Inflammatory Bowel Disease denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for infliximab therapeutic drug assay. Based on the recommendations in the current peer-reviewed medical literature, the testing of infliximab (Remicade) levels in response to suboptimal response to therapy is considered the standard of care. Specifically, patients may be found to have low levels of infliximab and require an increased dose. In other instances, patients may have high concentrations of neutralizing antibodies requiring a change of therapy. In this case, a high antibody concentration of circulating infliximab is driving the level down to an undetectable range. A therapeutic switch is indicated rather than increasing the infliximab dose. The results in this case highlight the importance of testing.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The parents of the patient requested authorization and coverage for infliximab-dyyb, biosimilar (Inflectra®) infusion, 10 mg (500 mg every eight weeks for one year). The submitted documentation supports the medical necessity of the treatment at issue. In current pediatric gastroenterology practice, successful treatment of IBD is not based on symptoms such as the presence or absence of clinical remission but based on mucosal healing. A patient with ongoing anemia, erythrocyte sedimentation rate (ESR) elevation, and rising fecal calprotectin cannot be considered in remission. In this clinical setting, intensification of treatment is warranted.

Where the denial was upheld

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 enrollee’s 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 patient’s 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.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the fecal calprotectin testing for evaluation of the enrollee’s possible inflammatory bowel disease. Findings: The 3 physician reviewers found that the use of fecal calprotectin testing to diagnose change in bowel habits has not been accepted for routine use in this clinical setting. According to the American College of Physicians (ACP) “a specialist might measure fecal calprotectin, but only in conjunction with detailed history-taking, clinical examination, and serum inflammatory markers or other blood tests, to determine the need for endoscopic evaluation”. The ACP also stated that “fecal calprotectin is elevated in several other gastrointestinal diseases, including viral, bacterial, and protozoal causes of infective diarrhea”.

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These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving inflammatory bowel disease, then check the rights and deadlines that apply to your plan.