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For Patients and Caregivers

Financial Assistance Options for Your Eligible Patients

Several options are available to help eligible patients with the out-of-pocket costs of XOLAIR.

Find the right patient assistance option for your patient using the Patient Assistance Tool.

  • Is your patient insured?

  • Does the patient's insurance cover his or her XOLAIR?

  • Does your patient have commercial insurance?

  • Has your patient already been referred to the XOLAIR Co-pay Program and is either ineligible or no longer receiving assistance?

  • Has your patient already been referred to an independent co-pay assistance foundation and is either ineligible or no longer receiving assistance?

  • Is the patient taking XOLAIR for an FDA-approved indication?

  • Does the patient obtain XOLAIR through 1 of the participating Specialty Pharmacies or receive treatment through a buy and bill office, alternate injection center (AIC) or hospital outpatient department (HOPD)?

Your Patient Might Qualify for a Referral to the XOLAIR Co-pay Program

If eligible commercially insured patients need assistance with their drug and/or injection out-of-pocket costs, the XOLAIR Co-pay Program may help.*

 

Learn More

 

*Eligibility criteria apply. Not valid for patients using federal or state government programs to pay for their medications and/or administration of their Genentech medication. Patient must be taking the Genentech medication for an FDA-approved indication. See full Terms and Conditions at XOLAIRcopay.com.

Your Patient Might Qualify for a Referral to an Independent Co-pay Assistance Foundation

For eligible patients with commercial or public health insurance, XOLAIR Access Solutions offers referrals to independent co-pay assistance foundations.*

 

Learn More

 

*Independent co-pay assistance foundations have their own rules for eligibility. Genentech and Novartis Pharmaceuticals Corporation have no involvement or influence in independent foundation decision-making or eligibility criteria and do not know if a foundation will be able to help your patient. We can only refer your patient to a foundation that supports their disease state. Genentech and Novartis Pharmaceuticals Corporation do not endorse or show preference for any particular foundation. The foundations to which we refer your patient may not be the only ones that might be able to help.

Your Patient Might Qualify for a Referral to the Genentech Patient Foundation

The Genentech Patient Foundation provides free XOLAIR to people who don't have insurance coverage or who have financial concerns and meet eligibility criteria.*

 

Learn More

 

*To be eligible for free Genentech medicine from the Genentech Patient Foundation, insured patients who have coverage for their medicine should try to pursue other forms of financial assistance, if available, and meet certain income requirements. Uninsured patients and insured patients without coverage for their medicine must meet a different set of income requirements. Genentech reserves the right to modify or discontinue the program at any time and to verify the accuracy of information submitted.

Does Your Patient Have Commercial Insurance?

XOLAIR Access Solutions can refer eligible patients to the XOLAIR Co-pay Program* for help with the out-of-pocket costs associated with XOLAIR and administration.

Learn More About the Co-pay Program

Does Your Patient Have Insurance?

If eligible publicly or commercially insured patients have difficulty paying for their co-pay, co-insurance, or other out-of-pocket costs, XOLAIR Access Solutions can refer them to an independent co-pay assistance foundation supporting their disease state.†

GET ASSISTANCE FOR PATIENTS

Does Your Patient Have No Insurance or Have Financial Concerns?

The Genentech Patient Foundation helps people affected by serious medical conditions get the XOLAIR they have been prescribed. People who do not have health insurance, who have health insurance that does not cover their XOLAIR, or who can’t afford their out-of-pocket costs may get free medicine.‡

WHO QUALIFIES

Is Your Patient Awaiting Coverage Determination?

With the XOLAIR Starter Program, eligible patients taking XOLAIR may receive free medicine while awaiting an insurance coverage determination.

COVERAGE OPTIONS

*This XOLAIR Co-pay Program is valid ONLY for patients with commercial insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medication. Patients using Medicare, Medicaid, or any other federal or state government program to pay for their medications are not eligible.

