Last Updated : June 20, 2025
Details
FilesGeneric Name:
efgartigimod alfa
Project Status:
Active
Therapeutic Area:
Chronic inflammatory demyelinating polyneuropathy
Manufacturer:
argenx Canada
Call for patient/clinician input open:
Brand Name:
Vyvgart
Project Line:
Reimbursement Review
Project Number:
SR0894-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Vyvgart (efgartigimod alfa injection) is indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
Submission Type:
Initial
Submission Complexity:
Standard Review
Fee Schedule:
Schedule A
Indications:
Vyvgart (efgartigimod alfa injection) is indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
- 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.
| Call for patient/clinician input open | April 22, 2025 |
|---|---|
| Call for patient/clinician input closed | June 13, 2025 |
| Submission received | June 05, 2025 |
| Submission accepted | June 19, 2025 |
| Review initiated | June 20, 2025 |
| Draft CADTH review report(s) provided to sponsor for comment | September 05, 2025 |
| Deadline for sponsors comments | September 16, 2025 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | October 09, 2025 |
| Expert committee meeting (initial) | October 22, 2025 |
| Draft recommendation issued to sponsor | November 03, 2025 To November 05, 2025 |
| Draft recommendation posted for stakeholder feedback | November 13, 2025 |
| End of feedback period | November 27, 2025 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | October 22, 2025 |
Files
Last Updated : June 20, 2025