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:

March 15, 2023

Brand Name:

Sogroya

Project Line:

Reimbursement Review

Project Number:

SR0779-000

Call for patient/clinician input closed:

May 9, 2023

NOC Status at Filing:

Pre NOC

Biosimilar:

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:

November 17, 2023

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.

Key Milestones²
Milestones title	Date
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

Recommendation and Reasons View PDF

Clinical, Pharmacoeconomic, and Stakeholder Input Combined Report View PDF

Stakeholder Feedback on Draft Recommendation View PDF

Last Updated : January 30, 2024