Appeals: Frequently Asked Questions

  • Q: What is an appeal?
  • A: An appeal is a request for reconsideration of services that were denied reimbursement by a health insurance plan. An appeal is filed if the health insurance plan does not pay or does not pay enough for a procedure or service. The appeal is made to the health insurance plan and there are usually specific guidelines.
  • Q: How long do I or my health care provider have to file an appeal or grievance?
  • A: Most often, there is a requirement that the member or the physician appeal a denial of a benefit or service in writing within a period of time as short as 15 to 60 days. Check with the health insurance plan to determine what that particular plan's guidelines are.
  • Q: Does XOLAIR Access Solutions send the appeal directly to my health insurance plan?
  • A: The XOLAIR Access Solutions appeals specialist, in coordination with you and your health care provider, will send the appeal packet to your health insurance plan after it has been approved by you and your health care provider. In some cases, however, the health insurance plan will not accept an appeal from XOLAIR Access Solutions, so the patient/prescriber will be asked to submit the appeal packet directly.
  • Q: How long does the appeal review process take?
  • A: The amount of time it takes a health insurance plan to review appealed medical claims varies. Please contact your health insurance plan's appeals department to receive an estimated timeline. The appeals process can take several months depending on the levels of appeals allowed.
  • Q: What is an "external review"?
  • A: An external review is an opportunity for an outside independent party to examine the denied services. This party is expected to provide an impartial expert opinion regarding the medical necessity of your treatment.
  • Q: Are external reviews available in every state?
  • A: External review laws have been adopted in approximately 40 states and the District of Columbia. You can visit the Kaiser Family Foundation website at www.kff.org for more information.
  • Q: Are external reviews available for every type of health insurance plan?
  • A: No, each state has its individual allowances in regard to the types of health insurance plans or organizations that meet the particular standards of the adopted laws. Managed care organizations and other health insurance plans are responsible for verifying the effective date of the relevant state laws.
  • Q: When can I request an external review of my health insurance plan's decision?
  • A: The member can only ask for an external review after they have exhausted their health insurance plan's internal appeals process.
  • Q: How do I ask for an external review?
  • A: You or your health care provider must ask for an external review from the State Insurance Department within 45 days of receiving the last treatment denial. Please see your Explanation of Benefits or contact your health insurance plan 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.

Please note: This website contains links to a number of other sites that may offer useful information. We suggest visiting those sites directly to obtain information on specific details of coverage as well as educational and financial support services for XOLAIR® (Omalizumab). Genentech, Inc. and Novartis Pharmaceuticals Corporation are not partners with or affiliated with any company listed. The availability of health insurance coverage and financial assistance varies from company to company, plan to plan and state to state. Genentech, Inc. and Novartis Pharmaceuticals Corporation do not imply or guarantee that a specific health insurance plan or any other company will provide coverage or assistance for XOLAIR therapy. Genentech, Inc. and Novartis Pharmaceuticals Corporation are not responsible for any decisions regarding partial or non-coverage of XOLAIR therapy.

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