Appeal type: Medical Necessity
Decision: Overturned

The patient is a 57-year-old male with moderate to severe allergic asthma and chronic sinusitis, with seasonal and year-round allergies. He has tried various medications but has been unresponsive to standard medical treatments. His lung function tests revealed a low FEV1.The patient underwent skin testing in 1997 with positive results to trees, grasses and weeds. His IgE level was reported as 39.1 IU/ml in May 1997. The patients current medications include Advair, Singulair, Flonase, Nexium, Zyrtec, Optivar, and Duratuss. He has also received a variety of other medications, including inhaled corticosteroids, theophylline and long-acting beta-agonists. Review of progress notes indicate the patient was taking 20mg prednisone in April 2002, indicating severe steroid dependency. He was seen in the emergency room in December 2000 for a persistent and productive cough and was diagnosed as having asthma. In addition, there is a documented decline in his FEV1 from 97% predicted to 60% predicted over a six-year period, indicating a lack of response to medications.Coverage for Xolair has been requested as medically necessary for treatment of the patients non-responsive allergic asthma. The Health Plan indicates the patients asthma is not medically maximized and the use of the requested medication does not meet therapeutic guidelines.Published studies have clearly shown that Xolair treatment improves asthma control in severely allergic asthmatics, reducing inhaled corticosteroids requirements without worsening of symptom control or increasing rescue medication use.The submitted records indicate the patient has received maximal treatment even though pharmacy records do not document consistent usage of particular medications. In spite of maximum medical treatment with standard therapies this patient has clearly not responded and additional medications are not likely to reverse the steady decline of FEV1 demonstrated in serial pulmonary functions. At this degree of change, it is expected that this patient will have serious chronic lung disease in a few years time. Though review of the submitted pulmonary functions shows only a slight increase of 3% after therapy, this would be an acceptable reversibility given that the patient had been taking Advair at this time. It is likely that the patient was already bronchodilated at the time of that testing.In this case it is important to evaluate the patient as a whole rather than focus on the single criteria for 12% reversibility of airflow, a criteria that was determined for clinical trials only. The patients clinical records indicate the patient meets community-based clinical standards for Xolair based upon the following: history of allergic asthma, with elevated IgE that falls within treatment range; maximization of medications including oral steroid dependency (some of the medications were provided by sampling); lack of clinical response to maximum oral and inhaled asthma medications; and declining FEV1 in the face of mild airway reversibility (the patient was on bronchodilators at the time of pulmonary function testing).Thus, the patient meets both the clinical and published treatment guidelines for the use of Xolair in that it has been demonstrated that he has allergic asthma with corresponding positive skin tests, IgE, and most importantly, steroid dependency at 20mg prednisone.Based upon the information set forth above, I have determined that the requested medication is medically necessary for treatment of the patients medical condition. The Health Plans denial should be overturned. The patient should receive a one-year trial of injectable Xolair.