Benefits Investigation

Before prescribing XOLAIR® (Omalizumab) for Subcutaneous Use, your doctor's office may want to make sure that your health insurance plan will cover some or all of the costs associated with this treatment. The process of determining your specific health insurance situation is known as “benefits investigation.”

Our XOLAIR® Access Solutions™ experts can help to carry out such benefits investigations on behalf of you and your doctor’s office. By conducting appropriate benefits investigations, you and your doctor can know exactly what is covered before you start treatment. Also, some insurance plans need to give prior approval (known as “prior authorization”) for the use of XOLAIR so that they can be sure it is being given only to patients who meet specific medical criteria.

The following summarizes the possible ways XOLAIR may be covered under your health insurance plan. (For more general information on insurance coverage, please see Insurance Overview.)

Prescription Drug Benefit

  • Product purchased through a participating retail pharmacy (e.g., Walgreens or CVS)
  • Usually a one-month supply
  • Co-payment will vary according to plan guidelines
  • Formulary or preferred drug lists may apply

Mail-Order Drug Benefit

  • Product purchased through a contracted mail-order pharmacy (e.g. Merck Medco)
  • Usually a three-month supply, a benefit for long-term maintenance prescriptions
  • Co-payment will vary according to plan guidelines
  • Formulary or preferred drug lists may apply

Major Medical Benefit

  • Prescription drug coverage may be available under Major Medical coverage if the patient's health insurance plan does not offer a separate drug benefit
  • Patient may have to use a contracted (specialty) pharmacy, depending upon the contract guidelines
  • Usually a one-month supply
  • Deductible and co-insurance limits will apply
  • Formulary or preferred drug lists may apply

XOLAIR (Omalizumab) for Subcutaneous Use Indication

XOLAIR is indicated for adults and adolescents (12 years of age and older) 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 ICS. XOLAIR has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions.

WARNING

Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, patients should be closely observed for an appropriate period of time after XOLAIR administration, and health care providers administering XOLAIR should be prepared to manage anaphylaxis that can be life-threatening. Patients should also be informed of the signs and symptoms of anaphylaxis and instructed to seek immediate medical care should symptoms occur (see WARNINGS, and PRECAUTIONS, Information for Patients).

XOLAIR Safety Information

  • XOLAIR should only be administered in a health care setting by health care providers prepared to manage anaphylaxis that can be life- threatening.
  • XOLAIR should not be administered to patients who have experienced a severe hypersensitivity reaction to XOLAIR (see Boxed WARNING). XOLAIR should be discontinued in patients who experience a severe hypersensitivity reaction.
  • Malignant neoplasms were observed in 20 of 4127 (0.5%) XOLAIR- treated patients compared with 5 of 2236 (0.2%) control patients in clinical studies of asthma and other allergic disorders.
  • Patients should be given and instructed to read the Medication Guide before starting treatment and before each subsequent treatment.
  • Patients receiving XOLAIR should be told not to decrease the dose of, or stop taking any other asthma medications unless otherwise instructed by their physician.
  • The adverse reactions most commonly observed among patients treated with XOLAIR in clinical studies included injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). These events were observed at similar rates in XOLAIR-treated patients and control patients.

Please see full Prescribing Information, including Boxed WARNING and Medication Guide, for additional Important Safety Information.

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