Imcivree (setmelanotide) — Highmark

Initial criteria

• Member is age ≥ 2 years
• Member has a diagnosis of obesity due to BBS
• Prescriber submits documentation of baseline 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

• Continuation (≥12 to <24 months): Member satisfies initial criteria AND (a) age ≥ 2 years AND (b) diagnosis of obesity due to BBS AND (c) documentation of baseline and current age, height, weight, and BMI AND (d) either ≥5% weight loss from baseline body weight OR ≥5% weight loss from baseline BMI if age <18 years
• Maintenance (≥24 months): Member satisfies initial criteria AND (a) age ≥ 2 years AND (b) diagnosis of obesity due to BBS AND (c) documentation of baseline and current age, height, weight, and BMI AND maintained weight loss from baseline

Approval duration

12 months initial; 12 months continuation/maintenance