Irritable Bowel Syndrome With Diarrhea denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for the medication Xifaxan.There has been a significant amount of investigation into the use of rifaximin in IBS-D over the last decade. Medical literatures performed a meta-analysis to evaluate the risk of adverse effects, specifically the number needed to harm (NNH), amongst common pharmacologic agents used to manage IBS-D. They found that the NNH for rifaximin was 8971 versus 18.3 for tricyclic antidepressant (TCA), concluding that rifaximin has a better safety profile. Further, they found that an adverse event resulting in discontinuation of TCA occurred for every 2.3 patients who benefited from the drug, versus every 846 patients who took rifaximin, further favoring rifaximin versus TCA.

Nature of Statutory Criteria/Case Summary: The patient has been diagnosed with irritable bowel syndrome with diarrhea (IBS-D). The patient reported diarrhea, nausea, and unintentional weight loss. The patient underwent a colonoscopy that revealed non-bleeding internal hemorrhoids. The random colon biopsies obtained were noted to be negative for adenomatous change or malignancy. The patient reported diarrhea and abdominal cramping, which improved after bowel movements. In the Health Plan Prescription Drug Prior Authorization or Step Therapy Exception Request Form, the provider noted loperamide was ineffective. A computed tomography scan of the abdomen and pelvis showed a distended gallbladder, diverticulosis, and a stable right lung nodule. An ultrasound of the abdomen, showed multiple gallstones in a nondilated gallbladder.

Where the denial was upheld

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary:The parent of a patient has requested reimbursement and prospective authorization and coverage for a medication for irritable bowel syndrome with diarrhea. This medication is approved for use in adults, and current clinical guidelines and literature do not support its use in pediatric patients. Available evidence for pediatric populations is limited, and potential risks have been identified without sufficient data demonstrating safety and efficacy in this age group. Standard management for pediatric patients includes dietary modification, behavioral interventions, and other therapies with established safety profiles. In this case, the requested medication is not supported by current medical evidence or guidelines for pediatric use.

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 irritable bowel syndrome with diarrhea, then check the rights and deadlines that apply to your plan.