Dendreon Prepares to Take Some Heat in the Other Washington Over Cancer Drug Prices

11/16/10Follow @xconomy

Cancer drugs cost a lot, and don’t work very well for most people. Not surprisingly, this is at least part of the reason there’s a popular backlash against drugmakers. And tomorrow, we’re going to see some unusual political theater that could say a lot about how cancer drugs get priced in the future.

Seattle-based Dendreon (NASDAQ: DNDN), a poster child for all sorts of controversy over the years, is gearing up to defend the effectiveness of its prostate cancer drug, sipuleucel-T (Provenge), in front of a panel of physicians and researchers in Washington D.C. on Wednesday. This advisory panel will make remarks to the Centers for Medicare and Medicaid Services (CMS) about how strong it thinks the evidence supporting the FDA-approved use of the drug is, and will talk about potential “off-label” uses of the treatment. And based at least in part on those comments, CMS will decide under what circumstances it will cover the treatment’s sky-high price tag.

Dendreon won FDA approval for sipuleucel-T, a first-of-a-kind immune boosting therapy, back in April—and promptly announced that it would charge $93,000 per patient for the product. Since this is for terminal forms of prostate cancer that afflict elderly men, it has been vital to the company that this product be reimbursed by Medicare, the national health insurance program for people over age 65. Medicare has basically automatically covered cancer drugs in the past when the FDA has cleared them as safe and effective. This time, it has opened up what it calls a “national coverage analysis” to discuss the strength of the evidence to support prescriptions of Provenge.

Nowhere in the 55-page briefing document prepared by Medicare staff for tomorrow’s meeting will you find the words “cost,” or “price,” or any reference to the drug’s $93,000 tab. And from what I can gather, the letter of the law doesn’t allow Medicare to refuse to pay for a drug because it costs too much. But as Pharmalot’s Ed Silverman fleshed out in this interview with a former CMS official, it’s the elephant in the room. What the agency really seems to be doing here is sending a message to other drugmakers with visions of big price tags in their heads, says David Miller, president of Biotech Stock Research in Seattle.

“It’s a shot across the bow,” Miller says. “Whoever is next in the pipeline, maybe will think twice about pricing strategy after watching this.”

Many Dendreon followers, I’m sure, have already … Next Page »

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  • http://www.xconomy.com/author/ltimmerman/ Luke Timmerman

    Readers—despite registering in advance for the CMS MEDCAC panel, I’m unable to login to the live webinar. I’m getting a weird message that says “As a registered guest, you do not have privileges to enter this room. Guests are not admitted into this meeting.” I’ve tried resetting the password, different browsers, checking my latest Adobe conference software update, and waiting too long on hold for help from CMS. It’s too much time to waste, so I’ll just look to sum up accounts from other people who are there later today.