Category: press release

Taiwan: Actemra Approved to Treat COVID-19

Posted on by Grayson

The following is a press release issued today by Chugai Pharmaceutical:

Chugai Pharmaceutical Co., Ltd.(TOKYO: 4519) announced that Chugai Pharma Taiwan Ltd., a wholly-owned subsidiary of Chugai, obtained an import drug license from the Taiwan Food and Drug Administration (TFDA) for Chugai’s Actemra® (tocilizumab) intravenous (IV) formulation for the treatment of COVID-19 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

This approval is based on the results from clinical studies evaluating Actemra in hospitalized patients, including an investigator-initiated, randomized, open-label, platform overseas study (RECOVERY study) and three placebo-controlled, randomized, double-blind, multicenter, global phase III studies conducted by Roche (COVACTA study, EMPACTA study, REMDACTA study).

About Actemra

Actemra is the first therapeutic antibody created in Japan by Chugai. It is designed to block the activity of IL-6, a type of inflammatory cytokine. First launched in June 2005, the intravenous injection is approved for seven indications in Japan: Castleman’s disease, rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, cytokine release syndrome induced by tumor-specific T cell infusion therapy, adult Still’s disease, and SARS-CoV-2 pneumonia. In addition, Actemra subcutaneous injection is approved for three indications in Japan: rheumatoid arthritis, Takayasu arteritis, and giant cell arteritis. Actemra has obtained regulatory approval in more than 110 countries worldwide.

As you may know, Actemra is one of a small number of medications FDA-approved for both SJIA and AOSD.

ACR: Medicare Drug Pricing Negotiation Methodology Should Include Real-World Experience

Posted on by Grayson

The following is a press release issue by the American College of Rheumatology on April 14, 2023:

The American College of Rheumatology (ACR) today submitted comments to the Centers for Medicare and Medicaid Services (CMS) administrator Chiquita Brooks-LaSure urging that Medicare’s drug price negotiation program balance cost with innovation, incorporate real-world experience from patients and providers, and improve transparency in the program’s methodology.

In its comment letter, the ACR urges CMS to:

  • Ensure that drug pricing timelines and eligibility requirements for negotiating high-spend drugs do not impede innovation and the development of new treatments.
  • Allow greater public participation as the process evolves, including public comment periods of at least 60 or 90 days.
  • Incorporate patient and provider perspectives throughout the process.
  • Make drug negotiation methodologies transparent, accessible, and understandable to all stakeholders.
  • Publish subsequent policies regarding drug price negotiations using the customary regulatory process including a more appropriate public comment period.

“While negotiations toward a maximum fair price are largely between the pharmaceutical industry and CMS, the implications of these negotiations are far-reaching,” said Douglas White, MD, PhD, President of the American College of Rheumatology. “We firmly believe that the real-world experience of patients and prescribers must be integrated into any attempts to identify and negotiate fair drug prices. The ACR appreciates the opportunity to contribute its experience to CMS’s process.”

ACR Urges CMS to Reconsider Copay Assistant Programs in CMS Proposed Rule

Posted on by Grayson

The following is a press release issued by the American College of Rheumatology dated January 31, 2023:

The American College of Rheumatology (ACR) today submitted comments to Centers for Medicare and Medicaid Services (CMS) administrator Chiquita Brooks-LaSure urging the agency to reconsider its current policies on essential copay assistance programs that enable patient access to needed treatments.

Current CMS policy allows insurers to exclude copay assistance from counting toward a patient’s deductible. Copay assistance programs provide patients with financial relief from the high costs associated with many treatments, such as biologics and biosimilar products, upon which they rely to control rheumatic diseases. Without copay assistance, many patients will be unable to pay their deductible, resulting in delays to needed treatment, medication rationing, or forfeiting treatment entirely.

“Rheumatologists care for patients with complex chronic and acute conditions that often require costly treatments. Without vital programs like copay assistance to help them afford treatment, our patients can face irreversible joint and tissue damage as well as serious declines in the quality of their everyday lives,” said Douglas White, MD, PhD, President of the ACR.

