Author Archives: Laura Benson

INSIDE THIS ISSUE Code Updates: Large Price Changes Reminder – New HCPCS C-Codes Effective April 1, 2018 Reminder – New HCPCS Q-Codes Effective April 1, 2018 Reminder – HCPCS Q-Code Description Change Effective April 1, 2018 Reminder – Deleted HCPCS Q-Code Effective April 1, 2018 CMS News: Reminder – Part B Biosimilar Biological Product Payment […]

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, […]

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 […]

Setting limits: What’s good for your waist may also be good for your (brown/white bagging) waste. It’s a new year! While packing my lunch these days, I find myself setting better limits.  In an attempt to prevent waist expansion, I check off my limits: 30 grams carbohydrate from grains 20 from fruit a fat limit […]

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 […]

Did you know : that healthcare fraud estimates in the United States exceed $68 billion annually? Did you know : the Federal Government won or negotiated over $2.5 billion in health care fraud judgments and settlements worth a total of over $1.9 billion in FY 2015? Did you know : that when differentiating fraud from waste and abuse, the […]