The FDA's approval of Dendreon (DNDN)'s Provenge vaccine for prostate cancer (pictured) sweeps away past doubts about the company -- over the quality of its data and whether there was a conspiracy to manipulate its stock -- but brings the company four new tests:
- How much will the company charge for the drug? Dendreon may want $62,000 for a full flight of treatments, analysts predicted. The low end of estimates was $40,000, the high was $75,000. But Dendreon will charge $93,000, according to Xconomy -- an eye-popping sum.
- Will insurers cover it? Even if it were $40,000, that's a lot of money, which means the drug's performance out in the real world will be monitored closely. Some studies show it's barely more effective than existing products like Taxotere.
- Will it work in a large mass of men with advanced prostate cancer? In some ways, scrutiny of this drug has only just begun. Right up until approval, Dendreon was touting studies that only had 237 patients in them. The real data on how effective this drug is will come from its real world use.
- And will patients actually want it, given that it's not a cure? Healthcare coverage will be all about reducing costs in the coming years. If reimbursers don't want to pay for it, will patients buy it with their own money, when it may only extend life by four months?
Image by Flickr user euthman, CC.