The ACR remains deeply concerned about cost-shifting tactics used by health insurers that place a disproportionate financial burden on patients with chronic rheumatic and musculoskeletal conditions like lupus and rheumatoid arthritis. With roughly 95% of expensive specialty medicines having no generic or lower-cost alternative, this proposed rule will leave many rheumatology patients in an untenable position.

“The ACR is deeply concerned that the proposed policies to increase the maximum out-of-pocket limitations, coupled with allowing insurers to exclude copay coupons to be applied toward a patient’s out-of-pocket limit, debilitates our patient’s ability to access the treatments needed to help manage their painful chronic condition,” wrote ACR in its letter. “While we understand the need to find solutions to help curb the increasing cost of healthcare, we cannot support policies that sacrifice our patients’ health in the name of cost savings.”

2022 Specialty Match Day Results Show Strong Appeal of Adult Rheumatology, Ongoing Need to Increase Interest in Pediatric Rheumatology

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The following is a press release from the ACR dated 12-21-2022:

The American College of Rheumatology is pleased to announce another successful recruitment season and welcomes this impressive pool of applicants to the field of rheumatology. 75 percent of the eligible candidates interested in adult rheumatology and 96 percent of eligible applicants interested in pediatric rheumatology were matched to fellowship programs for the 2023 appointment year as part of the annual National Residents Matching Program (NRMP).

Rheumatology leaders again noticed a stark contrast when looking at the percentage of available adult and pediatric fellowship slots that were filled. Whereas the adult programs filled 97.8 percent of their available slots, the pediatric programs only filled 62.8 percent, signaling a need to increase interest in pediatric rheumatology. While the number of adult fellowship matches has seen a steady increase over the past five years, interest from candidates has continued to exceed the number of available positions, suggesting ongoing opportunity to expand fellowship training opportunities. Continuing to make progress in these areas will be important given the workforce shortage projections identified in ACR’s 2015 workforce study.

“This year was the first time that the adult and pediatric fellowship Match dates aligned, allowing participants the opportunity to apply to and rank both adult and pediatric training programs in a single rank list by a dual-trained applicant or by a couple. This change has been welcome, as it facilitates the application process for a number of candidates,” said Beth Marston, MD, chair of the American College of Rheumatology’s (ACR) Committee on Training and Workforce Issues (COTW).

“Unfortunately, we continue to see limited numbers of applications for pediatric rheumatology fellowship positions, with 27 applicants filling only 26 of a possible 43 total positions. Other pediatric specialties such as pediatric pulmonology, nephrology, infectious disease, and endocrinology also had a significant number of unfilled positions; in contrast, the relatively new field of pediatric hospital medicine filled nearly all open positions, which may hint at the goals and training interests of current pediatric applicants. Many potential barriers have been suggested, including inadequate exposure and mentorship within these specialties, long periods of required training, and lower ultimate compensation for pediatric specialists, which might be targets for future work to improve our pediatric specialty workforce,” continued Marston.

“The adult rheumatology workforce also remains threatened, with ongoing national efforts by the ACR’s Workforce Solutions Committee to increase fellowships and fellowship positions, particularly in geographically underserved areas. Because a substantial number of applicants have remained unmatched over the last several years, any increase in the number of available fellowship positions is likely to continue to directly affect the future physician workforce within rheumatology,” Marston concluded.

In addition to efforts to continue to increase fellowship positions, the ACR continues to work to create new mechanisms to increase exposure to rheumatology earlier in training, to understand barriers to training in pediatric and combined internal medicine and pediatrics rheumatology, and to support programs and program directors as they navigate curricular and regulatory changes.

The NRMP, established in 1952 at the request of medical students, uses a computerized, mathematical algorithm to align the preferences of applicants and program directors to fill training positions available at teaching hospitals in the United States. Full details of the 2022 Match Day results for adult and pediatric fellowships can be found online here.

