Recertification: Frequently Asked Questions

  • Q: What is recertification?
  • A: When a health insurance plan issues an expiration date with the original (or any subsequent) authorization for a prescription, recertification is the process of making a request for reauthorization either before or after the expiration date.
  • Q: What is the Specialty Pharmacy Network?
  • A: The Specialty Pharmacy Network is a group of specialty pharmacies that have been selected to provide coverage and reimbursement support and to dispense XOLAIR to health care providers for their patients.
  • Q: I was told that my XOLAIR therapy is only authorized for one year. Why is this?
  • 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. Your health insurance plan is likely to require recertification of the authorization one month before the authorization is due to expire.
  • Q: How will I know if I need recertification for XOLAIR?
  • A: You will need recertification if your health insurance plan has issued an expiration date with the previous authorization for XOLAIR.
  • Q: How do I initiate a recertification request for XOLAIR?
  • A: For an overview of the process, see Recertification. In most cases, the specialty pharmacy will initiate the recertification process for you.
  • Q: How long will my health insurance plan take to determine if XOLAIR therapy will be recertified?
  • A: On average, when all of the necessary medical documentation has been submitted, health insurance plans will make a decision within 30 to 45 days from the date of submission.
  • Q: Can XOLAIR be purchased at my local retail pharmacy?
  • A: No, XOLAIR is available only through specialty pharmacies. The Specialty Pharmacy Network has been created to assist health care providers and patients with XOLAIR coverage and distribution issues. The specialty pharmacy from which XOLAIR can be obtained may be dependent upon your health plan.
  • Q: Why did my health insurance plan deny XOLAIR recertification?
  • A: It could be that a recertification was not initiated with your health insurance plan. The plan may also deny the request due to a lack of current medical documentation to support treatment.
  • Q: My health insurance plan has denied the request for recertification. 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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