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Mogamulizumab is a humanized monoclonal antibody being developed by Kyowa Hakko Kirin Co., Ltd. for the treatment of cutaneous and peripheral T-cell lymphomas, T-cell leukemia, and T-cell lymphomas. Mogamulizumab has shown promising efficacy in treating Cutaneous T-Cell Lymphoma (CTCL) in a phase III trial. The FDA granted mogamulizumab a Breakthrough Therapy Designation on August 25, […]

New Drug Overview: Epoetin alfa-epbx (Retacrit®) Generic Name Brand Name Manufacturer Approval Date Anticipated Availability Accelerated Review Epoetin alfa-epbx Retacrit® Hospira Inc., a Pfizer company May 15, 2018 Not available n/a Labeled Indications: For the treatment of anemia caused by Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis For the treatment […]

INSIDE THIS ISSUE Code Updates:         • NDC Crosswalk update for HCPCS Code(s) J7050, J7040, and J7030         • NEW HCPCS Q-Codes effective July 1, 2018  Drug Reimbursement Code Price Updates  Drugs/Devices:         • New Clinical and Billing Information     CODE UPDATES Large Price Changes: We identify and report on the codes with the most substantial pricing increases or decreases […]

Migraine is a debilitating disorder that affects millions of people in the United States. Migraine has the ability to affect individuals in a way that deprives them of their normal, daily activities, and often results in pain, physical impairment, lost productivity, and increased financial cost. Erenumab (Aimovig™, AMG-334) is a fully human monoclonal antibody being […]

In April there were a total of five new drug approvals by the FDA we deemed specific to the specialty market. One of these approvals was a first-time generic approval for Zavesca®. In addition, there were six supplemental drug approvals. The FDA had assigned seven new products for review. Finally, there were six potential specialty […]

Day 2 AMCP 2018 presentations provided continuing opportunities for learning, networking and the sharing of ideas. Today’s headline session presented by Douglas Long, BS, MBA focused on pharmacy marketplace trends.  Of note was that Hepatitis is no longer a key topic, demonstrating a trend towards successful treatment of this patient population.  While the data presented […]

In March there were a total of seven drug approvals by the FDA we deemed specific to the specialty market.  In addition to these approvals, the FDA had assigned five new PDUFA dates. Finally, there were fifteen potential specialty products with PDUFA dates in April, although two of those products received a complete response letter […]

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 […]