Evkeeza™ (evinacumab-dgnb)

Covered: Evkeeza is covered as adjunct therapy for homozygous familial hypercholesterolemia (HoFH) in patients aged ≥1 year (patients <1 year excluded; not covered as monotherapy) when HoFH is confirmed by pathogenic variants in LDLR/APOB/PCSK9/LDLRAP1 or by specified LDL-C thresholds (untreated LDL‑C >400 mg/dL or treated LDL‑C ≥300 mg/dL) plus qualifying clinical or parental history. Key requirements: for patients ≥10 years require documented ≥8‑week trials of a high‑intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg) plus ezetimibe and an ≥8‑week PCSK9 inhibitor trial (unless narrowly defined statin intolerance or two LDL‑receptor–negative alleles apply); required genetic/lipid/clinical documentation, dosing 15 mg/kg IV q4w, 12‑month approval with reauthorization requiring documented biochemical response.

"FDA-approved: Evkeeza as an adjunct to diet and exercise and other low-density lipoprotein cholesterol (LDL-C) lowering therapies to reduce LDL-C in adults and pediatric patients aged ≥1 year with ..."