Evkeeza™ (evinacumab-dgnb)

Evkeeza is covered as adjunct therapy for homozygous familial hypercholesterolemia in patients ≥5 years (patients <5 years and non‑HoFH uses excluded), dosed 15 mg/kg IV every 4 weeks with approvals limited to 12 months. Approval requires either genetic confirmation of HoFH or strict LDL‑C thresholds (>400 mg/dL untreated or ≥300 mg/dL treated) with supportive clinical/parental findings, plus documented prior trials of a high‑intensity statin and statin+ezetimibe (≥8 weeks) or a PCSK9 inhibitor (≥8 weeks) unless narrowly defined statin intolerance, two LDLR‑negative alleles, or other listed exceptions apply, and reauthorization requires demonstrated lipid response.

"Evkeeza is indicated as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of homozygous familial hypercholesterolemia (HoFH) in patients aged 5 ye..."