Under the program, the patient will pay a co-pay. After reaching the maximum program benefit, the patient will be responsible for all out-of-pocket expenses.

All participants are responsible for reporting the receipt of all program benefits as required by any insurer or by law. No party may seek reimbursement for all or any part of the benefit received through this program. The program is only valid in the United States and U.S. Territories. This program is void where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. The patient, guardian, prescriber, hospital and any other person using the program agree not to seek reimbursement for all or any part of the benefit received by the patient through the offer of this program. Genentech reserves the right to rescind, revoke or amend the program without notice at any time. Additional terms and conditions apply. Please visit XOLAIRcopay.com for the full list of Terms and Conditions.

†Genentech and Novartis Pharmaceuticals Corporation do not influence or control the operations or eligibility criteria of any independent co-pay assistance foundation and cannot guarantee co-pay assistance after a referral from XOLAIR Access Solutions. This information is provided as a resource to patients. Please note that this list is not indicative of Genentech or Novartis Pharmaceuticals Corporation’s endorsement or financial support of any particular disease area and/or foundation, nor is it exhaustive. There may be other foundations to support the patient’s disease state.

‡To be eligible for free XOLAIR medicine from the Genentech Patient Foundation, insured patients who have coverage for their medicine should try to pursue other forms of financial assistance, if available, and must meet certain income requirements. Uninsured patients and insured patients without coverage for their medicine must meet a different set of income requirements.

What Is XOLAIR Access Solutions?

XOLAIR Access Solutions provides reliable, effective access and reimbursement support to assist your patients and practice after XOLAIR is prescribed.

Learn how we help.

Determine which patient assistance option is right for your patient with the Patient Assistance Tool.

To enroll in XOLAIR Access Solutions, complete and submit the:

Prescriber Service Form—filled out by the health care provider and used to collect the patient's health insurance and treatment information

Respiratory Patient Consent Form—completed by the patient and gives permission for XOLAIR Access Solutions to work with you and the patient’s health insurance plan

Each program has its own time period in which your eligible patients will receive assistance. You can call us at (800) 704-6610 for more information.

To learn more about our programs and services:
• Visit Genentech-Access.com/XOLAIR
• Call (800) 704-6610

IMPORTANT SAFETY INFORMATION

INDICATIONS
XOLAIR® (omalizumab) is indicated for:

  • Adults and pediatric patients 6 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 inhaled corticosteroids.

    Limitations of Use: XOLAIR is not indicated for the relief of acute bronchospasm, status asthmaticus, or for treatment of other allergic conditions.

  • Add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

  • Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment.

    Limitations of Use: XOLAIR is not indicated for treatment of other forms of urticaria.

WARNING: Anaphylaxis

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, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis.

CONTRAINDICATIONS

XOLAIR is contraindicated in patients with a severe hypersensitivity reaction to XOLAIR or to any ingredient of XOLAIR.

WARNINGS AND PRECAUTIONS

Anaphylaxis
Anaphylaxis has been reported to occur after administration of XOLAIR in premarketing clinical trials and in postmarketing spontaneous reports. In premarketing clinical trials in patients with asthma, anaphylaxis was reported in 3 of 3507 (0.1%) patients. Anaphylaxis occurred with the first dose of XOLAIR in two patients and with the fourth dose in one patient. The time to onset of anaphylaxis was 90 minutes after administration in two patients and 2 hours after administration in one patient.

A case-control study showed that, among XOLAIR users, patients with a history of anaphylaxis to foods, medications, or other causes were at increased risk of anaphylaxis associated with XOLAIR, compared to those with no prior history of anaphylaxis.

In postmarketing spontaneous reports, the frequency of anaphylaxis attributed to XOLAIR use was estimated to be at least 0.2% of patients based on an estimated exposure of about 57,300 patients from June 2003 through December 2006. Approximately 60% to 70% of anaphylaxis cases have been reported to occur within the first three doses of XOLAIR, with additional cases occurring sporadically beyond the third dose.

