Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Asthma, Idiopathic Urticaria
 
Treatment: Xolair

The insurer denied the medication Xolair. The denial was upheld.   

This is a female patient with a medical history of asthma. She had a history of chronic idiopathic urticaria. It was reported that the patient had tried a series of medication to treat this chronic condition that include montelukast, famotidine, and Zyrtec all with poor responses.  Xolair was recommended as it would treat her asthma and chronic urticaria. It was noted that the patient asthma had been controlled.

Xolair is indicated for poorly controlled asthma. For hives, current guidelines state that for initial therapy: administer a second-generation antihistamine at standard therapeutic dose.  If step 1 does not control symptoms adequately within one to two weeks, therapy may be increased by advancing the dose of the second-generation antihistamine, adding a different second-generation antihistamine, adding an H2 antihistamine or adding a leukotriene-receptor antagonist or adding a first-generation H1 antihistamine at bedtime.   If the measures in step 2 do not result in adequate control of symptoms, the dose of the first-generation H1 antihistamine may be advanced gradually in step 3.  Patients whose symptoms are not controlled by step 3 therapies, or who are intolerant of dose advancement of first generation H1 antihistamines are considered to have refractory chronic urticaria (CU) and can be considered for Xolair.

"Multiple studies have compared first- and second-generation antihistamines, which differ in in vivo and in vitro in parameters such as histamine receptor binding affinity, onset of activity, and metabolism.31, 87, 88, 89, 90 Second-generation antihistamines are effective in patients with acute urticaria when used on a regular basis and titrated to an effective dose in most patients, with reassuring long-term safety, even in small children.15 Individual patient responses to different antihistamines can vary, both with respect to efficacy and dose-related sedation and impairment of performance. For this reason, management frequently entails periodic follow-up to monitor efficacy and untoward effects of medications and to individualize dosing of medication to optimize response to therapy. Other medications with potent antihistaminic activity, such as doxepin, might have efficacy for patients for whom conventional (or graduated) doses of FDA-approved antihistamines lack sufficient efficacy. Histamine 2 blockers, in combination with H1-antihistamines, might be considered as an additional therapeutic option; however, the evidence supporting this combination is weak.31 Summary Statement 9: In severe cases oral corticosteroids might be necessary to treat acute urticaria and angioedema. In patients with poor response to antihistamines, a brief course of oral corticosteroids might also be required while attempting to eliminate suspected triggers and develop an effective treatment plan. (C)." (Bernstein, et al 2014).

"Chronic urticaria (CU) is a common, heterogeneous, and debilitating disease. Antihistamines and omalizumab are the mainstay therapies of CU. Additional treatment options are needed. Here, we review the off and beyond label use of licensed drugs, novel treatments that are currently under development, and promising new targets." (Kolkhir, et al. 2020).        

The health care plan did act reasonably, with sound medical judgment, and in the best interest of the patient. 
Based on the above, the medical necessity for Xolair is not substantiated.  The insurer's denial is upheld.