Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the measurement of serum tumor necrosis factor (TNF) agents and anti-drug antibodies chemistry testing for evaluation of the enrollees ulcerative colitis. Findings:  2/3 of the physician reviewers found that In this case, measurement of serum TNF agents and anti-drug antibodies chemistry testing was recommended to determine the patients Remicade level, and whether antibodies to Remicade were present. Loss of response to Remicade can occur for many reasons, although there was not a clear loss of response to Remicade in this case. The presence of antibodies alone has not been demonstrated to result in loss of response to infliximab or infusion reactions, nor have threshold levels been established. Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response. A recent study concluded that prospective evaluation of the value of measuring serum concentrations of infliximab should be performed before these data can be included in patient management strategies. A systematic review reported that future prospective controlled studies are needed, especially considering anti-TNF levels are influenced by several variables that can fluctuate over time and among individuals. In sum, current medical literature lacks high-quality controlled studies to define drug level or antibody level thresholds requiring action, compare clinical strategies, or definitively establish that use of Anser IFX improves outcome. Moreover, the medical literature available is not sufficient to support improvement in health outcomes with testing. All told, the measurement of serum TNF agents and anti-drug antibodies chemistry testing performed was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Final Result: 2/3 of the reviewers determined that the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewer number one is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number two is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number three is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.