Prior Authorization: Frequently Asked Questions

  • Q: What is prior authorization?
  • A: Prior authorization is the process of obtaining approval from a health insurance plan for a medication or service before receiving it.
  • Q: How do I initiate a prior authorization request for XOLAIR?
  • A: For an overview of the process, see Prior Authorization. If you are enrolling in XOLAIR Access Solutions™ see How to Enroll for details.
  • Q: Why is XOLAIR only authorized for a specific period of time?
  • A: Most managed care organizations use the specific time period to ensure the appropriateness of care and to identify overuse or ineffective outcomes of therapies.
  • Q: How long will my health insurance plan take to determine if XOLAIR therapy will be covered?
  • A: The turnaround time varies among health insurance plans. On average, when all of the necessary medical documentation has been submitted, a decision is made within 30 to 45 days from the date of submission. Your health insurance plan should be able to provide its policy on prior authorization review turnaround time.
  • Q: How will I know if my health insurance plan will cover XOLAIR?
  • A: Most often, a letter of coverage determination is sent to you and to your health care provider's office.
  • Q: Which health benefit (e.g., prescription, Major Medical) will XOLAIR be covered under and what will my co-payment be?
  • A: Specific coverage for XOLAIR therapy is determined by your health insurance plan when an approval for coverage is in place.
  • Q: How long will it take to establish coverage for XOLAIR?
  • A: There are several factors that will affect when and where you can receive treatment. The time it takes to assess a prior authorization for medications and treatments varies among health insurance plans. In some cases, prior authorization is not required.
  • Q: Why did my health insurance plan deny XOLAIR coverage?
  • A: It could be that a prior authorization was not initiated with your health insurance plan. The health insurance plan may also deny the request due to lack of medical documentation to support treatment. Call the health insurance plan directly for specific information and next steps.
  • Q: My health insurance plan has denied prior authorization. What is my next step?
  • A: See the Appeals section for information on the appeals process. If you would like assistance from XOLAIR Access Solutions, please enroll (see How to Enroll for instructions). XOLAIR Access Solutions will review the denial and may contact your health insurance plan or your health care provider for further information if this is appropriate. Also, you can investigate alternative coverage options.

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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