Prior Authorization

Some health insurance plans need to give prior approval for the use of XOLAIR® (Omalizumab) for Subcutaneous Use so that they can be sure it is being given only to patients who meet specific medical criteria. This prior approval is known as “prior authorization.”

If necessary, our XOLAIR® Access Solutions™ experts can assist by:

  • Investigating the need for prior authorization for treatment with XOLAIR for your particular health insurance plan
  • Letting your doctor's office know if prior authorization is necessary
  • Helping to gather the information required by your health insurance plan if prior authorization is required

If you have been prescribed XOLAIR, but prior authorization is required by your health insurance plan, XOLAIR Access Solutions may be able to help. Here's what you and your health care provider can do:

    • Decide if you want to pursue prior authorization with or without the support of a specialty pharmacy.* Specialty pharmacies not only provide patient support for XOLAIR, they can also assist with obtaining prior authorization, benefits investigation, recertification and first-level appeal.

      With specialty pharmacy support

      • Select a specialty pharmacy from the Specialty Pharmacy Network
      • Have your doctor refer you to the selected specialty pharmacy (see How to Enroll for details)
      • Work with your doctor and the specialty pharmacy to get authorization
      OR

      Without specialty pharmacy support

      Although XOLAIR must be obtained through a specialty pharmacy, prior authorization can be pursued without the assistance of a specialty pharmacy. The information on this site may be used to help facilitate the process.
    • Work with XOLAIR Access Solutions to obtain prior authorization information for XOLAIR.
    • If your health insurance plan approves the request for prior authorization, they will notify you. XOLAIR can then be dispensed to your healthcare provider and then administered to you through an appropriate pharmacy.

      If your request for prior authorization is denied, please see Appeals for more information.

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.

*XOLAIR Access Solutions provides services for those patients who are not able to be serviced through the Specialty Pharmacy Network (see How to Enroll for details).

Please note: This description is provided for informational purposes only. The submission and completion of reimbursement- or coverage-related documentation is the responsibility of the patient and health care provider. Genentech, Inc. makes no representation or guarantees concerning reimbursement or coverage for any service or item.

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