Why the Prostate-Cancer Vaccine Provenge Will Do Just Fine in the Real World

Last Updated May 3, 2010 8:51 AM EDT

Dendreon Provenge launchNow that Dendreon's (DNDN) prostate cancer vaccine Provenge (sipuleucel-T) has achieved its long-sought, hard-fought FDA approval, debates about the always-controversial drug are shifting to whether or not it will survive in the real world.

I'm guessing it will. My BNET colleague Jim Edwards brought up a few of the top issues clouding Provenge's commercial future. Here's how the drug should be able to prevail:

  • How much will the company charge for the drug? Dendreon is charging $93,000 for a full course of treatment, and yes, that is a lot of money. But Dendreon explained its pricing strategy by noting that the drug extended survival by 4.1 months on average in a recent Phase III clinical trial, so the price can be thought of as $23,000 per month of survival. That's still a lot of money -- but it's in the same ballpark as other cancer drugs like Sanofi-Aventis' chemotherapy Taxotere (docetaxel).
  • Will insurers cover it? As Edwards explains in another post, most patients will likely be covered by Medicare, and Medicare doesn't have much choice about paying up. Dendreon said it expects private insurers to cover the drug as well.
  • Will it work in a large mass of men with advanced prostate cancer? Time will tell... but I'd bet Provenge will work even better in a broader population than it did in trials. New cancer drugs -- including Provenge -- are always tested and initially approved in the sickest patients. But cancer vaccines might work even better if doctors start trying them off-label in patients with earlier stages of cancer, because their immune systems have not been as ravaged yet and might be better able to mount a response.
  • And will patients actually want it, given that it's not a cure? I don't know if the average patient would want to pay $23,000 per month out of pocket for four months of survival. But as noted above, most patients probably won't have to make that choice, as they'll be covered by insurance. Either way, would you rather have chemotherapy that wreaks havoc on your body or a vaccine with relatively mild side effects?
Which is why analysts think peak sales of Provenge will eventually reach $3 billion to $4 billion. For now, the only thing holding Dendreon back is its own manufacturing capacity.

Launch photo by Flickr user p_c_w, CC.

  • Trista Morrison

    Trista Morrison is a staff writer at BioWorld Today, a daily newspaper that