Xolair denials in California external review

What the reviewers wrote

Where the denial was 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 patient’s 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.

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 patient’s 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 patient’s provider documented major improvement in the patient’s condition during the clinical trial of Xolair.

Where the denial was upheld

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 patient’s 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 patient’s diagnoses include: allergic rhinitis, allergic asthma, severe, and adrenal suppression secondary to systemic and bronchial corticosteroid usage.

The patient is a 54-year-old female with a history of asthma and allergies. The patient’s 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 patient’s 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.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Xolair, then check the rights and deadlines that apply to your plan.