Patient Name: Statement of Medical Necessity Form & Patient Authorization and Notice of Release of Information Form

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1 Patient Name: Statement of Medical Necessity Form & Patient Authorization and Notice of Release of Information Form XOLAIR is indicated for: Adults and adolescents (aged 12 years) 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 inhaled corticosteroids. 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). Please see accompanying full Prescribing Information, including Boxed WARNING and Medication Guide, for additional important safety information.

2 Statement of Medical Necessity (SMN) for Xolair (Omalizumab) for Subcutaneous Use Please see opposite page for instructions on completing this form. 1 2 Patient Information Name: Home Phone: Alternate Phone: Address: City: State: ZIP Code: Alternate Contact: Relationship: Home Phone: Work Phone: Patient Social Security Number: Male Female Date of Birth: Insurance Information Include all sources of insurance coverage including Medicare and Medicaid if eligible and provide copies of all cards (front/back) Primary Insurance: Phone: Subscriber Name: Subscriber ID Number: Group Number: Drug Card: Phone: Group Number: Change of Insurance Secondary Insurance: Phone: Subscriber Name: Subscriber ID Number: Group Number: Drug Card: Phone: Group Number: Prescriber Information 3 Prescriber Name: Phone: Fax: 4 5 Office Contact Name: Phone: Fax: Address: City: State: ZIP Code: Tax ID Number: NPI Number: DEA Number: License Number: Specialty: Allergist Pulmonologist ENT Primary Care Pediatrician Other (specify): Diagnosis and Clinical Information Primary ICD-9: 493. Secondary ICD-9: (Complete fourth and fifth digits to indicate the type of asthma or status asthmaticus condition) Other Asthma Therapies Clinical Notes: Short-acting Beta-agonist (SABA) Inhaled Corticosteroids (ICS without LABA) Long-acting Beta-agonist (LABA without ICS) Combination Therapy (ICS/LABA) Oral Steroids Other (specify): Lab Results History of positive skin or RAST test to a perennial aeroallergen Pretreatment serum IgE level IU/mL (1.0 ku/l=1.0 IU/mL; 2.4 ng/ml=1.0 IU/mL): Test Date: Patient Weight (divide lb by 2.2 to obtain kg): kg Weight Date: Prescription Prescription Type: New Start Continued Tx Drug Allergies NKDA Prescription: Dispense XOLAIR Subcutaneously, every 4 weeks: OR Subcutaneously, every 2 weeks: 150 mg/dose 225 mg/dose /dose /dose 375 mg/dose Refill: times Dispense as Written: (Initial) Substitution Allowed: (Initial) Dispense: Diluent: 10-cc vial preservative-free Sterile Water for Injection, USP; ancillary supplies: 3-cc syringes as needed for reconstitution; 18-gauge needles as needed for reconstitution; 25-gauge needles as needed for administration Ship to: Physician s Office Patient s Home HOPD/alternate injection center Other: If Buy and Bill, please check box Benefits investigation only UNAPPROVED USE WARNING: Please read the FDA-approved label for XOLAIR before prescribing. If the indication for which you are prescribing XOLAIR is not listed in the label, you are prescribing XOLAIR for an unapproved use. The fact that the use for which you are prescribing XOLAIR is not listed in the FDA-approved label indicates that the FDA has not approved the efficacy, dosage amount or safety of XOLAIR when used for such a use. Nevertheless, Genentech will consider providing XOLAIR for your patient with this admonition, based upon your medical order, within program requirements. By signing below, I certify that (a) the above therapy is medically necessary, (b) I have received the necessary authorization to release the above-referenced information and other protected health information (as defined in the Health Insurance Portability and Accountability Act of 1996 [HIPAA]) to Genentech USA, Inc., XOLAIR Access Solutions TM and contracted dispensing pharmacy or other contractors for the purpose of seeking reimbursement, assisting in initiating or continuing therapy and/or the evaluation of the patient s eligibility for the Genentech Access to Care Foundation program related to Genentech products, as a break in treatment would negatively impact the patient s therapeutic outcome, (c) I will not sell or bill for any free product received in my office for patients from the Genentech Access to Care Foundation, and (d) I appoint XOLAIR Access Solutions solely to convey on my behalf to the pharmacy chosen by the above-named patient the prescription described herein. I agree to comply with the program guidelines as established by Genentech USA, Inc. and understand that Genentech Access to Care Foundation, at its sole and absolute discretion, reserves the right to modify or discontinue the program at any time and to verify the accuracy of the information submitted. X Prescriber Signature* Date *This form cannot be processed without prescriber s signature. Please include a signed and dated Patient Authorization and Notice of Release of Information form. 02/08 Printed in USA

