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RJ identified a total of seven new FDA drug approvals specific to the specialty market in August 2018, and six supplemental drug approvals. The FDA had assigned four new products for review. Review the August 2018 RJ Health monthly specialty FDA actions newsletter below for more information. Drugs included in this review are generally regarded […]

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. Currently, the mainstay […]

FDA Approval: 8/23/2018 Hereditary angioedema (HAE) is a disease characterized by recurrent and debilitating attacks of angioedema, or severe swelling of the limbs, airway, face, or intestinal tract. HAE affects about one in 10,000 to 50,000 individuals worldwide and can have a significant impact on quality of life. There are currently six FDA-approved therapies available […]

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 […]

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

Control your Medical Drug Spend.  Learn about medical benefit drug pricing trends. Webinar: Addressing Escalating Medical Benefit Drug Pricing In this new webinar, Addressing Escalating Medical Benefit Drug Pricing, we will break down topics like: How to identify price trends for medically billed drugs and the reasons behind those trends. How to identify the top drug […]

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 […]

Hairy cell leukemia (HCL) is a rare, slow-growing cancer of the blood in which the bone marrow produces too many abnormal B cells or lymphocytes. This compromises the bone marrow’s ability to produce healthy blood cells and platelets. Patients with HCL may experience enlargement of the spleen, increased susceptibility to life-threatening conditions such as infections […]