Imcivree (setmelanotide subcutaneous injection – Rhythm) — Cigna

Initial criteria

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

Reauthorization criteria

• Patient is age ≥ 2 years; AND
• Genetic testing demonstrates homozygous or compound heterozygous mutations in POMC, PCSK1, or LEPR with the variant interpreted as pathogenic, likely pathogenic, or of uncertain significance; AND
• Patient meets ONE of the following: (a) has lost ≥ 5% of baseline body weight since initiating Imcivree; OR (b) has continued growth potential AND has lost ≥ 5% of baseline BMI since initiating Imcivree; AND
• 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