Low-Density Lipid Apheresis
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. The individual initially undergoes an apheresis procedure to isolate the plasma. The LDLs are then selectively removed from the plasma by either immunoadsorption, heparin-induced extracorporeal LDL precipitation (referred to as HELP), or dextran sulfate adsorption. LDL apheresis is a selective procedure in which only pathogenic LDLs are removed. The plasma is then returned to the individual. Lipid apheresis has been investigated as a technique to treat individuals with familial hypercholesterolemia (FH), 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 approximately 1 in 500 people and causes a 50% decrease in LDL receptors. Heterozygous FH results in serum LDL levels 2-3 times the acceptable level and can cause early development of coronary heart disease. These individuals may or may not respond adequately to lipid lowering medications. Homeozygous FH is rare, only occurring in 1 in 1 million individuals. Serum LDL levels may be elevated 6 fold due to a total lack of functioning LDL receptors and can result in severe aortic stenosis and coronary heart disease as early as age 20. These individuals typically do not respond to drug and diet modifications.
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, as an alternative to plasmapheresis, for the treatment of homozygous familial hypercholesterolemia is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Lipid apheresis for the treatment of heterozygous familial 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.
See also: Plasma Exchange
MEDICAL APPROPRIATENESS
Lipid apheresis for the treatment of hypercholesterolemia is considered medically appropriate if ANY ONE of the following criteria are met:
Homozygous familial hypercholesterolemia (as an alternative to plasmapheresis) with LDL-C greater than 500 mg/dL
Heterozygous familial hypercholesterolemia with ALL of the following:
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 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
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
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. The data is insufficient to determine its impact on health outcomes.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2011). Low-density lipid apheresis (8.02.04). Retrieved October 5, 2011 from BlueWeb. (12 articles and/or guidelines reviewed)
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 October 17, 2011 from http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3_rpt.htm.
Szczepiorkowski, Z., Winters, J., Bandarenko, N., Kim, H., Linenberger, M., Marques, M., et al. Guidelines on the use of therapeutic apheresis in clinical practice – Evidence-based approach from the Apheresis Applications Committee of the American Society for Apheresis. Journal of Clinical Apheresis 2010, (25) 83-177.
U. S. Food and Drug Administration. (1996, February). Center for Devices and Radiological Health. P910018. Liposorber® LA-15 system. Retrieved October 5. 2011, from http://www.accessdata.fda.gov/cdrh_docs/pdf/p910018.pdf.
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 October 5, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf/p940016.pdf.
Winifred S. Hayes, Inc. Medical Technology Directory. (2007, December, Last update December, 2010). Extracorporeal apheresis for conditions affecting the circulatory system and blood. Retrieved October 14, 2011 from www.Hayesinc.com/subscribers (46 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 5/1981
MOST RECENT REVIEW DATE: 12/8/2011
ID_BA
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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