somatrogon


( Last Updated : October 21, 2021)
Generic Name:
somatrogon
Project Status:
Active
Therapeutic Area:
Growth hormone deficiency
Manufacturer:
Pfizer Canada ULC
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0683-000
NOC Status at Filing:
Pre NOC

Details


Manufacturer Requested Reimbursement Criteria1:
Long-term treatment of pediatric patients who have growth hormone deficiency.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.
  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 open05-Apr-21
Call for patient/clinician input closed28-May-21
Clarification:

- No patient input submission received

Submission received03-Jun-21
Submission accepted17-Jun-21
Review initiated18-Jun-21
Draft CADTH review report(s) provided to sponsor for comment02-Sep-21
Deadline for sponsors comments14-Sep-21
CADTH responses on draft review report(s) provided to sponsor15-Oct-21
Expert committee meeting (initial)27-Oct-21
Draft recommendation issued to sponsorNovember 08, 2021
To
November 10, 2021
Draft recommendation posted for stakeholder feedback18-Nov-21
End of feedback period02-Dec-21