Analysis: Cost issue simmering in Medicare's Dendreon review

WASHINGTON Tue Nov 16, 2010 7:03am EST

WASHINGTON (Reuters) - When a U.S. Medicare advisory panel reviews Dendreon Corp's (DNDN.O) new prostate cancer therapy on Wednesday, there will be one issue on everyone's mind that advisers cannot consider: its $93,000 price tag.

The novel vaccine, called Provenge, was approved for the U.S. market in April to treat men with advanced prostate cancer after company data showed it help men live another 4.1 months.

Now it faces another test by the U.S. Centers for Medicare and Medicaid Services (CMS), which is deciding whether to pay for the treatment for the millions of older men in the nation's Medicare insurance program.

Its ruling is critical not only for patients seeking the therapy, but also the biotech's sales.

Nationwide Medicare coverage could ensure the product's success, but any limitations or a denial could sharply dent sales. Private insurers are also likely to follow suit.

Although CMS and its advisers can only legally consider whether use of the vaccine is "reasonable and necessary," cost is lurking in the background.

"This is overwhelmingly used in the Medicare population, and that is a red flag," said David Blaszczak, a health policy analyst for Potomac Research Group who follows CMS. "It's a high-volume, high-cost procedure."

"It won't come up at the meeting, but I think cost is at play," Blaszczak told Reuters.

On Wednesday, CMS's outside advisers will discuss use of the biotech's vaccine and offer recommendations. Agency officials are due to make an early decision in March before finalizing their payment rule by the end of June.

'A SIDE CONVERSATION'

Seattle-based Dendreon links Provenge's hefty price tag to the product's unique manufacturing.

Cells from a patient's tumor are removed and incorporated into a vaccine, then injected back into the patient. Unlike traditional vaccines that prevent disease, Provenge stimulates the body's immune system to attack malignant cells.

Dendron officials have declined to talk ahead of the meeting.

It's not clear exactly how much Medicare could end up spending on Provenge, although analysts so far expect overall peak sales of nearly $2.3 billion in 2016, according to Thomson Reuters data.

The government's National Cancer Institute estimates nearly 218,000 men will be diagnosed with the disease this year. But not all cases are advanced enough to qualify for Provenge and not all of patients would necessarily be enrolled in Medicare.

While Medicare's potential spending on one treatment is not likely to bankrupt the popular insurance program, the debate over costs comes amid larger worries about its overall fiscal health and the nation's swelling deficit.

Last week, a U.S. deficit commission called for sweeping changes to the program in an effort to reduce costs.

Even if CMS cannot legally weigh Provenge's cost, "I absolutely think that someone's going to raise it" at Wednesday's advisory meeting, said Amy Thornton, who follows the agency for Washington Research Group, a policy analysis firm owned by MF Global Holdings Ltd MF.N.

"Cost may play a side conversation role, but you're not going to see cost creep into any sort of coverage decision," Thornton told Reuters.

Cancer therapy in general can cost tens of thousands of dollars, especially when side effects arise. But unlike other cancer drugs, which can see costs stretched over months or years, Provenge's three doses are given just two weeks apart.

Patient groups in particular want cost off the table.

"We think that's a debate that's not going to concern CMS," said Kerry Donahue, a lawyer for CareToLive, a group representing doctors, patients and Dendreon investors that pushed for Provenge's FDA approval. "The agency should not get involved in looking at the cost."

In calling for the meeting, CMS said it will focus on the current evidence about the benefits and harms of Provenge when used as approved for advanced prostate cancer as well as wider, "off-label" use.

Many analysts expect the agency to ultimately cover the vaccine for FDA-approved use, although Medicare could also seek additional data as a condition of its payment.

"We are increasingly confident this meeting will go well" for Dendreon, Robert W. Baird & Co. analysts said last week.

(Reporting by Susan Heavey. Editing by Bernard Orr)

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Comments (3)
MyBloombergID wrote:
Yes, CMS reviews usually do NOT consider cost. But even if this panel were to do so, it would find that the costs associated with Provenge are the same as those associated with using chemotherapy, plus or minus, when you consider the cost of treating side effects associated with chemotherapy. See Miller,
http://www.minyanville.com/businessmarkets/articles/dendreon-provenge-cost-taxotere-sanofi-aventis/7/29/2010/id/29371?page=full

And with what treatment other than Provenge can men be back on the golf course in three days while Provenge contineus to work 24×7 fighting their cancer? No hair loss, no vomiting, no other effects associated with chemo. Just mild flu-like symptoms for two or three days. Provenge is a no-brainer!!!

PS The issue here is off-lable use. There is where the media should be focusing. At what stage should patients be eligible for Provenge?

Nov 16, 2010 9:04am EST  --  Report as abuse
Amer8898 wrote:
Thx Susan!
You Rock!

Here’s what this biotech has been up against over the last 15 years!
http://www.deepcapture.com/wp-content/uploads/2009/10/story-of-dendreon.pdf

Respectfully,
JW

Nov 16, 2010 9:34am EST  --  Report as abuse
Jeff1601 wrote:
$93,000 for an extra 4 months…yes that is a no brainer. Of course everyone wants to live as long as possible, but common sense must enter the equaison at some point. There is no free lunch and the bills must be paid…even from the governemnt…Higher taxes anyone….again?

Nov 17, 2010 9:03am EST  --  Report as abuse
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