Last Updated : January 6, 2025
Details
FilesGeneric Name:
cipaglucosidase alfa and miglustat
Project Status:
Active
Therapeutic Area:
Pompe disease
Manufacturer:
Amicus Therapeutics Canada Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0871-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Cipaglucosidase alfa: Indicated for use in combination with the enzyme stabilizer miglustat for long-term treatment in adult patients with late-onset Pompe disease (acid glucosidase deficiency). Miglustat: An enzyme stabilizer indicated for use in combination with the enzyme replacement therapy cipaglucosidase alfa for long-term treatment in adult patients with late-onset Pompe disease (acid glucosidase deficiency).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
• Cipaglucosidase alfa: Indicated for use in combination with the enzyme stabilizer miglustat for long-term treatment in adult patients with late-onset Pompe disease (acid α glucosidase deficiency). • Miglustat: An enzyme stabilizer indicated for use in combination with the enzyme replacement therapy cipaglucosidase alfa for long-term treatment in adult patients with late-onset Pompe disease (acid α glucosidase deficiency).
- 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 | October 23, 2024 |
|---|---|
| Call for patient/clinician input closed | December 13, 2024 |
| Submission received | November 29, 2024 |
| Submission accepted | December 13, 2024 |
| Review initiated | December 16, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | March 10, 2025 |
| Deadline for sponsors comments | March 20, 2025 |
| CADTH review report(s) and responses to comments provided to sponsor | May 15, 2025 |
| Expert committee meeting (initial) | May 28, 2025 |
| Draft recommendation issued to sponsor | June 09, 2025 To June 11, 2025 |
| Draft recommendation posted for stakeholder feedback | June 19, 2025 |
| End of feedback period | July 04, 2025 |
Files
Last Updated : January 6, 2025