avalglucosidase alfa


( Last Updated : October 21, 2021)
Generic Name:
avalglucosidase alfa
Project Status:
Active
Therapeutic Area:
Pompe disease
Manufacturer:
Sanofi Genzyme, a division of sanofi-aventis Canada Inc.
Call for patient/clinician input open:
Brand Name:
Nexviazyme
Project Line:
Reimbursement Review
Project Number:
SR0703-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC

Details


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).
  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 open01-Sep-21
Call for patient/clinician input closed25-Oct-21
Submission received30-Sep-21
Submission accepted15-Oct-21
Review initiated18-Oct-21
Draft CADTH review report(s) provided to sponsor for comment06-Jan-22
Deadline for sponsors comments17-Jan-22
CADTH review report(s) and responses to comments provided to sponsor10-Feb-22
Expert committee meeting (initial)23-Feb-22
Draft recommendation issued to sponsorMarch 07, 2022
To
March 09, 2022
Draft recommendation posted for stakeholder feedback17-Mar-22
End of feedback period31-Mar-22