Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the Anser infliximab (IFX) test for evaluation of the enrollees Crohns disease. Findings:  The 3 physician reviewers found that the patient is a female with Crohns disease, status post total colectomy with ileal pull through. In treatment of Crohns, the patient has been maintained on Remicade with last dose.  The available clinical records note that a pouchoscopy was performed in response to patients complaints of left lower quadrant abdominal pain and diarrhea. Mild pouchitis without obstruction was appreciated. Subsequently, with the stated purpose to monitor her response to treatment, the provider ordered an Anser infliximab (IFX) testing. Anser results showed detectable serum infliximab and undetectable antibodies to infliximab. The patient is requesting reimbursement for Anser IFX testing performed. Per the Health Plan, the Anser IFX testing was investigational for evaluation of this patient. There are few well controlled clinical trials to confirm that use of the Anser testing leads to improved patient outcomes or quality of life as opposed to standard methods of evaluation. There is some evidence to show that low serum levels of infliximab or adalimumab and/or the presence of antibodies to infliximab or adalimumab may play a role in primary or secondary response failures. Anti-drug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. The reasons for therapeutic failures remain unclear.  Some evidence exists that low serum levels of infliximab or adalimumab or the presence of infliximab or anti-drug antibodies have an adverse effect on the clinical outcome of a patients response to treatment. The medical studies have not established whether the use of threshold levels aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels have been established. As such, the Anser IFX testing rendered was not likely to be more efficacious than other methods of evaluating this patient. Final Result: The 3 reviewers determined that the services at issue were 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.