avalglucosidase alfa

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Generic 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
Performance Metric:
Achieved
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:
  1. 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.

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