3 Instructions for Completing the Statement of Medical Necessity Patient Information Write legibly and complete all sections to prevent delays Insurance Information This section should include both primary and secondary insurance to ensure that ALL potential coverage can be explored Include all sources of insurance coverage, including Medicare and Medicaid if eligible Make copies of both sides of the insurance card and drug card (if available), large enough so that all the information is readable (especially ID number, contact phone number and address) Prescriber Information Complete this section to ensure timely insurance review. Note that the office address listed here does not have to match the DEA or Medical License number addresses Diagnosis and Clinical Information Complete the ICD-9 code to the fifth digit to facilitate accurate billing and prompt insurance payment Other Asthma Therapies Provide information about past and current asthma therapies by checking the box next to the indicated therapy Provide further information in the clinical notes section, if needed Include theophylline in Other Lab Results Most payers require verification of a positive skin or RAST test for prior authorization You must specify the patient s pretreatment serum IgE level in IU/mL and the date of test. Conversion formulas are provided for your assistance You must specify the patient s weight in kilograms for the SMN to be processed. A conversion formula is provided for your assistance Prescription Indicate whether the prescription type is a New Start or a Continuing Therapy patient Be sure to check the correct dosage. The specialty pharmacy is not permitted to calculate this on its own and will not fill the prescription without it To avoid multiple callbacks from the specialty pharmacy, you must indicate the number of refills Due to the storage requirements for XOLAIR (must be refrigerated at 2 C-8 C [36 F-46 F]), it may be advisable to have shipments sent to your office For Buy and Bill, be sure to check box Include with Completed SMN A signed and dated PAN form with each SMN Copies of both sides of the insurance card and drug card (if available) REMINDER: This prescription will not be valid and this form cannot be processed without a signature and date. Please complete all sections and include a signed and dated PAN form.

4 XOLAIR Dosing Table How to Use the Dosing Tables 1. Select patient s pretreatment serum IgE level from the vertical column on the far left side of this chart and select body weight from the horizontal row at the top of the chart. 2. Find the box at the intersection to identify the appropriate dose (mg) and dosing schedule for XOLAIR. 3. Use the table below to determine the number of vials and injections per dose and the total injection volume. XOLAIR is Dosed Every 2 or 4 Weeks Pretreatment serum IgE (IU/mL) > > Q4 -week dosing table* Body weight Pounds > > > Kilograms >60-70 >70-90 > mg 150 mg 150 mg See table on right Pretreatment serum IgE (IU/mL) > > > > > > Q2 -week dosing table* Body weight Pounds > > > Kilograms >60-70 >70-90 > mg See table on left 225 mg 375 mg 375 mg 225 mg 225 mg 375 mg 225 mg DO NOT DOSE Dose and SC injection specifications Dose (mg) Number of vials per dose Number of injections Total volume injected (ml) 150 mg mg mg Total IgE levels are elevated during treatment and remain elevated for up to 1 year after the discontinuation of treatment. Retesting of IgE levels during XOLAIR treatment is unnecessary and cannot be used as a guide for dose determination. Dose determination after treatment interruptions lasting less than 1 year should be based on serum IgE levels obtained at the initial dose determination. Total serum IgE levels may be retested for dose determination if treatment with XOLAIR has been interrupted for 1 year or more. Doses should be adjusted for significant changes in body weight. * Each XOLAIR vial delivers 150 mg of XOLAIR per 1.2 ml upon reconstitution with 1.4 ml of Sterile Water for Injection (SWFI), USP. Doses of more than 150 mg are divided among more than one injection site to limit injections to not more than 150 mg per site. 1.2 ml maximum delivered volume per vial. XOLAIR is indicated for: Adults and adolescents (aged 12 years) 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 inhaled corticosteroids. 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. Important safety information XOLAIR should only be administered in a healthcare setting by healthcare 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 accompanying 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 Injection site reactions Injection site reactions of any severity occurred at a rate of 45% in XOLAIR-treated patients compared with 43% in placebo-treated patients. The types of injection site reactions included bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass and inflammation. Severe injection site reactions occurred more frequently in XOLAIR-treated patients compared with patients in the placebo group (12% versus 9%). The majority of injection site reactions occurred within 1 hour postinjection, lasted less than 8 days and generally decreased in frequency at subsequent dosing visits. Please see accompanying full Prescribing Information, including Boxed WARNING and Medication Guide, for additional important safety information.

