CDA | Evidence Driven
CDA | Evidence Driven

ravulizumab

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Generic 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.
  1. 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.
Key Milestones2
Call for patient/clinician input open22-Apr-24
Call for patient/clinician input closed17-Jun-24
Submission received04-Jun-24
Submission accepted18-Jun-24
Review initiated19-Jun-24
Draft CADTH review report(s) provided to sponsor for comment04-Sep-24
Deadline for sponsors comments13-Sep-24
CADTH review report(s) and responses to comments provided to sponsor10-Oct-24
Expert committee meeting (initial)23-Oct-24
Draft recommendation issued to sponsorNovember 04, 2024
To
November 06, 2024
Draft recommendation posted for stakeholder feedback14-Nov-24
End of feedback period28-Nov-24

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Patient and Clinician Group input View PDF
Last Updated : June 28, 2024