Eligibility / Terms and Conditions

A patient may be eligible for the Rituxan Immunology and ACTEMRA Co-pay Card Program if he or she:

  • Has been prescribed Rituxan or ACTEMRA for an FDA-approved indication
  • Is over the age of 18, or has a legal guardian over the age of 18 to manage the card (ACTEMRA for SJIA or PJIA patients only)
  • Has commercial (private or nongovernmental) insurance. This includes plans available through state and federal health care exchanges
  • Does not use a federal or state-funded health care program including, but not limited to, Medicare, Medicaid, Medigap, VA, DoD or TRICARE
  • Does not currently receive drug assistance from the Genentech® Access to Care Foundation (GATCF) or any other co-pay charitable organization
  • Lives and is treated in the United States or Puerto Rico
  • Does not reside in any state where the program is prohibited

 

Terms and Conditions

By using the Rituxan Immunology and ACTEMRA Co-pay Card Program, the patient acknowledges and confirms that, at the time of usage, (s)he is currently eligible and meets the criteria set forth in the terms and conditions described.

This Co-pay Card is valid ONLY for patients with commercial (private or non-governmental) insurance who are taking the medication for a Food and Drug Administration (FDA)-approved indication. Patients using Medicare, Medicaid, or any other government-funded program to pay for their medications are not eligible. Patients who start utilizing their government coverage during their enrollment period will no longer be eligible for the program.

This Co-pay Card Program is not health insurance or a benefit plan. Distribution or use of the Co-pay Card does not obligate use or continuing use of any specific product or provider. Patient or guardian is responsible for reporting the receipt of all Co-pay Card Program benefits or reimbursement received to any insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the Co-pay Card Program, as may be required.

The Co-pay Card is not valid for medications the patient receives for free or that are eligible to be reimbursed by private insurance plans or other health care or pharmaceutical assistance programs (such as Genentech® Access to Care Foundation (GATCF) or any other charitable organization) that reimburse the patient in part or for the entire cost of his/her Genentech medication. Patient, guardian, pharmacist, prescriber, and any other person using the Co-pay Card agree not to seek reimbursement for all or any part of the benefit received by the recipient through the offer.

The Co-pay Card will be accepted by participating pharmacies, physician offices, or hospitals. To qualify for the benefits of this Co-pay Card Program, the patient may be required to pay out-of-pocket expenses for each treatment. Once enrolled, this Co-pay Card Program will not honor claims with date of service or medication dispensing that precede program enrollment by more than 120 days. This Co-pay Card is only available with a valid prescription and cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription. Use of this Co-pay Card must be consistent with all relevant health insurance requirements and payer agreements. Participating patients, pharmacies, physician offices, and hospitals are obligated to inform third-party payers about the use of the Co-pay Card as provided for under the applicable insurance or as otherwise required by contract or law. The Co-pay Card may not be sold, purchased, traded, or offered for sale, purchase, or trade. The Co-pay Card is limited to 1 per person during this offer period and is not transferable. Program eligibility period is contingent upon patient's ability to meet and maintain all requirements as set forth by the program. Genentech will periodically verify eligibility and will terminate patients without obligation to pay claims if change to status is detected. This program is not valid where prohibited by law, and shall follow state restrictions in relation to AB-rated generic equivalents where applicable (e.g. MA, CA).

The patient or their guardian must be 18 years or older to receive Co-pay Card Program assistance. This Co-pay Card Program is (1) void if the card is reproduced; (2) void where prohibited by law; (3) only valid in the United States and Puerto Rico; and (4) only valid for Genentech products. Health Care providers may not advertise or otherwise use the program as a means of promoting their services or Genentech's products to patients. Genentech reserves the right to rescind, revoke, or amend the program without notice at any time.

Indication and Important Safety Information

 

  • Rituxan® (rituximab), in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more TNF antagonist therapies
  • Rituxan® (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)
  • Rituxan® (rituximab), is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris

Infusion Reactions: Rituxan administration can result in serious, including fatal infusion reactions. Deaths within 24 hours of Rituxan infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue Rituxan infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion reactions.

Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving Rituxan.

Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with Rituxan, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with Rituxan. Discontinue Rituxan and concomitant medications in the event of HBV reactivation.

Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving Rituxan.

Rituxan administration can also result in additional serious, including fatal, adverse reactions including:

  • Tumor lysis syndrome (TLS): Administer aggressive intravenous hydration, anti-hyperuricemic agents, monitor renal function
  • Infections: Withhold Rituxan and institute appropriate anti-infective therapy. Rituxan is not recommended for use in patients with severe, active infections
  • Cardiovascular adverse reactions: Discontinue infusions in case of serious or life-threatening events
  • Renal toxicity: Discontinue in patients with rising serum creatinine or oliguria
  • Bowel obstruction and perforation: Consider and evaluate for abdominal pain, vomiting, or related symptoms
  • Immunizations: Live virus vaccinations prior to or during Rituxan treatment are not recommended
  • Embryo-Fetal toxicity: Can cause neonatal harm. Advise of potential risk to neonates and use of effective contraception
  • Patients with RA should be closely observed for signs of infection if biologic agents and/or DMARDs other than methotrexate are used concomitantly
  • The use of Rituxan in patients with RA who have not had prior inadequate response to one or more TNF antagonists is not recommended
  • Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA, MPA, or PV patients exhibiting peripheral B-cell depletion following treatment with Rituxan
  • The safety and efficacy of retreatment with Rituxan have not been established in patients with GPA and MPA

Rheumatoid Arthritis (RA)
Most common adverse reactions (≥10%) in clinical trials: upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis. Other important adverse reactions include infusion reactions, serious infections, and cardiovascular events.

Granulomatosis With Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)
Most common adverse reactions (≥15%) in the clinical study were infections, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema. Other important adverse reactions include infusion reactions.

Pemphigus Vulgaris (PV)
Most common adverse reactions (≥15%) in the clinical trial were infusion reactions and depression. Other important adverse reactions include infections.

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.

For additional Important Safety Information, please see the Rituxan full Prescribing Information, including BOXED WARNINGS.

ACTEMRA is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

ACTEMRA is indicated for the treatment of giant cell arteritis (GCA) in adult patients.

ACTEMRA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

ACTEMRA is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

RISK OF SERIOUS INFECTIONS:

Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt ACTEMRA until the infection is controlled.

Reported infections include:

  • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before ACTEMRA use and during therapy. Treatment for latent infection should be initiated prior to ACTEMRA use.
  • Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
  • Bacterial, viral and other infections due to opportunistic pathogens.

The risks and benefits of treatment with ACTEMRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ACTEMRA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

ACTEMRA is contraindicated in patients with known hypersensitivity to ACTEMRA.

Other serious or potentially life-threatening adverse reactions that have been reported in clinical trials with ACTEMRA include gastrointestinal perforations. Use ACTEMRA with caution in patients who may be at risk for GI perforations.

Laboratory monitoring is recommended due to potential consequences of treatment-related laboratory abnormalities in neutrophils, platelets, lipids, and liver function tests.

Hypersensitivity reactions, including anaphylaxis and death, have occurred.

  • If anaphylaxis or other hypersensitivity reaction occurs, stop administration of ACTEMRA immediately and discontinue ACTEMRA permanently.

Avoid use of live vaccines concurrently with ACTEMRA, as clinical safety has not been established.

Other potential risks of ACTEMRA include demyelinating disorders and malignancies.
Treatment with ACTEMRA is not recommended in patients with active hepatic disease or hepatic impairment.

Common adverse reactions included upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, diarrhea and injection-site reactions (SC only).

Common adverse reactions in SJIA studies included upper respiratory tract infections, headache, nasopharyngitis, and diarrhea.

In general, the types of adverse drug reactions in patients with PJIA were consistent with those seen in RA and SJIA patients.

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.

Please see accompanying full Prescribing Information, including BOXED WARNING, for additional important safety information.