Tag Archives: Drug Alert

INSIDE THIS ISSUE CMS News 2019-2020 Influenza Vaccine Season NDCs Now Available 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 each month and detail the rationale for the change. Of the 87 […]

In July there were six new drug approvals by the FDA we deemed specific to the specialty market, three of the approvals were for biosimilar products. In addition, there were 2 supplemental drug approvals. The FDA had acted on assignment of eight new product reviews. Drugs included in this review are generally regarded by the […]

In June there were four new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were 12 supplemental drug approvals. The FDA had acted on assignment of six new product reviews. Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include anticipated […]

RJH – Drug Alert FDA Drug Approval – Ibalizumab-uiyk (TrogarzoTM) On March 6, 2018, the U.S. Food and Drug Administration (FDA) approved a first in class treatment for adults with multi-drug resistant (MDR) HIV-1 infection, with a manufacturer’s initial estimated annual treatment cost of $118,000. An initial overview is listed below.  For additional Information on […]

RJH – Drug Alert FDA Drug Approval – lutetium Lu 177 dotatate ( LUTATHERA ®) Generic Name Brand Name Manufacturer Approval Date Anticipated Availability Accelerated Review lutetium Lu 177 dotatate Lutathera Advanced Accelerator Applications USA. Inc. 1/26/2018 Not available Priority Review with Orphan Drug Designation Labeled Indication: Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), […]