From: Rightmire, Judy (jrightmire@Dendreon.com
Sent: Thu 7/08/10 3:22 PM
To: JOE T4
We understand and appreciate your questions regarding PROVENGE and the reimbursement process we are currently undergoing. We appreciate that many people have questions about this process and hope to share as much information as we can to keep people better informed.
As you may know, PROVENGE is currently covered by some of the local Medicare Administrative Contractors (MACs) and private payers. Upon FDA approval, PROVENGE was given a generic J code, and we expect to receive a specific code when new J codes are scheduled to be administered in early 2012 (which is the case for any drug approved after March 31, 2010).
Last week, the Centers for Medicare and Medicaid Services (CMS) initiated a National Coverage Analysis (NCA). A NCA is generally a review of evidence to determine if the use of a product is reasonable and necessary. In CMS announcement of the NCA, CMS stated it is requesting public comments on the effects of PROVENGE on health outcomes in patients with prostate cancer. It is not a change in Medicare coverage policy.
What that means for physicians is that NCAs do not impact existing coverage decisions, nor do they restrict local Medicare contractors from covering PROVENGE. Therefore, Medicare beneficiaries are still able to access PROVENGE and private payers can also still cover PROVENGE.
We will work closely with CMS through this process. We appreciate your support.