RheumWATCH Archives

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Read the RheumWATCH archives on topics such as rheumatology advocacy, policy updates, insurance advocacy, and practice management.

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ACR RheumWATCH: February 18, 2016

Sign Up for RISE to Meet the Meaningful Use Deadline!

Per Meaningful Use guidelines, eligible providers must now actively engage with a public health agency to submit electronic public health data. Rheumatologists must sign up for at least two of three registries by February 29 in order to avoid financial penalties. The ACR’s RISE Registry meets the specialized registry specification. Participation in RISE is free and registration is easy.

RISE is an EHR-enabled registry that has captured data on more than one million patient encounters and is one of the largest rheumatology patient registries in the country.

To learn more about how the RISE Registry can help with Meaningful Use attestation, please contact ACR staff at RISE@rheumatology.org or 404-633-3777.

ACR Encourages Safe Adoption of Biosimilars during FDA Public Hearing

During a public meeting held last week by the FDA’s Arthritis Advisory Committee to review the license application of CT-P13, the ACR provided recommendations for policy guidelines to implement as the committee decides whether to license additional biosimilars for sale in the U.S. If approved, CT-P13 (a proposed biosimilar to infliximab) will be the first biosimilar available for the possible treatment of rheumatic disease.

Infliximab is currently used to treat rheumatoid arthritis, ankylosing spondylitis (a type of spondyloarthritis) and psoriatic arthritis.

Angus Worthing, MD, FACP, FACR, a practicing rheumatologist and member of the ACR Government Affairs Committee, testified on behalf of the College. Highlights from his remarks include:

  • A call for clinical data to ensure safety and efficacy prior to approval and collection of long-term, post-marketing studies of approved biosimilars to monitor for adverse events;
  • Reiteration of the ACR’s position that distinct names for biosimilars are needed to ensure correct prescribing and dispensing, post-marketing monitoring of the individual drugs, increased prescriber confidence and enhanced market uptake;
  • Advice that the FDA use caution when considering approving extrapolation of biosimilar products for indications where the reference biologic has already been approved in the absence of safety data specific to the biosimilar agent and the patient population in question; and
  • A call for FDA labeling that indicates whether a biosimilar is interchangeable with the reference biologic, lists all indications for which the biosimilar is approved and specifies whether supporting clinical data were derived from studies of the biosimilar or the reference biologic.

The safe adoption of biosimilars has been a top legislative priority for the ACR. In March 2015, the ACR released a position statement encouraging scientific study of biosimilars and physician involvement shortly after the FDA’s approval of Zarxio (filgrastim-sndz) for sale in the U.S. The organization later applauded the FDA in August 2015 for issuing draft guidance requiring separate and distinct names for biosimilars and biologic therapies. The guidance, "Nonproprietary Naming of Biologic Products” ,would designate separate and distinct, non-proprietary names for originator biologic products, related biologic products and biosimilar products. In December 2015, Dr. Worthing was invited to testify at a public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA), where he expressed the ACR’s support for the legislation and called for performance goals that encourage greater transparency in biosimilar product naming and packaging to ensure patient safety.

“As more biologic drugs are used to treat rheumatic diseases, rheumatologists are increasingly concerned about their high costs and patients being able to afford them, so the ACR strongly believes that safe and effective treatment alternatives should be made available to patients at the lowest possible cost,” said Dr. Worthing.

“However, we need to be able to confidently prescribe these therapies to our patients and feel comfortable that proper mechanisms are in place for rheumatologists to monitor patient reactions to prescribed biosimilars. Rheumatologists have been working with biologics for quite some time, and our patients take them for lengthy periods of time to manage their conditions, so we have a unique understanding of the extreme complexities of these medications. Even slight changes in molecular structure could mean that a patient reacts different to the biosimilar than they do to the reference biologic.”

View Dr. Worthing’s testimony in its entirety.

ACR and Partners Call for Dedicated Arthritis Research Funding Stream at DoD

The ACR recently hosted a Capitol Hill briefing in partnership with the Arthritis Foundation and American Osteopathic Association to call on Congress to direct $20 million within the Department of Defense’s Congressionally Directed Medical Research Program (CDMRP) to arthritis treatment and prevention. Arthritis is the primary cause of disability among U.S. military veterans and the second most common reason for medical discharge from the U.S. Army. One in three veterans is diagnosed with arthritis, compared to one in five members of the general U.S. population.

