BlueCross BlueShield of Tennessee Medical Policy Manual

Lipoprotein-Associated Phospholipase in the Assessment of Cardiovascular Risk

DESCRIPTION

Lipoprotein-associated phospholipase A2 (Lp-PLA2), also known as platelet-activating factor acetylhydrolase, is a vascular inflammatory enzyme that hydrolyzes phospholipids and is primarily associated with low density lipoproteins.  Lp-PLA2 (i.e., PLAC ® Test) is proposed as a biomarker of coronary artery disease and has been proposed as an adjunct to conventional risk assessment in individuals to determine who might benefit from specific risk-reducing interventions such as pharmacological therapies and behavior modification strategies.

POLICY

See also: Novel Biomarkers in Risk Assessment and Management of Cardiovascular Disease

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

Direct evidence for improved health outcomes with the use of Lp-PLA2 in clinical practice is lacking.  Changes to an individual’s health management that would occur as a result of obtaining Lp-PLA2 levels in practice are not well-defined.  The evidence is insufficient to determine the effects of the technology on health outcomes.

SOURCES

American Association of Clinical Endocrinologists. (2012). American Association of Clinical Endocrinologists’ guidelines for management of dyslipidemia and prevention of atherosclerosis. Retrieved June 6, 2016 from the National Guideline Clearinghouse (NGC:009162)

American College of Cardiology/American Heart Association (2013) 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk. Retrieved March 14, 2017 from: http://circ.ahajournals.org.

BlueCross BlueShield Association. Medical Policy Reference Manual. (12.2016). Measurement of lipoprotein-associated phospholipase A2 in the assessment of cardiovascular risk (2.04.32). Retrieved March 14, 2017 from BlueWeb. (42 articles and/or guidelines reviewed)

Cai, A., Li, G., Chen, J., Li, X., Li, L., & Zhou, Y. (2015). Increased serum level of Lp-PLA2 is independently associated with the severity of coronary artery diseases: a cross-sectional study of Chinese population. BMC Cardiovascular Disorders, 15 (14), DOI 10.1186/s12872-015-0001-9. (Level 3 evidence)

Celik, O., Ozturk, D., Akin, F., Satilmis, S., Yalcin, A., Erturk, M., et al. (2015). Evaluation of lipoprotein-associated phospholipase A2 and plaque burden/composition in young adults. Coronary Artery Disease, 26 (3), 266-271. Abstract retrieved June 6, 2016 from PubMed database.

European Society of Cardiology. (2012, July). European guidelines on cardiovascular disease prevention in clinical practice (version 2012). Retrieved June 6, 2016 from the National Guideline Clearinghouse. (NGC:009545).

Li, D., Zhao, L., Yu, J., Zhang, W., Du, R., Liu, X., et. al. (2017, February) Lipoprotein-associated phospholipase A2 in coronary heart disease: Review and meta-analysis. Clinica Chimica Acta; 465:22-29. Abstract retrieved March 14, 2017 from PubMed database.

Palmetto Government Benefits Administrators (2017, January) Local Coverage Determination (LCD): MolDX: Biomarkers in Cardiovascular Risk Assessment (L36129) Retrieved March 14, 2017 from https://www.cms.gov.

U.S. Food and Drug Administration. (2005, June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K050523. Retrieved September 26, 2008 from http://www.accessdata.fda.gov.

U.S. Food and Drug Administration. (2006, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K062234. Retrieved March 1, 2012 from http://www.accessdata.fda.gov.

U.S. Food and Drug Administration. (2007, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K072599. Retrieved July 2, 2010 from http://www.accessdata.fda.gov.

U.S. Food and Drug Administration. (2014, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K141575. Retrieved June 6, 2016 from http://www.accessdata.fda.gov.

Ueshima, H., Kadowaki, T., Hisamatsu, T., Fujiyoshi, A., Miura, K., Ohkubo, T., et al. (2016). Lipoprotein-associated phospholipase A2 is related to risk of subclinical atherosclerosis but is not supported by Mendelian randomization analysis in a general Japanese population. Atherosclerosis, 246, 141-147. Abstract retrieved June 6, 2016 from PubMed database.

ORIGINAL EFFECTIVE DATE:  2/8/2009

MOST RECENT REVIEW DATE:  5/11/2017

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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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