ravulizumab


( Last Updated : December 6, 2022)
Generic Name:
ravulizumab
Project Status:
Active
Therapeutic Area:
Atypical hemolytic uremic syndrome
Manufacturer:
Alexion Pharma GmBH
Brand Name:
Ultomiris
Project Line:
Reimbursement Review
Project Number:
SR0740-000
NOC Status at Filing:
Pre NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For the treatment of adults and pediatric patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
The treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement mediated thrombotic microangiopathy (TMA).
  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 openMay 10, 2022
Call for patient/clinician input closedJuly 04, 2022
Clarification:

- Patient input submission received from aHUS Canada

Submission receivedJune 08, 2022
Submission acceptedJune 22, 2022
Review initiatedJune 23, 2022
Draft CADTH review report(s) provided to sponsor for commentSeptember 08, 2022
Deadline for sponsors commentsSeptember 19, 2022
CADTH review report(s) and responses to comments provided to sponsorOctober 14, 2022
Expert committee meeting (initial)October 26, 2022
Draft recommendation issued to sponsorNovember 08, 2022
Draft recommendation posted for stakeholder feedbackNovember 17, 2022
End of feedback periodDecember 01, 2022
Final recommendation issued to sponsor and drug plans
Final recommendation posted
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)
CADTH review report(s) posted