ACR Cheers Funding for Rheumatology Research, Workforce Relief Inclusion

The following is a press release issued by ACR on March 25, 2024:

The American College of Rheumatology (ACR) today expressed strong support for several key measures included in the Fiscal Year (FY) 2024 budget. The budget allocates crucial funding to the Department of Defense’s Congressionally Directed Medical Research Program (CDMRP) for research on arthritis risks, outcomes, and treatments among service members; secures a significant funding increase for the National Institutes of Health (NIH), the cornerstone of medical research in the United States; and extends the Conrad 30 program. This program allows foreign-trained physicians to seamlessly enter the United States healthcare workforce after residency completion.

“The ACR applauds Congress for including provisions in the budget that prioritize the future of rheumatology. This budget recognizes the critical need for both a stronger physician workforce and continued research funding for arthritis and rheumatic diseases, ultimately benefiting millions of patients,” said Deborah Dyett Desir, MD, president of the ACR.

The Further Consolidated Appropriations Act of 2024 delivers a win for veterans and active-duty service members. The act allocates $10 million in the CDMRP for needed arthritis-related research among those who serve our nation. This targeted funding is crucial considering the alarming statistic that one in three veterans is battling arthritis, making it the second leading cause of medical discharge from the Army. By supporting research in this area, the CDMRP benefits veterans and service members and contributes to a broader understanding of rheumatic diseases.

This package also secures a notable funding boost for the NIH, reversing earlier proposals for deep cuts. Importantly, it protects funding for the National Institute of Allergy and Infectious Diseases (NIAID), which plays an important role in ongoing public health battles. This robust NIH funding ensures continued progress in critical medical research, including advancements in treatments and prevention strategies for rheumatic diseases.

The final spending bill also includes an extension of the Conrad 30 program, which allows U.S.-educated and trained physicians with a J-1 visa to enter the American medical workforce upon the completion of their residency. This delivers a much-needed boost to the American medical workforce given the current physician shortage. Typically, J-1 visa-holders training in the U.S. must return to their home country for two years after their program ends before they can apply for a work visa or green card to work in America. Each Conrad 30 waiver translates directly to a physician serving patients in underserved communities, for at least three years, who might otherwise face limited access to care.

“This budget represents a major victory for the 53.2 million Americans living with physician-diagnosed rheumatic conditions,” said Desir. “Including these vital programs promises to unlock significant patient care and research advancements in the coming years. We eagerly await the positive impact this will have on millions of lives.”

ACR Commends Congress for Mitigating Medicare Cuts, Calls for Ongoing Healthcare Reforms

The following is a press release issued by the ACR on March 11, 2024:

The American College of Rheumatology (ACR) applauds Congress for passing legislation to mitigate the 3.4 percent reduction in physician payments outlined in the Medicare Physician Fee Schedule (MPFS) Final Rule for CY2024 but also calls on policymakers to seek long-term systemic policy changes that will provide more stability and predictability for providers.

“While we commend Congress for this partial fix, rheumatologists remain concerned that without long-term reform to the Medicare payment system, maintaining access to quality care for individuals managing rheumatic diseases and other chronic conditions will be in jeopardy,” remarked Deborah Dyett Desir, MD, President of the American College of Rheumatology. “The annual recurrence of MPFS cuts underscores the urgent need for comprehensive healthcare reforms. The American College of Rheumatology urges Congress to prioritize sustainable solutions, ensuring patient access to essential services and fair reimbursement for healthcare providers.”

The payment cut reduction, from 3.4 percent to 1.68 percent, was included in recently passed broader funding legislation. This reduction comes on top of cumulative cuts that, when adjusted for inflation, amount to an overall decline in Medicare physician payment of 30 percent since 2001, according to the American Medical Association.

As the nation’s leading medical specialty society representing rheumatologists, the ACR remains committed to advocating for policies that prioritize patient well-being and support the needs of rheumatology practices across the country.

