Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Omalizumab (Xolair) may be considered medically necessary for use in individuals who meet the following criteria:
- Individual is greater than or equal to six (6) years of age; and
- Individual diagnosed with moderate to severe persistent asthma; and
- Individual must be compliant with current therapeutic regimen; and
- Have a positive skin test or in vitro reactivity to a perennial aeroallergen; and
- Baseline IgE titer greater than or equal to 30 IU/mL; and
- Symptoms are inadequately controlled despite a three month trial of the following:
- A medium or high-dose inhaled corticosteroid; or
- A systemic corticosteroid; and
- A long-acting beta-agonists; or
- A leukotriene receptor antagonist.
Continuation of therapy with omalizumab (Xolair) after twelve months may be considered medically necessary for the treatment of an individual with documented moderate to severe persistent asthma when the following criteria are met:
- Treatment with omalizumab (Xolair) has resulted in clinical improvement as documented by ONE or more of the following:
- Decreased utilization of rescue medications; or
- Decreased frequency of exacerbations (defined as worsening of asthma that requires an increase in ICS dose or treatment with systemic corticosteroids); or
- Increase in predicted forced expiratory volume in one second (FEV1) from pretreatment baseline; or
- Reduction in reported asthma-related symptoms, such as, asthmatic symptoms upon awakening, coughing, fatigue, shortness of breath, sleep disturbance, or wheezing; and
- Individual is not receiving omalizumab (Xolair) in combination with mepolizumab (Nucala), benralizumab (Fasenra) or reslizumab (Cinqair).
The use of omalizumab (Xolair) for any indication not listed on this policy is considered experimental/investigational, and therefore, not covered. Scientific evidence does not support the use of omalizumab for any other indications not listed above.