ACR Educating Dermatologists and Nephrologists on Lupus Clinical Trials Racial Disparities

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The following is a press release issued by ACR this morning (Nov 2, 2022).

The American College of Rheumatology (ACR) has released Continuing Medical Education (CME) for dermatologists and nephrologists to help them learn more about clinical trials for lupus patients in their respective treatment areas and the importance of getting more of their African American/Black patients enrolled.

Lupus is a multisystem disease and is frequently managed by a care team including rheumatologists, nephrologists, dermatologists, and other specialists. African American/Black, Hispanics and Native Americans are also disproportionately affected by the condition. This new CME is part of the ACR’s “Materials to Increase Minority Involvement in Clinical Trials” (MIMICT) initiative and is aimed at educating these providers on the importance of increasing minority participation in lupus clinical trials.

“In the United States, African American/Black patients represent approximately 43 percent of lupus cases, however, only 14 percent of lupus clinical trial participants are African American/Black,” said Starla H. Blanks, Senior Director of Collaborative Initiatives for the American College of Rheumatology. “African American/Black patients with lupus. They are also four times more likely to get lupus nephritis, a type of kidney disease, which can increase the mortality rate.”

The new CME provides nephrologists and dermatologists with specific information on racial disparities in lupus clinical trials, why it’s important to increase minority participation in lupus clinical trials, and the barriers providers face when encouraging patients to participate in lupus clinical trials.

“Skin and kidney symptoms are common in lupus patients and there are clinical trials specifically targeting these two organ systems. The CME training addresses barriers like patient mistrust, lack of familiarity with trials, and an intimidating consent process,” said Rosalind Ramsey-Goldman, MD, DrPH, chair of the ACR’s Collaborative Initiatives Committee. “It also addresses facilitators like culturally sensitive communication and social support by emphasizing skills that provide support for both the provider and the patient.”

The new CME for nephrologists and dermatologists can be found on the ACR’s Lupus Initiative website. The expansion of MIMICT was made possible by a two-year grant for the ACR’s Training to Increase Minority Enrollment in Lupus Clinical Trials with CommunitY Engagement (TIMELY) project from the U.S. Department of Health and Human Services Office of Minority Health. More information about the ACR’s work on lupus awareness and educational programs can be found at www.thelupusinitiative.org.

Updated Guideline Introduces Recommendations for Prevention and Treatment of Glucocorticoid-Induced Osteoporosis

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The following is a press release from this past week, care of the ACR.

The American College of Rheumatology (ACR) released a summary of its updated guideline for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis. Many patients take glucocorticoids for a variety of inflammatory conditions, and anyone who is taking glucocorticoid medications and has other risk factors for osteoporosis increases their risk of developing glucocorticoid-induced osteoporosis. New osteoporosis medications and new literature have become available since the last ACR treatment guideline was published in 2017.

“One major side effect of glucocorticoid therapy is bone loss and an increase in the risk of fractures. Fractures can cause significant morbidity and be associated with an increased risk of mortality,” said Mary Beth Humphrey, MD, PhD, co-principal investigator of the guideline and interim Vice President for Research and a Professor of Medicine at the University of Oklahoma Health Sciences Center. “With newly approved osteoporosis medications and a review of the relevant literature, we felt it was important to update the guideline.”

The guideline team conducted an updated systematic literature review for clinical questions on non-pharmacologic and pharmacologic treatment addressed in the 2017 guideline, and for questions on new pharmacologic treatments, discontinuation of medications, sequential and combination therapy.  The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to rate the certainty of evidence. A Voting panel including clinicians and patients achieved ≥70% consensus on the direction (for or against) and strength (strong or conditional) of recommendations.

The guideline includes recommendations on abaloparatide and romosozumab, which are two medications that are newly available since the 2017 guideline, as well as recommendations for other osteoporosis medications.

The guideline also recommends sequential therapy (any treatment regimen in which the patient is given one treatment followed by another), which was not addressed in the previous guideline. The recommendations for sequential therapies are based in part on some study designs, long term follow-up studies, and new clinical trials.

