Evinacumab-dgnb (Evkeeza™)

Covered only for FDA‑approved HoFH in patients ≥12 years (not for other indications) when strict genetic or specified LDL‑clinical criteria are met. Approval requires documentation of either two mutant alleles (LDLR/APOB/PCSK9/LDLRAP1) OR untreated LDL‑C >500 mg/dL or treated LDL‑C ≥300 mg/dL with early HoFH signs or parental HeFH, plus trials of high‑intensity statin and high‑intensity statin+ezetimibe ≥8 weeks (or policy‑defined statin intolerance), a PCSK9 inhibitor trial ≥8 weeks unless two LDL‑receptor‑negative alleles, specialist prescribing/consultation, IV dosing 15 mg/kg no more often than every 4 weeks, and is authorized for 12 months.

"PCSK9 requirement: trial of a PCSK9 inhibitor (Repatha or Praluent) for ≥8 continuous weeks is required unless the patient is known to have two LDL-receptor negative alleles."

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