FDA approved the expanded use of Lymphoseek (technetium Tc 99m tilmanocept) injection for lymphatic mapping in solid tumors, and adding sentinel lymph node detection for breast cancer and melanoma to the approved indications.
The FDA also allowed expanded utilization of Lymphoseek with or without scintigraphic imaging, known as lymphoscintigraphy, to enable pre-operative imaging and mapping of lymph nodes to facilitate node localization during surgical procedures. Lymphoseek is developed by Navidea Biopharmaceuticals Inc.
Lymphoseek is the first and only FDA-approved radiopharmaceutical agent for sentinel lymph node detection, is the only FDA-approved agent for lymphatic mapping of solid tumors, and will be immediately available using existing reimbursement codes for this expanded population of cancer patients.
The expanded approval is supported by data from Navidea’s combined analysis of Lymphoseek’s prospective phase III data in melanoma, breast cancer, and certain head and neck cancers from more than 500 subjects. Findings indicated that Lymphoseek accurately identified lymph nodes for assessment in the trial subjects, and is likely to be predictive of overall node pathology status.
THE CENTERS FOR MEDICARE AND MEDICAID SERVICES published a draft local coverage determination for the Decipher Prostate Cancer Classifier developed by GenomeDx Biosciences. The determination describes coverage and payment policy for use of the Decipher test in men who have undergone radical prostatectomy.
Under Medicare policies, a 45-day comment period will commence on Nov. 10. After comments are received and revisions, if any, are made to the draft LCD, the final LCD will be posted within 45 calendar days.
Palmetto GBA, a national contractor that administers Medicare benefits, has issued the draft LCD through the MolDX Program for Decipher. MolDX, developed in 2011, facilitates the clinical review, coverage and payment policies for molecular diagnostic tests. The MolDX Program is a contractor to Noridian, a national contractor that administers Medicare benefits for Jurisdiction E, where GenomeDx is located.
Decipher is a unique genomic test intended for men who have had prostate surgery and are considered by guidelines to be at high-risk for their cancer returning. These are men who have specific risk factors for cancer recurrence, including positive surgical margins, stage T3 disease (seminal vesicle invasion, extraprostatic extension, bladder neck invasion) or rising PSA after initial PSA nadir.
