Last Updated : August 10, 2022
Details
FilesGeneric Name:
immune globulin human and recombinant human hyaluronidase
Project Status:
Complete
Therapeutic Area:
Humoral immunodeficiency
Manufacturer:
Takeda Canada Inc.
Brand Name:
HyQvia
Project Line:
Reimbursement Review
Project Number:
ST0695-000
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Application held awaiting decision by Health Canada
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As replacement therapy for primaryhumoral immunodeficiency (PI) and secondary humoralimmunodeficiency (SI) in adult patients.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
N/A
Indications:
As replacement therapy for primaryhumoral immunodeficiency (PI) and secondary humoralimmunodeficiency (SI) in adult patients.
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 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 | 27-May-21 |
| Call for patient/clinician input closed | 16-Jul-21 |
| Clarification: - Patient input submission received from The Canadian Immunodeficiencies Patient Organization (CIPO) | |
| Submission received | 24-Jun-21 |
| Submission accepted | 09-Jul-21 |
| Review initiated | 12-Jul-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 29-Sep-21 |
| Deadline for sponsors comments | 08-Oct-21 |
| CADTH review report(s) and responses to comments provided to sponsor | 12-Nov-21 |
| Expert committee meeting (initial) | 24-Nov-21 |
| Draft recommendation issued to sponsor | 20-Jan-22 |
| Draft recommendation posted for stakeholder feedback | 27-Jan-22 |
| End of feedback period | 10-Feb-22 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | 27-Apr-22 |
| Draft recommendation issued to sponsor | 10-May-22 |
| Draft recommendation posted for stakeholder feedback | 19-May-22 |
| End of feedback period | 03-Jun-22 |
| Final recommendation issued to sponsor and drug plans | 15-Jun-22 |
| Final recommendation posted | 04-Jul-22 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 29-Jun-22 |
| CADTH review report(s) posted | 10-Aug-22 |
Files
Last Updated : August 10, 2022