Author Archives: Todd Cooperman

May 2018 Specialty Drug FDA Actions In May there were a total of five new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were eight supplemental drug approvals. The FDA had assigned eight new products for review and assigned five potential specialty products with June 2018 PDUFA dates. […]

INSIDE THIS ISSUE Code Updates:         • NDC Crosswalk update for HCPCS Code(s) J7050, J7040, and J7030         • NEW HCPCS Q-Codes effective July 1, 2018  Drug Reimbursement Code Price Updates  Drugs/Devices:         • New Clinical and Billing Information     CODE UPDATES Large Price Changes: We identify and report on the codes with the most substantial pricing increases or decreases […]

In April there were a total of five new drug approvals by the FDA we deemed specific to the specialty market. One of these approvals was a first-time generic approval for Zavesca®. In addition, there were six supplemental drug approvals. The FDA had assigned seven new products for review. Finally, there were six potential specialty […]

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, […]