reviewed the Medicare agency’s 55-page briefing document in advance of tomorrow’s hearing. I personally didn’t think it added much to what those of us who follow Dendreon has already written ad nauseam, but you can check out Forbes’ Matthew Herper’s initial take on the document if you’re curious.
The Cliff’s Notes version is essentially this: The Dendreon drug was approved on the strength of a clinical trial of 512 men, called Impact, that showed that patients lived a median time of 25.8 months if they got the drug compared to 21.7 months if they got a placebo. This finding represents a 4.1 month advantage in median survival on the drug. Side effects were mostly fever and chills that lasted one or two days after injections. The approval followed an aggressive attempt on the part of Dendreon a couple years earlier to win approval based on a thinner clinical trial database of 127 men, which essentially showed the same thing as the bigger trial eventually did.
The watershed Impact trial was conducted in men whose prostate cancer had spread through the body and had stopped responding to standard hormone-deprivation therapies. The FDA approved label for the Dendreon drug states clearly that this is the type of patient for whom the drug is approved, but physicians are free to prescribe any drug they want for any condition, whether it’s in the drug label or not. And because Dendreon’s treatment is an immune-boosting therapy, most scientists suspect it will work better against earlier forms of prostate cancer.
Prostate cancer kills 30,000 men in the U.S. each year, but it is diagnosed in more than 200,000 men a year. Dendreon already projects that its drug will generate U.S. sales of $1.2 to $2.5 billion a year for the approved use, and if it starts being prescribed “off-label” at early stages of disease, at $93,000 a patient, then you’re talking about really serious money, even to Uncle Sam. Still, there is more than one side to this story. As I noted a couple weeks back, while it’s politically difficult for an agency to shell out billions of tax dollars for a single drug made by one company, it’s even more politically controversial to deny dying constituents access to a potentially life-saving therapy to save some money. So it’s likely the agency will want to strike a balance, Miller says.
“I think they see the demand, they see the patient excitement,” Miller says. “I think they hope this will limit off-label use. That’s primary.”
Dendreon already tossed out a few trial balloon arguments
