Dendreon’s Provenge Launch Story Enters Second Chapter, With Today’s Earnings Call

11/3/10Follow @xconomy

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about how the drug may be used for patients beyond the strict group of people outlined in the FDA-approved prescribing information.

The drug is approved for patients who have prostate cancer that has spread, and no longer responds to standard hormone-blocking therapies. Many researchers, even though this hasn’t been proven and it’s extremely difficult to prove in a clinical trial, believe an immunotherapy approach like Dendreon’s is likely to be even more effective in patients with earlier stages of disease. That could get expensive in a hurry at $93,000 a patient, but it’s a disease that kills about 30,000 men in the U.S., and is diagnosed in many more. About 217,000 patients are diagnosed with prostate cancer every year, according to the American Cancer Society.

David Miller, the president of Biotech Stock Research in Seattle and a longtime Dendreon bull, has said it’s unlikely that Medicare will crack down too hard on reimbursement. Essentially, 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 in the name of saving some money.

While there’s much fretting on the Internet about what Medicare will do, fewer people realize that Dendreon said back in August that nine of the 15 regional Medicare units had published reimbursement guidelines, and five more had given e-mail or verbal assurance to doctors in their regions that it was coming soon. Dendreon disclosed that rate of progress in its last quarterly earnings call.

“Our sense is there is an 80 percent chance nothing will come of the whole [Medicare coverage analysis] except coverage of Provenge on label, and a higher hurdle (clinical trials instead of compendia listings) for off-label reimbursement,” Miller wrote in a note to clients Oct. 8.

Manufacturing may be an even bigger deal. Dendreon has said it plans to spend $460 million of its cash and investments this year on the Provenge rollout, including $200 million on capital spending for its new two factories in Georgia and southern California. By the middle of 2011, Dendreon hopes to have those facilities up and running, and to be operating its current facility in New Jersey at full capacity. All three of those plants, operating at full tilt, should be able to provide the U.S. market with between $1.2 billion to $2.5 billion worth of Provenge supplies, the company has said.

Any slippage in the timelines for getting those factories operational would certainly send fearful shivers down the spines of Dendreon lovers, and a shot of excitement for the Dendreon haters. It may still be too early for the company to say much with clarity about how the factory preparations are going. But it will be an absolute key over the next couple quarters if Dendreon is going to deliver on the high hopes that so many people have for it.

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  • Bill

    “That could get expensive in a hurry at $93,000 a patient per year”.

    I don’t understand why we are STILL reading that the treatment costs $93k “per year”. The treatment takes 4 weeks to complete…and that’s it! Done! Nothing “per year”. What’s so hard to understand about that??

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

    Bill–you’re right, it’s $93,000 per patient. There’s no need to take it year after year. This was a slip, and it’s been fixed.

  • Bill

    Luke…Thanx for the correction.

    Here’s a request, for someone interested in publishing an accurate comparison. I’m constantly reading about the $93k cost of Provenge. Instead of focussing on the one-time cost of $93k for Provenge, with almost no serious side affects, vs the cost of chemo alone, I wish someone would do a comprehensive cost comparison of Provenge to chemo, and include ALL the additional treatment costs the chemo patients will require simply to treat the greuling chemo-induced side effects. And let’s not forget steroidal pre-treatment, which can severely damage the already weak patient’s immune system before they can even start chemo.

    This assumes, of course, that the patient is actually willing to undergo the chemo, and endure all of it’s severe side effects with minimal benefits, rather than just refusing that additional misery, as many do, and opting to just die quietly.

    Doing the above would then paint a more accurate picture of what Medicare would actually be spending…or saving…by covering Provenge, both on and possibly off-label. I would assume that this simple logic would come into focus during the CMS review process…but who knows?

    And how do we put a value on superior quality of life, and extended overall survival?? Both have real value, which must be considered when reviewing the cost of Provenge.

  • Trond

    >>Here’s a request, for someone interested in publishing an accurate comparison.

    Bill, David Miller (referenced in the article) did exactly that about three or four months ago. I do not have the link handy but a google search should find it pretty quickly.

    Luke, another great article. Appreciate your coverage of Dendreon!

    Regards,
    Trond

  • Trond
  • Bill

    Trond…Thanx. I missed that one. It was almost perfect as to what I was looking for. And the outcome of comparative costs were as I suspected…very similar…yet no one complains about the high cost of Taxotere. Just the terrible side effects.

    The only thing I wish we had here in the US…and we might get it soon enough with O’care…is a subjective value placed on quality of life…as well as a value for extended overall survival…but how would it be calculated? This would indeed make PV much more worthwhile when compared to chemo!

    Thanx again.

    Bill