Last Updated : September 17, 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 | April 22, 2024 |
|---|---|
| Call for patient/clinician input closed | June 17, 2024 |
| Submission received | June 04, 2024 |
| Submission accepted | June 18, 2024 |
| Review initiated | June 19, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | September 06, 2024 |
| Deadline for sponsors comments | September 17, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | October 10, 2024 |
| Expert committee meeting (initial) | October 23, 2024 |
| Draft recommendation issued to sponsor | November 04, 2024 To November 06, 2024 |
| Draft recommendation posted for stakeholder feedback | November 14, 2024 |
| End of feedback period | November 28, 2024 |
Files
Last Updated : September 17, 2024