Commercial Payer Information

Commercial Payer Information

Payers create their own policies with regard to product coverage. Since information varies by payer, it is important to contact the payer directly or consult its Web site to obtain product-specific coverage information.

Select a state to learn more about reimbursement coverage in that state.

Commercial and Medicare Part D payers each have their own forms and requirements for requesting prior authorization of a prescription drug. In the Commercial table below are links to payer Web sites where you may obtain more information on the approval process, policies and direct links to drug prior authorization forms. For Medicare Part D, click on the link for Contact Janssen CarePath Support. It is important to contact the payer directly or consult its Web site to obtain product-specific information.

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

Some health plans in select states must use their state's Uniform Prior Authorization request form. Please contact Janssen CarePath at 877-CarePath (877-227-3728) for assistance in obtaining prior authorization forms.

Click here to see if your state is included:

Uniform Prior Authorization Information for Select States

Third-party reimbursement is affected by many factors. The content provided is for informational purposes only and is not intended to provide reimbursement or legal advice and does not promise or guarantee coverage, levels of reimbursement, payment, or charge. Similarly, all CPT®* and HCPCS codes are supplied for informational purposes only and represent no promise or guarantee that these codes will be appropriate or that reimbursement will be made. It is not intended to increase or maximize reimbursement by any payer. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. While we have made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. We strongly recommend that you consult with your payer organization(s) for local or actual coverage and reimbursement policies and with your internal reimbursement specialist for any reimbursement or billing questions.

*CPT® copyright 2016 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association.

Janssen CarePath does not endorse and is not responsible for the content on any of the Web sites listed below, or the services provided by these organizations. Clicking on any of the links below will take you to a Web site to which our privacy policy does not apply. We encourage you to read the privacy policy of every Web site you visit.

Commercial Payer Prior Authorization Information

Payer Prior Authorization Information
Aetna Pharmacy Clinical Policy Bulletins and Prior Authorization
Arkansas Blue Cross and Blue Shield Prior Authorization Request Form
Blue Cross of Idaho Provider Prior Authorization Requirements: Pharmacy Requests
Blue Cross and Blue Shield of Alabama Specialty Pharmacy Form
Blue Cross Blue Shield of Arizona Prior Authorization Guidelines
Blue Cross and Blue Shield of Florida/Florida Blue Medication Guides
Quantity Limit Request Form
Specialty Pharmacy Request Form
Blue Cross and Blue Shield of Illinois Prior Authorization and Step Therapy Programs
Blue Cross and Blue Shield of Kansas Prescription Drugs
Prior Authorization
Blue Cross and Blue Shield of Minnesota Minnesota Uniform Form for PA Requests and Formulary Exceptions
Blue Cross and Blue Shield of Montana Provider Forms
Pharmacy Prior Authorization
Blue Cross and Blue Shield of Nebraska Policies & Forms: Pre-Authorization Forms
Blue Cross and Blue Shield of New Mexico Prior Authorization and Step Therapy Programs
Blue Cross and Blue Shield of North Carolina Prior Review and Limitations
Blue Cross and Blue Shield of Oklahoma Prior Authorization and Step Therapy Programs
BlueCross BlueShield of South Carolina Prior Authorization
BlueCross BlueShield of Texas Prior Authorization and Step Therapy Programs
Blue Cross Blue Shield of Wyoming Pharmacy Guide & Forms
CareFirst BlueCross BlueShield Prior Authorization/Step Therapy
Cigna Pharmacy Forms
CVS Caremark Prior Authorization Information
Electronic Prior Authorization
Electronic Prior Authorization FAQs
Clinical Prior Authorization Criteria Request Form
Geisinger Health/Geisinger Health Plan Prior Authorization Form
Gundersen Health Plan Pharmacy Forms for Healthcare Providers: Prior Authorization
Highmark Blue Cross Blue Shield Process for Requesting Drug Coverage from a Pharmaceutical Management Program
Highmark Blue Cross Blue Shield (formerly Blue Cross of Northeastern Pennsylvania) Provider Rx Prior Authorization Form
Drug Utilization Management Criteria
Humana Provider Prior Authorization
Independence Blue Cross Prior Authorization
Midwest Health Plan, Inc. Request for Prior Authorization
Medical Mutual of Ohio Provider Area
Prior Approval List
Prior Authorization Form
Neighborhood Health Plan Standardized Prior Authorization Request Form
Regence BlueCross BlueShield RegenceRx Pharmacy page
Prior Authorization
Wellmark Blue Cross and Blue Shield Provider Drug Information
Provider Prior Authorization

 

Alabama

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Alaska

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Arizona

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Arkansas

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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California

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Anthem Blue Cross of California Yes 3, Medical benefit Yes For more information
Cigna Yes 3   For more information
Health Net Yes     For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Colorado

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Connecticut

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Delaware

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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District of Columbia DC

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Florida

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Blue Cross and Blue Shield of Florida, Inc./Florida Blue Yes Medical Benefit Yes For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
SantaFe HealthCare, Inc./AvMed Health Plans Yes   Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Georgia

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Hawaii

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Idaho

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Illinois

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Blue Cross and Blue Shield of Illinois Yes Specialty, Medical   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Indiana

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Iowa

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Kansas

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Kentucky

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Louisiana

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Maine

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Maryland

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Massachusetts

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Michigan

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Minnesota

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Mississippi

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Missouri

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Montana

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Nebraska

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Nevada

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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New Hampshire

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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New Jersey

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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New Mexico

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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New York

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Empire BlueCross BlueShield Yes 3   For more information
Excellus BlueCross BlueShield Yes Medical Benefit Yes For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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North Carolina

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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North Dakota

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Ohio

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Oklahoma

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Oregon

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Pennsylvania

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Rhode Island

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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South Carolina

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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South Dakota

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Tennessee

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Texas

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
BlueCross BlueShield of Texas Yes Specialty, Medical   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Utah

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Vermont

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Virginia

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Washington

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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West Virginia

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Wisconsin

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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Wyoming

Commercial
Payer Prior Authorization Tier Quantity Limits Exception & Appeals Process (EAP) Information
Aetna Yes Medical benefit   For more information
Cigna Yes 3   For more information
Humana Yes Medical Coverage (may apply) Yes For more information
UnitedHealthcare Yes Specialty   For more information

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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, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS).

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.

The most common adverse reactions (incidence ≥ 3%) reported in clinical trials were: upper respiratory tract infection, alanine aminotransferase increase, viral infection, aspartate aminotransferase increase, neutrophil count decrease, bronchitis, hypertension, and rash. In the controlled phase of Trial RA, 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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