Boost for Dendreon, as CMS to cover Provenge treatment and FDA OKs production facility

There was a batch of good news for Seattle, USA-based Dendreon (Nasdaq: DNDN) that support broad availability for on-label use of its novel, but expensive ($93,000 therapy cost), prostate cancer treatment Provenge (sipuleucel-T). Also, the Food and Drug Administration approved the company’s second manufacturing facility for the product.

The Centers for Medicare and Medicaid Services (CMS) issued a final National Coverage Decision (NCD) for PROVENGE on June 30, Medicare contractors to cover the use of Provenge for treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. The NCD will standardize coverage processes across the country for all Medicare patients with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer and provides the local Medicare Administrative Contractors (MACs) specific criteria, consistent with the label, on how Provenge should be covered.

Provenge was issued a product specific Q-code effective July 1, 2011, which allows for electronic submission of claims and is expected to accelerate time to payment for physicians, the company noted.