Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: This patient is a 54-year-old female who has irritable bowel syndrome, constipation predominant subtype (IBS-C) and apparently was tested for small bowel bacteria with positive results. Her treating physician is now recommending treatment with a recently described antimicrobial regimen of Xifaxan and neomycin in an effort to resolve her bacterial overgrowth and symptoms of IBS-C. The Health Plan has denied coverage for Xifaxan on the basis it is considered investigational for treatment of the patients medical condition.The issue of the prevalence and putative association of small intestinal bacterial overgrowth with IBS and functional dyspepsia have been and remain controversial. Much of the recent work in this field comes from a single center/investigator and has neither been confirmed in a general population (versus narrow referral population) nor validated by a gold standard test, if one actually exists. Furthermore, the optimal therapy and whether therapy results in long-term improvement has not been established in appropriately designed, multicenter studies that have been subject to peer review. Moreover, this patient does not fit the typical patient profile postulated to be related to bacterial overgrowth, which is diarrhea predominant IBS. For these reasons, I have determined that the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2: The patient is a 54-year-old woman with constipation predominant irritable bowel syndrome (IBS) and migraine headache. She was treated with Zelnorm with response but she had side effects, which prevented her continued use of the medication.  There is no indication of what standard treatments she underwent prior to or after treatment with Zelnorm. She underwent breath hydrogen and methane testing with lactulose as a substrate and had no methane production but a rise in hydrogen production that was interpreted as demonstrating small intestinal bacterial overgrowth (SIBO). Xifaxan and neomycin were prescribed and coverage for the use of Xifaxan was denied by the Health Plan. The patient is reported to have constipation predominant IBS. Treatment of IBS is symptomatic and individualized. The theory that IBS is secondary to SIBO is one of many proposed and has been outlined in the article provided. The treatment of IBS with antibiotics has not been the subject of more than scattered reports and has not gained significant acceptance in the gastroenterology community at this time. At present, Xifaxan is FDA approved for treatment of travelers diarrhea due to non-invasive e coli and not for IBS secondary to SIBO.  The investigational use of Xifaxan in this setting is interesting, and will undoubtedly be the subject of further investigation.  However, at this time there is very little data available on the usage of the proposed medication for treatment of the patients condition and thus, there is insufficient evidence that it is likely to be more effective than standard of care modalities. Based upon the information set forth above, I have determined that the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3: The patient is a 54-year-old female who has irritable bowel syndrome (IBS) and a positive hydrogen breath test. Xifaxan and neomyacin have been prescribed for treatment of the patients symptoms. The Health Plan has denied coverage for Xifaxan on the basis it is considered investigational in this clinical setting.The use of Xifaxan for treatment of bacterial overgrowth is not considered FDA approved and has not been established as efficacious in peer-reviewed scientific literature. Additionally, based on the information provided, the patient has not been tried on other antibiotics such as Doxycycline, Augmentin and Flagyl, which are standard medications for bacterial overgrowth. For these reasons, I have determined that the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.