“We are very pleased that Axumin has been added to the NCCN Guidelines, as we believe it further validates its clinical usefulness in patients with recurrent prostate cancer,” said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. “Inclusion in these decision-making standards can help facilitate patient access to Axumin, and, in conjunction with our continuing efforts to increase U.S. commercial supply, is part of Blue Earth’s commitment to make Axumin widely available for patients and their physicians.”“The NCCN Guidelines are widely used by clinicians and healthcare providers as a benchmark to assess clinical utility, and this update recognizes the important diagnostic ability of PET imaging to detect and localize the sites of recurrence in men with biochemically recurrent prostate cancer,” said Gerald L. Andriole, MD, the Robert K. Royce Distinguished Professor and Chief of Urologic Surgery at Washington University School of Medicine in St. Louis. “Many treatment options exist for these men and when PSA levels rise after primary treatment, knowing where the disease has recurred is essential to making appropriate patient management decisions. PET imaging can provide reliable information for these patients."
“Referring physicians need actionable information to guide patient management decisions,” said Lale Kostakoglu, MD, MPH, Professor of Radiology and Chief of Nuclear Medicine and Molecular Imaging, Icahn School of Medicine at Mount Sinai, New York, NY. “A PET imaging agent such as Axumin that can reliably detect and localize recurrent prostate cancer is important, due to the limited ability of other currently used imaging procedures to identify the extent and localization of recurrent disease in these patients.”
Axumin received Transitional Pass-Through Status in the Hospital Outpatient Prospective Payment System 2017 Final Rule from the Centers for Medicare & Medicaid Services (CMS), effective since January 1, 2017. This also provides a product-specific A-code (A9588) for use with Medicare and private insurer patient claims. Axumin is currently available from 18 radiopharmacies throughout the United States, with additional manufacturing sites planned for 2018.
Prostate cancer is the second leading cause of cancer death in men in the United States. While most primary prostate cancer can be successfully treated, recurrence occurs in up to one-third of patients. Recurrent disease is typically detected by a rise in PSA levels, but often the location and extent of the disease cannot be detected by conventional imaging. Of those patients who experience biochemical recurrence, approximately one-third go on to develop metastatic prostate cancer.
The National Comprehensive Cancer Network® (NCCN®) is a not-for-profit alliance of 27 of the world’s leading cancer centers, working together to development treatment guidelines for most cancers, and dedicated to research that improves the quality, effectiveness and efficiency of cancer care. NCCN offers a number of programs to give clinicians access to tools and knowledge that can help guide decision-making in the management of cancer.
Read More:
The FALCON Trial: Impact of 18F-fluciclovine PET/CT on Clinical Management Choices for Men with Biochemically Recurrent Prostate Cancer
EVERYDAY UROLOGY: Axumin™ [Fluciclovine F18]: An Accurate Imaging Approach for Patients with Biochemically Recurrent Prostate Cancer-Full text article
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