Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/ Case Summary:  The enrollee requested reimbursement for laboratory testing (Fecal Calprotectin) and laboratory testing for (Adalimumab Drug Level and Anti-drug Antibody). The patient has a history of pan ulcerative colitis. She underwent a colonoscopy and had moderate inflammatory changes from the rectum to descending colon. The histopathology showed moderate inflammation, inflammatory changes from the descending colon to the rectum and severe active colitis. The patient started Humira, but still had four to six loose stools per day. Her gastroenterologist advised continuation of Humira but ordered a fecal calprotectin to determine if there was any improvement after starting the medication.  He also ordered a complete blood count (CBC) and comprehensive metabolic panel (CMP).  A note indicated the patients calprotectin level was markedly elevated and the Humira may not have been effective after three months. However, prior to this, he ordered adalimumab levels and stool for comprehensive assessment for gastrointestinal pathogens. Review of the record indicates the patient was not responding appropriately to therapy, making it necessary to rule out an infectious process. Fecal calprotectin is an indirect marker of neutrophil infiltration and inflammation of the colon that has a very high sensitivity and specificity to predict if there is active disease in the colon in a non-invasive way.  In multiple studies, fecal calprotectin was useful to identify active disease of the intestines without needing to perform a colonoscopy to monitor disease activity, mucosal healing and to predict clinical remission.  This test is very useful as a non-invasive modality to assess for active inflammatory bowel disease without performing frequent endoscopic evaluation. In order to optimize the use of anti-TNF agents for patients with inflammatory bowel disease (IBD), it is necessary to monitor the drug concentrations and antibodies to the drug. Therapeutic drug monitoring can be used in patients in remission and patients with active disease.  Studies have shown that targeting specific drug concentrations can decrease the complications from IBD, including fewer flares, lower risk of medical therapy failure, lower risk of hospitalizations and lower risk of requiring surgery while being treated with anti-TNF agents. Measuring antibodies to Adalimumab has also been shown to be helpful to identify patients who will have lower levels of the drug and therefore an inferior response to treatment. Checking blood levels of adalimumab and doing a comprehensive viral, bacteriologic, and parasitologic study is in best interest of the patient. Final Result: Three of the three reviewers determined the requested services are likely to be more beneficial than any available standard therapy for treatment of the enrollees medical condition. Credentials/Qualifications: Three reviewers are board certified 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 orcurrent actual clinical experience treating those with the same or a similar medical condition.