Dendreon has found at least two champions in the U.S. Senate. John Kerry and Arlen Specter, both Democrats, are questioning the Centers for Medicare & Medicaid Services review of Dendreon's new prostate cancer vaccine Provenge. In a letter to the agency, the lawmakers cited concerns that the review would end up restricting Medicare coverage of the treatment.
"Only three times in the past has CMS issued a National Coverage Analysis on a new treatment for cancer," the senators write, noting that each of those reviews focused on the need to curtail off-label use of the drugs. But the Provenge review is different--and more worrisome--because it seems to be "focused on whether or not to cover appropriate on-label use," the letter states.
Cancer-drug coverage is a highly charged topic, and Provenge in particular has sparked lots of emotional debate. When CMS announced it would review the vaccine, the agency got plenty of feedback from worried doctors and patients. As Pharmalot notes, even the American Society of Clinical Oncology opposed the review.
- read the Pharmalot report