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

Initial criteria

• Patient has diagnosis of POMC, PCSK1, or LEPR deficiency AND genetic testing with an FDA-approved test has confirmed variants in POMC, PCSK1, or LEPR genes 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 Patient has diagnosis of BBS confirmed by four primary features or three primary and two secondary features (medical records required)
• If patient has an FDA labeled indication, patient’s age is within FDA labeling OR there is support for using for that age
• For adult patients: BMI ≥ 30 kg/m² OR For pediatric patients: weight ≥ 95th percentile (for POMC, PCSK1, or LEPR) or ≥ 97th percentile (for BBS) using growth chart assessments
• Patient is newly starting therapy OR meets response criteria if already treated (POMC/PCSK1/LEPR: has received <16 weeks or ≥16 weeks with ≥5% weight or BMI loss; BBS: has received <1 year or ≥1 year with ≥5% weight or BMI loss)
• Prescriber is a specialist in endocrinology, genetics, or metabolic disorders OR has consulted with such specialist
• Patient has no FDA labeled contraindications to the requested agent

Reauthorization criteria

• Patient previously approved through plan prior authorization
• For adult patients: achieved and maintained ≥5% weight loss from baseline OR For POMC, PCSK1, or LEPR with continued growth potential: maintained ≥5% BMI loss from baseline OR For BBS patients aged <18 years: maintained ≥5% BMI loss from baseline
• Prescriber is a specialist in endocrinology, genetics, or metabolic disorders OR has consulted with such specialist
• Patient has no FDA labeled contraindications to the requested agent

Approval duration

Initial: 4 months (POMC/PCSK1/LEPR) or 12 months (BBS); Renewal: 12 months; BCBSIL: 12 months