Appeal type: Experimental/Investigational
Decision: Overturned

Physician #1:  The patient is a 42-year-old male who was diagnosed with eosinophilic gastroenteritis in 1990. The patient has participated in an NIH study using Xolair, an interleukin agent, with significant improvement in his symptoms. The patients provider has recommended that the patient be continued on Xolair. The patient is seeking coverage for past and future use of Xolair, which has been denied by the Health Plan on the basis that the medication is considered experimental in this setting.The diagnosis of eosinophilic gastroenteritis in this patient appears to be well documented. With the exception of systemic steroids, treatment of this disease with pharmacologic therapies is generally ineffective. Furthermore, the patients provider documented major improvement in the patients condition during the clinical trial of Xolair. Based on these results, and the lack of available alternative therapies in this case, the patients continued use of Xolair is medically appropriate and indicated. Therefore, I have determined that the medication at issue is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician #2:  The patient is a 42-year-old male with more than a 15-year history of eosinophilic gastroenteritis. The patients disease was initially treated with steroids. He then participated in an NIH protocol and was placed on the IgE inhibitor, Xolair. The patient apparently improved and reduced his steroid use. The Health Plan has denied coverage for Xolair indicating that its efficacy for treatment of the patients condition remains unproven.Although the patient has improved to some degree while on Xolair, the standard of care in cases such as this is to place the patient on a 6-MP/azathioprine medication as a steroid-sparing agent. These agents have proven efficacy and are safe for long-term use. The long-term efficacy of Xolair for the patients condition has not been established. Accordingly, I have determined that the medication at issue 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 42-year-old male who has a history of eosinophilic gastroenteritis. He has been taking Xolair for symptom relief, which has reduced his dependence on prednisone. The patient wishes to continue on Xolair. The Health Plan indicates Xolair is considered experimental/investigational for the patients diagnosis. Review of the submitted clinical evidence demonstrates Xolair has been effective in relieving the patients symptomatology secondary to eosinophilic gastroenteritis. The patients condition is generally treated with steroids. However, long-term use of steroids often results in significant side effects. The records provided indicate the patient has been able to achieve symptom relief with Xolair thereby reducing his need for steroids and their untoward side effects. As such, it is medically reasonable and appropriate for the patient to continue treatment with Xolair. Based upon the information set forth above, I have determined that the medication at issue is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.