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Last Updated: November 5, 2019
Result type: Reports
Project Number: SR0623-000
Product Line: Common Drug Review

Generic Name: ravulizumab

Brand Name: TBC

Manufacturer: Alexion Pharma Canada Corp

Indications: Paroxysmal nocturnal hemoglobinuria.

Manufacturer Requested Reimbursement Criteria1: For the treatment of adult patients with paroxysmal nocturnal hemoglobinuria.

Submission Type: New

Project Status: Suspended

Biosimilar: No

Companion Diagnostics: No

Fee Schedule: Schedule A

  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 input postedMay 27, 2019
Patient group input closedJuly 16, 2019

- Patient input submission received from Aplastic Anemia and Myelodysplasia Association of Canada (AAMAC) and the Canadian Association of PNH Patients

Patient input summary sent for review to patient input groupsAugust 08, 2019
Patient group comments on input summary closedAugust 15, 2019

- Patient input summary feedback received

Submission receivedJuly 04, 2019
Submission accepted for reviewJuly 18, 2019
Review initiatedJuly 23, 2019

- Submission temporarily suspended at the request of the sponsor

Draft CADTH review report(s) sent to sponsor-
Comments from sponsor on draft CADTH review report(s) received-
CADTH review team's comments on draft CADTH review report(s) sent to sponsor-
Canadian Drug Expert Committee (CDEC) meeting-
CDEC recommendation sent to sponsor and drug plans-