Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Humira (adalimumab) antibodies test. The Health Plan has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.Findings Generally, except on a rare case-by-case basis, diminished or suboptimal response to infliximab or adalimumab can be managed in several ways: shortening the interval between doses, increasing the dose, switching to a different anti-tumor necrosis factor (TNF) agents in patients who continue to have loss of response after receiving the increased dose, or switching to a non-anti-TNF agent based on clinical observation in lieu of Anser testing. The Prometheus Anser IFX test is a quantitative measurement of serum infliximab (IFX) and anti-IFX antibodies, and the Anser ADA test assesses serum adalimumab (ADA) and anti-ADA antibodies. The tests are not U.S. Food and Drug Administration approved. Some evidence exists 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. In 2017, the American Gastroenterological Association (AGA) issued new guideline recommendations on therapeutic drug monitoring (TDM) in patients with inflammatory bowel disease (IBD) treated with anti-tumor necrosis factor (TNF) agents and thiopurines. Pertinent to this review, AGA conditionally suggested use of reactive TDM to guide treatment changes in patients with active IBD, but acknowledged there currently exist no defined cut-offs by which to judge low versus high titer anti-drug antibodies. Some evidence exists that low serum levels of infliximab and/or the presence of antibodies to infliximab may play a role in primary or secondary response failures. However, while there have been testimonials, there are few well controlled clinical trials to confirm Prometheus Anser ADA diagnostic testing leads to improved patient outcomes or quality of life as opposed to the standard methods of 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 been established. According to the current medical literature as well as the documentation provided, Humira (adalimumab) antibodies test was not likely to have been more efficacious when compared to other available modalities for the evaluation of this patients medical condition.Final Result: All three 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:  All three reviewers are board certified in internal medicine with sub-specialty certification in gastroenterology and are actively practicing. All three reviewers are experts 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.