Category: press release

ACR Applauds Prior Authorization Rule

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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

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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

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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

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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

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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

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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.

ACR Whitepaper Shows that Rheumatologists help Reduce Hospitalization Costs and Readmissions and Increase Quality of Care for Patients

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The following is a press release from the ACR dated August 30, 2023.

The American College of Rheumatology (ACR) has developed a new whitepaper and position statement that outlines the Clinical and Economic Value of Rheumatology in various hospital and practice settings. The documents emphasize the benefit to the quality of patient care when a rheumatologist is a part of the care team and the positive financial impact rheumatologists have on healthcare systems and the economy.

“Many rheumatologists can attest to the value they bring to the care team at a healthcare system,” said Christina Downey, MD, corresponding author of the white paper and chair of the ACR’s government affairs committee. “Our goal with the paper and position statement is to emphasize what that value looks like from a preventive and financial perspective. A rheumatologist on the care team benefits patients, practices, and the economy.”

The paper, an analysis based on adjusted insurance claims data, focuses on two aspects of economic value: preventive value and direct value. The study compared markets with high and low rheumatologist supply and found that markets with an increased supply of rheumatologists had lower costs per patient. Ultimately, having an appropriate supply of rheumatologists is crucial for optimizing patient outcomes and increasing the economic benefits within healthcare systems.

Highlights from the white paper, and emphasized in the position statement, include:

  • Markets with a high supply of rheumatologists had lower average costs per patient for emergency room visits and hospitalizations than those with a low supply.
  • Rheumatologists generate $3.5M annually in revenue for healthcare systems by calculating direct and downstream billings associated with a full-time equivalent (FTE) rheumatologist. The calculation includes office visits, lab testing, radiology services, therapy referrals, consultations, etc.
  • The preventive value of rheumatology care was estimated to be $2,762 per patient per year, representing the cost savings associated with a high supply of rheumatologists.
  • The need for expensive and invasive joint replacement surgery due to rheumatoid arthritis has fallen substantially in recent years because of medications that only rheumatologists have the experience and expertise to administer.
  • Appropriate medical therapy with disease-modifying anti-rheumatic drugs (DMARDs) or biologics provided by rheumatologists can significantly decrease disease activity, modify comorbidities, and improve the quality of life for patients with rheumatoid arthritis (RA).
  • Systemic lupus erythematosus (SLE) is among the leading causes of death of young women in the United States. They have higher disease activity, morbidity, and mortality, which often leads to one of the highest 30-day hospital readmission rates among chronic diseases in the nation. Access to a rheumatology clinic post-discharge reduces rates of readmission in this group.
  • Rheumatologists have developed electronic registries, such as the Rheumatology Informatics System for Effectiveness (RISE), to nationally track and improve the quality of care administered by rheumatologists. This registry provides timely feedback on the performance of 24 quality metrics like functional status and receipt of DMARD prescriptions for RA patients.

“Emphasizing the impact rheumatologists have on the entire medical community is more important than ever, especially as we contend with an impending rheumatology workforce shortage coupled with an expected increase in patient demand for rheumatologic care” Downey said. “This paper supports our recruitment and sustainability efforts for the specialty by spotlighting the significant contributions we make every day and every year to patient outcomes, hospitals, and other healthcare practices.”

An ACR task force, commissioned by the ACR board of directors, worked with ECG Management Consultants to analyze the value of care given by rheumatologists. ECG has worked with other specialties, such as primary care, to help quantify their economic value.

View the full Clinical and Economic Value of Rheumatology: An Analysis of Market Supply and Utilization in the United States whitepaper and position statement at https://rheumatology.org/policy-position-statements.

ACR Reacts to List of Initial Drugs Impacted by Medicare Drug Price Negotiation Program

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The following is a press release issued by the ACR on Tuesday, August 29, 2023.

The American College of Rheumatology (ACR) issued its initial reaction to the recent announcement from the Centers for Medicare & Medicaid Services (CMS) regarding which ten drugs will be subject to pricing negotiations, including Enbrel and Stelara, medications frequently used to treat rheumatic diseases.

As part of the implementation of the Inflation Reduction Act, Medicare can now negotiate the price of select medicines directly with pharmaceutical companies.

