Vol. 3 No. 12 (2023)
Reimbursement Reviews

Setmelanotide (Imcivree)

Published December 20, 2023

Key Messages

  • CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class.
  • The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada's federal, provincial, and territorial governments, with the exception of Quebec.
  • This review assesses setmelanotide (Imcivree), 10 mg/mL solution in a 1 mL multiple-dose vial, administered through once-daily SC injection.
  • Indication: For weight management in adult and pediatric patients aged 6 years and older with obesity due to:
    • Bardet-Biedl syndrome
    • 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.