5 Patient Authorization and Notice of Release of Information Dear Patient: XOLAIR Access Solutions TM is a program sponsored by Genentech USA, Inc. that provides support services such as benefits investigations, prior authorizations and appeals assistance at no charge to patients and assists them in obtaining reimbursement for XOLAIR (Omalizumab). If a patient does not have insurance or is deemed uninsured due to denial by private and public payers, and the patient meets certain financial criteria, the Genentech Access to Care Foundation may provide XOLAIR free of charge. Additional information about these programs can be found at. In order for XOLAIR Access Solutions and Genentech Access to Care Foundation to provide the described services, we will need to review, use and disclose your protected health information (PHI). By law, only with your prior written authorization may your healthcare provider, health plan or health insurer disclose your PHI to XOLAIR Access Solutions and Genentech Access to Care Foundation. As soon as we obtain your prior written authorization, we will work to provide you with the services. You are not required to agree to this Authorization. However, failure to provide this Authorization may prevent you from becoming eligible for the XOLAIR Access Solutions coverage and reimbursement assistance or Genentech Access to Care Foundation patient assistance programs, which may result in your need to pay for certain products with your own funds. You will receive a copy of the Authorization you sign. Please review this Authorization carefully. If you have any questions regarding this Authorization, please contact your healthcare provider s office. Contact information is included below. AUTHORIZATION I. Information to Be Disclosed or Used This Authorization permits my healthcare providers, health plans and health insurers who provide services to me to use and disclose to XOLAIR Access Solutions or Genentech Access to Care Foundation, or their authorized agents or assignees, all medical records and financial information with respect to my treatment, which may have bearing on the benefits payable for services or products provided through my healthcare provider, health plan or insurer under any plan providing benefits or services, including, without limitation, the dollar balance of benefits remaining under any applicable lifetime maximum benefits provisions, or which may have a bearing on my medical condition or compliance with therapy. All of this information may be considered PHI, and may, if relevant, include information about HIV/AIDS and/or other communicable diseases, mental health information, and/or information concerning genetic test results. II. Persons Authorized to Disclose Information The PHI identified in Paragraph I may be disclosed by my healthcare provider, health plan, health insurer or others who may hold my PHI. III. Persons to Whom Disclosure May Be Made The PHI identified in Paragraph I may be disclosed to and/or used by XOLAIR Access Solutions or Genentech Access to Care Foundation, its sponsor, Genentech USA, Inc., a biopharmaceutical manufacturer located at 1 DNA Way, Mail Stop #210, South San Francisco, CA 94080, and its related entities, their agents or assignees, your healthcare provider and certain Genentech business partners such as Novartis Pharmaceuticals Corporation, as well as other companies involved in the administration of certain Genentech products. IV. Description of Each Purpose My PHI may be used for the purposes of reimbursement and/or participation in a coverage and reimbursement assistance or patient assistance program administered by XOLAIR Access Solutions and Genentech Access to Care Foundation, respectively. My PHI also may be used for purposes of tracking the general use of a Genentech product, assessing and improving Genentech s coverage and reimbursement and patient assistance services, and proper management and administration of Genentech s business. In addition, should I elect to participate in the Xpansions program, a free patient support program sponsored by Genentech USA, Inc. and Novartis Pharmaceuticals Corporation, my PHI may be shared with the Xpansions program.

