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
Performance Metric:
Achieved
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 openMarch 15, 2023
Call for patient/clinician input closedMay 09, 2023
Clarification:

- Patient input submission received from The MAGIC Foundation

Submission receivedApril 27, 2023
Submission acceptedMay 12, 2023
Review initiatedMay 15, 2023
Draft CADTH review report(s) provided to sponsor for commentJuly 28, 2023
Deadline for sponsors commentsAugust 09, 2023
CADTH review report(s) and responses to comments provided to sponsorSeptember 15, 2023
Expert committee meeting (initial)September 27, 2023
Draft recommendation issued to sponsorOctober 11, 2023
Draft recommendation posted for stakeholder feedbackOctober 19, 2023
End of feedback periodNovember 02, 2023
Final recommendation issued to sponsor and drug plansNovember 17, 2023
Final recommendation postedDecember 05, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)December 01, 2023
CADTH review report(s) postedJanuary 30, 2024