Evkeeza™ (evinacumab-dgnb)

Covered: Evkeeza is approved only as an adjunct to other LDL‑C–lowering therapies for homozygous familial hypercholesterolemia (HoFH) in patients ≥5 years (not for <5 years or non‑HoFH/monotherapy use). Key requirements: prior documentation of HoFH (genetic/phenotypic confirmation or two LDLR‑negative alleles), specified LDL‑C thresholds (e.g., untreated >400 mg/dL or treated ≥300 mg/dL with required clinical/family findings; post‑therapy LDL‑C ≥70 mg/dL), trials of high‑intensity statin and statin+ezetimibe ≥8 weeks and a PCSK9 inhibitor ≥8 weeks unless statin intolerance/exceptions apply, dosing per label, 12‑month approval, and reauthorization requires documented lipid response.

"Age documentation showing the patient is ≥5 years of age."

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