First time in our country's history

[striper swiper]

That Was Quick… For First Time Ever Obama Administration Cuts Medicare Treatment For Cancer Patients

Posted by Jim Hoft on Sunday, August 15, 2010, 9:31 AM
HERE COME THE DEATH PANELS…

For the first time in history Medicare will not cover an FDA-approved anti-cancer therapy.
Doug Ross reported:

Just days after the recess appointment of Donald Berwick, the controversial new head of Medicare and Medicaid, the Ovarian Cancer National Alliance posted the following grim news: for the first time in history, an FDA-approved anti-cancer therapy may not be covered by Medicare.

Provenge, a vaccine to treat the recurrence of prostate cancer, has been approved by the Food and Drug Administration (FDA)… Medicare usually covers the cost of FDA-approved anti-cancer therapies. However, the Centers for Medicare and Medicaid Services (CMS) is still reviewing whether it will cover Provenge, and at what rate.
The CMS statute states that Medicare must cover therapies that are reasonable and necessary, while the FDA is instructed to approve drugs that are safe and effective. Because of the conflicting Federal coverage and approval requirements, there are some non-FDA approved drugs (called off-label drugs) that are paid for by CMS. However, with respect to Provenge, it appears that CMS is arguing that while the treatment is safe and effective, it may not be reasonable and necessary. For the first time, an FDA approved anti-cancer therapy may not be covered by Medicare.

A life-saving cancer treatment “may not be reasonable and necessary”? Gee, that kind of decision-making by an unelected federal bureaucracy certainly sounds like a death panel to me.

[Big Fish Billy]

Boy there's starting to be a lot of stuff needing un-winding in a couple years.....

[Fishing Report]

FDA scolds Dendreon on Provenge marketing
August 9, 2010 — 10:33am ET | By Tracy Staton

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* NEJM analyzes data on Provenge
* Private payers mull restrictions on Provenge
* Dendreon: Provenge to cost $93K for full course
* CMS looking into whether to pay for Provenge
* Provenge scrips hit 500 as payers agree to pay

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Dendreon (NASDAQ: DNDN) is in hot water with the FDA's marketing watchdogs already. The company's sales materials for the brand-new prostate cancer vaccine Provenge don't pass muster, the agency says, because they exaggerate the novel treatment's benefits and soft-pedal its risks.

"These promotional materials are false or misleading because they omit and minimize the risks and overstate the efficacy of Provenge," the FDA says in a letter to the company, Reuters reports. The agency also tells Dendreon to stop using the offending materials immediately, and to also pull any other sales aids that make similar claims.

Granted, it's not easy to explain the subtleties of Dendreon's data on Provenge. The FDA appears to acknowledge that in its letter, saying that one piece lacked "sufficient contextual information" that would "convey the limitations" of Dendreon's main study of the drug.

Read more: FDA scolds Dendreon on Provenge marketing - FiercePharma http://www.fiercepharma.com/story/fd...#ixzz0wn1YOQ6I
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Dendreon: Provenge to cost $93K for full course
April 30, 2010 — 10:47am ET | By Tracy Staton

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* CMS looking into whether to pay for Provenge
* Private payers mull restrictions on Provenge
* FDA scolds Dendreon on Provenge marketing
* Provenge scrips hit 500 as payers agree to pay
* NEJM analyzes data on Provenge

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One of the most pressing questions analysts and patients have had about Provenge is how much Dendreon would charge for its newly approved prostate cancer drug. Now we know: Each infusion of Provenge will cost $31,000, bringing the full cost of treatment to $93,000.

Read more: Dendreon: Provenge to cost $93K for full course - FiercePharma http://www.fiercepharma.com/story/de...#ixzz0wn1wReDP
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Private payers mull restrictions on Provenge
July 9, 2010 — 9:57am ET | By Tracy Staton

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* Dendreon: Provenge to cost $93K for full course
* FDA scolds Dendreon on Provenge marketing
* Provenge scrips hit 500 as payers agree to pay
* NEJM analyzes data on Provenge
* CMS looking into whether to pay for Provenge

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How are insurers likely to treat Dendreon's (NASDAQ: DNDN) new prostate cancer vaccine Provenge? Very carefully, at least according to a new survey from Reimbursement Intelligence. Some 65 percent of national and regional insurers said they may somehow restrict patient access to the pricey vaccine.

As Pharmalot reports, three-fourths of the survey respondents expected to require prior authorization, sometimes including documented use of other therapies. Almost half wouldn't pay for Provenge for patients who hadn't had chemotherapy first. More than half would only provide the vaccine to patients whose cancer had metastasized.

Now, these restrictions aren't likely to make much difference for awhile. Dendreon is turning out only a small amount of Provenge right now. It's ramping up manufacturing as quickly as possible, but expects that process to take many months. Supply is expected to fall short of demand for at least 12 months; two new plants are slated to be up to speed by the end of next year.

[Fishing Report]

CMS looking into whether to pay for Provenge
June 30, 2010 — 10:47pm ET | By Liz Jones Hollis



Dendreon shares fell $5.64, or 17.5 percent, in after-hours trading last night after Medicare officials said they looking into whether to pay for Provenge. "We are opening this national coverage analysis to determine whether or not autologous cellular immunotherapy is reasonable and necessary under sections 1862(a)(1)(A) and/or 1862(a)(1)(E) of the Social Security Act," CMS says. And as the Seattle Times notes, that left the stock at less than half its peak above $55 just before the FDA approved the prostate-cancer immunotherapy.

A Roth Capital Partners' research notes says that the reaction represented a misunderstanding of "something that is considered standard operating procedure and we believe that this is a clear buy on weakness event for Dendreon's shares." A Leerink Swann note is of a same mind, saying it is unlikely that CMS won't cover Provenge.

If CMS decides to cover Provenge, it would help increase the number of patients eligible and potentially prompt private insurers to do the same, Dow Jones reports. However, a denial could severely stifle the expensive product's growth. The Provenge question also could be viewed as a test of healthcare reform, Dow Jones says. The government's costs from the treatment could rise significantly when the 32 million currently uninsured Americans are expected to join the nation's healthcare system in 2014.

However, Beth Steindecker and Ira Loss of Washington Analysis express doubt in a research note "that the agency would eventually issue a non-coverage decision for the vaccine or even place severe restrictions beyond the FDA approved indication and label for use in metastatic, hormone-refractory prostate cancer patients."

They add "since CMS' actual posting cites examining whether autologous cellular immunotherapy for the treatment of metastatic prostate cancer is reasonable and necessary, whatever CMS decides could affect usage of a rival prostate cancer vaccine in development--Biosante's (BPAX-$2) GVAX vaccine--were it to be approved by the FDA."

"Dendreon welcomes the opportunity to continue our discussions with CMS about how Provenge will be provided to Medicare beneficiaries, particularly given the survival benefit and safety profile of Provenge," the company says in a statement. "We plan on continuing to work closely with CMS during this process to ensure patients with advanced prostate cancer have broad access to Provenge."

A proposed decision memo due date is set for March 30, 2011, while a final ruling is due June 30, 2011, according to CMS.

Read more: CMS looking into whether to pay for Provenge - FiercePharma http://www.fiercepharma.com/story/cm...#ixzz0wn2WiQvw
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