Category Archives: Industry Insights

Generic Name Brand Name Manufacturer Approval Date Anticipated Availability Accelerated Review filgrastim-aafi Nivestym ™ Pfizer Inc. 07/20/2018 n/a n/a Labeled Indications Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever Reduce the time to neutrophil […]

Familial chylomicronemia Syndrome (FCS) is a genetic disorder characterized by impaired function of the enzyme lipoprotein lipase (LPL), leading to the inability to break down chylomicrons and the buildup of chylomicrons in the blood. Chylomicrons are lipoprotein particles primarily made up of triglycerides. This buildup results in a significant increase in triglyceride levels, severe abdominal […]

INSIDE THIS ISSUE Code Updates: Large Price Changes HCPCS Code Update for Makena Subcutaneous Auto-Injector NDC Crosswalk update for HCPCS Code(s) J7060 and J7070 (Dextrose) NDC Crosswalk update for HCPCS Code J0461 Reminder – NEW HCPCS Q-Codes effective July 1, 2018 NEW HCPCS C-Codes for Hospital OPPS Billing effective July 1, 2018 Deleted HCPCS Code […]

Hereditary transthyretin (TTR)-mediated amyloidosis (hATTR) is an inherited and debilitating disease that is characterized by mutations in the TTR gene. These gene mutations can cause accumulation of abnormal amyloid proteins in body organs and tissue, leading to damage of these areas, such as the peripheral nerves. Peripheral, autonomic, or cardiomyopathy can result from this accumulation […]

There were a total of three new FDA drug approvals in June that we deemed specific to the specialty market. In addition, there were six supplemental drug approvals. The FDA had assigned six new products for review. Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include anticipated […]

RJ Health has a new white paper available for download. Automated Controls for Medical Drug Spend by RJ Health’s Chief Innovation Officer, George Herchenroether – Appropriate reimbursement for drugs covered by the medical benefit requires more data and structure than most medical claims or billing systems were originally intended to process. This applies even more […]

New Drug Overview: Pegfilgrastim-jmdb (Fulphila™) The first FDA approved biosimilar to Pegfilgrastim (Neulasta®) Generic Name Brand Name Manufacturer Approval Date Anticipated Availability Accelerated Review Pegfilgrastim-jmdb Fulphila ™ Mylan GmbH June 4, 2018 In the coming weeks n/a Labeled Indication: Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving […]

INSIDE THIS ISSUE Code Updates: Large Price Changes Reminder – NEW HCPCS Q-Codes effective July 1, 2018  CMS NEWS: April 1, 2018 NOC Pricing File Updated Drug Reimbursement Code Price Updates  Drugs/Devices: New Clinical and Billing Information New Webinar: Shedding Light on Medically Covered Specialty Drug Pricing Methods Let’s discuss Specialty Drug Pricing Methods… WAC. […]

Control your Medical Drug Spend.  Learn about medically covered specialty drug pricing methods.  Explore the differences between AWP, WAC, ASP, APC.  Discover NDC level pricing and Code level pricing. Webinar: Shedding Light on Medically Covered Specialty Drug Pricing Methods In this new ReimbursementCodes webinar, Shedding Light on Medically Covered Specialty Drug Pricing Methods, we will […]

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. […]