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Last Updated: August 10, 2020
Result type: Reports
Project Number: SR0640-000
Product Line: Common Drug Review

Generic Name: eculizumab

Brand Name: Soliris

Manufacturer: Alexion Pharma Canada Corp.

Indications: Neuromyelitis optica spectrum disorder

Manufacturer Requested Reimbursement Criteria1: For the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Submission Type: New

Project Status: Active

Companion Diagnostics: No

Fee Schedule: Schedule B

  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 openJanuary 24, 2020
Call for patient input closedMarch 16, 2020

- Patient input submission received from Multiple Sclerosis Society of Canada

Submission receivedFebruary 25, 2020
Submission acceptedMarch 10, 2020
Review initiatedMarch 11, 2020

- Selected for CADTH/INESSS Joint Clinician Engagement

Draft CADTH review report(s) provided to sponsor for commentJune 03, 2020
Deadline for sponsors commentsJune 12, 2020
CADTH responses on draft review report(s) provided to sponsorJuly 03, 2020
Expert committee meeting (initial)July 15, 2020
Draft recommendation issuedJuly 28, 2020
End of embargo periodAugust 12, 2020
Final recommendation issued to sponsor and drug plansAugust 19, 2020
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)-
CADTH review report(s) posted-