“It’s clear that lower costs are needed to improve rheumatology patients’ access to necessary drug therapies and treatments. High drug costs create an enormous financial burden for too many Americans living with rheumatic disease,” said Douglas White, MD, PhD, president of the ACR. “However, even with anticipated lower costs from negotiations, there is concern that patient access will remain limited if Congress fails to exempt Medicare Part B reimbursements from the sequestration reductions included in the Budget Control Act of 2011. On behalf of rheumatology providers, we are optimistic that these negotiations will yield savings for our patients. However, we ask that policymakers address the root causes of drug pricing increases throughout the drug supply chain to truly help patients afford their medications.”

ACR Introduces New Guidelines to Screen, Monitor and Treat Interstitial Lung Disease in Patients with Rheumatic Conditions

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The following is a press release issued by the ACR on August 22, 2023:

The American College of Rheumatology (ACR) released summaries of two new guidelines for the Screening and Monitoring of Interstitial Lung Disease in People with Systemic Autoimmune Rheumatic Disease and for the Treatment of Interstitial Lung Disease in People with Systemic Autoimmune Rheumatic Diseases (SARDs). The guideline summaries provide recommendations for screening, monitoring, and treating patients with rheumatic conditions like rheumatoid arthritis, systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM) who may be at risk of interstitial lung disease (ILD) development or progression.

“Interstitial lung disease is a major cause of morbidity and mortality across several systemic autoimmune rheumatic diseases,” said Sindhu R. Johnson, MD, Ph.D., lead author on the guidelines and director of the University of Toronto’s clinical epidemiology & healthcare research program. “Guidance was needed for which tests to use for screening and monitoring this particular disease.”

A few recommendations from the guidelines include:

  • A conditional recommendation to screen patients at high risk of ILD with HRCT chest, PFTs, or both
  • A conditional recommendation to monitor ILD progression with PFTs and/or HRCT chest, albeit with different frequency.
  • A conditional recommendation to monitor with ambulatory desaturation testing.
  • A conditional recommendation against screening and monitoring with a 6-minute walk test distance (6MWD), chest radiography, and bronchoscopy.
  • For people with SARD-ILD other than SSc-ILD, we conditionally recommend glucocorticoids as a short-term, first-line ILD treatment.
  • A strong recommendation against glucocorticoids as a first-line ILD treatment for people with systemic sclerosis-associated ILD.
  • A conditional recommendation for use of mycophenolate, rituximab, cyclophosphamide, and azathioprine as first-line ILD treatment options.
  • A conditional recommendation against using leflunomide, methotrexate, TNF inhibitors, and abatacept as first-line ILD treatment options.
  • For people with SARD-ILD progression despite first ILD treatment, it is conditionally recommended to use mycophenolate, rituximab, cyclophosphamide, and nintedanib as treatment options.
  • For people with Sjogren’s-ILD and IIM-ILD progression despite first ILD treatment, a conditional recommendation against using tocilizumab as a treatment option.

“In those with systemic sclerosis-ILD, we strongly recommend against using glucocorticoids as a first-line ILD therapy or after ILD progression because glucocorticoids confer an increased risk of scleroderma renal crisis,” said Johnson. “Given the moderate certainty of the evidence for harm and low certainty of the evidence for benefit, we voted strongly against using this treatment for patients with systemic sclerosis-ILD.”

These new recommendations will provide guidance for clinicians on the screening, monitoring, and use of a wide range of treatments for patients with rheumatic diseases. The ACR developed these with the best available evidence and consensus across a range of expert opinions and incorporated patient values and preferences. These guidelines may reduce regional variation in patient care and may be used for patient advocacy.

“We know that early detection and hastened referral to care, in collaboration with pulmonology, is critical for the best patient outcomes,” said Sonye K. Danoff, MD, Ph.D., guideline author, pulmonologist and director of the Interstitial Lung Disease/ Pulmonary Fibrosis program at Johns Hopkins University School of Medicine. “Because symptoms of ILD (cough, shortness of breath, fatigue) can be subtle or result from other common diseases, the diagnosis of ILD can be delayed. Increasing awareness of the groups at highest risk for developing ILD and implementing appropriate screening and treatment practices should have long-term benefits.”

Full manuscripts have been submitted for journal peer review. Both are anticipated to be published in rheumatology journals by early 2024. View the complete summaries of the guideline recommendations at https://rheumatology.org/interstitial-lung-disease-guideline.