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SEATTLE, Nov. 17, 2010 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) reviewed the impact of labeled and unlabeled use of PROVENGE® (sipuleucel-T) treatment on health outcomes of patients with advanced prostate cancer. This panel was convened as a part of the National Coverage Analysis (NCA) that was initiated by the Centers for Medicare and Medicaid Services (CMS).
"PROVENGE is an important new treatment for patients with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer," said Mitchell H. Gold, M.D., president and chief executive officer. "We look forward to working closely with CMS throughout the NCA process to ensure patients with advanced prostate cancer have access to PROVENGE."
PROVENGE is the first in a new therapeutic class known as autologous cellular immunotherapies and is indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. On June 30, 2010, CMS initiated the NCA of PROVENGE. According to CMS, a draft guidance memo will be issued by March 30, 2011, and the expected NCA completion date is June 30, 2011.
The NCA does not impact existing coverage decisions, nor does it restrict local Medicare Administrative Contractors (MACs) from covering PROVENGE. Therefore, Medicare beneficiaries are able to access PROVENGE, and private payers are also able to cover PROVENGE throughout the NCA process. Currently, MACs covering 14 of the 15 regional territories have established coverage guidelines and/or provided customers with written or verbal guidance on coverage.
PROVENGE Safety
PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
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