Dendreon's Medicare Coverage Conundrum

Do you think Provenge's high cost of $93,000 per treatment course has anything to do with all this?

Under CMS' own rules, the cost of therapy is not supposed to factor into coverage decisions. Do I think that rule is adhered to in all situations by CMS, especially with the red-hot focus lately on the high cost of cancer drugs and health care reform?

No, I don't.

Did the market over-react to the CMS announcement?

Ah, saving the tough question for the end. Let's not forget that Dendreon launched Provenge in May under manufacturing supply constraints and has already told us that only about 2,000 patients will be treated in the first year. It's hard to believe that Dendreon won't find 2,000 prostate cancer patients who want Provenge, especially given the reports of patient waiting lists.

By the time Dendreon expands Provenge manufacturing capacity in the middle of 2011, CMS will have already announced its tentative NCD decision. If the NCD is positive, then all the concerns about Provenge reimbursement will be put to bed and Dendreon is off to the races.

Aha! So, you're saying Dendreon in the mid-to-high $20s is a huge buying opportunity?

Objectively, I say yes, Dendreon looks very tempting down here, but…

But? Why does there have to be a but?

C'mon, you knew this was coming… The problem with going all-in on Dendreon today is that the stock doesn't trade on a cold, objective read of the fundamentals. You can't discount completely the possibility of CMS making an adverse coverage decision on Provenge. Fear matters. Risk matters. These overhangs may stick with Dendreon for a long time.

Investors don't like surprises. They like it when drug launches follow precedent. In Dendreon's case, unfortunately, CMS looks like it is breaking precedent. Now, this may turn out to be a great thing for Dendreon, but no one can predict the outcome with 100% accuracy.

And keep in mind, Dendreon doesn't trade in a vacuum. The volatility in the overall market -- more to the downside than up lately -- is also placing investors under enormous stress. Investors' appetite for risk, especially biotech-like risk around a first-of-its-kind drug launch, isn't at a high water mark these days.

I've talked to plenty of fund managers in the past weeks who really believe in the long-term blockbuster value of Provenge, but who nonetheless have no interest in owning Dendreon today because of the supply-constrained launch. Add in this new CMS coverage controversy and the stock looks even less appealing.

What a headache.

You got that right. The Dendreon drama never ends.

-- Reported by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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