CDA | Evidence Driven
CDA | Evidence Driven

ravulizumab

Details

Generic Name:
ravulizumab
Project Status:
Pending
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:
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:
Pending
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.
Anticipated Date:
  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.
Last Updated : April 22, 2024