Imcivree (setmelanotide) — Highmark

Initial criteria

• Member is age ≥ 2 years
• Member has a pathogenic, likely pathogenic, or uncertain significance genetic variant in POMC, PCSK1, or LEPR genes
• Prescriber submits documentation of baseline age, height, weight, and BMI
• Prescriber submits documentation of current age, height, weight, and BMI
• Member meets one of the following: (a) age ≥ 2 and < 6 years with baseline weight ≥ 97th percentile and body weight ≥ 20 kg; OR (b) age ≥ 6 and ≤ 19 years with baseline weight ≥ 95th percentile; OR (c) age ≥ 20 years with baseline BMI ≥ 30 kg/m2

Reauthorization criteria

• Member has maintained weight loss from baseline

Approval duration

4 months initial; 12 months continuation/maintenance