Evkeeza (evinacumab-dgnb)

Evkeeza (evinacumab‑dgnb) is covered only as an adjunct to other LDL‑C–lowering therapies for FDA‑approved treatment of homozygous familial hypercholesterolemia (HoFH) in patients ≥5 years and is not covered for non‑HoFH indications or patients <5 years. Approval (12 months) requires documented genetic confirmation OR specified LDL‑C thresholds (untreated >500 mg/dL or treated ≥300 mg/dL) with parental or early clinical HoFH findings, documented trials of a high‑intensity statin and high‑intensity statin+ezetimibe for ≥8 weeks (and a PCSK9 inhibitor trial for ≥8 weeks unless exceptions apply), narrow statin‑intolerance criteria or two LDL‑receptor‑negative alleles if applicable, prescription/consultation by a cardiology/endocrinology/lipid specialist, adherence to dosing (15 mg/kg IV q4w), and reauthorization requires documented lipid response.

"Adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of homozygous familial hypercholesterolemia (HoFH) in patients aged 5 years and older (FDA-approved..."