Initiate XOLAIR only in a healthcare setting equipped to manage anaphylaxis which can be life-threatening. Observe patients closely for an appropriate period of time after administration of XOLAIR, taking into account the time to onset of anaphylaxis seen in premarketing clinical trials and postmarketing spontaneous reports. Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs or symptoms occur.

Once XOLAIR therapy has been established, administration of XOLAIR Prefilled Syringe outside of a healthcare setting by a patient or a caregiver may be appropriate for selected patients. Patient selection, determined by the healthcare provider in consultation with the patient, should take into account the pattern of anaphylaxis events seen in premarketing clinical trials and postmarketing spontaneous reports, as well as individual patient risk factors (e.g. prior history of anaphylaxis), ability to recognize signs and symptoms of anaphylaxis, and ability to perform subcutaneous injections with XOLAIR Prefilled Syringe with proper technique according to the prescribed dosing regimen and Instructions for Use.

Discontinue XOLAIR in patients who experience a severe hypersensitivity reaction.

Malignancy
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 adults and adolescents (≥12 years of age) with asthma and other allergic disorders. The observed malignancies in XOLAIR-treated patients were a variety of types, with breast, non-melanoma skin, prostate, melanoma, and parotid occurring more than once, and five other types occurring once each. The majority of patients were observed for less than 1 year. The impact of longer exposure to XOLAIR or use in patients at higher risk for malignancy (e.g., elderly, current smokers) is not known.

A subsequent 5-year observational study of 5007 XOLAIR-treated and 2829 non-XOLAIR-treated adolescent and adult patients with moderate to severe persistent asthma and a positive skin test reaction or in vitro reactivity to a perennial aeroallergen found that the incidence rates of primary malignancies (per 1000 patient years) were similar in both groups (12.3 vs 13.0, respectively). Study limitations which include the observational study design, the bias introduced by allowing enrollment of patients previously exposed to XOLAIR (88%), enrollment of patients (56%) while a history of cancer or a premalignant condition were study exclusion criteria, and the high study discontinuation rate (44%) preclude definitively ruling out a malignancy risk with XOLAIR.

Acute Asthma Symptoms and Deteriorating Disease
XOLAIR has not been shown to alleviate asthma exacerbations acutely. Do not use XOLAIR to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with XOLAIR.

Corticosteroid Reduction
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of XOLAIR therapy for asthma or nasal polyps. Decrease corticosteroids gradually under the direct supervision of a physician. In CSU patients, the use of XOLAIR in combination with corticosteroids has not been evaluated.

Eosinophilic Conditions
In rare cases, patients with asthma on therapy with XOLAIR may present with serious systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between XOLAIR and these underlying conditions has not been established.

Fever, Arthralgia, and Rash
In post-approval use, some patients have experienced a constellation of signs and symptoms, including arthritis/arthralgia, rash, fever, and lymphadenopathy with an onset 1 to 5 days after the first or subsequent injections of XOLAIR. These signs and symptoms have recurred after additional doses in some patients. Physicians should stop XOLAIR if a patient develops this constellation of signs and symptoms.

Parasitic (Helminth) Infection
Monitor patients at high risk of geohelminth infection while on XOLAIR therapy. Insufficient data are available to determine the length of monitoring required for geohelminth infections after stopping XOLAIR treatment.

Laboratory Tests
Due to formation of XOLAIR:IgE complexes, serum total IgE levels increase following administration of XOLAIR and may remain elevated for up to 1 year following discontinuation of XOLAIR. Do not use serum total IgE levels obtained less than 1 year following discontinuation to reassess the dosing regimen for asthma or nasal polyps patients, because these levels may not reflect steady state free IgE levels.

