Diagnosis: Respiratory System-Asthma.
Treatment: Pharmacy/Prescription medications-Xolair.
The health plan denied Xolair as not medically necessary.
The reviewer has upheld in whole the health plan's determination.

This is a patient who has a history of Rheumatoid Arthritis (RA), Graves' disease, allergic rhinitis, and is being seen for eosinophilic asthma. She had at least 1 exacerbation requiring systemic steroids. She has numerous triggers on allergy testing. Total Immunoglobulin E(IgE) was 3066 international units per milliliter (IU/mL). She takes Breo, Singulair, and Flonase. Of note, she has several environmental sensitizations including dust mite, cat, dog, grasses, molds, and trees; she still has a dog that she refuses to part with. Xolair has been ordered to help with relief of her asthma symptoms. The patient has a body mass index (BMI) of 27.32 kilograms per square meter(kg/m2).

Xolair(omalizumab) is not medically necessary for this patient. The total IgE level was 3066 IU/mL. When considering her weight and her total IgE level, the amount needed to lower her total IgE levels to see a significant response is beyond any safe dosing.
There is no data to prove efficacy with an elevated IgE level as elevated as in this patient. Studies that have looked at using omalizumab in patients outside the standard range have not studied levels this high. Even in other countries outside the United States with an extended range have cutoffs usually around 2000 IU/mL. Additionally, Global Initiative for Asthma (GINA) guidelines would first support trigger avoidance as one of the first steps in controlling a patient's asthma, which this patient is not doing with her pet. Again, given poor compliance and lack of any data supporting safety and efficacy in a patient with these criteria, omalizumab is not medically necessary.
With her total IgE level beyond what is safe In using omalizumab for a significant clinical response, Xolair is not medically necessary for this patient.