AAOS February 20, 2018
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Bipartisan Budget Deal Addresses Numerous
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House Subcommittee Discusses Consolidation

President Trump’s Budget Request

Good Samaritan Legislation Passes House Committee

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Congress Focuses on Rheumatoid Arthritis Therapies

AMA National Advocacy Conference 2018

ICYMI: AAOS Responds to RFI on Choice and Competition

State Corner: Trump Administration Expanding State Waiver Authorities

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Senate Legislative Activities
 
 
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Congress Focuses on Rheumatoid Arthritis Therapies

On February 7, 2018, the Senate Special Aging Committee held a hearing titled “Rheumatoid Arthritis Therapies Cost and Competition.” The focus of the testimony centered on the development of new medicines to treat rheumatoid arthritis (RA) – in particular, the development of a class of drugs called biologic disease-modifying antirheumatic drugs, or DMARDS. They are called “biologics” because they are proteins made from living organisms, and they are all administered via injection under the skin or by intravenous infusion supervised by a physician. There are only 10 therapies available in this class, and they are costly, marketed at over $50,000 per year.

“The Committee will examine why prices have soared for drugs used to treat a disease affecting 1.3 million Americans – rheumatoid arthritis, a chronic autoimmune and inflammatory condition that attacks the lining of joints,” stated Committee Chairman Susan M. Collins (R-ME). “Untreated, RA can lead to permanent joint damage and is associated with significant morbidity. While it can begin at any age, the likelihood of onset increases with age and is highest among women in their sixties. Biologic medicines have proven life-changing for many patients, halting the progression of symptoms and allowing them to remain actively engaged at work, at home, and in life. Derived from living organisms, biologics are much more complex than their chemical counterparts. They may require special handling and are often administered by injection or infusion. Sometimes referred to as “specialty drugs,” these medicines can have astonishingly high price tags that are continuing to increase every year… We look forward to hearing from all of our witnesses today and to better understanding what can be done to moderate the price of prescription drugs without discouraging the innovation that helps us live healthier lives.”

Generic versions of these treatments, called biosimilars, have begun to make their way onto the market but face significant legal and regulatory challenges. Notably, the importance of biosimilars was highlighted during the hearing. Specifically, it was highlighted that biosimilars introduced in Europe have resulted in a 30 percent reduction in the cost of treatment of RA. Witnesses urged the committee to support adequate funding of the FDA to enable rapid approval for additional biosimilars. The FDA has approved 9 biosimilars to date, but patent litigation has held up all but 2 biosimilars from entering the market.

“The sheer number of people who may be diagnosed with arthritis gives us good reason to examine this illness and its treatments,” stated Sen. Bob Casey (D-PA). “We must promote pathways to foster innovation and promote access to life changing medications. Indeed, with the emergence of novel treatments for rheumatoid arthritis over the last two decades people are living longer, fuller lives. But these treatments are not always affordable… there is much more that can be done to ensure that seniors and people with disabilities can afford life-sustaining and life-saving treatments. These are issues that span research and innovation, regulatory approvals, market forces and coverage. Our witnesses will shed light onto these different factors and more. I look forward to the committee’s discussion.”

Watch the hearing and find additional information online here.