Although it may not be available until 2017, the FDA approved the use of etanercept-szzs for multiple autoimmune diseases…
What Do Patients Know about Biosimilar Drugs?
(Reuters Health)—Many patients haven’t heard of biosimilars, generic versions of complex biotech drugs, and even some who say they’re familiar with these medicines may still be confused about them, a small European survey suggests.1 To see what patients know about biosimilars, researchers analyzed data from online surveys completed by 1,181 patients with irritable bowel disease…
Novartis Bid to Sell New Biosimilar Crimped by U.S. Court Battles
ZURICH (Reuters)—Novartis has won U.S. approval for a copy of Amgen’s blockbuster arthritis drug Enbrel, but the Swiss drugmaker’s bid to muscle in on the medicine’s $4.7 billion in annual U.S. revenue remains blocked by court battles. Novartis’s Sandoz unit said on Tuesday the U.S. Food and Drug Administration (FDA) approved Erelzi, its biosimilar copy…
Prepare Now—Not Later—to Meet New Medicare Reimbursement Requirements
Providers are urged to prepare quickly to meet the new Medicare reimbursement requirements mandated by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). “The first measurement year starts Jan. 1, 2017, so providers need to prepare quickly,” emphasizes William F. Harvey, MD, MSc, Government Affairs Committee chair, American College of Rheumatology (ACR). 2…
How to Maintain HIPAA Compliance
In 2010, the federal government published a guide, titled Basic Security for the Small Healthcare Practice, complete with best practices and checklists to help small providers achieve and maintain HIPAA compliance.1 This year, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR)—following a critical report of its HIPAA compliance audit and enforcement…
Rheumatology Advocates to Visit Capitol Hill
On Sept. 12–13, a group of more than 100 rheumatologists, rheumatology health professionals and patients will converge on Capitol Hill to take part in advocacy efforts and provide education on issues affecting the rheumatology community. During the 2016 Advocates for Arthritis event, the group will visit more than 100 Congressional offices, says ACR Government Affairs…
RISE Offers Hope & Enhances Patient Care
For more than a decade, Kaleb Michaud, PhD, has volunteered for the American College of Rheumatology (ACR). As an associate professor at the University of Nebraska Medical Center, he spent much of that time serving on a task force dedicated to the development of RISE (the Rheumatology Informatics System for Effectiveness). As an enhanced version…
U.S. FDA Approves Biosimilar to Etanercept
(Reuters)—The U.S. Food and Drug Administration on Tuesday approved Novartis AG’s biosimilar version of Amgen Inc.’s arthritis drug etanercept (Enbrel). The FDA approved the drug, Erelzi, known also as etanercept-szzs, for multiple inflammatory conditions, including rheumatoid arthritis and plaque psoriasis, a skin condition. The agency approved the drug as a biosimilar, meaning there is no…
European Group Offers Guidance on Managing Juvenile Dermatomyositis
NEW YORK (Reuters Health)—A European working group has formulated consensus-based recommendations for the diagnosis and treatment of juvenile dermatomyositis (JDM) with the goal of producing a “standard of care” for patients with JDM throughout Europe. The group is part of a European initiative called SHARE [Single Hub and Access point for pediatric Rheumatology in Europe]…
Adalimumab Lowers Risk of Uveitic Flare
NEW YORK (Reuters Health)—Adalimumab reduces the risk of uveitic flare after corticosteroid withdrawal in patients with inactive, noninfectious uveitis, according to results from VISUAL II. “Tumor-necrosis factor (TNF) inhibition, which has been demonstrated to have strong efficacy in rheumatologic disorders, can also have significant role in the management of noninfectious uveitis, even amidst the challenges…
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