Canada’s Drug Agency | Drugs, Health Technologies and Systems.
Canada’s Drug Agency | Drugs, Health Technologies and Systems.

somatrogon

Details

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Generic Name:
somatrogon
Project Status:
Complete
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
Performance Metric:
Achieved
Biosimilar:
No
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).
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 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 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 Canada's Drug Agency review report(s) provided to sponsor for comment02-Sep-21
Deadline for sponsors comments14-Sep-21
Canada's Drug Agency responses on draft review report(s) provided to sponsor15-Oct-21
Expert committee meeting (initial)27-Oct-21
Draft recommendation issued to sponsor10-Nov-21
Draft recommendation posted for stakeholder feedback18-Nov-21
End of feedback period02-Dec-21
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting23-Feb-22
Final recommendation issued to sponsor and drug plans08-Mar-22
Final recommendation posted24-Mar-22
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)22-Mar-22
Canada's Drug Agency review report(s) posted11-May-22

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : May 11, 2022