CADTH | Evidence Driven
CADTH | Evidence Driven

setmelanotide

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Generic Name:
setmelanotide
Project Status:
Complete
Therapeutic Area:
Bardet-Biedl syndrome
Manufacturer:
Rhythm Pharmaceuticals, Inc.
Call for patient/clinician input open:
Brand Name:
Imcivree
Project Line:
Reimbursement Review
Project Number:
SR0769-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Rhythm requests that IMCIVREE be reimbursed for weight management in adult and pediatric patients 6 years of age and older with obesity due to Bardet-Biedl syndrome (BBS).
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
IMCIVREE (setmelanotide solution for subcutaneous injection) is indicated for weight management in adult and pediatric patients 6 years of age and older with obesity due to: Bardet-Biedl syndrome (BBS) Genetically confirmed biallelic pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency due to variants interpreted as pathogenic, likely pathogenic, or of uncertain significance
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input open09-Jan-23
Call for patient/clinician input closed06-Mar-23
Clarification:

- Patient input submission received from the Bardet Biedl Syndrome Foundation

Submission received07-Mar-23
Submission accepted22-Mar-23
Review initiated23-Mar-23
Draft CADTH review report(s) provided to sponsor for comment06-Jul-23
Deadline for sponsors comments17-Jul-23
CADTH review report(s) and responses to comments provided to sponsor11-Aug-23
Expert committee meeting (initial)23-Aug-23
Draft recommendation issued to sponsor07-Sep-23
Draft recommendation posted for stakeholder feedback14-Sep-23
End of feedback period28-Sep-23
Clarification:

- Reconsideration: minor revisions requested by sponsor

- Request for reconsideration not accepted

Final recommendation issued to sponsor and drug plans16-Oct-23
Final recommendation posted01-Nov-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)30-Oct-23
CADTH review report(s) posted22-Dec-23

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, Ethics, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : December 22, 2023