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202006-129346

2020

Fidelis Care New York

Medicaid

Skin Disorders

Pharmacy/ Prescription Drugs

Medical necessity

Overturned

Case Summary

Diagnosis: History of hypertension, gastroesophageal.
reflux disease (GERD), anemia and chronic. kidney disease. Chronic Urticaria.
Treatment: Xolair 150MG/ML SC Sosy.
The insurer denied the Xolair 150MG/ML SC Sosy.
The denial is overturned.

The patient is a female with a history of chronic idiopathic urticaria unresponsive to H1 (histamine 1) and H2 (histamine 2) antihistamines. The request is approval for Xolair.

Yes, the treatment with Xolair is medically necessary.

The patient is older than 12 years of age. The patient experienced inadequate response or intolerance to second generation H1 (histamine 1) antihistamines with cetirizine 10mg (milligrams) twice a day. The patient tried dose advancement of H1 (histamine 1) antihistamine, as cetirizine was increased from once a day to twice a day. The patient tried addition of another H2 (histamine 2) antihistamine in the form of famotidine. The patient tried leukotriene receptor inhibitors for at least six weeks in the form of montelukast. The patient tried first generation H1 (histamine 1) antihistamines at bedtime in the form of hydroxyzine 25mg (milligrams) at night. The patient tried dose advancement of H1 (histamine 1) antihistamines. The patient therefore meets guidelines for Xolair for the indication of chronic idiopathic urticaria.

The patient has shown persistent refractory symptoms of hive on face, body despite treatments with multiple H1 (histamine 1) antihistamines in combination with H2 (histamine 2) antihistamines and montelukast. The patient is a young person with active lifestyle. Overmedication with multiple antihistamines can lead to excessive drowsiness, which can further impact school and work.

Omalizumab (Xolair) has received FDA (Food and Drug Administration) approval for the treatment of patients with chronic Idiopathic Urticaria in adults and adolescents (12 years of age and above) who remain symptomatic despite H1 (histamine 1) antihistamine treatment. Based on the clinical information provided, the patient has remained symptomatic with urticaria despite H1 (histamine 1) and H2 (histamine 2) antihistamine treatment and will benefit from omalizumab treatment.

Therefore, given the above, the treatment with Xolair is medically necessary.

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