Prior authorization is recommended. To authorize, call the Blue Cross and Blue Shield of Montana (BCBSMT) Customer Service Department at 1-800-447-7828 or fax your request to the Medical Review Department at 406-437-7863. A retrospective review is performed if services are not prior authorized.
BCBSMT strongly recommends Xolair only be used under the supervision of an Allergist, Pulmonologist, or immunologist. BCBSMT considers the use of Xolair medically necessary when ALL of the following criteria are met:
Note: Omalizumab (Xolair) will, initially, be approved for 12 months. Ongoing use after inital approval will require submission of medical documentation to support evidence of efficacy and medical necessity for ongoing use.
- Patient is age 12 or older;
- Diagnosis of allergic asthma based on skin testing;
- IgE level greater than or equal to 30 IU/ml and less than or equal to 700 IU/ml.
- Clinical documentation that patient is compliant with high-dose inhaled corticosteroids and long-acting inhaled beta-2 agonists (Step 5 of the National Asthma Treatment Guidelines) and use of oral corticosteroids for exacerbation unless contraindicated.Evidence of reversible disease with treatment as demonstrated by at least:
- Clinical documentation of poor asthma control or recurrent exacerbation requiring additional medication treatment:
- Additional medical treatment may include any of the following: treatment with oral corticosteroids, ER visits, hospitalizations, or frequent office visits.
- Poor asthma control may include (but is not limited to) clinical documentation of limitation of activities of daily living (ADLs), nighttime awakening, or dyspnea.
- Recurrent exacerbation is defined as 2 or more acute exacerbations in a 12-month period.
Underlying conditions or triggers for asthma or pulmonary disease are being maximally managed.
BCBSMT considers the use of Xolair not medically necessary when used for the following conditions:
- Allergic Rhinitis
- Prevention of peanut or other food allergies
When the criteria for coverage is not met, BCBSMT encourages all participating providers to have a member complete and sign an Advanced Member Notification (AMN) form stating that BCBSMT will not cover this service, supply, device, or drug. If an AMN is signed prior to delivery of the service, participating providers can balance bill the patient. If an AMN is not signed, participating providers are financially liable and cannot balance bill the BCBSMT member for denied services. Services provided by an out-of-state provider that are denied as not medically necessary are the financial responsibility of the patient even if an AMN is signed.
Refer to the Advanced Member Notification medical policy for more information. The AMN form is available at www.bcbsmt.com (Click on Providers and then Forms).
Federal mandate prohibits denial of any drug, device, or biological product fully approved by the FDA as investigational for the Federal Employee Program (FEP). In these instances coverage of these FDA-approved technologies are reviewed on the basis of medical necessity alone. Call the BCBSMT FEP Customer Service Department at 1-800-634-3569 for benefit information.
Omalizumab is approved for adolescents (12 years and above) and adults with moderate-to-severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.
Omalizumab is only covered under the medical benefit. Omalizumab is not considered a self-injectable medication due to product labeling indicating that medical observation for hypersensitivity reactions is necessary following administration.
Omalizumab increases the number of patients who are able to reduce or withdraw their inhaled steroids and is effective in reducing asthma. [1, 2, 4, 7]
Efficacy and dosing of omalizumab in patients with IgE levels greater than 700 have not been established. 
The National Heart, Lung, and Blood Institute (NHLBI) defines asthma as a chronic inflammatory disorder of the airways in which many cells and cellular elements (multiple cytokines and mediators, as well as potentially IgE-mediated events involving mast cells and basophils) play a role (in particular, mast cells, eosinophils, T lymphocytes, macrophages, neutrophils and epithelial cells). IgE may be in the inflammatory cascade of some events leading to asthmatic airway inflammation, it is only one part of the picture.
Efficacy and dosing of omalizumab in patients whose weight is outside the range provided in the standard dosing table for omalizumab has not been established (weight-IgE level combinations yielding doses greater than 750 mg every 4 weeks were excluded from clinical trials). [24, 25, 37]
There are no available data demonstrating that omalizumab is superior to preferred options recommended in national treatment guidelines for moderate-to-severe persistent asthma. [14, 15, 20]
Strict compliance with omalizumab is necessary because there is a 6 to 12 week lag before beneficial effects are apparent. (Effects are not immediate and explain the various phases that are included in study protocols.)
Phase II results (suggesting benefits of another anti-IgE compound-TNX-901) cannot be extrapolated to the use of omalizumab to protect against anaphylaxis in patients with peanut allergy. 
There are no published randomized controlled trials supporting the safety and efficacy of omalizumab (Xolair) in the treatment of chronic refractory autoimmune urticaria. Case reports, although are suggestive of benefit larger randomized control trials are needed to confirm these findings.
Omalizumab reduces seasonal and perennial allergic rhinitis symptoms, [3, 9, 22, 23] but has not been shown to have better efficacy than first-line alternatives (such as nasal corticosteroids, antihistamines, or allergen desensitization therapy). 
The efficacy of omalizumab in patients with a history of smoking has not been established (patients with a smoking history in the previous two years or who had a previous history of greater than or equal to 10 pack-years were excluded from omalizumab clinical trials). 
Total IgE Levels
Omalizumab (Xolair) is dosed according to IgE levels between 30 to 700 IU/ml. There is no established dose or benefit for IgE levels outside of this range. There are studies that have included patients with IgE levels beyond 700 IU/ml. These trials were not designed to detect a difference between patients with lower IgE levels and those beyond the dosing recommendation in the manufacturer’s label. The majority of data on the use of omalizumab (Xolair) in patients with baseline IgE >700 IU/ml are limited to case reports with inconsistent results of effectiveness. IgE levels after administration of Xolair are relatively insignificant in trying to quantify because there are no labs to differentiate between bound and unbound (free) IGE.
There is a black box warning for anaphylaxis.
- Anaphylaxis in patients after treatment with omalizumab. These reactions generally occur within two hours of receiving omalizumab.
- Delayed anaphylaxis—with onset two to 24 hours or even longer—after receiving omalizumab treatment.
- Anaphylaxis can occur after any dose.
- It is recommended that patients be observed for at least two hours after omalizumab is administered.
- Urticaria is the most frequent adverse effect reported with short-term therapy. 
There have been some initial concerns with elevated risks of cancer with omalizumab; however, an independent committee of oncologists reviewed available data and were unable to establish a direct correlation. [18, 19]
The FDA is evaluating interim long-term safety data that suggest a risk of cardiovascular and cerebrovascular adverse events.