Imcivree (setmelanotide) — Medica

Initial criteria

• age ≥ 2 years
• Genetic testing demonstrates homozygous or compound heterozygous mutations in one of the following genes: POMC, PCSK1, or LEPR
• The genetic variant is interpreted as pathogenic, likely pathogenic, or of uncertain significance
• Patient meets ONE of the following: (a) age ≥ 18 years and BMI ≥ 30 kg/m2; OR (b) age 6–17 years and body weight ≥ 95th percentile for age; OR (c) age 2–5 years and body weight ≥ 97th percentile for age
• The medication is prescribed by or in consultation with an endocrinologist, a geneticist, or a physician who specializes in metabolic disorders

Reauthorization criteria

• age ≥ 2 years
• Genetic testing demonstrates homozygous or compound heterozygous mutations in POMC, PCSK1, or LEPR
• The genetic variant is interpreted as pathogenic, likely pathogenic, or of uncertain significance
• Patient has achieved ONE of the following: (a) ≥ 5% reduction in baseline body weight; OR (b) for patients with continued growth potential, ≥ 5% reduction in baseline BMI
• The medication is prescribed by or in consultation with an endocrinologist, a geneticist, or a physician who specializes in metabolic disorders

Approval duration

Initial: 4 months; Reauthorization: 1 year