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Read the RheumWATCH archives on topics such as rheumatology advocacy, policy updates, insurance advocacy, and practice management.
The Food and Drug Administration (FDA) announced yesterday the approval of Inflectra (infliximab-dyyb), the first biosimilar to receive approval in the U.S. for the treatment of rheumatic diseases, including rheumatoid arthritis and psoriatic arthritis.
The safe adoption of biosimilars into the U.S. marketplace remains a top priority for the American College of Rheumatology (ACR). Biologics are a lifeline for patients living with rheumatic disease, helping many to avoid pain, long-term disability, and life-threatening complications. Unfortunately, many of our patients struggle to afford these complex therapies due to their high cost.
The ACR welcomes the introduction of biosimilars to the U.S. healthcare system and is hopeful that the decrease in cost resulting from the availability of safe and effective biosimilars in the U.S. will increase our patients’ access to life-changing therapies and improve their overall health.
While America’s rheumatologists support the development of new biosimilar therapies, the safety of our patients remains our highest priority. As such, we encourage the FDA to continue to apply distinct names for future biosimilars, and to maximize clarity in the labeling of biosimilars, specifically with respect to their interchangeable status and the origins (reference drug versus biosimilar) of clinical data upon which FDA approval is based.
The ACR supports distinct naming and transparent labeling for all biosimilar products to ensure correct prescribing and dispensing, post-marketing surveillance, prescriber confidence, and enhanced market uptake.
We will continue to provide input to the FDA as the agency works to bring breakthrough therapies to patients that are clinically appropriate and effective, without compromising patients’ health or safety.”
On April 1, CMS announced the beginning of the 45-day Open Payments Review and dispute period, which will conclude on May 15. After the period is concluded, on June 30, CMS will publish 2015 payment data along with updates to the 2013 and 2014 data.
If you are reviewing your 2015 Open Payments Data, please test your CMS Enterprise Portal (EIDM) login credentials beforehand. Locked accounts and other login issues can be troubleshot by visiting Frequently Asked Questions for EIDM Users.
You can also access CMS Guidance for step-by-step instructions about registering, reviewing, and disputing your data. For answers to additional questions, please email Medicare’s Open Payment Help Desk at firstname.lastname@example.org or call 855-326-8366.
It is important that all rheumatologists access their Quality and Resource Use Reports (QRURs) so that they can gauge how CMS is assessing the quality and cost of the services provided, and any possible upcoming payment bonuses or penalties. CMS now has made available 2015 mid-year QRURs to groups and solo practitioners. The information provided in the QRUR is based on care provided from July 1, 2014 through June 30, 2015.
The mid-year QRUR provides interim information about performance on the cost and quality outcomes measures that CMS calculates from Medicare claims, which are some of the measures that will be used to calculate the 2017 Value Modifier. Access your QRUR in the CMS Enterprise Portal.
Please visit the CMS website for more information on the QRUR and the 2017 Value Modifier. If you have any questions or need assistance, please contact ACR staff at email@example.com.
Last week the FDA issued new draft guidance recommending that biosimilar labeling clearly differentiates biosimilars from their reference (“originator”) drugs. The ACR commends the FDA for this recommendation. We also applaud the recommendation to specifically identify the branded biologic upon which the biosimilar is based. The draft guidance is the latest in a series of steps by the FDA to make biosimilar labeling and naming as transparent and specific as possible. This will help ensure correct prescribing and dispensing, post-marketing surveillance, prescriber confidence, and enhanced market uptake.
The rheumatology community – both patient groups and providers – has long been active in calling for distinct naming of biosimilar products. Biosimilar naming is a topic of great importance to the rheumatology community, since many of our patients rely on the administration of safe and effective biologic therapies to manage their chronic conditions. Physicians must be able to confidently prescribe these therapies to patients and know that proper mechanisms are in place to allow rheumatologists to monitor patients’ responses and reactions to biosimilars.
As such, the ACR supports additional measures that would provide physicians with vital information to assess the safety and efficacy of the biosimilar product. We believe that the clinical trial data for the biosimilar should be included in the labeling, and that the label should specify whether the supporting clinical data for each indication are derived from studies of the biosimilar or the reference biologic.
The ACR will continue to review the FDA’s draft guidance and submit detailed comments in the coming weeks. We look forward to continued dialogue with the FDA as the agency works to bring safe and effective biosimilars to market. If you have questions or comments about these developments, or if you’d like to get involved in advocacy or practice discussions, I hope you will reach out to ACR staff at firstname.lastname@example.org.
Joan M. Von Feldt, MD, MSEd
President, American College of Rheumatology