Forms and Documents
To enroll your patient in XOLAIR® Access Solutions, please complete the forms described below. Then fax them to us at (800) 704-6612. Each form is an Adobe® Reader® PDF document. You may type in the form on your computer and print it out, or you may print it out and write in the needed information.
Statement of Medical Necessity (SMN)
The SMN is needed to refer your patient to XOLAIR Access Solutions, a specialty pharmacy (SP) and the Genentech® Access to Care Foundation (GATCF). It may also be used to request a prior authorization or recertification if you are doing this with XOLAIR Access Solutions or a SP. The physician must sign and date the SMN.
Patient Authorization and Notice of Release of Information (PAN)
The PAN is a form each patient signs for XOLAIR Access Solutions or GATCF. The PAN lets XOLAIR Access Solutions look at your patient's health records. We use this information only for the purpose of helping with reimbursement, assisting with appeals or finding other help for eligible patients. The SMN must be faxed with the PAN for processing.
Fax Cover Sheet
For your convenience, we have provided a fax cover sheet with the contact information already completed. You may use this when you are enrolling a patient in XOLAIR Access Solutions or GATCF.
Starter Program Request Form
The Starter Program Request form is needed when requesting the XOLAIR Starter Program. A SMN and PAN must be faxed with the Starter Program Request for processing.
MD Profile
The XOLAIR MD Profile form is a one-page document that can be used to collect information from you, the Health Care Provider. This information is used to customize communication and interactions with XOLAIR Access Solutions.
Sample Appeal Letter
This Sample Appeal Letter provides you with a template for the approved XOLAIR indication. You may use this when appealing a denial on behalf of your patient.
Medicare Appointment of Representative (AOR)
If your patient would like you to assist with an appeal, Medicare may require this form. This form needs to be completed by you and the patient.
XOLAIR (omalizumab) for subcutaneous use Indications and Important Safety Information
Who is XOLAIR for?
XOLAIR® (omalizumab) for subcutaneous use is an injectable, prescription medicine for patients ages 12 and older. It is for patients with moderate to severe persistent allergic asthma caused by year-round allergens in the air. A skin or blood test is done to see if you have allergic asthma. XOLAIR is for patients who are not controlled by asthma medicines called inhaled steroids.
XOLAIR helps reduce the number of asthma attacks in people with allergic asthma who still have asthma symptoms even though they are taking inhaled steroids.
Important Limitations of Use
- XOLAIR has not been proven to work in other allergic conditions.
- XOLAIR is not a rescue medicine and should not be used to treat sudden asthma attacks.
- XOLAIR should not be used in children under 12 years of age.
IMPORTANT SAFETY INFORMATION
XOLAIR should always be injected in a doctor's office. You should read the Medication Guide before starting XOLAIR treatment and before each and every treatment.
A severe allergic reaction called anaphylaxis has happened in some patients after they received XOLAIR. Anaphylaxis is a life-threatening condition and can lead to death. Seek emergency medical treatment right away if symptoms occur. Signs and symptoms of anaphylaxis include:
- wheezing, shortness of breath, cough, chest tightness, or trouble breathing
- low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of "impending doom"
- flushing, itching, hives, or feeling warm
- swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing
You should not receive XOLAIR if you have ever had an allergic reaction to a XOLAIR injection. Do not use XOLAIR if you are allergic to any of its ingredients.
In clinical studies 0.5% of patients receiving XOLAIR developed cancer, compared to 0.2% of patients receiving placebo (an injection with no active medicine).
In patients 
12 years of age, the most commonly observed side effects in asthma studies that had a 1% difference between XOLAIR and placebo were joint pain (8%), pain (general) (7%), leg pain (4%), tiredness (fatigue) (3%), dizziness (3%), fracture (2%), arm pain (2%), itching (2%), inflammation of the skin (2%), and earache (2%).
In asthma studies, the most common side effects in patients, who either needed to stop XOLAIR or needed medical attention, were injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and sore throat (11%). These side effects were seen at the same rates in XOLAIR-treated patients as in patients in the control group who received placebo.
XOLAIR is not a rescue medicine and should not be used to treat sudden asthma attacks.
XOLAIR is not a substitute for the medicines you are already taking. Do not change or stop taking any of your other asthma medicines unless your doctor tells you to do so. You may not see an immediate improvement in your asthma when beginning XOLAIR therapy.
You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch, or by calling 1-800-FDA-1088. You may also report any side effects at 1-866-4XOLAIR (1-866-496-5247).
Talk to your doctor for more information and if you have any questions about your treatment.
Please see full Prescribing Information, including Medication Guide for additional important safety information.
XOLAIR® and its logo are registered trademarks of Novartis Pharmaceuticals Corporation.
The Access Solutions logo and the Access Solutions Treatment made possible logo are trademarks of Genentech USA, Inc.
