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DESCRIPTIONInfliximab (Remicade) is an intravenous tumor necrosis factor (TNF) alpha blocking agent approved by the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis (RA), Crohn disease, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and ulcerative colitis. Adalimumab (Humira) is a subcutaneous TNF alpha inhibitor that is FDA-approved for treatment Crohn disease and ulcerative colitis in adults only and juvenile idiopathic arthritis. Following primary response to infliximab and adalimumab, some patients become nonresponders. The development of antidrug antibodies (ADA) is considered to be a cause of this secondary nonresponse.
Infliximab and Adalimumab in Autoimmune Disease
Detection of Antidrug Antibodies
Disadvantages of the RIA method are associated with the complexity of the test and prolonged incubation time, and safety concerns related to the handling of radioactive material. The HMSA measures antidrug antibodies when infliximab is present in serum. Studies evaluating the validation of results between different assays are lacking, making interstudy comparisons difficult. One retrospective study in 63 patients demonstrated comparable diagnostic accuracy between two different ELISA methods in patients with IBD (ie, double-antigen ELISA and antihuman lambda chain-based ELISA). This study did not include an objective clinical and endoscopic scoring system for validation of results.
Treatment Options for Secondary Loss of Response to Anti-TNF Therapy
Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests (LDTs) must meet the general regulatory standards of the Clinical Laboratory Improvement Act (CLIA). Laboratories that offer LDTs must be licensed by CLIA for high-complexity testing. To date, the U.S. Food and Drug Administration has chosen not to require any regulatory review of this test.
Prometheus® Laboratories, a College of American Pathologists--accredited under CLIA, offers non-radio-labeled, fluid-phase HMSA tests called Anser™IFX (for infliximab) and Anser™ADA (for adalimumab). Neither is based on an enzyme-linked immunosorbent assay (ELISA), and each can measure antidrug antibodies in the presence of detectable drug levels, improving on a major limitation of the ELISA method. Both tests measure serum drug concentrations and antidrug antibodies.
POLICYMeasurement of antibodies to infliximab in a patient receiving treatment with infliximab, either alone or as a combination test, which includes the measurement of serum infliximab levels, is considered investigational.
Measurement of antibodies to adalimumab in a patient receiving treatment with adalimumab, either alone or as a combination test, which includes the measurement of serum adalimumab levels, is considered investigational.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY11/15/2012: Approved by Medical Policy Advisory Committee.
12/13/2013: Added Adalimumab to the policy title and description. Added the following policy statement: Measurement of antibodies to adalimumab in a patient receiving treatment with adalimumab, either alone or as a combination test which includes the measurement of serum adalimumab levels, is considered investigational.
01/06/2015: Policy reviewed; description updated. Policy statement unchanged.
07/31/2015: Code Reference section updated for ICD-10.
01/12/2016: Policy description updated regarding reasons for therapeutic failures and to add laboratory testing information. Policy statements unchanged. Investigative definition updated in policy guidelines section.
06/07/2016: Policy number A.2.04.84 added.
12/05/2016: Policy description updated. Policy statements unchanged.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.04.84
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
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