efgartigimod alfa

Details

Generic Name:
efgartigimod alfa
Project Status:
Active
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:
argenx Canada Inc. is requesting that efgartigimod be reimbursed for the treatment of adult patients with gMG who have antibodies targeted against acetylcholine receptors (AChR-Ab+).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Vyvgart ​(efgartigimod solution, for intravenous use) is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG).
  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 openMarch 21, 2023
Call for patient/clinician input closedMay 15, 2023
Clarification:

- Patient input submission received from Muscular Dystrophy Canada

Submission receivedMay 10, 2023
Submission acceptedMay 25, 2023
Review initiatedMay 26, 2023
Draft CADTH review report(s) provided to sponsor for commentAugust 10, 2023
Deadline for sponsors commentsAugust 21, 2023
CADTH review report(s) and responses to comments provided to sponsorSeptember 15, 2023
Expert committee meeting (initial)September 27, 2023
Draft recommendation issued to sponsorOctober 11, 2023
To
October 13, 2023
Draft recommendation posted for stakeholder feedbackOctober 19, 2023
End of feedback periodNovember 02, 2023