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Last Updated: December 9, 2020
Result type: Reports
Project Number: SR0605-000
Product Line: Reimbursement Review

Generic Name: eculizumab

Brand Name: Soliris

Manufacturer: Alexion Pharma Canada Corp.

Therapeutic Area: Myasthenia Gravis (gMG), adults

Indications: ​Soliris is indicated in adult patients with generalized Myasthenia Gravis (gMG).

Manufacturer Requested Reimbursement Criteria1: Soliris is indicated in adult patients with generalized Myasthenia Gravis (gMG).

Submission Type: Initial

NOC Status at Filing: Post NOC

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: October 19, 2020

Recommendation Type: Reimburse with clinical criteria and/or conditions

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 openMarch 04, 2020
Call for patient input closedApril 23, 2020

- Patient input submission received from the Muscular Dystrophy Canada

Submission receivedApril 01, 2020
Submission acceptedApril 16, 2020
Review initiatedApril 17, 2020
Draft CADTH review report(s) provided to sponsor for commentJuly 02, 2020
Deadline for sponsors commentsJuly 13, 2020
CADTH responses on draft review report(s) provided to sponsorAugust 07, 2020
Expert committee meeting (initial)August 19, 2020
Draft recommendation issued to sponsorSeptember 02, 2020
End of embargo periodOctober 09, 2020

- Request for extension to embargo period received from the sponsor

- Embargo extension request granted

Final recommendation issued to sponsor and drug plansOctober 19, 2020
Final recommendation postedOctober 21, 2020
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)November 02, 2020
CADTH review report(s) postedDecember 09, 2020