Lipid Apheresis for the Treatment of Hypercholesterolemia
DESCRIPTION
Lipid apheresis is a general term that refers to several different approaches that selectively remove low-density lipoprotein (LDL) cholesterol and other lipoproteins from the plasma of individuals with refractory hypercholesterolemia. Currently, there are three selective approaches commonly used: LDL immunoadsorption, dextran sulfate chemoadsorption and heparin-induced extracorporeal LDL precipitation (HELP). Lipid apheresis has been investigated as a technique to treat individuals with familial hypercholesterolemia (FH). FH is a dominantly inherited disorder involving a mutation of the gene that encodes for the specific cell surface receptor responsible for LDL uptake by the cells. The heterozygous form of FH affects about 1 in 500 people; the homozygous form occurs in only 1 in 1 million people.
Frequency of lipid apheresis varies, but typically averages about once every two weeks to obtain an interapheresis level of LDL cholesterol less than 120 mg/dL. Individuals with homozygous FH may be treated more frequently. Individuals are simultaneously treated with diet and drug therapy.
POLICY
Lipid apheresis for the treatment of hypercholesterolemia is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Lipid apheresis for all other uses, including use in preeclampsia is considered investigational.
MEDICAL APPROPRIATENESS
Lipid apheresis for the treatment of hypercholesterolemia is considered medically appropriate if ALL of the following criteria are met:
Diet therapy has been ineffective
Maximum tolerated combination drug therapy has been ineffective or not tolerated
The individual has ANY ONE of the following conditions:
Functional hypercholesterolemic homozygotes with LDL-C greater than 500 mg/dL
Functional hypercholesterolemic heterozygotes with LDL-C greater than or equal to 300 mg/dL
Functional hypercholesterolemic heterozygotes with LDL-C greater than or equal to 200 mg/dL and documented coronary heart disease
ADDITIONAL INFORMATION
Maximal tolerated combination drug therapy is defined as a trial of drugs from at least two separate classes of hypolipidemic agents such as bile acid sequestrants, HMG-C0A reductase inhibitors, fibric acid derivatives, or Niacin/Nicotinic acids.
Documented coronary artery disease includes a history of myocardial infarction, coronary artery bypass surgery, percutaneous transluminal coronary angioplasty or alternative revascularization procedure, or progressive angina documented by exercise or non-exercise stress test.
Reports of LDL-apheresis used for other indications were identified, including the treatment of small cohorts with preeclampsia. While these studies lack the methodologic rigor required to add medically necessary indications to the policy statement, they suggest potential investigational uses for LDL-apheresis. LDL apheresis for other uses, such as preeclampsia, is considered investigational. The data is insufficient to determine its impact on health outcomes.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2005). Low-density lipid apheresis (8.02.04). Retrieved January 12, 2009 from BlueWeb.
National Institutes of Health. National Heart, Lung, and Blood Institute. (2002, September). Detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). Retrieved January 13, 2009 from http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3_rpt.htm.
The Technology Evaluation Center. (1999, May). Lipid apheresis in the treatment of severe, refractory hypercholesterolemia (Vol. 14, No. 3). Chicago: BlueCross BlueShield Association.
U. S. Food and Drug Administration. (1996, February). Center for Devices and Radiological Health. P910018. Premarket approval of Kaneka America Corporation Liposorber® LA-15 system. Retrieved January 13, 2009, from http://www.fda.gov/cdrh/pmafeb96.html.
U. S. Food and Drug Administration. (1997, September). Center for Devices and Radiological Health. P940016. H.E.L.P. (Heparin-induced extracorporeal lipoprotein precipitation) System. Retrieved January 13, 2009 from http://www.fda.gov/cdrh/pmasep97.html.
ORIGINAL EFFECTIVE DATE: 5/1981
MOST RECENT REVIEW DATE: 2/12/2009
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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