ravulizumab

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Generic Name:
ravulizumab
Project Status:
Complete
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
Performance Metric:
Achieved
Biosimilar:
No
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).
Recommendation Type:
Do not reimburse
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input open26-Sep-22
Call for patient/clinician input closed18-Nov-22
Clarification:

- Patient input submission received from Muscular Dystrophy Canada

Submission received25-Oct-22
Submission accepted08-Nov-22
Review initiated09-Nov-22
Draft CADTH review report(s) provided to sponsor for comment03-Feb-23
Deadline for sponsors comments14-Feb-23
CADTH review report(s) and responses to comments provided to sponsor09-Mar-23
Expert committee meeting (initial)22-Mar-23
Draft recommendation issued to sponsor04-Apr-23
Draft recommendation posted for stakeholder feedback13-Apr-23
End of feedback period27-Apr-23
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting26-Jul-23
Final recommendation issued to sponsor and drug plans08-Aug-23
Final recommendation posted24-Aug-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)22-Aug-23
CADTH review report(s) posted27-Oct-23