13
Table 14. LDL Apheresis
a
NLA Criteria from Expert Panel on FH FDA-Approved Indication
LDL apheresis may be considered for the following
patients who, after 6 months, do not have adequate
response to maximum tolerated drug therapy:
• Functional homozygous FH with LDL-C
≥300 mg/dL (or non-HDL-C ≥330 mg/dL)
• Functional heterozygous FH with LDL-C
≥300 mg/dL (or non-HDL-C ≥330 mg/dL) and
0-1 risk factors
• Functional heterozygous FH with LDL-C
≥200 mg/dL (or non-HDL-C ≥230 mg/dL) and
high-risk characteristics, such as 2 risk factors
or high lipoprotein (a) (≥50 mg/dL using an
isoform-insensitive assay)
• Functional heterozygous FH with LDL-C
≥160 mg/dL (or non-HDL-C ≥190 mg/dL) and
very high risk characteristics (established CHD,
other cardiovascular disease, or diabetes)
LDL apheresis is considered
medically necessary when
patients have failed diet
and maximum drug therapy
from ≥2 separate classes of
hypolipidemic drugs for
≥6 months in addition to any 1
of the following criteria:
• Homozygous FH with
LDL-C ≥500 mg/dL
• Heterozygous FH with
LDL-C ≥300 mg/dL
• Functional heterozygous FH
with LDL-C ≥200 mg/dL
in patients with coronary
artery disease
a
e NLA criteria are more inclusive than the FDA-approved indication criteria. Clinicians should
be aware of this with regard to reimbursement.
Side Effects Contraindications
▶ Myopathy
▶ ▶ LFT values
▶ May increase
plasma glucose
levels
Absolute:
▶ Active or chronic liver disease
▶ Pregnancy, lactation, or desire to become
pregnant
Relative (statin specific: see individual PI):
▶ Concomitant use of certain drugs
(cyclosporine, macrolide antibiotics,
various antifungal agents and
cytochrome P-450 inhibitors [fibrates
and niacin should be used with
appropriate caution])
▶ GI distress
▶ Constipation
▶ Decreased
absorption of
other drugs
Absolute:
▶ Dysbetalipoproteinemia
▶ TG >400 mg/dL
Relative:
▶ TG >200 mg/dL
