Category Archives: Educational Resources

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 […]

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 […]

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 for individuals with […]

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. […]

Review of Herceptin biosimilars in the drug pipeline Herceptin® (trastuzumab) is a recombinant monoclonal antibody used for the treatment of breast cancer and gastric cancer in combination with other chemotherapy agents. In 2017, it gained $2,804 million in sales in the United States, which has made it a target for the development of biosimilars. Currently, […]

Where will tildrakizumab be positioned in the psoriasis marketplace once approved by the FDA? Plaque psoriasis (psoriasis vulgaris) (ICD-10 L40.0), which is commonly referred to simply as psoriasis, is the most common form of the skin disease with a prevalence of 2-3% worldwide.  GlobalData estimates that the biologics total drug sales for psoriasis in 2012 […]

Review of ibalizumab-uiyk (TrogarzoTM) a novel biologic for patients with multi-drug resistant HIV-1 Multi-drug resistant HIV (MDR-HIV) carries a greater risk of disease progression and leaves HIV patients with limited treatment options. There are currently 10,000 people living with MDR-HIV in the United States, and due to this prevalence, it has become necessary to consider drug […]