Medicare

SIMPONI ARIA® and Medicare

Overview of Medicare

Medicare is a federal program that provides health insurance coverage to the following types of people:

  • Individuals over age 65 with a work history
  • Individuals with certain disabilities who have been disabled for at least 2 years
  • Individuals diagnosed with end-stage renal disease (ESRD)

While Medicare covers many healthcare needs, it may not cover all of the patient's healthcare costs. The patient may have to pay a monthly premium for Medicare and then pay a coinsurance and deductible for many services.

Medicare Coverage of SIMPONI ARIA®

Medicare covers most physician-administered drugs like SIMPONI ARIA® under Medicare Part B. There are comprehensive published Part B coverage policies specific to SIMPONI ARIA®. Copies of coverage policies (for example, local coverage determinations, or LCDs) are available on your regional Medicare Administrative Contractor's, or MAC’s, Web site.

Medicare typically places few restrictions on SIMPONI ARIA® coverage. However, some Medicare policies may limit coverage of SIMPONI ARIA® to certain diagnoses, such as:

  • Rheumatoid arthritis

MAC Quick Reference Flashcard

SIMPONI ARIA® is covered under Medicare Part B by all Medicare Administrative Contractors (MACs). Use this checklist for medical necessity documentation and to see a listing of MAC payers. Click here for the MAC Quick Reference Flashcard.

You can check your regional MAC Web site for coverage policies for SIMPONI ARIA® or call Janssen CarePath at 877-CarePath (877-227-3728) for more assistance.

The 4 Parts of Medicare

Medicare is divided into 4 parts: A, B, C, and D. Part A covers facility care such as hospitals, and Part B covers physician and other outpatient services. Part C, which is known as the Medicare Advantage program, allows private managed care plans to administer a patient's Medicare benefits.

Medicare Part D offers prescription drug coverage to anyone enrolled in Medicare Parts A or B. Table 1 provides additional detail regarding the 4 parts of the Medicare program.

 

Table 1. The 4 Parts of Medicare

Part A

Typically known as the hospital benefit, Part A provides coverage for services such as hospitalizations, hospice care, skilled nursing facility stays, and home health services.

Part B

Part B benefits provide reimbursement for physician services, clinical laboratory services, hospital outpatient services, prescription drugs administered "incident to" a physician's services, durable medical equipment, and some home health services.

Part C

Also known as Medicare Advantage, this benefit provides Medicare Part A, B and often Part D coverage through managed care plans.

Part D

Prescription drug coverage for medicines that are usually self-administered or taken orally.

To learn more about the different parts of Medicare, you can call the Medicare program at 1-800-MEDICARE (1-800-633-4227) or visit Medicare.gov

Our Medicare Resource Guide provides important information for your patients to consider as they are selecting their insurance coverage.

Medicare Part D

Contact Janssen CarePath Support

The information provided presents no statement, promise, or guarantee by Janssen Biotech, Inc., concerning levels of reimbursement, payment, or charge. Please consult your payer organizations with regard to local or actual coverage and reimbursement policies and determination processes.

Linked documents shown are only a sample of the payer's available documents and are not representative of all documents available for payer plans.

Alabama

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Alaska

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Arizona

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Arkansas

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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California

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Health Net Yes 5   For more information
Kaiser Permanente   5, Specialty    
UnitedHealthcare Yes 5   For more information

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Colorado

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Connecticut

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Delaware

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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District of Columbia DC

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Florida

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
SantaFe HealthCare, Inc./AvMed Health Plans Yes 5   For more information
UnitedHealthcare Yes 5   For more information

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Georgia

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Hawaii

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Idaho

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Illinois

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Indiana

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Iowa

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Kansas

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Kentucky

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Louisiana

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Maine

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Maryland

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Massachusetts

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Michigan

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Minnesota

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Mississippi

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Missouri

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Montana

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Nebraska

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Nevada

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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New Hampshire

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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New Jersey

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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New Mexico

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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New York

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Excellus BlueCross BlueShield Yes 3, 5   For more information
UnitedHealthcare Yes 5   For more information

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North Carolina

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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North Dakota

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Ohio

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Oklahoma

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Oregon

Oregon requires that certain health plans must use the uniform Prior Authorization (PA) Request Form. In addition, there are new rules in Oregon regarding the PA process. The rules are effective July 1, 2015. Click on the PDF below for more information.

Uniform Prescription Drug Prior Authorization Request Form & Notification Requirements for Health Plans in Oregon

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Pennsylvania

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Blue Cross of Northeastern Pennsylvania   5, Specialty   For more information
Independence Blue Cross Yes 3, 4   For more information
UnitedHealthcare Yes 5   For more information

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Rhode Island

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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South Carolina

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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South Dakota

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Tennessee

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Texas

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Utah

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Vermont

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Virginia

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Washington

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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West Virginia

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Wisconsin

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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Wyoming

Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
UnitedHealthcare Yes 5   For more information

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The information provided presents no statement, promise, or guarantee by Janssen Biotech, Inc., concerning levels of reimbursement, payment, or charge. Please consult your payer organizations with regard to local or actual coverage and reimbursement policies and determination processes.

INDICATION

SIMPONI ARIA® is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate.

IMPORTANT SAFETY INFORMATION For SIMPONI ARIA®
SERIOUS INFECTIONS

Patients treated with SIMPONI ARIA® (golimumab) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue SIMPONI ARIA® if a patient develops a serious infection.

Reported infections with TNF blockers, of which SIMPONI ARIA® is a member, include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before SIMPONI ARIA® use and during therapy. Initiate treatment for latent infection prior to SIMPONI ARIA® use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Consider the risks and benefits of treatment with SIMPONI ARIA® prior to initiating therapy in patients with chronic or recurrent infection. Do not start SIMPONI ARIA® in patients with clinically important active infections, including localized infections. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with SIMPONI ARIA®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection.

