ravulizumab

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Generic Name:
ravulizumab
Project Status:
Complete
Therapeutic Area:
Paroxysmal nocturnal hemoglobinuria
Manufacturer:
Alexion Pharma Canada Corp.
Brand Name:
Ultomiris
Project Line:
Reimbursement Review
Project Number:
SR0700-000
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Ultomiris (ravulizumab for injection) is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
N/A
Indications:
Ultomiris (ravulizumab for injection) is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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 open23-Jun-21
Call for patient/clinician input closed16-Aug-21
Clarification:

- Patient input submission received from Canadian Association of PNH Patients

Submission received22-Jul-21
Submission accepted06-Aug-21
Review initiated09-Aug-21
Draft CADTH review report(s) provided to sponsor for comment22-Oct-21
Deadline for sponsors comments02-Nov-21
CADTH review report(s) and responses to comments provided to sponsor03-Dec-21
Expert committee meeting (initial)15-Dec-21
Draft recommendation issued to sponsor05-Jan-22
Draft recommendation posted for stakeholder feedback13-Jan-22
End of feedback period27-Jan-22
Final recommendation issued to sponsor and drug plans11-Feb-22
Final recommendation posted02-Mar-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)28-Feb-22
CADTH review report(s) posted22-Apr-22