XOLAIR Access Solutions is a free program for you from Genentech. We work to help you pay for your XOLAIR (omalizumab) for subcutaneous use. We can help in many different ways. We assist people who have a health care plan as well as those who don t. If you don t have a health care plan, or your plan won t pay for your XOLAIR, we might be able to help. If you meet certain financial and medical standards, we can supply free medicine. This is done through the Genentech Access to Care Foundation (GATCF). For us to help, we need to look at, use and disclose your personal health information (PHI). Your doctor and health care plan may disclose your PHI to us only with your written consent. Once you sign this form and it is sent back to us, we can start to provide these services. We can provide you with a copy of this Release. You need to ask us for this first before we can send the copy back to you. You do not have to agree to this Release. But we cannot provide our services without it. This means you might need to pay for certain medicines on your own. PLEASE READ THROUGH THIS FORM CAREFULLY. IF YOU HAVE ANY QUESTIONS, TALK TO YOUR DOCTOR S OFFICE OR CALL US AT THE PHONE NUMBER LISTED AT THE TOP OF THIS PAGE. 1. Information to Be Disclosed or Used This signed form lets my doctors and health care plans send my PHI to XOLAIR Access Solutions and/or GATCF. This includes: All my health records relating to my treatment Information about my health care plan benefits The dollar balance left on the total of the lifetime payments covered by my health care plan policy (if this applies to my plan) Any information having a bearing on my health or my adherence to my treatment All of the above is considered part of my PHI. I know this could include information about: Sexually transmitted diseases Mental health conditions Genetic test results We are not looking for this information. It might be part of the medical record sent to us. 1/5
2. Who May See and Use My Personal Health Information (PHI) My PHI may be seen by XOLAIR Access Solutions, sponsored by Novartis Pharmaceuticals Corporation (NPC) and Genentech. In addition, my PHI may be seen by GATCF, a program sponsored by Genentech. It may also be seen by anyone helping NPC and/or XOLAIR Access Solutions perform services. My PHI may be used only in these ways: Helping with my health care plan coverage for XOLAIR (omalizumab) for subcutaneous use Applying to GATCF Tracking my use of XOLAIR For NPC and/or Genentech s administration purposes 3. Expiration Date This Release is in effect for 1 year once I have signed it. I may also withdraw it in writing at any time. 4. Notices Once I sign this form, I know my PHI might not be covered by any federal law about the use of my PHI or how it is disclosed. There is no guarantee my PHI might not be released to a third party. This third party might not need to follow the conditions of this Release. I know I can refuse to sign this form. I may withdraw it at any time and for any reason. This won t affect the start or continuing of my treatment. It will have no effect on the quality of my treatment. I know this Release stays in effect for 1 year or until I withdraw it in writing. To withdraw it, I must send a written notice to Genentech. It can be sent by fax or by mail to the address below. This withdrawal goes into effect once it is received by Genentech. It will have no impact on my treatment by my doctor. If I don t sign this form or withdraw it, I may be responsible for the costs of my treatment. 5. Distribution Acceptance If I receive free XOLAIR product from GATCF, I will use XOLAIR as my doctor has prescribed it to me. I will not sell or distribute XOLAIR. I understand it is unlawful to do this. I am responsible for ensuring XOLAIR is sent to a secure address when it is shipped to me. I know it is my duty to control any XOLAIR while it stays in my possession. SECTION 6 ON THE NEXT PAGE IS REQUIRED. This written notice must be signed, dated and mailed or faxed to: XOLAIR Access Solutions 1 DNA Way, Mail Stop #858a South San Francisco, CA 94080-4990 Fax: (800) 704-6612 2/5
You must sign and date here 6. Signature and Date (REQUIRED) You must print your name here 7. Financial Information Sign and date here (if needed) Sign and date here to enroll I have read and understand the terms of this Release form. I have had the chance to ask questions about the use of my personal health information (PHI) and who may see it. By signing this form below, I know I am releasing my PHI as discussed in this form. (Please fill in all information below. Be sure to sign and date this form. If you don t, it could hold up the process for helping you.) Signature of Patient or Guardian* Description of Authority Date Print Patient s Name Patient/Guardian Address *If the patient is an unemancipated minor or otherwise incapacitated (physically or mentally). Fill out this section only if you want to apply for help from GATCF. Household Adjusted $0-$25,000/yr $50,001-$75,000/yr Gross Income: $25,001-$50,000/yr $75,001-$100,000/yr Other: I know that to qualify for free medicine, my household adjusted gross income may not be more than $100,000 per year. I certify the above statement of my income for last year is true. I do not have the financial resources to pay for XOLAIR (omalizumab) for subcutaneous use. I agree to give GATCF proof of my income. This may be a copy of my IRS 1040 form from last year. It may be other proof of my income as well. I will send this to GATCF within 45 days after this form is submitted. I know if I fail to supply this, GATCF won t be able to keep helping me. Signature of Patient or Guardian 8. Xpansions an Optional and Free Patient Support Program I want to enroll in Xpansions. This is an optional and free patient support program from Genentech and Novartis Pharmaceuticals Corporation. I understand my PHI is needed for me to be a part of this program. I also know my PHI will be shared with XOLAIR Access Solutions and Xpansions. I may choose to be contacted by mail, email or phone. I understand my PHI won t be shared outside of Genentech and Novartis or by its agents. I agree to let Genentech and Novartis or its agents contact me in the future about this program. The Genentech privacy policy can be found at XOLAIRAccessSolutions.com. I understand I do not have to sign this part of the form. It plays no role in getting my medicine. It is not part of receiving help from XOLAIR Access Solutions. I also know I may cancel this enrollment in Xpansions at any time. To cancel, I can call (866) 496-5247. I can also cancel at www.xpansions.com. This is the preferred way to contact me. (Please check the boxes that apply and fill in your information. You can check more than one box.) Email: Phone: Okay to leave a message? Yes No Address: Signature of Patient or Guardian Date Date 3/5
WHO IS XOLAIR FOR? XOLAIR (omalizumab) for subcutaneous use is an injectable, prescription medicine for patients 12 years of age 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. 4/5
IMPORTANT SAFETY INFORMATION (cont) 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. and Medication Guide, for important safety information. XOLAIR and its logo are registered trademarks of Novartis Pharmaceuticals Corporation. The Access Solutions logo is a registered trademark of Genentech, Inc. 2012 Genentech USA, Inc. and Novartis Pharmaceuticals Corporation. All rights reserved. XOL0001086800 06/12 Printed in USA on E recycled paper 5/5