About XOLAIR® Access Solutions™: Frequently Asked Questions

Here are some questions frequently asked about XOLAIR Access Solutions:

  • Q: What is XOLAIR Access Solutions?
  • A: Genentech develops medicines like XOLAIR for serious or life-threatening medical conditions and we believe they should be accessible to the patients who need them. For patients and their health care providers, XOLAIR Access Solutions provides coverage and reimbursement support, patient assistance and informational resources.
  • Q: How can I contact XOLAIR Access Solutions?
  • A: Please click here for contact information.
  • Q: Should I contact XOLAIR Access Solutions for general questions about XOLAIR?
  • A: No. Questions about XOLAIR should be directed to (866) 4XOLAIR / (866) 496-5247. XOLAIR Access Solutions can respond only to questions involving access- and reimbursement-related issues.
  • Q: Do I have to register with XOLAIR Access Solutions prior to treatment?
  • A: No. Pre-registration is not required for the XOLAIR Access Solutions program. However, enrollment in XOLAIR Access Solutions is required for assistance with issues of access and coverage. XOLAIR Access Solutions is a voluntary program that is available at no charge.
  • Q: When should I enroll if I think I may need help?
  • A: You can enroll in XOLAIR Access Solutions at any point during the treatment process, including:
    • At the start of treatment
    • To continue treatment (recertification)
    • When you or your health care provider receives the initial insurance denial
    • After you or your health care provider has attempted a first-level appeal
  • Q: How do I enroll in XOLAIR Access Solutions?
  • A: Please see How to Enroll for enrollment instructions.
  • Q: Why does XOLAIR Access Solutions ask for medical documentation?
  • A: XOLAIR Access Solutions provides access and reimbursement information and assistance, on behalf of a patient, based on your clinical situation and your health insurance plan's coverage requirements. XOLAIR Access Solutions needs the medical documentation in order to support any prior authorization or recertification request and customize any appeal letter.
  • Q: What types of co-pay assistance are available?
  • A: If you have difficulty covering your co-pay* for XOLAIR, XOLAIR Access Solutions can refer you to an independent, non-profit organization for financial assistance.†
  • Q: Does XOLAIR Access Solutions send the appeal directly to the health insurance plan?
  • A: The patient, in coordination with the health care provider, is responsible for reviewing, approving and sending the appeal packet to the payer. Please see Appeals for more information.
  • Q: Is there assistance for uninsured patients who are prescribed XOLAIR?
  • A: Yes. The Genentech® Access to Care Foundation was established to help qualified patients with unmet medical needs to receive appropriate treatment. The Genentech Access to Care Foundation may be available to help those who are not able to obtain XOLAIR for financial reasons.

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.

*"Co-pay" refers to a cost-sharing arrangement in which members of health insurance plans pay a specified charge for a product or service, such as a prescription or an office visit. Members are typically responsible for this payment at the time of the service.

†We cannot guarantee co-pay assistance once you have been referred by XOLAIR Access Solutions. The independent, non-profit organizations to which we refer patients each have their own criteria with regard to eligibility, including financial eligibility. Genentech does not influence or control the operations of these independent, non-profit organizations, but XOLAIR Access Solutions can help you navigate the process of seeking co-pay assistance by referring you to an appropriate organization and by assisting you with the application process.

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