Mecasermin (Increlex)

Mecasermin (Increlex) is covered only for the two FDA‑approved pediatric indications—severe primary IGF‑1 deficiency with growth failure and growth hormone gene deletion with neutralizing GH antibodies—and is excluded for off‑label uses, active/suspected neoplasia, and as a substitute for GH. Coverage requires documentation of open epiphyses, pretreatment height and basal IGF‑1 ≥3 SD below the mean, normal/elevated GH, exclusion of secondary causes, specified safety/administration measures (no IV use, give around meals, glucose monitoring, funduscopic and orthopedic surveillance), and is authorized for up to 12 months with reauthorization needing continued diagnosis and demonstrated treatment response.

"Treatment of growth failure in children with severe primary insulin-like growth factor-1 (IGF-1) deficiency (FDA-approved)."

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