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Please read the Medication Guide for REMICADE® and discuss with your doctor.

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Is REMICADE Covered by Insurance?

Therapy with REMICADE for ulcerative colitis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and rheumatoid arthritis is covered by most insurance plans, including commercial insurers, Medicare, and Medicaid. Coverage policies may vary by insurer, by individual, or even between plans offered by the same insurer. If you have any questions about insurance coverage or reimbursement, you should first call your insurance company or Medicare. If you have questions or concerns, or if you need additional information related to medical coverage for REMICADE, you may call AccessOne^® at 1-888-ACCESS-1 (222-3771) for free assistance.

Your benefits may vary depending on:

Whether your doctor is part of your health plan (e.g., "in network" vs. "out of network")
The location where you get therapy with REMICADE (e.g., doctor's office, home infusion setting, or hospital outpatient department)
Rules for preauthorization or referral forms for visits to outpatient departments or medical specialists

Medicare: Medicare Carriers and Fiscal Intermediaries (claims processors) for all states cover infusions of REMICADE in doctors' offices and hospital outpatient facilities. The traditional Medicare Fee-For-Service Program does not cover infusions of REMICADE when provided by home infusion companies or retail pharmacies.

Medicaid: Medicaid also covers infusions of REMICADE, but coverage may be restricted to certain treatment settings or may require precertification. You should contact your insurance company or call AccessOne^® at 1-888-ACCESS-1 (222-3771) for help in meeting any precertification requirements.

Managed Care Plans: Most managed care plans such as Health Maintenance Organizations (HMOs) and Preferred Provider Organizations (PPOs) cover therapy with REMICADE. Managed care plans typically require some cost sharing by you for infusion therapies. However, these plans are likely to require precertification and completion of referral forms for specialist care, and may limit the choice of providers from whom you may obtain treatment.

Traditional Health Insurance: These plans usually cover therapy with REMICADE. Typically, this insurance offers coverage for a wider range of services, but with a higher level of copayment than a managed care organization. Precertification or prior authorization usually is not required. To find out if your insurance benefits cover REMICADE, call your insurer directly or contact AccessOne^® at 1-888-ACCESS-1 (222-3771).

In addition to obtaining insurance information, it might also be helpful to locate condition-specific support groups and resources.

IMPORTANT SAFETY INFORMATION

How will my doctor decide if REMICADE^® is right for me?

Only your doctor can recommend a course of treatment after checking your health condition. Your doctor should discuss with you any potential benefits and risks and help you make the best treatment decision. While REMICADE^® may help you feel better, like other medicines that affect your immune system, it can cause serious side effects such as lowering your ability to fight infections. There are reports of serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE.^® You should discuss any concerns about your health and medical care with your doctor.

What should I tell my doctor before I take REMICADE^®?

You should let your doctor know if you have or ever had any of the following:

Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start REMICADE.^®
Lived in a region where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
An infection that keeps coming back (or any problems that increase the risk of infection) or have diabetes.
Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
Heart failure or any heart condition. Many people with heart failure should not take REMICADE.^®
Hepatitis B virus (HBV) infection or think you may be a carrier of HBV.
Nervous system disorders (like multiple sclerosis or Guillain-Barré syndrome).

Also tell your doctor about any medications you are taking, including vaccines or Kineret (anakinra), and if you are pregnant, plan to become pregnant or are nursing. Adults and children should not receive a live vaccine while taking REMICADE.^®

What should I watch for and talk to my doctor about before or while taking REMICADE^®?

The following serious (sometimes fatal) side effects have been reported in people taking REMICADE.^®

You should tell your doctor right away if you have any of the signs listed below:

Infections (like TB, bremicadelood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. REMICADE^® can make you more likely to get an infection or make any infection that you have worse.
Lymphoma, or any other cancers. A rare form of fatal lymphoma has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking REMICADE^® and azathioprine or 6-mercaptopurine.
Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
Liver injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
Blood disorders—fever that doesn't go away, bruising, bleeding or severe paleness.
Nervous system disorders—numbness, weakness, tingling, changes in your vision or seizures.
Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun. The more common side effects with REMICADE^® are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.

Medication Guide for REMICADE^®

Please read the Medication Guide for REMICADE^® and discuss with your doctor.
(Requires Adobe^® Acrobat^® Reader^®. Click here to download.)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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Last Updated: January 19, 2009