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DESCRIPTIONInfliximab (Remicade®, Janssen Biotech) 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's disease, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and ulcerative colitis. Adalimumab (Humira®, AbbVie) is a subcutaneous TNF alpha inhibitor that is FDA-approved for treatment of these indications (Crohn’s disease and ulcerative colitis in adults only) plus juvenile idiopathic arthritis. Secondary loss of response to infliximab and adalimumab is seen in a certain percentage of patients; the development of antidrug antibodies has been suggested as one reason for 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 has the advantage of being able to measure antidrug antibodies when infliximab is present in the 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, ie, double antigen ELISA and antihuman lambda chain ELISA. This study did not include an objective, clinical and endoscopic scoring system for validation of results.
Treatment Options for Patients with Secondary Loss of Response to Anti-TNF Therapy A diminished or suboptimal response to infliximab and adalimumab can be managed in several ways: shortening the interval between doses, increasing the dose, switching to a different anti-TNF agent (in patients who continue to have loss of response after receiving the increased dose), or switching to a non-anti-TNF agent.
Prometheus® Laboratories Inc. offers nonradiolabeled, fluid-phase HMSA tests called Anser™IFX for infliximab and Anser™ADA for adalimumab. Neither test is ELISA-based, and each can measure antidrug antibodies in the presence of detectable drug levels, improving upon a major limitation of the ELISA method. Both tests measure serum drug concentrations and antidrug antibodies.
These tests were developed and their performance characteristics determined by Prometheus Laboratories Inc. Neither has 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.
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.
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.
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.
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.