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

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the amount of a type of drug (tumor necrosis factor antagonists (TNF)) in the blood for evaluation of the enrollees inflammatory bowel disease (IBD). Findings:  The physician reviewer found that There is not currently sufficient medical evidence to support the effectiveness of Anser ADA compared with conventional courses of action in the management this patients medical condition. The published studies on the use of anti-adalimumab antibodies and serum levels are small, retrospective, and/or observational rather than controlled in nature, preventing firm conclusions about cause and effect. These small studies at best demonstrated correlations between treatment failure and the presence of anti-adalimumab antibodies, which do not allow firm conclusions regarding cause and effect. Additionally, the ATLAS study showed that patients with loss of response may actually have high, rather than low, serum levels.  It is possible that active disease results in low adalimumab levels due to loss of adalimumab, rather than low adalimumab levels resulting in loss of disease control.  Controlled studies are lacking to show that use of the test results in improved long term health outcomes for patients with ulcerative colitis when compared with other standard methods of managing this condition. There is not sufficient evidence from controlled studies to definitively demonstrate that Anser ADA is more beneficial than any available standard therapy for the management of this patients irritable bowel disease. Accordingly, laboratory testing for the amount of a type of drug (tumor necrosis factor antagonists (TNF)) in the blood received on 10/4/16 was not likely to have been superior over the conventional therapies available for the evaluation of this patients medical condition. Final Result: The reviewers determined that the services at issue were not likely to have been 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.