CADTH | Evidence Driven
CADTH | Evidence Driven

efgartigimod alfa

Details

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Generic Name:
efgartigimod alfa
Project Status:
Complete
Therapeutic Area:
Generalized myasthenia gravis (gMG)
Manufacturer:
Argenx Canada Inc.
Call for patient/clinician input open:
Brand Name:
Vyvgart
Project Line:
Reimbursement Review
Project Number:
SR0782-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Add-on therapy for acetylcholine receptorantibody positive (AChR-Ab+) adult gMG patients whose symptoms persist despite adequate treatment with acetylcholinesterase inhibitors (AChEIs), corticosteroids, and/or non-steroidal immunosuppressants (NSISTs).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Vyvgart (efgartigimod alfa for injection) is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are antiacetylcholine receptor (AChR) antibody positive.
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input open21-Mar-23
Call for patient/clinician input closed15-May-23
Clarification:

- Patient input submission received from Muscular Dystrophy Canada

Submission received10-May-23
Submission accepted25-May-23
Review initiated26-May-23
Draft CADTH review report(s) provided to sponsor for comment14-Aug-23
Deadline for sponsors comments23-Aug-23
Clarification:

- Submission temporarily suspended September 6, 2023

- Submission lifted September 12, 2023

CADTH review report(s) and responses to comments provided to sponsor13-Oct-23
Expert committee meeting (initial)25-Oct-23
Draft recommendation issued to sponsor08-Nov-23
Draft recommendation posted for stakeholder feedback16-Nov-23
End of feedback period30-Nov-23
Final recommendation issued to sponsor and drug plans14-Dec-23
Final recommendation posted09-Jan-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)05-Jan-24
CADTH review report(s) posted04-Apr-24

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : April 8, 2024