“Some physicians may be surprised about the need for sequential therapy when completing a course of denosumab, parathyroid hormone/parathyroid hormone related protein, or romosozumab. If not done, patients could be at risk of rapidly developing vertebral fractures and bone loss,” said Linda Russell, MD, Director of Perioperative Medicine, Director of the Osteoporosis and Metabolic Bone Health Center for the Hospital for Special Surgery and co-principal investigator of the guideline.

The updated guideline also gives more flexibility on drug selection and considers patient and physician preferences.

“The previous guideline rank-ordered medication for the treatment of glucocorticoid induced osteoporosis. We felt it was important that this guideline reflect patient/physician decision making,” said Dr. Humphrey.

A full manuscript has been submitted for journal peer review and is anticipated to be published in rheumatology journals in early 2023. The summary of the guideline recommendations can be viewed in full on the ACR website.

ACR Applauds FTC Decision to Investigate PBM Business Practices

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The following is a press release from the American College of Rheumatology:

The American College of Rheumatology applauds the Federal Trade Commission’s decision to investigate the business practices of pharmacy benefit managers (PBMs), which continue to increase PBM profit margins while placing the burden of skyrocketing drug costs on America’s most vulnerable patients, including those living with chronic and severe rheumatic diseases.

This welcomed news follows sustained calls from the rheumatology community for greater oversight over the insurance middlemen who drive up drug costs for our patients. The FTC investigation is a critical step toward greater transparency and oversight over PBMs’ opaque business practices, as well as the enactment of meaningful drug pricing reforms that will reduce costs and expand access to important therapies for our patients.

While PBMs were originally conceived to help manage the complexities of prescription drug benefits, they have since become massive, consolidated, profit-driven enterprises that exercise immense control over our patients’ access to needed treatments. Their business practices are detrimental to policy efforts to curb the high cost of prescription drugs.

The FTC announced today it will examine the role of PBMs, which are hired by insurers to negotiate rebates and fees with drug manufacturers as well as develop drug formularies that impact reimbursement to pharmacies for patient medications. Citing “complicated and opaque methods to determine pharmacy reimbursement, prevalence of prior authorizations and other administrative restrictions and the use of specialty drug lists surrounding specialty drug policies” as some areas of investigation, the FTC noted it has received more than 24,000 public comments to date regarding the potential investigation of PBMs.

Extending Telehealth for Medicare Recipients

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The following is an email from the US Pain Foundation dated yesterday, March 21:

Since access and coverage of telehealth has been a wonderful and safe convenience for people with chronic pain during the pandemic, we have been closely following government policy around telehealth coverage and want to update you on recent developments.

Last week, President Biden signed into law HR 2471, the Consolidated Appropriations Act of 2022 which finalized the fiscal year 2022 federal budget and included a number of provisions to extend Medicare telehealth coverage implemented as part of the government’s response to COVID-19. The COVID-19 Public Health Emergency (PHE) has not yet officially ended but is expected to end sometime in the next few months. HR 2471 will extend Medicare telehealth coverage for 151 days or approximately five months after the PHE ends. These extensions include the following:

  • Patients’ Location – Medicare beneficiaries can continue to receive coverage for telehealth services from wherever they are located within the U.S., including their homes. Before the PHE, telehealth coverage was restricted to beneficiaries being located in hospitals and certain provider locations in order to receive coverage for telehealth.
  • Eligible Practitioners – Medicare beneficiaries can continue to receive coverage for telehealth services from physical therapists and occupational therapists.
  • Mental Health Coverage – Medicare beneficiaries can continue to receive coverage for telehealth services from mental health providers without the requirement of an in-person visit within six months of the first telehealth service with that provider nor the requirement of an in-person visit every 12 months.
  • Audio-only Telehealth – Medicare beneficiaries can continue to receive coverage for telehealth services using audio-only technology.

This is great news for Medicare beneficiaries! However, although Medicare coverage policies tend to be a bellwether for changes in private payer and Medicaid coverage, please keep in mind that private payer and Medicaid coverage for telehealth services varies by state.

