BlueCross BlueShield of Tennessee Medical Policy Manual

Serum Biomarker Panel Testing for Systemic Lupus Erythematosus

DESCRIPTION

Biomarkers are "chemicals" or proteins found in blood, urine or tissue that can indicate both normal and abnormal processes. Systemic lupus erythematosus (SLE) is an autoimmune connective tissue disease that can be difficult to diagnose because individuals often present with diverse, nonspecific symptoms. Currently, the diagnosis of SLE depends on a combination of clinical signs and symptoms and individual laboratory tests.  Recently, laboratory-developed, diagnostic panel tests with proprietary algorithms and/or index scores for the diagnosis of SLE have become commercially available. These panel tests include markers that are standard in the work-up of SLE, but also contain novel markers, most notable cell-bound complement activation products (CB-CAPs).

Currently there is one laboratory developed test (i.e., Avise™ 2.0) which contains 22 different biomarker tests.  It combines two smaller panels; a 10-marker panel that includes common SLE tests as well as a 12-marker panel that focuses on connective tissue diseases other than SLE.  All 22 markers are assessed when the full panel is ordered. Specific biomarkers in these panels are listed in the table below.

10-marker Avise SLE 2.0 Test

Auto-antibodies: ANA, anti-dsDNA, anti-mutated citrullinated vimentin, C4d erythrocyte-bound complement fragment, C4d lymphocyte-bound complement, anti-Sm, Jo-1, Sci-70, CENP, SS-B/La

12-marker Avise SLE + Connective Tissue 2.0 test

Auto-antibodies: U1RNP, RNP70, SS-A/Ro

Rheumatoid arthritis auto-antibodies: rheumatoid factor IgM, rheumatoid factor IgA, anticyclic citrullinated peptide IgG

Anti-phospholipid syndrome auto-antibodies: cardiolipin IgM, cardiolipin IgG, β2-glycoprotein 1 IgG, β2-glycoprotein 1 IgM

Thyroid auto-antibodies: thyroglobulin IgG, thyroid peroxidase IgG

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

No controlled studies were found in the published literature that validates the clinical utility of assessing multiple biomarkers simultaneously, rather than the more commonly performed testing. Therefore, this technology remains investigational.

SOURCES 

Agmon-Levin, N., Damoiseaux, J, Kallenberg, C., Sack, U., Witte, T., Herold, M., et al. (2014). International recommendations for the assessment of auto antibodies to cellular antigens referred to as anti-nuclear antibodies. Annals of the Rheumatic Diseases, 73 (1), 17-23. Abstract retrieved March 7, 2016 from PubMed database.

American College of Rheumatology (ACR). (1997) The 1997 update of the 1982 American College of Rheumatology revised criteria for classification of systemic lupus erythematosus. Retrieved March 7, 2016 from http://www.rheumatology.org.

American College of Rheumatology. (2015, February) Systemic lupus erythematosus, case studies. Retrieved December 4, 2017 from http://www.rheumatology.org.

BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2017). Serum biomarker panel testing for systemic lupus erythematosus. (2.04.123). Retrieved December 4, 2017 from BlueWeb. (16 articles and/or guidelines reviewed)

Dervieux, T., Conklin, J., Ligayon, J., Wolover, L., O'Malley, T., Alexander, R., et al. (2017, July) Validation of a multi-analyte panel with cell-bound complement activation products for systemic lupus erythematosus. Journal of Immunologic Methods, 446, 54-59. Abstract retrieved December 4, 2017 from PubMed database.

Kalunian, K., Chatham, W., Massarotti, E., Reyes-Thomas, J., Harris, C., Furie, R., et al. (2012). Measurement of cell-bound complement activation products enhances diagnostic performance in systemic lupus erythematosus. Arthritis and Rheumatism, 64 (12), 4040-4047. Abstract retrieved March 7, 2016 from PubMed database.

Liu, C., Kao, A., Manzi, S, & Ahearn, J. (2013). Biomarkers in systemic lupus erythematosus: challenges and prospects for the future. Therapeutic Advances in Musculoskeletal Disease, 5 (4), 210-233. (Level 5 evidence)

Mossell, J., Goldman, J., Barken, D., & Alexander, R. (2016). The Avise lupus test and cell-bound complement activation products aid the diagnosis of systemic lupus erythematosus. The Open Rheumatology Journal, 10, 71-80. (Level 4 evidence)

Putterman, C., Furie, R., Ramsey-Goldman, R., Askanase, A., Buyon, J., Kalunian, K., et al. (2014). Cell-bound complement activation products in systemic lupus erythematosus: comparison with anti-double-stranded DNA and standard complement measurements. Lupus, Science & Medicine, 1 (1). (Level 5 evidence)

ORIGINAL EFFECTIVE DATE:  4/9/2015

MOST RECENT REVIEW DATE:  1/25/2018

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