immune globulin human and recombinant human hyaluronidase (TBC)


( Last Updated : October 21, 2021)
Generic Name:
immune globulin human and recombinant human hyaluronidase (TBC)
Project Status:
Active
Therapeutic Area:
Humoral immunodeficiency
Manufacturer:
Takeda Canada Inc.
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
ST0695-000
NOC Status at Filing:
Pre NOC

Details


Manufacturer Requested Reimbursement Criteria1:
As replacement therapy for primary humoral immunodeficiency and secondary humoral immunodeficiency in adult and pediatric patients two years of age and older
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
N/A
Indications:
As replacement therapy for primary humoral immunodeficiency and secondary humoral immunodeficiency in adult and pediatric patients two years of age and older
  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 sponsorDecember 06, 2021
To
December 08, 2021
Draft recommendation posted for stakeholder feedback16-Dec-21
End of feedback period07-Jan-22