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Imcivree (setmelanotide acetate) — Blue Cross Blue Shield of Illinois

Syndromic obesity due to Bardet-Biedl syndrome (BBS)

Initial criteria

  • Diagnosis of monogenic obesity due to POMC, PCSK1, or LEPR deficiency AND genetic testing with an FDA-approved test confirming variants in POMC, PCSK1, or LEPR genes (medical records required) AND genetic status is bi-allelic, homozygous, or compound heterozygous (NOT double heterozygous) AND variant is pathogenic, likely pathogenic, or of uncertain significance (NOT benign or likely benign) OR diagnosis of syndromic obesity due to Bardet-Biedl syndrome (BBS) clinically confirmed by four primary features OR three primary and two secondary features (medical records required).
  • If the patient has an FDA labeled indication, the patient's age is within FDA labeling for the requested indication OR there is support for use in the patient’s age for the requested indication.
  • For adult patients, BMI ≥ 30 kg/m^2 OR for pediatric patients, weight ≥ 95th percentile (for POMC, PCSK1, or LEPR) or ≥ 97th percentile (for BBS) using growth charts.
  • The patient is newly starting therapy OR has received less than 16 weeks (POMC/PCSK1/LEPR) or less than one year (BBS) of therapy OR has received ≥16 weeks (POMC/PCSK1/LEPR) or ≥1 year (BBS) of therapy and achieved ≥5% weight or BMI reduction from baseline (depending on growth potential).
  • The prescriber is a specialist in endocrinology, genetics, or metabolic disorders, or has consulted with such a specialist.
  • The patient does not have any FDA labeled contraindications to Imcivree.

Reauthorization criteria

  • The patient was previously approved for Imcivree through prior authorization.
  • For adults: patient has achieved and maintained ≥5% weight loss from baseline body weight prior to initiation.
  • For pediatric patients with POMC, PCSK1, or LEPR deficiency and continued growth potential: patient has achieved and maintained ≥5% BMI reduction from baseline.
  • For patients with BBS aged <18 years: patient has achieved and maintained ≥5% BMI reduction from baseline.
  • The prescriber is a specialist in endocrinology, genetics, or metabolic disorders, or has consulted with such a specialist.
  • The patient does not have any FDA labeled contraindications to Imcivree.

Approval duration

12 months (BCBSIL); 4 months initial for POMC, PCSK1, or LEPR deficiency and 12 months for BBS for other plans; 12 months renewal