Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease. 

Treatment: Laboratory test measurement of Infliximab and Infliximab antibodies. 

The insurer denied coverage for laboratory test measurement of Infliximab and Infliximab antibodies. 

The denial is upheld. 

This testing would not be appropriate/indicated for this particular member based upon the member's clinical history and the evidence-based literature.  Although antibodies to Infliximab can occur and lead to resistance to therapy, routine assay of antibody levels to Infliximab are not standard of care.  The decision to continue, or increase the dose of Remicade, is based upon the clinical response of the patient.  Whether to continue or discontinue Infliximab is determined by the patient's clinical status and not based on antibody assays to Infliximab.  A diminished or suboptimal response to infliximab can be managed in several ways: shortening the interval between doses, increasing the dose, switching to a different anti-TNF (tumor necrosis factor) agent, or switching to a non-anti-TNF agent.  Measurement 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 not medically necessary.  The detection and quantitative measurement of anti-infliximab antibodies has technical difficulties. First-generation assays, (i.e., enzyme-linked immunoabsorbant assays [ELISA]) can only measure antidrug antibodies in the absence of detectable drug levels due to interference of the drug with the assay, limiting clinical utility.  Antibodies to infliximab (ATI) are present in a substantial number of patients treated with infliximab, and there may be a correlation between the level of these antibodies and clinical response.  However, the clinical utility of measuring anti-infliximab antibody concentrations has not been established, as it is not known how patient management would change based on test results.  Limited evidence describes changes in management after measurement of ATI, but does not compare these management changes to those made in the absence of ATI measurement.  In addition, there are technical factors relating to the use of different assay methods across studies, it has not yet been established whether the use of threshold level aids in the discrimination of response to infliximab, nor has the optimal timing of when to measure antibody levels been established.  Therefore, the measurement of antibodies to infliximab in a patient receiving treatment with infliximab is considered investigational. 

While the Anser IFX (infliximab) diagnostic test is Food and Drug Administration (FDA) approved for the determination of antibodies to infliximab, the routine use of such a test is not considered standard of care for the management of inflammatory bowel disease such as Crohn's Disease.  Although antibodies can develop during the course of the use of infliximab the decision to continue, discontinue, or change the dose of infliximab therapy remains a clinical one based on observation of the patient and their response to the therapy as provided.  As such the use of the Anser IFX test in this type of clinical condition as performed on these two dates is not supported by the literature. 
  
The requested testing is not likely to be more beneficial than any standard testing for this patient's clinical scenario. 

The carrier's denial of coverage for laboratory test measurement of Infliximab and Infliximab antibodies should be upheld.