Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1


A 49-year-old female enrollee has requested reimbursement for the Anser ADA testing performed on 1/11/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that in this case, Anser ADA was used to direct the management of the patients Crohns disease. However, the use of the Anser ADA test has not been clinically proven to improve patient clinical outcomes, and has not definitively demonstrated clinical utility. The effectiveness of Anser ADA compared with conventional courses of action remains unproven. Patients being treated with Humira may experience loss of response, but the appropriate method for determination of the cause for loss of response is not clear. The published studies on the use of anti-adalimumab antibodies and serum levels are retrospective and/or observational in nature (Karmiris, et al; Imaeda, et al; Lichtenstein, et al). Moreover, prospective controlled trials providing evidence for the effectiveness of anti-adalimumab antibody testing and serum level testing as part of a clinical management strategy are lacking. Therefore, clinical literature does not support the Anser ADA test performed on 1/11/16 as likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.


A 49-year-old female enrollee has requested reimbursement for the Anser ADA testing performed on 1/11/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that the Prometheus Anser ADA test is a quantitative measurement of serum adalimumab (ADA) and anti-ADA antibodies. Some evidence exists that low serum levels of adalimumab and/or the presence of antibodies to adalimumab may play a role in primary or secondary response failures. Antidrug 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 adalimumab or the presence of ADA antibodies have an adverse effect on the clinical outcome of a patients response to treatment. While there have been testimonials, 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 the standard method of treatment (Steenholdt, et al; Nanda, et al). As such, the clinical utility of measuring drug antibody concentrations has not been established, and it has not been determined how patient management should change based on test results. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement (Yanai, et al). All told, the Anser ADA testing performed on 1/11/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.