ravulizumab


( Last Updated : November 21, 2022)
Generic Name:
ravulizumab
Project Status:
Active
Therapeutic Area:
AChR antibody-positive generalized Myasthenia Gravis
Manufacturer:
Alexion Pharma GmBH
Brand Name:
Ultomiris
Project Line:
Reimbursement Review
Project Number:
SR0765-000
NOC Status at Filing:
Pre NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalized Myasthenia Gravis (gMG).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​For the treatment of adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalized Myasthenia Gravis (gMG).
  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 openSeptember 26, 2022
Call for patient/clinician input closedNovember 18, 2022
Clarification:

- Patient input submission received from Muscular Dystrophy Canada

Submission receivedOctober 25, 2022
Submission acceptedNovember 08, 2022
Review initiatedNovember 09, 2022
Draft CADTH review report(s) provided to sponsor for commentJanuary 30, 2023
Deadline for sponsors commentsFebruary 08, 2023
CADTH review report(s) and responses to comments provided to sponsorMarch 10, 2023
Expert committee meeting (initial)March 22, 2023
Draft recommendation issued to sponsorApril 03, 2023
To
April 05, 2023
Draft recommendation posted for stakeholder feedbackApril 13, 2023
End of feedback periodApril 27, 2023