As detailed in Ed Silverman's Pharmalot blog, two US Senators are asking questions with regard to Medicare's review of Provenge. They note that it is not standard by any means to review a drug for an approved use. Off-label? Yes. Approved on-label? No.
The Senators suspect that Medicare may wish to restrict coverage - presumably due to its high cost. Such a review is NOT common for new drugs and price is NOT supposed to be part of the analysis. Stay tuned.
Posted by Bruce Lehr August 26th 2010.