Is CMS decision to conduct Provenge NCA based on cost?

On August 18th during a meeting with “The Pink Sheet Daily” Biotechnology Industry Organization CEO Jim Greenwood said, CMS decision to conduct Provenge NCA could be “Chilling to future innovation.”

A course of Provenge therapy costs $93,000, but CMS is not supposed to take cost into consideration in deciding whether to cover a product, only if it is considered a “reasonable and necessary” treatment.

According to Greenwood, “To initiate an NCA soon after approval for what looks like cost-only reasons is, we think, a very chilling thing for the CMS to do, very chilling to future innovation. This product works, and the value is very difficult to put a price on. When you think about the savings-if patients can avoid long and not only painful and debilitating but expensive chemotherapy processes, then those benefits need to be taken into consideration, not just the sticker price.”

Similar sentiments are expressed in comments on the NCA that BIO submitted to CMS July 30. The comments say the NCA “could establish a precedent that affects Medicare patient access to a wide range of innovative drug and biological therapies on a national basis.”

Once CMS completes the NCA process in mid-2011, the agency could make a national coverage determination, which would set a national Medicare coverage policy for the product.

BIO’s comments add, “By questioning whether this therapy should be covered for its labeled indication, CMS risks contravening the statute and challenging congressional intent to protect access to approved drugs and biologicals used to treat cancer. There should be no question that an approved therapy should be covered for the patients and conditions indicated on its label.”

The comments note that the statute’s definition of drugs and biologicals covered by Medicare includes any drugs or biologicals used in an anticancer chemotherapeutic regimen for a medically accepted indication.
 

Dendreon submitted its own comments to CMS suggesting the NCA is unnecessary given the amount of information the company has already provided the agency.
 

Despite the NCA, most regional Medicare contractors, which make their own coverage decisions in the absence of a national coverage determination, are covering Provenge.