CDA | Evidence Driven
CDA | Evidence Driven

eculizumab

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Generic Name:
eculizumab
Project Status:
Complete
Therapeutic Area:
Neuromyelitis optica spectrum disorder
Manufacturer:
Alexion Pharma Canada Corp.
Call for patient/clinician input open:
Brand Name:
Soliris
Project Line:
Reimbursement Review
Project Number:
SR0640-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
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:
Initial
Fee Schedule:
Schedule B
Indications:
For the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
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 January 24, 2020
Call for patient input closed March 16, 2020
Clarification:

- Patient input submission received from Multiple Sclerosis Society of Canada
Submission received February 25, 2020
Submission accepted March 10, 2020
Review initiated March 11, 2020
Clarification:

- Selected for CADTH/INESSS Joint Clinician Engagement
Draft CADTH review report(s) provided to sponsor for comment June 03, 2020
Deadline for sponsors comments June 12, 2020
CADTH responses on draft review report(s) provided to sponsor July 03, 2020
Expert committee meeting (initial) July 15, 2020
Draft recommendation issued July 28, 2020
End of embargo period August 12, 2020
Final recommendation issued to sponsor and drug plans August 19, 2020
Final recommendation posted August 24, 2020
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) September 02, 2020
CADTH review report(s) posted October 21, 2020

Files

Recommendation and Reasons View PDF
Clinical Report View PDF
Pharmacoeconomic Report View PDF
Patient Group Input Submissions View PDF
Last Updated : November 2, 2020