Last Updated : January 30, 2024
Details
FilesGeneric 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:
- 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.
| Call for patient/clinician input open | March 15, 2023 |
|---|---|
| Call for patient/clinician input closed | May 09, 2023 |
| Clarification: - Patient input submission received from The MAGIC Foundation | |
| Submission received | April 27, 2023 |
| Submission accepted | May 12, 2023 |
| Review initiated | May 15, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | July 28, 2023 |
| Deadline for sponsors comments | August 09, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | September 15, 2023 |
| Expert committee meeting (initial) | September 27, 2023 |
| Draft recommendation issued to sponsor | October 11, 2023 |
| Draft recommendation posted for stakeholder feedback | October 19, 2023 |
| End of feedback period | November 02, 2023 |
| Final recommendation issued to sponsor and drug plans | November 17, 2023 |
| Final recommendation posted | December 05, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | December 01, 2023 |
| CADTH review report(s) posted | January 30, 2024 |
Files
Last Updated : January 30, 2024