Abbott Lab's statement regarding the CMS announcement on medicare demonstration project for self-injectable drugs

Main Category: Medicare / Medicaid / SCHIP
Article Date: 28 Jun 2004 - 9:00 PDT

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USA - Abbott Laboratories have said that the plan by the Centers for Medicare and Medicaid Services (CMS) to provide America's seniors with access to self-administered prescription medicines through the Medicare replacement drug demonstration program represents an important step in meeting the needs of Medicare beneficiaries with serious or life-threatening diseases. Through the demonstration program, patients will save thousands of dollars on new, innovative treatments that they can administer at home.

Abbott is pleased that the demonstration program will cover medications for rheumatoid arthritis (RA), including Abbott's self-injected biologic treatment, HUMIRA(reg) (adalimumab). The program will expand available treatment options for thousands of patients fighting this serious and potentially crippling condition.

Until now, under Medicare Part B, the only treatments available to many Medicare patients were those administered in a physician's office. Under the demonstration project, choice of treatment will not be limited based on route of administration, and patients will have access to the most innovative and convenient treatments.

Abbott has always been and will continue to be committed to helping patients in need gain access to the newest, most effective treatments for their disease. The HUMIRA Medicare Assistance Program (MAP), which has been providing HUMIRA free to eligible RA patients on Medicare with no prescription-drug coverage, will continue to exist for patients who do not qualify for coverage under the government's program. MAP has helped thousands of Medicare beneficiaries gain access to HUMIRA since its inception in January 2003.

About RA

More than 5 million people worldwide suffer from RA, a chronic autoimmune disease that causes pain, swelling and stiffness in the joints of the hands, feet and wrists and often leads to the destruction of joints. Unlike osteoarthritis, the most common form of arthritis, RA is an autoimmune disease where joints are inflamed, often resulting in eventual destruction of the joint's interior and the surrounding bone.

About HUMIRA

On December 31, 2002, HUMIRA became the first fully human monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) for reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderately to severely active RA who have had insufficient response to one or more disease modifying antirheumatic drugs (DMARDs). HUMIRA can be used alone or in combination with methotrexate (MTX) or other DMARDs. The efficacy and safety of HUMIRA have been studied in 23 clinical trials and in more than 2,300 patients, making it the most-studied TNF antagonist for RA at the time of regulatory submission.

HUMIRA offers convenient every-other-week dosing by subcutaneous injection (shot beneath the skin) via a specially designed pre-filled syringe.

Clinical trials are also currently underway evaluating the potential of HUMIRA in other autoimmune diseases.

HUMIRA was discovered through a broad scientific collaboration between Abbott and Cambridge Antibody Technology (CAT). As part of the collaboration, Abbott had the right to select several target antigens for which a joint Abbott/CAT research team would discover human antibody therapeutics.

HUMIRA was isolated and optimized by Abbott and CAT as part of this collaboration. Abbott owns exclusive worldwide rights to HUMIRA, including responsibility for clinical development, manufacturing, sales and marketing. Abbott will book all revenues for HUMIRA, and CAT will receive a royalty fee based on HUMIRA sales.

Important Safety Information

Cases of tuberculosis (TB), frequently disseminated or extra pulmonary at clinical presentation, have been observed in patients receiving HUMIRA. Serious infections and sepsis, including fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA. Many of these infections occurred in patients on concomitant immunosuppressive therapy that in addition to their underlying disease could predispose them to infections. Other invasive opportunistic fungal infections have also been observed in patients treated with TNF-blocking agents, including HUMIRA.

TNF-blocking agents, including HUMIRA, have been associated in rare cases with exacerbation of demyelinating disease. Lymphoma has been observed in patients treated with TNF-blocking agents. The most frequent adverse events seen in the placebo-controlled clinical trials in rheumatoid arthritis (HUMIRA vs. placebo) were injection site reactions (20 percent vs. 14 percent), upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo. As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before initiating therapy.

About Abbott

Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000 people and markets its products in more than 130 countries.

http://www.abbott.com/news