Category Archives: Industry News

INSIDE THIS ISSUE Code Updates: Large Price Changes New Q-Codes Effective October 1, 2018 New C-Codes for Hospital OPPS use Effective October 1, 2018 CMS News: Medicare Influenza Vaccine Pricing 2018-2019 Season NEW Influenza CPT® Code 90689 Effective January 1, 2019 Medicare Coverage Indicator Change for Q9994 Drug Reimbursement Code Price Updates Drugs/Devices: New Clinical […]

FDA Approval: 8/8/2018 Mogamulizumab-kpkc is a humanized monoclonal antibody developed by Kyowa Hakko Kirin Co., Ltd. for the treatment of cutaneous 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, […]

FDA Approval: 8/10/2018 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 […]

New Drug Overview – iobenguane I 131 (Azedra®) On July 30, 2018, the U.S. Food and Drug Administration (FDA) approved iobenguane I 131 (Azedra®) for treatment of adults and adolescents age 12 and older with unresectable pheochromocytoma or paraganglioma that has metastasized or is locally advanced and requires systemic anticancer therapy.  Patients must test positive […]

INSIDE THIS ISSUE Code Updates: Large Price Changes COMING SOON – New Q-Code Effective October 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 each month and detail the rationale for […]

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 […]

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. […]

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. […]

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 […]