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

The patient is a 39-year-old male with asthma. Progress notes from February 2005 indicate the patient has been seen since 2001 for the diagnosis of asthma with allergies, as well as a six-month history of fatigue. The patient has had an endocrinology evaluation and has partial adrenal insufficiency, likely due to his use of steroids. It is stated the patients spirometry showed an FEV1 of 104% with flow rates of 77% (almost normal). There is no statement of reversibility with bronchodilator. It is also stated that since the patient is capable of treating himself during severe exacerbations, he has not required emergency room care. The patients diagnoses include: allergic rhinitis, allergic asthma, severe, and adrenal suppression secondary to systemic and bronchial corticosteroid usage. Skin test records dated January 1997 indicate sensitivity to dust mites by intradermal testing.In May 2005, the patients provider stated the patient has an anti-dust program in his home and is receiving immunotherapy. It is indicated that the patient is using Advair 250/50, Flovent 220 and Singulair on a regular basis, as well as albuterol at night on awakening. It is also stated that the patient has documented adrenal suppression from his use of inhaled corticosteroids, and has been on three prednisone bursts since September 2004. The patients provider has recommended a six-month trial of Xolair. The Health Plan has denied authorization and coverage for Xolair on the basis it is not medically necessary for treatment of the patients condition.The FDA approved indications and medical necessity of Xolair for this patient are not established in the submitted records. The FDA approved indication for Xolair is 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 pre-treatment total IgE levels of 30 or greater. Xolair is this clinical setting is not in accordance with these criteria. While the submitted information may support the possibility that the patients total IgE has been depressed by the use of corticosteroids, there is no documentation the patient meets the criteria of a total IgE range greater than 30 IU/mL. A literature review includes a single abstract, which found that inhaled BDP significantly improved asthma symptom scores and forced expiratory volume, and decreased blood eosinophil counts, total serum IgE levels and specific IgE antibodies to house dust mite and cedar. Decreases in total serum IgE significantly correlated with an improvement in asthma symptom scores. The authors concluded inhaled corticosteroids might improve the subsequent clinical course of atopic asthma in association with reduction of serum IgE levels.  The submitted records do not provide laboratory confirmation of active reversible airway disease  (i.e., reversibility with bronchodilator). Current positive skin tests or RAST assay have not been submitted for review.  The last skin test submitted is dated 1997. Based on the submitted documentation, the patient does not meet medical necessity criteria for authorization of Xolair at this time. Therefore, the Health Plans denial should be upheld at this time. However, the patient should undergo further workup to determine if Xolair is medically necessary for his diagnosis of severe allergic asthma. An up-to-date skin test or RAST assay for perennial aeroallergen sensitivity should be obtained as well as complete pulmonary function data to determine the presence of deterioration of pulmonary function, and/or response to bronchodilator therapy. Additionally, total IgE level should be obtained once the patient is on a lower dose of inhaled corticosteroid therapy and off systemic steroid therapy. Depending upon the results of these tests, the patients request for Xolair should be reconsidered.