The US Food and Drug Administration approved sipuleucel-T, marketed as Provenge, last April for the treatment of a form of prostate cancer, and, with a $31,000 price tag per treatment, the Centers for Medicare and Medicaid Services decided to conduct its own review of the drug, write James Chambers and Peter Neumann from Tufts Medical Center in an online first New England Journal of Medicine perspective. Much of the new review was a duplication of effort, they write, though the agencies have different goals; FDA looks at the safety and effectiveness of a drug while CMS evaluates whether it is a reasonable and necessary treatment. The decision to re-review the drug was unusual, Chambers and Neumann say, and it seems to be due to the impact the drug will have on the budget. "In all likelihood, sipuleucel-T is a harbinger of many more cases of expensive emerging technologies, particularly therapies for cancer. With the CMS unable to absorb the costs of all high-priced technologies, future coverage decisions promise to be complex and perhaps contentious affairs," Chambers and Neumann say.
This Week in NEJM: Apr 7, 2011
Apr 07, 2011