ADVERSE REACTIONS

Asthma
In patients ≥12 years of age, the most common adverse reactions (≥1% more frequent in XOLAIR-treated patients) were: arthralgia (8%), pain (general) (7%), leg pain (4%), fatigue (3%), dizziness (3%), fracture (2%), arm pain (2%), pruritus (2%), dermatitis (2%), and earache (2%). In pediatric patients 6 to <12 years of age, the most commonly observed adverse reactions (≥3% more frequent in XOLAIR-treated pediatric patients) were: nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bite, and epistaxis.

Nasal Polyps
The most common adverse reactions (≥3% incidence in XOLAIR-treated patients and more frequent than placebo) included: headache (8.1%), injection site reaction (5.2%), arthralgia (3.0%), upper abdominal pain (3.0%), and dizziness (3.0%).

Chronic Spontaneous Urticaria
The most common adverse reactions (≥2% XOLAIR-treated patients and more frequent than in placebo) for XOLAIR 150 mg and 300 mg, respectively, included: headache (12%, 6%), nasopharyngitis (9%, 7%), arthralgia (3%, 3%), viral upper respiratory infection (2%, 1%), nausea (1%, 3%), sinusitis (1%, 5%), upper respiratory tract infection (1%, 3%), and cough (1%, 2%).

Injection Site Reactions

Asthma
In adults and adolescents with asthma, injection site reactions of any severity occurred at a rate of 45% in XOLAIR-treated patients compared with 43% in placebo-treated patients. Severe injection site reactions occurred more frequently in XOLAIR‑treated patients compared with patients in the placebo group (12% vs 9%, respectively). The types of injection site reactions in asthma studies included: bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation.

Nasal Polyps
Injection site reactions occurred at a rate of 5.2% in XOLAIR-treated patients compared with 1.5% in placebo-treated patients. Injection site reactions were mild to moderate severity and none resulted in study discontinuation.

Chronic Spontaneous Urticaria
Injection site reactions of any severity occurred in more XOLAIR-treated patients (11 patients [2.7%] at 300 mg, 1 patient [0.6%] at 150 mg) compared with 2 placebo-treated patients (0.8%). The types of injection site reactions included: swelling, erythema, pain, bruising, itching, bleeding, and urticaria. None of the events resulted in study discontinuation or treatment interruption.

Cardiovascular and Cerebrovascular Events from Clinical Studies in Patients with Asthma
A 5-year observational study was conducted in 5007 XOLAIR-treated and 2829 non-XOLAIR-treated patients ≥12 years of age with moderate to severe persistent asthma and a positive skin test reaction to a perennial aeroallergen to evaluate the long term safety of XOLAIR, including the risk of malignancy. Similar percentages of patients in both cohorts were current (5%) or former smokers (29%). Patients had a mean age of 45 years and were followed for a mean of 3.7 years. More XOLAIR-treated patients were diagnosed with severe asthma (50%) compared to the non-XOLAIR-treated patients (23%). A higher incidence rate (per 1000 patient-years) of overall cardiovascular and cerebrovascular serious adverse events (SAEs) was observed in XOLAIR-treated patients (13.4) compared to non-XOLAIR-treated patients (8.1). Increases in rates were observed for transient ischemic attack (0.7 vs 0.1), myocardial infarction (2.1 vs 0.8), pulmonary hypertension (0.5 vs 0), pulmonary embolism/venous thrombosis (3.2 vs 1.5), and unstable angina (2.2 vs 1.4), while the rates observed for ischemic stroke and cardiovascular death were similar among both study cohorts. The results suggest a potential increased risk of serious cardiovascular and cerebrovascular events in patients treated with XOLAIR, however the observational study design, the inclusion of patients previously exposed to XOLAIR (88% for a mean of 8 months), baseline imbalances in cardiovascular risk factors between the treatment groups, an inability to adjust for unmeasured risk factors, and the high study discontinuation rate (44%) limit the ability to quantify the magnitude of the risk.

Pregnancy
Data with XOLAIR use in pregnant women are insufficient to inform on drug associated risk.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

Please see full Prescribing Information, including Boxed WARNING and Medication Guide, for additional Important Safety Information.

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