Imcivree (setmelanotide) — Medica

Initial criteria

• age ≥ 2 years
• Clinical diagnosis of Bardet-Biedl Syndrome meeting ONE of the following: (a) ≥ 4 primary features (rod-cone dystrophy, polydactyly, obesity, learning disability, renal anomalies, or male hypogonadism); OR (b) ≥ 3 primary features AND ≥ 2 secondary features (speech disorder/delay, strabismus/cataracts/astigmatism, brachydactyly/syndactyly, developmental delay, polyuria/polydipsia, ataxia/poor coordination/imbalance, mild spasticity, diabetes mellitus, dental crowding/hypodontia/small roots/high arched palate, left ventricular hypertrophy/congenital heart disease, hepatic fibrosis)
• Patient meets ONE of the following: (a) age ≥ 18 years and BMI ≥ 30 kg/m2; OR (b) age < 18 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
• Patient has achieved ONE of the following: (a) ≥ 5% reduction in baseline body weight; OR (b) if age < 18 years, ≥ 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: 1 year; Reauthorization: 1 year