Author Archives: Laura Benson

In February there were two new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were two supplemental drug approvals. The FDA had acted on assignment of new PDUFA dates for three new products for review. Finally, there was one complete response letter issued. Drugs included in this review […]

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 […]

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, […]

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. […]

FDA Approval: 9/28/2018 Cutaneous squamous cell carcinoma (CSCC) is the second most deadly skin cancer following melanoma. CSCC leads to about 3,900 to 8,800 deaths per year in the United States. Prior to Cemiplimab approval, there were no FDA-approved treatments for advanced CSCC which is metastatic or where surgery is not an option. The rarity […]

New Drug Overview – galcanezumab-gnlm (Emgality™) On September 27, 2018, the U.S. Food and Drug Administration (FDA) approved galcanezumab-gnlm (Emgality™) for the preventive treatment of migraine in adults.  Galcanezumab-gnlm is the third calcitonin-gene related peptide antagonist to be approved for this indication this year after fremanezumab-vfrm and erenumab-aooe, approved on 9/14 and 5/17 respectively.  According […]