Support is available to help your patients with lupus nephritis start and stay on a prescribed Genentech medication.
Genentech is committed to helping your patients access medicine, regardless of their ability to pay, and has created a program to help make their out-of-pocket costs more affordable.
The GAZYVA Immunology Co-pay Program provides financial assistance to eligible commercially insured patients who may pay as little as $0 co-pay. *
The program can cover up to $15,000 for GAZYVA drug out-of-pocket costs per calendar year and up to $2,000 for GAZYVA administration out-of-pocket costs per calendar year. For more information on the GAZYVA Immunology Co-pay Program, visit gazyvaimmunologycopay.com/hcp or call (844)-GZ-COPAY (844-492-6729).
Patients who do not have health insurance coverage or have financial concerns and meet eligibility criteria may be able to get free medicine from the Genentech Patient Foundation.† Publicly or commercially insured patients can be referred to independent co-pay assistance foundations that support their diagnosis. ‡
Genentech Immunology Access Solutions Case Managers can provide live support and help your patients navigate benefits investigations, prior authorizations, denials, and appeals. §ᴵᴵ
Case managers are available at genentech-pro.com/patient-support-services or at (866) 681-3261, Monday through Friday, 9 AM to 8 PM ET.
*Terms and conditions apply.
†To be eligible for free Genentech medicine, insured patients who have coverage 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 the information submitted.
‡Independent co-pay assistance foundations have their own rules for eligibility. Genentech has no involvement or influence in independent formulation decision-making or eligibility criteria and does not know if a foundation will be able to help your patient. Genentech can only refer your patient to a foundation that supports their disease state. Genentech does not endorse or show preference for any particular foundation. The foundations to which Genentech refers your patient may not be the only ones that might be able to help.
§The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and healthcare provider. Genentech makes no representation or guarantee concerning coverage or reimbursement for any service or item.
“Genentech provides coverage and reimbursement services to patients to help them understand benefits, coverage, and reimbursement. Genentech provides these services to patients only after a healthcare provider has prescribed a Genentech product.
Terms and Conditions
The Co-pay Program (“Program”) is valid ONLY for patients with commercial (private or non-governmental) insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medicine. The Program is not available to patients whose prescriptions are reimbursed under any federal, state, or government-funded insurance programs (included but not limited to Medicare, Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs Programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state or government-funded healthcare programs, the patient will no longer be eligible for the Program.
Under the Program, the patient may be required to pay a co-pay. The final amount owed by a patient may be as little as $0 for the Genentech medicine (see Program specific details available at the Program website). The total patient out-of-pocket cost is dependent on the patient’s health insurance plan. The Program assists with the cost of the Genentech medicine only. It does not assist with the cost of other medicines, procedures or office visit fees. After reaching the maximum annual Program benefit amount, the patient will be responsible for all remaining out-of-pocket expenses. The Program benefit amount cannot exceed the patient’s out-of-pocket expenses for the Genentech medicine.
All participants are responsible for reporting the receipt of all Program benefits as required by any insurer or by law. The Program is only valid in the United States and U.S. Territories, is void where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. No party may seek reimbursement for all or any part of the benefit received through the Program. The value of the Program is intended exclusively for the benefit of the patient. The funds made available through the Program may only be used to reduce the out-of-pocket costs for the patient enrolled in the Program. The Program is not intended for the benefit of third parties, including without limitation third party payers, pharmacy benefit managers, or their agents. If Genentech determines that a third party has implemented a program that adjusts patient cost-sharing obligations based on the availability of support under the Program and/or excludes the assistance provided under the Program from counting towards the patient’s deductible or out-of-pocket cost limitations, Genentech may impose a per fill cap on the cost-sharing assistance available under the Program. Submission of true and accurate information is a requirement for eligibility and Genentech reserves the right to disqualify patients who do not comply with Genentech Program Terms and Conditions. Genentech reserves the right to rescind, revoke or amend the Program without notice at any time.
Additional terms and conditions apply. Please visit the Co-pay Program website for the full list of Terms and Conditions.
Indication
GAZYVA® (obinutuzumab) is indicated for the treatment of adult patients with active lupusnephritis (LN) who are receiving standard therapy.
Important Safety Information
BOXED WARNINGS: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
• Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV-positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation
• Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving GAZYVA
Contraindications
GAZYVA is contraindicated in patients with known hypersensitivity reactions (e.g.anaphylaxis) to obinutuzumab or to any of the excipients, or serum sickness with prior obinutuzumab use
Additional Warnings and Precautions
• Infusion-Related Reactions: GAZYVA can cause severe and life-threatening infusion-related reactions. Premedicate patients with a glucocorticoid, acetaminophen, and antihistamine. Monitor patients closely during infusions. Interrupt, reduce rate, or discontinue for infusion-related reactions based on severity
• Hypersensitivity Reactions Including Serum Sickness: Discontinue GAZYVA permanently
• Serious, Including Fatal, Infections: Fatal and serious bacterial, fungal, and new or reactivated viral infections can occur during and following GAZYVA therapy. Do not administer GAZYVA to patients with an active infection. Patients with a history ofrecurring or chronic infections may be at increased risk of infection. In patients who develop a serious infection while receiving GAZYVA, immediately discontinue GAZYVA and institute appropriate treatment.
• Neutropenia: Severe and life-threatening neutropenia, including febrile neutropenia, has been reported during treatment with GAZYVA. In patients with Grade 3 to 4 neutropenia, monitor laboratory tests until resolution and for infection. Consider dose delays and infection prophylaxis, as appropriate
• Thrombocytopenia: Severe and life-threatening thrombocytopenia and fatal hemorrhagic events have been reported during treatment with GAZYVA in combination with chemotherapy. Monitor for decreased platelet counts and bleeding. Transfusion may be necessary
• Disseminated Intravascular Coagulation: Fatal and severe DIC has been reported in patients receiving GAZYVA for treatment of CLL and NHL. Evaluate cause and monitor for bleeding, thrombosis, and need for supportive care
• Immunization: Avoid administration of live virus vaccines during GAZYVA treatment and until B-cell recovery
• Embryo-Fetal Toxicity: GAZYVA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception
Additional Important Safety Information
• The most common adverse reactions (incidence ≥5%) observed in patients with LN in the GAZYVA arm were upper respiratory tract infection, COVID-19, urinary tract infection, bronchitis, pneumonia, infusion-related reactions, and neutropenia
You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
Please see the full Prescribing Information for additional Important Safety Information, including BOXED WARNINGS.
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