Last Updated : June 28, 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
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Call for patient/clinician input open | 22-Apr-24 |
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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 | 04-Sep-24 |
Deadline for sponsors comments | 13-Sep-24 |
CADTH review report(s) and responses to comments provided to sponsor | 10-Oct-24 |
Expert committee meeting (initial) | 23-Oct-24 |
Draft recommendation issued to sponsor | November 04, 2024 To November 06, 2024 |
Draft recommendation posted for stakeholder feedback | 14-Nov-24 |
End of feedback period | 28-Nov-24 |
Files
Last Updated : June 28, 2024