6 Patient Authorization and Notice of Release of Information V. Expiration Date or Event California residents only: This Authorization will be effective, unless revoked by me in writing, until December 31, All other residents: This Authorization will be effective, unless revoked by me in writing, up to one year from the date of this Authorization. VI. Notices I understand that once my health information is disclosed pursuant to this Authorization, there is no guarantee under federal law that the recipient will not redisclose my health information to a third party. Any such third party may not be required to abide by this Authorization or applicable federal law governing the use and disclosure of my health information. I understand that I may refuse to sign or may revoke (at any time) this Authorization for any reason and that such refusal or revocation will not affect the commencement, continuation or quality of my healthcare provider s treatment of me. If I refuse to sign or revoke this Authorization, however, I may be responsible for costs that may have otherwise been covered by XOLAIR Access Solutions or Genentech Access to Care Foundation. I understand that this Authorization will remain in effect until it expires as described or I provide a written notice of revocation via mail to XOLAIR Access Solutions, 1 DNA Way, Mail Stop #210, South San Francisco, CA or via fax to (800) The revocation will be effective immediately upon my healthcare provider s receipt of my written notice, except that the revocation will not have any effect on any action taken by my healthcare provider or others referenced in this Authorization, including without limitation XOLAIR Access Solutions or Genentech Access to Care Foundation, in reliance on this Authorization before my healthcare provider received my written notice of revocation. VII. Distribution Acknowledgment I hereby state (or my parent/guardian hereby states) that if I should receive free product from Genentech Access to Care Foundation, I will utilize XOLAIR for the reason that my physician has prescribed it to me. I will not sell or distribute XOLAIR, as I acknowledge it is unlawful to do so. I will be responsible to ensure that XOLAIR will be delivered to a secure address for purposes of receipt of shipment, and I understand it is my duty to control XOLAIR while it remains in my possession. VIII. Signature I have read and understand the terms of this Authorization and I have had an opportunity to ask questions about the use and disclosure of my health information. By my signature below, I hereby knowingly and voluntarily authorize the use and/or disclosure of my health information in the manner described. Patient Authorization Notice Signature Required Print Patient s Name X Signature of Patient or Guardian* Description of Authority Date *If the patient is an unemancipated minor or otherwise incapacitated (physically or mentally). Patient s/guardian s Address

7 Patient Authorization and Notice of Release of Information IX. Financial Information Only uninsured patients (and patients whose insurance has denied treatment) who wish to apply to Genentech Access to Care Foundation for assistance need to fill out this section There is no need to complete this section if the patient has insurance coverage for XOLAIR Complete If Necessary Household Adjusted Gross Income: q $0-25K/yr q $25,001-50K/yr q $50,001-75K/yr q $75, K/yr I understand that in order to qualify, my adjusted gross income may not exceed $100K/yr. I certify that the above statement of my previous year s income is true and that I have no medical insurance coverage for XOLAIR, including Medicare, Medicaid or other public programs, and that I have insufficient financial resources to pay for the prescribed therapy. I also agree to furnish my IRS1040 (or if none, then my Social Security Benefit Statement or W-2) within 45 days of the submission of this form. I understand that failure to provide this documentation may result in an interruption in therapy. Signature of Patient (complete if necessary) Date Signed (complete if necessary) Xpansions/Free Patient Support Plan I authorize Genentech USA, Inc. and Novartis Pharmaceuticals Corporation ( Sponsors ) to enroll me in Xpansions, a patient support program. I understand that my personally identifiable information related to allergic asthma and my treatment with XOLAIR are required for participation in the support program. In addition to the information that I provide directly to the program, I understand that any personal information that I have provided will be shared between XOLAIR Access Solutions and the Xpansions program. By joining the Xpansions program, I understand that my personal information will be used by health professionals to support me while I am on XOLAIR. My personal information will also be used to track the general use of XOLAIR, to improve the support program, to provide me with relevant program materials and to help the Sponsors manage their businesses. I understand that my personally identifiable information will be shared with the Sponsors, their agents and affiliates, and my healthcare provider. I agree that I may be contacted in the future by mail, and/or telephone concerning the Xpansions program. The personal information you supply to us will be shared with and among our business partners, affiliates and agents to provide you with information, products, programs and services, and to conduct market research. I understand that I do not have to sign this Authorization in order to receive XOLAIR or to be eligible for assistance from the XOLAIR Access Solutions/Genentech Access to Care Foundation programs and that I may cancel this Authorization at any time by calling (800) Optional Xpansions X Signature of Patient* Patient s Address Patient s Phone *You must sign above to enroll in the Xpansions program. Date 2008 Genentech, Inc. and Novartis Pharmaceuticals Corporation 02/08 Printed in USA

8 Fax Cover Form From: to: Fax Number: Fax Number: Number of Pages: phone Number: Phone Number: date: Notes: to Prescribe xolair (Omalizumab), Fax the Following: Completed Statement of Medical Necessity (SMN) form Signed and dated Patient Authorization and Notice of Release of Information (PAN) form Copies of both sides of insurance card and drug card (if available) Accredo Nova Factor, Inc. Phone: (866) Fax: (866) CuraScript Pharmacy, Inc Phone: (888) Fax: (866) Caremark Rx, Inc. Phone: (800) Fax: (800) Option Care, Inc. Phone: (888) Fax: (888) XOLAIR Access Solutions Phone: (800) Fax: (800)

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