Last Updated : September 13, 2022
Details
FilesGeneric Name:
avalglucosidase alfa
Project Status:
Complete
Therapeutic Area:
Pompe disease
Manufacturer:
Sanofi Genzyme, a division of sanofi-aventis Canada Inc.
Brand Name:
Nexviazyme
Project Line:
Reimbursement Review
Project Number:
SR0703-000
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As per Health Canada submitted indication, for the long-term treatment of patients with Pompe disease and as per current access of the other ERT available for the treatment of Pompe Disease, Alglucosidase alfa (Myozyme).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Avalglucosidase alfa is an enzyme replacement therapy (ERT) indicated for the long-term treatment of patients with Pompe disease (acid α-glucosidase deficiency).
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 open | 01-Sep-21 |
| Call for patient/clinician input closed | 25-Oct-21 |
| Clarification:
- Patient input submission received from Muscular Dystrophy Canada |
|
| Submission received | 30-Sep-21 |
| Submission accepted | 15-Oct-21 |
| Review initiated | 18-Oct-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 06-Jan-22 |
| Deadline for sponsors comments | 17-Jan-22 |
| CADTH review report(s) and responses to comments provided to sponsor | 10-Feb-22 |
| Expert committee meeting (initial) | 23-Feb-22 |
| Draft recommendation issued to sponsor | 09-Mar-22 |
| Draft recommendation posted for stakeholder feedback | 17-Mar-22 |
| End of feedback period | 31-Mar-22 |
| Clarification:
- Reconsideration: major revisions requested by sponsor |
|
| Expert committee meeting | 22-Jun-22 |
| Final recommendation issued to sponsor and drug plans | 05-Jul-22 |
| Final recommendation posted | 21-Jul-22 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 19-Jul-22 |
| CADTH review report(s) posted | 12-Sep-22 |
Files
Last Updated : September 13, 2022