somatrogon


( Last Updated : November 18, 2021)
Generic Name:
somatrogon
Project Status:
Active
Therapeutic Area:
Growth hormone deficiency
Manufacturer:
Pfizer Canada ULC
Brand Name:
Ngenla
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:
The long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency).
  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.

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Key Milestones

Call for patient/clinician input open 05-Apr-21
Call for patient/clinician input closed 28-May-21
Clarification:

- No patient input submission received

Submission received 03-Jun-21
Submission accepted 17-Jun-21
Review initiated 18-Jun-21
Draft CADTH review report(s) provided to sponsor for comment 02-Sep-21
Deadline for sponsors comments 14-Sep-21
CADTH responses on draft review report(s) provided to sponsor 15-Oct-21
Expert committee meeting (initial) 27-Oct-21
Draft recommendation issued to sponsor 10-Nov-21
Draft recommendation posted for stakeholder feedback 18-Nov-21
End of feedback period 02-Dec-21