Category Archives: Drug Update

In January there was one new drug approval by the FDA we deemed specific to the specialty market. In addition, there were three supplemental drug approvals. The FDA had acted on assignment of new PDUFA dates for three new products for review. Finally, there were two complete response letters issued and one manufacturer triggered withdrawal […]

INSIDE THIS ISSUE Code Updates: Large Price Changes New HCPCS® Codes and Changed Code Descriptions are Now Effective Code Strength Description Changes for New HCPCS® Codes CMS News: CMS Final Ruling on Medicare Physician Schedule Now Effective Quarterly ASP (Average Sales Price) Pricing File Released Hospital OPPS (Outpatient Prospective Payment System) Update Drug Reimbursement Code […]

INSIDE THIS ISSUE Code Updates: Large Price Changes New HCPCS® Codes and Changed Code Descriptions Effective January 1, 2019 CMS News: CMS Final Ruling on Medicare Physician Schedule Effective January 1, 2019 Drug Reimbursement Code Price Updates: 47 Drug Codes required a recalculation of their AWP Code Price Drugs/Devices: New Clinical and Billing Information CODE UPDATES Large […]

New Drug Overview – emapalumab-lzsg (Gamifant®) On November 20, 2018, the U.S. Food and Drug Administration (FDA) approved emapalumab-lzsg (Gamifant®) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Primary HLH is an ultra-rare disease, […]

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

FDA Approval: 11/2/18 Febrile neutropenia is a complication that can occur in cancer patients receiving chemotherapy. Normally, neutrophils (a type of white blood cell) protect against infections; however, chemotherapy treatments may cause a reduction in neutrophils to abnormal levels in cancer patients, known as neutropenia. When significant neutropenia occurs in the presence of a fever, […]

INSIDE THIS ISSUE Code Updates: Update -J-Code 1599 Addition of 12 active NDCs Update- Removal of minimum and maximum dosing for J1325 and J3285 Update- Revision of maximum dose for J2278  CMS News: Medicare Influenza Vaccine Pricing 2018-2019 Season NEW Influenza CPT® Code 90689 Effective January 1, 2019 NEW HCPCS® Codes and Changed Code Descriptions […]

New Drug Overview – levoleucovorin (Khapzory™) On October 19, 2018, the U.S. Food and Drug Administration (FDA) approved levoleucovorin (Khapzory™) for three indications. Rescue after high-dose methotrexate therapy in patients with osteosarcoma. Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination. The treatment of patients with metastatic colorectal cancer in […]

FDA Approval: 10/5/2018 Familial amyloid polyneuropathy (FAP, also called transthyretin amyloidosis) is a hereditary neurodegenerative disease that is characterized by the accumulation and deposition of the transthyretin protein (TTR) in the tissues and peripheral nervous system, and often causes pain, muscle weakness, and autonomic dysfunction. Eventually, the disease progresses into a sensory and motor polyneuropathy. […]

New Drug Overview – elapegademase-lvlr (Revcovi™) On October 5, 2018, the U.S. Food and Drug Administration (FDA) approved elapegademase-lvlr (Revcovi™) for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.  (ADA-SCID) is a rare genetic disorder that primarily affects infants and young children and is fatal if left untreated. […]