Forty-three states and the District of Columbia (DC) have laws that govern private payer reimbursement of telehealth but what specific services and providers are covered varies greatly. And, while all 50 states and DC now reimburse for some types of telehealth services in Medicaid, many of the reimbursement policies have restrictions and limitations. It is important to check with your state Medicaid program or private insurer to find out what telehealth services are covered.

You can learn more about the efforts that the US Pain Foundation takes around advocacy – including ways to get involved – here.

Abivax Reports Promising ABX464 Phase 2a One-Year Maintenance Results in Rheumatoid Arthritis

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Below is a press release dated today (3/10/22) from Abivax:

The Quick Basics

Out of the 40 patients who enrolled into the ABX464 maintenance study, 23 patients have now reached the first year of treatment and all achieved at least an ACR201, with 19 and 12 patients achieving ACR50 and ACR70 respectively.

Long-term safety profile (50mg ABX464 once daily + MTX) favorable and consistent with previous observations.

The induction and maintenance results support further clinical development of ABX464 in RA and potentially other rheumatology indications.

The clinical induction and maintenance data in ulcerative colitis and rheumatoid arthritis underpin the potential of ABX464 to address a broad range of chronic inflammatory diseases.

In G7 countries, the market for ulcerative colitis, Crohn’s disease and rheumatoid arthritis is expected to grow to approximately USD 50B in 2026.

The Full Press Release

Abivax SA (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company developing novel therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer, today reports promising results from its phase 2a maintenance trial in rheumatoid arthritis (RA) after one year of continued daily treatment with 50mg ABX464.

Continue reading “Abivax Reports Promising ABX464 Phase 2a One-Year Maintenance Results in Rheumatoid Arthritis” →

Autoimmune Community Institute to Host Inaugural Autoimmune Health Equity Summit [postponed]

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Update:

With deep sadness, the Autoimmune Community Institute announces today that we must postpone the Inaugural Autoimmune Health Equity Summit originally planned for Saturday, March 12 due to technical issues. 

While compiling our pre-recorded interviews to create the final product, we noticed that the video from some of our amazing speakers did not record. This error is not one that could have been foreseen or prevented, as this is the first time an error like this has occurred. As a result, we felt it necessary to postpone the event to rectify these issues and ensure our speakers can be seen and heard properly.

Dr. April Moreno, Founder at Autoimmune Community Institute has provided the following statement:

“Unfortunately, we experienced technical difficulties with the video service platform and will need time to correct some of the recordings for the event.”

Despite these unfortunate setbacks, registration will continue to be open for the postponed event, which will now occur on March 19, 2022, at 12pm Pacific Time (3pm Eastern Time. We continue to look forward to hosting the event and apologize again for any inconvenience or disappointment. 

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The following is a press release dated March 7 from the Autoimmune Community Institute.

The Autoimmune Community Institute is dedicated to autoimmune health equity through community-based research and support services. The all-volunteer team strives to fulfill that mission by creating spaces for diverse autoimmune voices and experiences in community-centered research design, community support, and health equity advocacy every single day.

Today, ACI is taking a momentous step to further its mission and fulfill its goals by announcing the Inaugural Autoimmune Health Equity Summit. The ACI Health Equity Summit is our signature event to highlight the importance of diversity and representation in autoimmune communities.

This free event will discuss the importance of diversity and representation in research, policy, advocacy, and community support services; as well as the difference between equality and health equity and why we must work toward equity in all policies. Participants will also be introduced to some of our excellent partners in autoimmune health serving diverse communities.

The summit is designed for autoimmune patients, clinicians, researchers, and anyone who works with or has an interest in autoimmune topics. It will be held on March 12, 2022, at 12 pm Pacific Time (3 pm Eastern Time). Registration for the event is now open here! 

Please share this event widely within your networks. The staff at ACI is extremely excited to be hosting this event, and cannot wait to see you there!

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