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
Companion Diagnostics: No
Date Recommendation Issued: October 19, 2020
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule B
- 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.
|Call for patient input open||March 04, 2020|
|Call for patient input closed||April 23, 2020|
- Patient input submission received from the Muscular Dystrophy Canada
|Submission received||April 01, 2020|
|Submission accepted||April 16, 2020|
|Review initiated||April 17, 2020|
|Draft CADTH review report(s) provided to sponsor for comment||July 02, 2020|
|Deadline for sponsors comments||July 13, 2020|
|CADTH responses on draft review report(s) provided to sponsor||August 07, 2020|
|Expert committee meeting (initial)||August 19, 2020|
|Draft recommendation issued to sponsor||September 02, 2020|
|End of embargo period||October 09, 2020|
- Request for extension to embargo period received from the sponsor
- Embargo extension request granted
|Final recommendation issued to sponsor and drug plans||October 19, 2020|
|Final recommendation posted||October 21, 2020|
|Deadline for sponsor to submit redaction requests on draft CADTH review report(s)||November 02, 2020|
|CADTH review report(s) posted||December 09, 2020|