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

somapacitan

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Generic Name:
somapacitan
Project Status:
Complete
Therapeutic Area:
Growth Hormone Deficiency (GHD)
Manufacturer:
Novo Nordisk Canada Inc.
Call for patient/clinician input open:
Brand Name:
Sogroya
Project Line:
Reimbursement Review
Project Number:
SR0779-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
The long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone (Growth Hormone Deficiency (GHD)).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Sogroya (somapacitan ) is indicated for: • the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone (Growth Hormone Deficiency (GHD)).• the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (AGHD).
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 open15-Mar-23
Call for patient/clinician input closed09-May-23
Clarification:

- Patient input submission received from The MAGIC Foundation

Submission received27-Apr-23
Submission accepted12-May-23
Review initiated15-May-23
Draft CADTH review report(s) provided to sponsor for comment28-Jul-23
Deadline for sponsors comments09-Aug-23
CADTH review report(s) and responses to comments provided to sponsor15-Sep-23
Expert committee meeting (initial)27-Sep-23
Draft recommendation issued to sponsor11-Oct-23
Draft recommendation posted for stakeholder feedback19-Oct-23
End of feedback period02-Nov-23
Final recommendation issued to sponsor and drug plans17-Nov-23
Final recommendation posted05-Dec-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)01-Dec-23
CADTH review report(s) posted30-Jan-24

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : December 12, 2024