NCA reviews are considered unusual for newly licensed products. And to make it more so, CMS apparently plans to ask questions about the drug's efficacy for on label uses! Part of its charter? See prior blog post on Senate queries into why Medicare was conducting an NCA review in the first place.
Writes ISI Group biotech analyst Marc Schoenebaum. “This is the first time we’ve seen Medicare analyze the efficacy of a drug.” There apparently is a first for everything.
Posted by Bruce Lehr September 27th 2010.