Histrelin acetate subcutaneous implant (Supprelin LA)

Supprelin LA is covered only for the FDA‑approved indication of central precocious puberty in children (no off‑label uses) and is contraindicated in patients with hypersensitivity to GnRH analogs and in females who are or may become pregnant. Approval requires documented CPP by pubertal LH response to a GnRH stimulation test or pubertal‑range basal LH, significantly advanced bone age, onset of secondary sex characteristics before age 8 (girls)/9 (boys) with current age below ~11 (girls)/12 (boys), exclusion of tumors when suspected, one implant every 12 months, required monitoring (LH/FSH and estradiol/testosterone at 1 month then every 6 months; height and bone age every 6–12 months), and demonstrated clinical improvement for reauthorization.

"Treatment of children with central precocious puberty (FDA-approved indication)."

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