Author Archives: Todd Cooperman

In March there were a total of seven drug approvals by the FDA we deemed specific to the specialty market.  In addition to these approvals, the FDA had assigned five new PDUFA dates. Finally, there were fifteen potential specialty products with PDUFA dates in April, although two of those products received a complete response letter […]

Enacted in 1992, the Prescription Drug User Fee Act (PDUFA) was created to authorize the Food and Drug Administration (FDA) to collect fees from companies that produce certain human drug and biological products. These fees serve as a secondary source of funding for the FDA and serve to expedite the review process. The FDA establishes […]

2017 was a busy year for the Food and Drug Administration (FDA) with a 100 percent score in meeting the assigned (Prescription Drug User Fee Act) PDUFA dates for 46 products. Of these products 33% were first in class, 39% had an orphan designation, 85% were approved on the first review, and 78% were approved […]

INSIDE THIS ISSUE Code Updates:         • Large Price Changes         • New HCPCS C-Codes Effective April 1, 2018         • New HCPCS Q-Codes Effective April 1, 2018         • HCPCS Q-Code Description Change Effective April 1, 2018         • Deleted HCPCS Q-Code Effective April 1, 2018 CMS News:         • Part B Biosimilar Biological Product Payment Effective April 1, 2018         • Implementation of the Transitional Drug Add-On […]

INSIDE THIS ISSUE Webinar:         •  Solving for Incorrectly Mapped NDC to HCPCS/CPT® Codes And Improperly Reported NDC Units Blog Updates:         •  Hemlibra Introductory Pricing Drugs/Devices:         •  New/Updated Billing and Clinical Information Code Updates:         •  Large Price Changes         •  HCPCS/CPT Codes With Price Changes         •  Reminder – New HCPCS Drug Codes for 2018   WEBINAR Solving for Incorrectly Mapped NDC to HCPCS/CPT® […]

INSIDE THIS ISSUE WEBINAR – February 1st, 2:00PM EST:         • Solving for Incorrectly Mapped NDC to HCPCS/CPT® Codes And Improperly Reported NDC Units Blog Updates:         • Rituxan (Rituximab) Biosimilars – 2018 Drug Pipeline Review         • Trends in FDA approval of Specialty Drugs 1990 through 2017 HCPCS Drug Code Updates:         • Large Price Changes         • Reminder – NEW HCPCS […]

Rituxan (Rituximab) is utilized as one of the treatment options for rheumatoid arthritis (RA), Non-Hodgkins Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), and Wegner’s Granulomatosis (WG). In 2016 Rituxan had over $4 billion in sales in the United States, making it a lucrative area for the development of biosimilars.  As of the publication of this article, […]

Intro: There are several publications on the Food and Drug Administration’s (FDA) activities over time, but specific information on specialty drug approvals and trends since 1990 are difficult to find. Our overall purpose for this blog is to review the history of approvals and trends since 1990 for specialty medically covered drug.  Initially, we will […]

Myasthenia Gravis is a neuromuscular disorder that impacts over 50 thousand patients in the United States (U.S.). Of those patients that are diagnosed, approximately 95 percent are treated with immunosuppressants, intravenous immunoglobulin, and/or plasma exchange. The total number of treated patients is expected to grow at an annual rate of 1.7 percent.  Of those patients […]

Are you weighing the decision to enforce an NDC mandate on ALL Medical Pharmacy Claims? RJ Health’s Analytics team shares the pro’s & con’s of NDC mandates across Pricing, Formulary, and Network Quality Considerations. Here are some practical examples to help illustrate how, at the end-of-the-day, RJ Health believes the answer to the NDC vs. […]