Capitol Hill brefing

The February 10 briefing on Capitol Hill featured ACR volunteer leader Colin Edgerton, MD, a practicing rheumatologist, U.S. Army combat veteran and former Army rheumatologist; Zack Fitzgerald, Private First Class, U.S. Army National Guard, and Arthritis Foundation Advocate; Kay Harvey, U.S. Army veteran and Arthritis Foundation Advocate; and Steve Sampson, DO, an osteopathic physician. Congressman David McKinley (R-WV), the lead sponsor and champion of the Patients’ Access to Treatments Act (H.R. 1600), provided a welcome and remarks about the importance of establishing this funding.

Currently, the CDMRP has $78 million of funds that have not yet been committed to a project. We are asking that $20 million be dedicated to finding more effective ways to treat and prevent arthritis. To support this important program, please visit the ACR’s Legislative Action Center and select this issue under Take Action.

Please also take a moment to sign this online petition from the Arthritis Foundation and American College of Rheumatology, asking Congress to establish a dedicated and well-funded CDMRP account for arthritis research, and encourage your patients to sign the petition and demonstrate their support.

Message from a Former Army Rheumatologist

Colin Edgerton, MD Medical research within the military has led to exciting breakthroughs and discoveries that benefit not only U.S. service members and veterans, but all Americans who are affected by disease.

The patient population within the military health system would provide unique opportunities to conduct clinical trials, test prevention strategies and track disease progression over time by tapping into the well-documented medical histories of active duty personnel.

Despite this, there remains very little military-funded research for one of the most painful and debilitating conditions affecting many of those who serve our country: Arthritis.

A serious, chronic and progressively degenerative disease affecting the body’s joints and connective tissues, arthritis disproportionately impacts our service members. In fact, one in three veterans is diagnosed with arthritis—compared to one in five Americans in the general population. Arthritis is the primary cause of disability among U.S. veterans today and the second leading cause of medical discharge from the U.S. Army.

It’s not surprising why arthritis impacts so many in the military community. The physical demands of the job lead to high-impact injuries, creating long-term damage to joints, tissue and cartilage. Even basic training activities—like wearing 100-plus pound packs or jumping from trucks with heavy gear on—can result in injuries that affect service members for the rest of their lives.

I know this because I’ve seen it firsthand. As an active duty rheumatologist who served in the U.S. Army for 13 years, I witnessed many service members sustain these injuries early in their careers. And while there is a “window of opportunity” for damaged joint tissue to heal on its own, it is generally frowned upon in the military to complain about pain, or slack off on physical activity during injury. As a result, many service members and veterans end up suffering in silence, delaying diagnosis and treatment. At my rheumatology practice in Charleston, S.C., I treat many veterans who have developed post-traumatic osteoarthritis as a result of their service.

Because arthritis has been a “silent enemy” in the military for so long, we are just beginning to understand the enormous physical, financial and societal costs of this disease. We know that many veterans suffer from reduced quality of life that requires years of ongoing therapy, medications and potential surgeries. Likewise, arthritis has become responsible for rising Department of Defense (DoD) and Veterans Affairs health costs.

Despite the prevalence and impact of arthritis in the military, there is no dedicated budget at the DoD to conduct arthritis research that could aid prevention, diagnosis and treatment efforts.

Recently, I traveled to our nation’s capital on behalf of the American College of Rheumatology to educate Congressional leaders about the need to create a standalone arthritis medical research program within the DoD’s Congressionally Directed Medical Research Program (CDMRP). By providing $20 million in dedicated funding for arthritis research, we would better meet the growing needs of active military personnel and veterans who have irreversible and lifelong medical conditions related to their service.

I am inviting you to join me in asking lawmakers to support investment in DoD-funded arthritis research for our service members and veterans. You can do this right now by visiting the ACR’s Legislative Action Center and sending a quick message. You’ll see a suggested message that you can modify if you wish.

Please also take a moment to sign this online petition from the Arthritis Foundation and American College of Rheumatology, asking Congress to establish a dedicated and well-funded CDMRP account for arthritis research, and encourage your patients to sign the petition so they can indicate their support.

Together, we can ensure the thousands of members of our military living with arthritis are given the care they deserve.

Colin Edgerton, MD, FACP, FACR, RhMSUS
Member, ACR Committee on Rheumatology Care
Alternate Delegate, ACR Delegation to the AMA House of Delegates

Dr. Edgerton is a former Army rheumatologist and practicing rheumatologist at Low Country Rheumatology in Charleston, S.C.