Risk of infection may be higher in patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. Other serious infections observed in patients treated with SIMPONI ARIA® included sepsis, pneumonia, cellulitis, and abscess.

MALIGNANCIES

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which SIMPONI ARIA® is a member. Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies usually associated with immunosuppression and malignancies not usually observed in children or adolescents. Malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.

In the controlled portions of clinical trials of TNF blockers including the subcutaneous formulation of golimumab, more cases of lymphoma have been observed among patients receiving anti-TNF treatment compared with patients in the control groups. In clinical trials, the incidence of malignancies other than lymphoma and non-melanoma skin cancer per 100 patient-years of follow-up was 0.56 (95% CI: 0.01, 3.11) in the SIMPONI ARIA® group compared with an incidence of 0 (95% CI: 0.00, 3.79) in the placebo group. Cases of acute and chronic leukemia have been reported with TNF-blocker use, including SIMPONI ARIA®. The risks and benefits of TNF-blocker therapy should be considered prior to initiating therapy in patients with a known malignancy or who develop a malignancy.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers. These cases have had a very aggressive disease course and have been fatal. Nearly all reported cases have occurred in patients with Crohn’s disease or ulcerative colitis, and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. A risk for the development for HSTCL in patients treated with TNF blockers cannot be excluded.

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocking agents, including
SIMPONI ARIA®. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

HEPATITIS B REACTIVATION

The use of TNF blockers, of which SIMPONI ARIA® is a member, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers. In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority of these reports have occurred in patients who received concomitant immunosuppressants.

All patients should be tested for HBV infection before initiating TNF blocker therapy. For patients who test positive for hepatitis B surface antigen, consult a physician with expertise in the treatment of hepatitis B before initiating TNF-blocker therapy. Exercise caution when prescribing SIMPONI ARIA® for patients identified as carriers of HBV and closely monitor for active HBV infection during and following termination of therapy with SIMPONI ARIA®. Discontinue SIMPONI ARIA® in patients who develop HBV reactivation, and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of SIMPONI ARIA®, and monitor patients closely.

HEART FAILURE

Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers, including SIMPONI ARIA®. Some cases had a fatal outcome. Exercise caution in CHF patients receiving SIMPONI ARIA® and monitor them closely during therapy. Discontinue SIMPONI ARIA® if new or worsening symptoms of heart failure appear.

DEMYELINATING DISORDERS

Use of TNF blockers, of which SIMPONI ARIA® is a member, has been associated with rare cases of new-onset or exacerbation of demyelinating disorders, including multiple sclerosis (MS) and Guillain-Barré syndrome. Cases of central demyelination, MS, optic neuritis, and peripheral demyelinating polyneuropathy have rarely been reported in patients treated with the subcutaneous formulation of golimumab. Exercise caution in considering the use of SIMPONI ARIA® in patients with these disorders. Consider discontinuation if these disorders develop.

AUTOIMMUNITY

Treatment with TNF blockers, including SIMPONI ARIA®, may result in the formation of antinuclear antibodies. Rarely, treatment with TNF blockers may result in a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

USE WITH OTHER DRUGS

The concomitant use of a TNF blocker and abatacept or anakinra was associated with a higher risk of serious infections, therefore the use of SIMPONI ARIA® in combination with these products is not recommended. Care should be taken when switching from one biologic to another since overlapping biological activity may further increase the risk of infection. A higher rate of serious infections has also been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. The concomitant use of SIMPONI ARIA® with biologics approved to treat RA is not recommended because of the possibility of an increased risk of infection.

HEMATOLOGIC CYTOPENIAS

There have been reports of pancytopenia, leukopenia, neutropenia, and thrombocytopenia in patients receiving SIMPONI ARIA® in clinical trials. Additionally, aplastic anemia has been reported in patients receiving TNF blockers. Exercise caution when using SIMPONI ARIA® in patients who have or had significant cytopenias.

VACCINATIONS/THERAPEUTIC INFECTIOUS AGENTS

People receiving SIMPONI ARIA® can receive vaccinations, except for live vaccines. Use of live vaccines could result in clinical infections, including disseminated infections. Administration of live vaccines to infants exposed to SIMPONI ARIA® in utero is not recommended for 6 months following the mother’s last SIMPONI ARIA® infusion during pregnancy due to an increased risk of infection. It is recommended that therapeutic infectious agents not be given concurrently with SIMPONI ARIA® due to the possibility of clinical infections, including disseminated infections.

HYPERSENSITIVITY REACTIONS

Serious systemic hypersensitivity reactions (including anaphylaxis) have been reported following administration of the subcutaneous formulation of golimumab and SIMPONI ARIA®, some occurring after the first dose. Hypersensitivity reactions including hives, pruritus, dyspnea, and nausea, were reported in association with infusions of SIMPONI ARIA®. If an anaphylactic or other serious allergic reaction occurs, discontinue SIMPONI ARIA® immediately and institute appropriate therapy.

ADVERSE REACTIONS

The most serious adverse reactions were serious infections and malignancies.

Upper respiratory tract infection was the most common adverse reaction reported in the Phase 3 trial through Week 24, occurring in 6.5% of patients treated with SIMPONI ARIA® as compared with 7.6% of patients in the control group. The rate of infusions associated with an infusion reaction was reported in 1.1% of SIMPONI ARIA® infusions compared with 0.2% of infusions in the control group.

Please see the full Prescribing Information and Medication Guide for SIMPONI ARIA®. Provide the Medication Guide to your patients and encourage discussion.

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