immune globulin human and recombinant human hyaluronidase


( Last Updated : July 4, 2022)
Generic Name:
immune globulin human and recombinant human hyaluronidase
Project Status:
Active
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

Details


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:
  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 open27-May-21
Call for patient/clinician input closed16-Jul-21
Clarification:

- Patient input submission received from The Canadian Immunodeficiencies Patient Organization (CIPO)

Submission received24-Jun-21
Submission accepted09-Jul-21
Review initiated12-Jul-21
Draft CADTH review report(s) provided to sponsor for comment29-Sep-21
Deadline for sponsors comments08-Oct-21
CADTH review report(s) and responses to comments provided to sponsor12-Nov-21
Expert committee meeting (initial)24-Nov-21
Draft recommendation issued to sponsor20-Jan-22
Draft recommendation posted for stakeholder feedback27-Jan-22
End of feedback period10-Feb-22
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting27-Apr-22
Draft recommendation issued to sponsor10-May-22
Draft recommendation posted for stakeholder feedback19-May-22
End of feedback period03-Jun-22
Final recommendation issued to sponsor and drug plans15-Jun-22
Final recommendation posted
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)
CADTH review report(s) posted