Appeals

You have been prescribed XOLAIR^® (Omalizumab) for Subcutaneous Use, but your authorization/recertification request has been denied by your health insurance plan.

Now it's time to appeal, and XOLAIR^® Access Solutions™ may be able to help. Here's what you and your health care provider can do:

- Understand why the prior authorization request or claim has been denied by reading your health insurance plan's denial letter or your Explanation of Benefits (EOB).
- Work with a specialty pharmacy or XOLAIR Access Solutions for appeal support.
  - If you are already working with a specialty pharmacy, the specialty pharmacy will support you throughout the appeal process.
  - If you are not already working with a specialty pharmacy, your health care provider may contact XOLAIR Access Solutions for appeal assistance. 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).
- Complete and submit the required forms and documents to your health insurance plan before the appeal deadline. XOLAIR Access Solutions or the specialty pharmacy will facilitate this process.
- If your health insurance plan approves the appeal, they will notify you. XOLAIR can then be dispensed to your healthcare provider and then administered to you through a specialty pharmacy.
  
  If your appeal is denied, contact your specialty pharmacy or XOLAIR Access Solutions for more information

An appeal may be pursued without the assistance of XOLAIR Access Solutions or a specialty pharmacy. Here's what to do:

- Understand why the request has been denied by reading your denial letter.
- Gather the documents and information you need for a successful appeal using our online resources.
  - Questions to Ask Insurance helps you ask the right questions
  - Frequently Asked Questions gives you answers you may need
  - Informational Resources includes valuable Resource Links, downloadable Forms and Documents and even a Glossary
    
    OR
    
    Enroll in XOLAIR Access Solutions if your case is complex or you and your prescriber just need some help. See How to Enroll for instructions.
- Complete and submit the required forms and documents to your health insurance plan before the appeal deadline.
  
  If your health insurance plan approves the appeal, they will notify you. XOLAIR can then be dispensed to your healthcare provider and then administered to you through an appropriate pharmacy.
  
  If the appeal is not successful, you can try to obtain alternative coverage (see Other Funding Sources and Genentech^® Access to Care Foundation).

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 description of the appeals process is provided for informational purposes only. The submission and completion of reimbursement- or coverage-related documentation are 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.