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

Initial criteria

• Patient’s benefit plan covers the requested agent
• Diagnosis of monogenic obesity due to POMC, PCSK1, or LEPR deficiency AND genetic testing with an FDA-approved test has confirmed variants in POMC, PCSK1, or LEPR genes (medical records required) AND genetic status is bi-allelic, homozygous, or compound heterozygous (NOT double heterozygous) AND genetic variant is interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS) AND genetic variant is NOT classified as benign or likely benign OR diagnosis of syndromic obesity due to Bardet-Biedl syndrome (BBS) with clinical confirmation by four primary features OR three primary and two secondary features (medical records required) [primary features: rod-cone dystrophy, polydactyly, obesity, genital anomalies, renal anomalies, learning difficulties; secondary features: speech delay, developmental delay, diabetes mellitus, dental anomalies, congenital heart disease, brachydactyly/syndactyly, ataxia/poor coordination, anosmia/hyposmia]
• If FDA labeled indication applies, then patient’s age is within FDA labeling OR there is support for use of the requested agent for the patient’s age for the requested indication
• For adults, BMI ≥ 30 kg/m² OR for pediatric patients weight ≥ 95th percentile (POMC, PCSK1, or LEPR) or ≥ 97th percentile (BBS)
• Patient is newly starting therapy OR (for POMC, PCSK1, or LEPR deficiency) currently being treated with <16 weeks therapy OR after ≥16 weeks therapy achieved ≥5% weight loss of baseline body weight or ≥5% decrease in baseline BMI (for those with continued growth potential) OR (for BBS) currently treated <1 year OR after ≥1 year achieved ≥5% weight loss of baseline body weight or ≥5% decrease in baseline BMI for patients <18 years
• Prescriber is a specialist in the area of the diagnosis (e.g., endocrinologist, geneticist, metabolic disorder specialist) or has consulted with one
• No FDA labeled contraindications to the requested agent

Reauthorization criteria

• Patient previously approved for the requested agent through plan’s prior authorization process
• Benefit plan covers the agent
• For adults, achieved and maintained ≥5% weight loss of baseline body weight OR for POMC, PCSK1, or LEPR deficiency and continued growth potential, achieved and maintained ≥5% decrease in baseline BMI OR for BBS and age <18 years, achieved and maintained ≥5% decrease in baseline BMI
• Prescriber is a specialist in the area of the diagnosis or has consulted with one
• No FDA labeled contraindications to the requested agent

Approval duration

4 months (POMC/PCSK1/LEPR); 12 months (BBS); reauth 12 months