Extracorporeal Immunoadsorption (ECI) Using Protein A Columns
DESCRIPTION
Extracorporeal immunoadsorption (ECI) using protein A columns, also referred to as protein immunoadsorption therapy, consists of highly purified protein A (isolated from Staphylococcus aureus) that is bonded to a silica matrix. Plasma is collected from the individual in a pheresis procedure and then is passed over the column. Circulating immune complexes (CICs) and IgG bind to protein A and are thus selectively removed from the plasma. The plasma can then be returned to the individual, thus eliminating the need for a plasma exchange.
Pathogenic levels of IgG and circulating immune complexes are associated with a number of diseases such as idiopathic thrombocytopenic purpura (ITP), hemolytic uremic syndrome, and red cell aplasia. In the past, plasma exchange was used to remove CICs and IgG. ECI represents a selective removal of the pathogenic substances and has been investigated as an alternative to plasma exchange, particularly for individuals with ITP.
Immunoadsorption columns have been investigated in individuals with rheumatoid arthritis with long-standing disease who have failed or are intolerant to disease-modifying anti-rheumatic drugs (e.g., methotrexate [Rheumatrex], hydroxychloroquine [Plaquenil], sulfasalazine [Azulfidine], gold [Ridaurs, Solganal], azathioprine [Imuran], D-penicillamine [Depen, Cuprimine], etanercept, and leflunomide).
POLICY
Extracorporeal immunoadsorption for the treatment of idiopathic thrombocytopenic purpura is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Extracorporeal immunoadsorption for the treatment of rheumatoid arthritis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Extracorporeal immunoadsorption for the treatment of other conditions/diseases, including, but not limited to, the following is considered investigational:
Cancer
Autoimmune diseases
Thrombotic microangiopathies
Renal transplant recipients
See also: Plasma Exchange
MEDICAL APPROPRIATENESS
Extracorporeal immunoadsorption is considered medically appropriate if ANY ONE of the following:
Treatment of individuals with idiopathic thrombocytopenic purpura with ALL of the following
Unresponsive to other therapies
ANY ONE of the following:
A platelet count below 20,000
A platelet count below 50,000 with evidence of bleeding
Treatment of adult individuals with rheumatoid arthritis and ALL of the following:
Presence of signs and symptoms of moderate to severe rheumatoid arthritis
A history of long-standing rheumatoid arthritis
Documented inability to tolerate disease-modifying anti-rheumatic drugs (DMARDS) or documented failure to respond to treatment of either methotrexate or at least 2 other second-line DMARDS
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
Individuals with idiopathic thrombocytopenia typically receive 6 treatments over the course of 2 to 3 weeks. Individuals with rheumatoid arthritis typically receive 1 treatment per week for 12 weeks.
There are inadequate, well-designed studies to validate the effectiveness of this treatment for other conditions.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2008). Extracorporeal immunoadsorption using protein A columns - Archived (8.02.03). Retrieved September 21, 2011 from BlueWeb.
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, August). Extracorporeal immunoadsorption (ECI) using protein A columns (NCD 20.5, p. 2-7). Ingenix.
Swenger, V., & Morath, C. (2010) Immunoadsorption in nephrology and kidney transplantation. Nephrology Dialysis Transplantation, 25 (8), 2407 -2413. (Level 5 Evidence)
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. (1999, March). Center for Devices and Radiological Health. ProsorbaŽ column - P850020/S011. Retrieved January 13,2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf/P850020S011b.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: 7/1/2000
MOST RECENT REVIEW DATE: 11/10/2011
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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