in support of Medicare coverage of its drug earlier this month on its quarterly conference call, showing it isn’t exactly striking a conciliatory tone. The company raised more than $1 billion to get where it is, and has never turned an annual profit since its founding in 1992. It plans to burn through $460 million in cash this year for a massive manufacturing and marketing push. Chief Operating Officer Hans Bishop noted on the call with investors that Provenge showed a median survival advantage of more than four months when compared to placebo, and “over the last 15 years, only three therapies in metastatic cancer have been able to show a survival benefit of four months or more.”
The process of Wednesday’s meeting will be a bit unusual for biotech executives and investors who are a lot more familiar with the public hearings run by the FDA. The advisors to Medicare will not be asked to make an up-or-down recommendation on whether to reimburse for the Dendreon drug. They will record their confidence, on a scale of 1-to-5 on various questions about the clinical trial evidence. The Medicare agency will issue a draft report in March, take more public comments, and make a final decision in June, Miller says.
The most likely outcome is that Medicare says it will reimburse for the Dendreon drug as long as it is used in accordance with the FDA approved label, Miller says. That’s just fine for Dendreon, because it has limited manufacturing capacity at the moment, and can’t fulfill all the demand from patients that it wants to anyway. Regional Medicare agencies, except for one out of 15 around the country, have already started reimbursing or have stated they plan to reimburse for the treatment. The national coverage analysis could offer new rules for the regional units to follow.
I have registered for the webinar, so I will plan to report on this tomorrow as it’s happening. I’m sure many of our regular readers will be listening too. If you aren’t already, I encourage you to follow me on Twitter, or send me notes at [email protected] on how you think things are going, or what you think might be good questions to ask.