ACGME and Docs with Disabilities Initiative Partner for Disability Hub

The following are excerpts from a press release issued by the Accreditation Council for Graduate Medical Education on January 23, 2024:

The ACGME, in partnership with the Docs with Disabilities Initiative (DWDI), is a recipient of the Josiah Macy Jr. Foundation Catalyst Award for Transformation in Graduate Medical Education for their project, Multimedia Resource Hub for Disability Inclusion in Graduate Medical Education. The aim of the project is to support education and enhance disability inclusion, learner safety, and accessibility in the clinical learning environment for residents and fellows.

The Multimedia Resource Hub for Disability Inclusion in Graduate Medical Education will be added to the content portfolio available on the ACGME’s distance learning portal, Learn at ACGME. The ACGME Equity Matters® program supports the development of innovative resources that increase workforce diversity, encourage adoption of equity practices, and foster inclusive learning environments.

Calls for community involvement and inclusion in the hub will be forthcoming.

Read the full press release here.

ACR Applauds Prior Authorization Rule

The following is a press release issued on January 17, 2024:

The American College of Rheumatology (ACR), on behalf of over 7,900 rheumatologists and rheumatology professional team members, applauds the Centers for Medicare and Medicaid Services (CMS) for finalizing its Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations rule recently.

“Prior authorization policies create significant undue burdens on patients and healthcare professionals and often result in significant delays to needed care, treatment abandonment, and irreversible harm to patients’ health,” said Deborah Dyett Desir, MD, president of ACR. “The ACR commends CMS for recognizing the negative impact of prior authorization on patients and the need to streamline the process to promote greater transparency between doctors’ offices and payers.”

Specifically, the rule would reduce the decision time to 24 hours for urgent requests and seven days for non-urgent requests. The rule also requires payers to provide the reason for prior authorization denials, creating greater transparency and establishing a more streamlined practice for resubmissions and appeals.

However, the ACR is concerned with the inclusion of e-prior authorization measures for merit-based incentive payment system (MIPS)-eligible providers under the performance improvement (PI) category as it will create additional burden for physicians.

While this final rule addresses many concerns about the use of utilization management tools, the ACR continues to urge Congress to pass the Improving Seniors’ Timely Access to Care Act (S. 3018/H.R. 3173) to statutorily address prior authorization issues in Medicare, Medicare Advantage and Medicaid plans.

“The ACR welcomes the opportunity to be a part of this discussion as policymakers work to ensure these programs are implemented in a way that streamlines patient care and minimizes administrative burden on physicians,” Desir concluded.

ACR Applauds Dedicated Arthritis Research Funds in the NDAA

The following is a press release issued by the ACR on December 14, 2023:

Full title: ACR Applauds Lawmakers for First-Time Dedicated Arthritis Research Funds in the National Defense Authorization Act

Today, the American College of Rheumatology (ACR) celebrates the first new medical research line item in the Congressionally Directed Medical Research Program (CDMRP) in eight years for arthritis research under the Department of Defense’s (DoD) C recently passed National Defense Authorization Act (NDAA) for fiscal year 2024.

“Investment in arthritis research will not only benefit those serving in our armed forces, but also the thousands of Americans, including many veterans, living with arthritis,” said Deborah Dyett Desir, MD, president of the American College of Rheumatology. “Efforts from this program will not only help curb the costs associated with managing and treating this disease but will also spur innovations and a better understanding of arthritis in the servicemember population.”

Arthritis research has been funded through the DoD’s Peer Reviewed Medical Research Program (PRMRP) at varying levels since 2009, but given the many priorities of the PRMRP, funding is not guaranteed. The ACR and Arthritis Foundation have advocated for this CDMRP line item to designate specific funding annually to arthritis research and advance research on arthritis risks, outcomes, and treatments among service members. The ACR thanks House appropriations leaders for recognizing the necessity and value of arthritis research in the DoD with this $10M annual line item for arthritis research.

