Category Archives: Drug Update

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 […]

X-Linked Hypophosphatemia (XLH) is a rare genetic musculoskeletal disorder that is characterized by low levels of phosphate and has the potential to lead to bone abnormalities or rickets. Current conventional treatment of XLH includes daily phosphate and active vitamin D doses to serve as replacement therapy, but this does not treat or correct the underlying […]

Review of Herceptin biosimilars in the drug pipeline Herceptin® (trastuzumab) is a recombinant monoclonal antibody used for the treatment of breast cancer and gastric cancer in combination with other chemotherapy agents. In 2017, it gained $2,804 million in sales in the United States, which has made it a target for the development of biosimilars. Currently, […]

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 […]

Where will tildrakizumab be positioned in the psoriasis marketplace once approved by the FDA? Plaque psoriasis (psoriasis vulgaris) (ICD-10 L40.0), which is commonly referred to simply as psoriasis, is the most common form of the skin disease with a prevalence of 2-3% worldwide.  GlobalData estimates that the biologics total drug sales for psoriasis in 2012 […]

Review of ibalizumab-uiyk (TrogarzoTM) a novel biologic for patients with multi-drug resistant HIV-1 Multi-drug resistant HIV (MDR-HIV) carries a greater risk of disease progression and leaves HIV patients with limited treatment options. There are currently 10,000 people living with MDR-HIV in the United States, and due to this prevalence, it has become necessary to consider drug […]

RJHS – 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 […]

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® […]

RJHS – 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), […]

What value did the manufacturer place on bleed prevention with Hemlibra (emicizumab-kxwh) versus on-demand treatment with current bypassing agents? On November 16, 2017, the FDA announced the approval of Hemlibra (emicizumab-kxwh), a first-in-class monoclonal antibody for the prevention or reduction in the frequency of bleeding episodes in patients with hemophilia A who have factor VIII […]