Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

The patient is a 54-year-old female with a history of asthma and allergies. The patients provider indicates the patient has specific IgE disease with a pre-Xolair IgE of 3. In addition, the provider notes the patient has positive allergy testing. The patients pulmonary function tests showed an FEV1 of 71% and a post-test FEV1 of 82% showing reversibility. In May 2004, the patient was taking Advair 500/50, Singulair, and Combivent inhaler. She was also taking Zyrtec D, Diflucan QD, Tamoxifen, Prednisone, and Albuterol nebulizer. The submitted notes indicate the patient was experiencing exacerbations and urgent unscheduled visits to her physician. She reports she wakes up at night frequently with a cough and wheeze, gets short of breath with normal daily activities, and cannot participate in any activity that requires physical exertion.Review of the diagnostic tests indicates the patient has mild obstruction on pulmonary function testing, with moderate reversibility post-bronchodilator. Skin test results from May 2004 indicate weak reactions to various inhalants. Serum IgE was within normal range at 30 IU/ml. A CT scan of the chest performed in May 2003 revealed focal areas of mild bronchiectasis in the right upper lobe and the right middle lobe where a mucus-impacted dilated bronchus was evident. There was also some irregular scarring in the right middle lobe and a cavernous hemangioma was seen in the left liver lobe. A smaller lesion was seen in segment #8, possibly another hemangioma. Additionally, the scan revealed focal speculated soft tissue density along the outer edge of the right lateral chest wall. A follow-up chest CT scan performed in October 2003 revealed a history of bronchiectasis with no significant interval changes in six months since the last study and a large fixed hiatal hernia.The patients provider has recommended Xolair for treatment of the patients asthma. The Health Plan has determined Xolair is not medically necessary for treatment of the patients medical condition.The FDA approved indication for Xolair is for patients who meet the following criteria: moderate to severe persistent asthma in patients who have a positive skin test or invitro reactivity to a perennial aeroallergen; symptoms inadequately controlled with inhaled corticosteroids and compliance with maximum standard therapy; and pre-treatment total IgE levels of 30/ml or greater. The submitted records do not document positive reactivity to perennial aeroallergens as the skin test results demonstrate minimal sensitivity (all reactions measured at 1, with the exception of a single 2). The patients IgE level of 30 IU/ml was within normal range based on the laboratory standards (less than or equal to 114 IU/ml). Furthermore, the patients diagnosis of asthma does not appear definitive. The patients pre-bronchodilator obstruction may be related to the CT findings of bronchiectasis. The post-bronchodilator findings indicate moderate reversibility. The CT scans revealed the presence of a large fixed hiatal hernia, which may be contributing to the patients condition. Finally, based upon the evidence provided, it does not appear the patient has been maximized on standard therapy for her condition. Given these findings, the patient does not meet medical necessity criteria for treatment with Xolair.Based upon the information provided, I have determined that the requested medication is not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.