“We know that one in three veterans are diagnosed with arthritis, and it is the second-leading cause of medical dismissals from the military.  This funding is critical to advancing arthritis research and I’m optimistic that we will see the impact and benefits of this investment for years to come,” Dr. Desir concluded.

The Association of Rheumatology Professionals Selects Long Time Physical Therapist to Lead the Organization

The following is a press release issued by the ACR on Nov 14, 2023:

Today, the Association of Rheumatology Professionals (ARP), a division of the American College of Rheumatology (ACR), announced the appointment of Aileen Ledingham, PT, MS, PhD as the ARP’s  58th president during ACR Convergence 2023, the ACR’s annual meeting.

“The ARP has been a professional home for me for more than a decade—providing the support, resources and educational value needed to excel in my rheumatology career,” said Ledingham. “To now be trusted to lead this organization and all it does to serve rheumatology health professionals and their patients is a true honor.”

As an ARP member, Ledingham has held various leadership positions including co-chair of the ACR membership & awards committee and chair of the ARP eLearning subcommittee. She has also been a member of the ACR finance and education committees, and the ARP nominations and appointments committee. For the past few years, she has been a member of the ARP executive committee as secretary and president-elect leading up to her appointment as ARP president.

Ledingham earned a bachelor’s degree in physical therapy from Northeastern University, a master’s degree in pediatric physical therapy from Long Island University, and a doctorate in rehabilitation sciences from Boston University. She is currently a physical therapist clinical scientist working at Mount Auburn Hospital in Cambridge, Massachusetts. Her research interest is in the field of knee osteoarthritis, specifically on how to help patients use exercise and physical activity to improve their quality of life.

Ledingham’s term begins this month along with the recently appointed 2023-2024 ARP Executive Committee:

  • President Elect – Adam Goode, PT, DPT, PhD
  • Secretary – Becki Cleveland, PhD
  • Immediate Past President – Kori Dewing, ARNP, DNP
  • Practice Committee Chair – Annelle Reed, CPNP, MSN
  • eLearning Committee Chair – Adena Batterman, MSW
  • ARP AMPC Chair – Priscilla Calvache, MSW, LCSW
  • Member-at-Large, Finance – Jillian Rose-Smith, MSW, MPH, PhD
  • Member-at-Large – Bharati Bhardwaja, PharmD, BCPS, LSSBB
  • Member-at-Large – Yvonne Golightly, PT, MS, PhD
  • Committee on Research Liaison – Kaleb Michaud, PhD
  • Committee on Government Affairs Liaison – Donald Miller, PharmD, FASHP
  • ACR Representative – Sam Lim, MD, MPH

The ARP, which serves more than 1,200 members, exists to equip rheumatology professionals with the tools needed to provide quality care for patients with rheumatic and musculoskeletal diseases. ARP members include nurses, nurse practitioners, occupational therapists, physician assistants, physical therapists, pharmacists, practice managers, researchers, social workers and other non-physician professionals in various rheumatology and healthcare settings.

About the Association of Rheumatology Professionals

The Association of Rheumatology Professionals (ARP) is a division of the American College of Rheumatology built by rheumatology professionals, for rheumatology professionals. Our goal is to empower rheumatology professionals by providing education, advocacy, and practice management tools. For more information, visit rheumatology.org/about 

FDA Approves Actemra Biosimilar TOFIDENCE™ (tocilizumab-bavi) by Biogen

The following is a press release dated Sept 29, 2023:

Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

TOFIDENCE is the first tocilizumab biosimilar approved in the United States. Biosimilars are biologic products that have been demonstrated to have equivalent efficacy and comparable safety as the approved reference product, with the advantage that they may offer cost savings and promote expanded and sustainable access to therapies. Spending on therapies for autoimmune diseases has consistently increased by 10%–25% each year over the past decade. Since biosimilar entry in the US, medicines with biosimilar competition have experienced greater patient adoption equaling more than 150 million days of patient therapy.

“The approval of TOFIDENCE in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for healthcare systems and an increase in physician choice and patient access to biologics.”

