With the advent of biosimilars to the marketplace, the Centers for Medicare and Medicaid Services (CMS) now requires modifiers to identify the manufacturer of a biosimilar/biological product on Part B claims. Modifiers were put in place to provide the CMS with the necessary data needed to track claims payments, as well as the ability to…
Biosimilars to Raise Unique Questions
Rheumatologists are accustomed to educating patients about medications, but biologic medications—and now biosimilars—require some additional time and discussion. “Biologics are inherently more complex [than other medications], and there are multiple issues to consider before initiating treatment,” says K. “Kwas” Huston, MD, The Center for Rheumatic Disease, Kansas City, Mo. The first FDA-approved biosimilar to become…
Pfizer Announces Medicare Reimbursement for Inflectra (infliximab-dyyb), the First Biosimilar Monoclonal Antibody Available in the United States
On Jan. 6, Pfizer Inc. announced that the Centers for Medicare and Medicaid Services (CMS) has included payment information for INFLECTRA (infliximab-dyyb), a biosimilar to REMICADE (infliximab), in its January Average Selling Price (ASP) pricing file. This pricing took effect as of January 1, 2017. Additional claims processing information is listed in the MLN Matters…
Rheumatology Drug Updates: Infliximab Biosimilar Gets FDA Approval & More
April 5, 2016, marks a revolutionary day in the treatment of autoimmune diseases: The U.S. Food and Drug Administration (FDA) approved an infliximab (Remicade) biosimilar, known as Inflectra (infliximab-dyyb). Infliximab-dyyb, which is administered by intravenous infusion, is the first biosimilar drug approved to treat rheumatic disease in the U.S.1 Infliximab-dyyb has received approval for almost…