CDA | Evidence Driven
CDA | Evidence Driven

eculizumab

Details

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Generic Name:
eculizumab
Project Status:
Complete
Therapeutic Area:
Myasthenia Gravis (gMG), adults
Manufacturer:
Alexion Pharma Canada Corp.
Call for patient/clinician input open:
Brand Name:
Soliris
Project Line:
Reimbursement Review
Project Number:
SR0605-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Soliris is indicated in adult patients with generalized Myasthenia Gravis (gMG).
Submission Type:
Initial
Fee Schedule:
Schedule B
Indications:
​Soliris is indicated in adult patients with generalized Myasthenia Gravis (gMG).
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
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 input open March 04, 2020
Call for patient input closed April 23, 2020
Clarification:

- 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
Clarification:

- 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

Files

Recommendation and Reasons View PDF
Clinical Report View PDF
Pharmacoeconomic Report View PDF
Patient Group Input Submissions View PDF
Last Updated : December 10, 2020