on what the drug’s FDA-approved prescribing information looks like, he says.
If the prescribing label for Provenge says that it is cleared for all patients whose prostate cancer has spread after they stopped responding to hormone deprivation therapy, then Dendreon likely won’t face much resistance from insurers, Miller says. Things get more complicated if the FDA-approved label contains fine print that says the drug approval is limited to patients within that group who are considered “asymptomatic,” meaning they haven’t started to feel the pain that sets in when the cancer migrates into their bones. If that more restrictive language is in the prescribing label, then insurers might hassle with doctors to demonstrate that the drug is in fact always being prescribed for exactly the patients covered by the FDA label—no more.
“That’s where the insurers could be aggressive,” Miller says.
For men with prostate cancer who have heard about the Dendreon drug, and for one reason or another don’t meet the criteria in the prescribing label and therefore won’t have full insurance coverage, the price will be daunting. For everyone else, it’s the sort of thing we all absorb in our health insurance premiums, and don’t really see in tangible way.
“It’s an expensive drug. It will be expensive for CMS [the Center for Medicare and Medicaid Services], the VA [Veterans Administration], and for large insurers,” Miller says. “But it’s not going to be unusually expensive for a cancer drug.”
One cancer physician I talked with, Peter Eisenberg of California Cancer Care in Marin County, CA, a former board member of the American Society of Clinical Oncology and a critic of high drug prices, told me he’s not that familiar with the recent clinical trial data Dendreon has generated or how that might justify the price. But he sounded like he would need a lot of convincing before he would start writing prescriptions.
“Most of the folks we see in Marin County have insurance, so their out of pocket cost is zero. So sure, those folks will go for it,” Eisenberg says. “But I’m not sure I’d spend that much money for an average of four extra months of life. I’d rather give the money to my family.”
