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DESCRIPTIONInfliximab (Remicade® Centocor) is a tumor necrosis factor (TNF) alpha blocking agent approved by the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and ulcerative colitis. Secondary loss of response to infliximab is seen in a certain percentage of patients; the development of anti-infliximab antibodies has been suggested as one reason for nonresponse.
Infliximab 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 has the advantage of being able to measure antidrug antibodies when infliximab is present in the serum. Studies evaluating the validation of the results between different assays are lacking, making interstudy comparisons difficult.
Treatment Options for Patients with Secondary Loss of Response to Infliximab
Prometheus® Laboratories Inc. offers an ELISA-based test for the measurement of serum infliximab and human antichimeric antibodies (HACA). This test is set to be discontinued in August 2012 and replaced with an HMSA called the Anser™IFX test. The Anser IFX test is not ELISA-based and can measure antibodies to infliximab in the presence of serum infliximab, improving upon a major limitation of the ELISA method. Anser IFX is offered as a combined test measuring serum concentrations of infliximab and antibodies to infliximab.
This test was developed and its performance characteristics determined by Prometheus Laboratories Inc. It has not been cleared or approved by the U.S. Food and Drug Administration. Prometheus Laboratories Inc. is a CAP-accredited Clinical Laboratory Improvement Amendment (CLIA) laboratory.
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.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/15/2012: Approved by Medical Policy Advisory Committee.
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.