Category Archives: Industry Insights

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 […]

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 […]

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 […]

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 […]

Medical Specialty Drug management landscape – Providing a healthy environment for [Pharma] innovation and [CMS] scale to flourish. RJ Health occupies a “crossroads” piece of real estate within the Specialty Drug landscape – or, think of us as a reimbursement compass where the needle is pointing to the proper reimbursement rate for drug therapies that […]

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 […]

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® […]

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 […]

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 […]