Last Updated : May 25, 2023
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).
- 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/clinician input open | March 21, 2023 |
|---|---|
| Call for patient/clinician input closed | May 15, 2023 |
| Clarification: - Patient input submission received from Muscular Dystrophy Canada | |
| Submission received | May 10, 2023 |
| Submission accepted | May 25, 2023 |
| Review initiated | May 26, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | August 10, 2023 |
| Deadline for sponsors comments | August 21, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | September 15, 2023 |
| Expert committee meeting (initial) | September 27, 2023 |
| Draft recommendation issued to sponsor | October 11, 2023 To October 13, 2023 |
| Draft recommendation posted for stakeholder feedback | October 19, 2023 |
| End of feedback period | November 02, 2023 |
Last Updated : May 25, 2023