Biogen and Bio-Thera entered into a commercialization and license agreement for TOFIDENCE (BAT1806/BIIB800) in April 2021. Developed by Bio-Thera, TOFIDENCE will be commercialized by Biogen in the United States. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau and Taiwan). Biogen is currently evaluating the potential launch timeline for TOFIDENCE in the U.S.

The FDA approval of TOFIDENCE was based on a comprehensive analytical, non-clinical and clinical data package submitted by Biogen to the FDA in Sept 2022. Extensive analytical characterization of the structural, physicochemical, and biological properties of TOFIDENCE was conducted and supports biosimilarity with the reference product. Additionally, a randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety and immunogenicity of TOFIDENCE with both the US and EU reference tocilizumab in healthy volunteers, while a randomized, double-blind, multi-dose, three-arm parallel phase III study compared TOFIDENCE with tocilizumab to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with rheumatoid arthritis inadequately controlled by methotrexate. The totality of evidence demonstrated TOFIDENCE is a biosimilar of the reference biologic.

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EU has its first RoActemra biosimilar — Tyenne

The following is an except from an article on Pharmaphorum, dated Sept 20, 2023:

The biosimilar of IL-6 inhibitor tocilizumab, called Tyenne (formerly MSB11456), has been approved for the same indications as Roche’s brand, including rheumatoid arthritis, systemic juvenile idiopathic arthritis (sJIA), juvenile idiopathic polyarthritis (pJIA), giant cell arteritis (GCA), CAR-T cell-induced severe or life-threatening cytokine release syndrome and severe COVID-19.

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ACR Launches Biosimilar Patient Education Campaign for Rheumatic Disease Awareness Month

The following is a press release issued by the ACR September 12, 2023.

The American College of Rheumatology (ACR) today launched its patient education campaign, Biosimilars & You: A Guide to for Patients with Rheumatic Disease as part of Rheumatic Disease Awareness Month (RDAM). The campaign aims to help individuals diagnosed with a rheumatic disease better understand what biosimilars are and that these therapies may offer a treatment option as safe and effective as the original biologic they are based upon.

A 2023 survey looking at US patients’ attitudes about biosimilars found that patients expressed a desire to know more about biosimilars in general and specifically about how they compare with original biologics, their benefits, and their cost. The ACR, in consultation with practicing rheumatologists and rheumatology health professionals, developed resources, which include a video; an infographic; a patient fact sheet, and additional materials, to meet this need.

“Biosimilars are a class of medications that rheumatologists have long been prescribing in the US and Europe to successfully treat rheumatic conditions,” said Marcus Snow, MD, chair of the ACR Committee on Rheumatologic Care and spokesperson for RDAM 2023. “They go through a very stringent review process with the FDA and are verified to be just as safe as the biologics they are based upon. With so many new biosimilars available this year, we knew patients would have questions and providers would be seeking resources to share with their patients.”

More than 58.5 million American adults have been diagnosed with a rheumatic disease, and an estimated 300,000 children live with some type of juvenile arthritis. Prior to the advent of biosimilar therapies, there has been only one medication healthcare providers could prescribe for their patients with rheumatoid arthritis, psoriatic arthritis, lupus, and several other rheumatic diseases over the past decade. With new biosimilars available, the hope is that in addition to more options for treatment, there may also be potential for cost savings for patients. However, this has yet to be determined.

“With more and more biosimilars becoming available, it’s important to note that they are not synonymous with a ‘generic drug’ because they are not identical to the original biologic,” Snow said. “The difference between biosimilars and the original reference biologic compares to the difference between two buildings created from the same blueprints. The buildings will look the same, be the same height and have the same number of rooms and functionality. But they might have different paint colors, doorknobs, or other small differences. However, those differences do not change how the building functions; both have a sound foundation. ”

The ACR aims to be a one-stop shop for patients and their healthcare providers to learn more about biosimilars. View all biosimilar resources from the patient education campaign at www.RDAM.org.