Forms and Documents
To enroll your patient in XOLAIR® Access Solutions, please complete the forms described below. Both forms must be submitted to receive assistance from XOLAIR Access Solutions.
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.
Download the SMN by clicking on the button below, or begin online submission by logging in to My Patient Solutions.
Patient Authorization and Notice of Release of Information (PAN)
The PAN is a form patients sign to allow XOLAIR Access Solutions or GATCF to view their Personal Health Information. It may also be used to view a patient's financial information.
Patients can complete and return the PAN 1 of 2 ways:
1. Print the PAN and have your patients sign a hard copy.
OR
2. Patients can fill out and submit the PAN online.
To access the PAN electronically and have your patients fill it out immediately, click on the link below. Otherwise, you can either print the form for your patients by downloading it here, or instruct your patients to fill out the form by visiting the XOLAIRSolutions.com patient site. Once the PAN is signed and dated by your patient, fax it along with the SMN to us at (800) 704-6612.
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.
Recertification Reminder Enrollment Form
The Recertification Reminder Enrollment Form allows Physicians and their Practices to easily enroll into the XOLAIR Recertification Reminder Program.
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.
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 so get emergency medical treatment right away if signs or symptoms of anaphylaxis occur after receiving XOLAIR.
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
Anaphylaxis from XOLAIR can happen:
- Right after receiving a XOLAIR injection or hours later
- After any XOLAIR injection. Anaphylaxis has occurred after the first XOLAIR injection or after many XOLAIR injections
Your healthcare provider should watch you for some time in the office for signs or symptoms of anaphylaxis after injecting XOLAIR. If you have signs or symptoms of anaphylaxis, tell your healthcare provider right away.
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, a variety of cancer types, including breast, skin, prostate, and parotid (a type of salivary gland), were reported in more patients who received XOLAIR than in patients who did not receive XOLAIR.
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.
Some patients on XOLAIR may have an abnormal increase in eosinophils (a type of white blood cell) in the blood or tissues, sometimes causing an inflammation of blood vessels which can lead to rash, worsening of respiratory symptoms, heart trouble, and/or nerve pain and weakness.
Joint inflammation or pain, rash, fever, and swollen lymph nodes have been seen in some patients taking XOLAIR after the first or subsequent injections. Talk to your doctor if you¿ve experienced any of these signs and symptoms.
The most commonly seen side effects occurring more frequently in patients receiving XOLAIR than in patients who received placebo (an injection with no active medicine) were joint pain, pain (general), leg pain, tiredness (fatigue), dizziness, fracture, arm pain, itching, inflammation of the skin, and earache.
In asthma studies, the most common side effects in patients, who either needed to stop XOLAIR or needed medical attention, were injection site reaction, viral infections, upper respiratory tract infection, sinusitis, headache, and sore throat. These side effects were seen at similar rates in XOLAIR-treated patients as in patients that did not receive XOLAIR.
There are other possible side effects with XOLAIR. Talk to your doctor for more information and if you have any questions about your treatment.
XOLAIR has not been studied in pregnant women. Pregnant women exposed to XOLAIR are encouraged to enroll in the XOLAIR Pregnancy Exposure Registry. You can get more information by calling 1-866-4XOLAIR (1-866-496-5247) or by speaking with your doctor.
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 is a trademark of Genentech USA, Inc.
