America (MGFA) clinical classification Class II to IV and a Myasthenia Gravis Activities of Daily Living (MG-ADL) total score ≥ 6.
- 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 | 22-Apr-24 |
|---|---|
| Call for patient/clinician input closed | 17-Jun-24 |
| Submission received | 04-Jun-24 |
| Submission accepted | 18-Jun-24 |
| Review initiated | 19-Jun-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 06-Sep-24 |
| Deadline for sponsors comments | 17-Sep-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 10-Oct-24 |
| Draft recommendation issued to sponsor | 05-Nov-24 |
| Draft recommendation posted for stakeholder feedback | 21-Nov-24 |
| Clarification: - Posting of draft recommendation postponed from 14-Nov-2024 to 21-Nov-2024 | |
| End of feedback period | 05-Dec-24 |
Files
Last Updated : November 21, 2024