Low-density lipoprotein (LDL) apheresis may be considered medically necessary in patients with homozygous familial hypercholesterolemia as an alternative to plasmapheresis.
LDL apheresis may be considered medically necessary in patients with heterozygous familial hypercholesterolemia who have failed diet therapy and maximum tolerated combination drug therapy (see Policy Guidelines section) AND who meet the following U.S. Food and Drug Administration approved indications (all LDL levels represent the best achievable LDL level after a program of diet and drug therapy):
Functional hypercholesterolemic heterozygotes with LDL ≥300 mg/dL
Functional hypercholesterolemic heterozygotes with LDL ≥200 mg/dLa AND documented coronary artery disease.a
LDL apheresis is considered investigational for other uses, including nonfamilial hypercholesterolemia, nephrotic syndrome, sudden sensorineural hearing loss, severe diabetic foot ulcerations, peripheral artery disease, preeclampsia, non-arteritic acute anterior ischemic optic neuropathy, and acute coronary syndrome.
Therapeutic apheresis with selective high-density lipoprotein delipidation and plasma reinfusion is considered investigational for all indications, including but not limited to acute coronary syndrome.
a For definitions of maximum tolerated drug therapy and documented coronary artery disease, see the Policy Guidelines section.
