After months of anticipation, the Centers for Medicare & Medicaid Services has decided that the Provenge prostate cancer vaccine is eligible for reimbursement. The unsurprising decision comes just four months after a CMS advisory panel voted that Dendreon’s Provenge vaccine for advanced prostate cancer shows “clinically significant” improvement in survival (look here)
The panel was convened, however, after the agency last year unexpectedly initiated a so-called National Coverage Determination in response to questions raised by Medicare contractors amid concerns over off-label use. Such a review was unusual, given that Medicare generally pays automatically for FDA-approved oncology meds (read here).
For that reason, the CMS review set off a firestorm of protest that the agency was using Provenge as a litmus test for health care rationing. Among those registering concern was the American Society of Clinical Oncology and several US senators (see this and this). All totaled, CMS received 657 comments and the overwhelming majority - 620, or 94.4 percent - supported coverage.
At issue has been whether coverage for the $93,000 treatment, which is sold by Dendreon and is the first such therapeutic cancer vaccine, is deemed reasonable and necessary. The drug was approved last year based on a study showing a four-month survival benefit and most patients who qualify for Provenge treatment also qualify for Medicare.
In the memo released today, CMS officials stated that "we do not believe there is any persuasive evidence for the off label use of (Provenge) at this time," because it appears "virtually nil’’ that Provenge was effective for men who had other stages of the disease and so off-label should not be reimbursed. But the agency is going to leave more specific coverage decisions to each of the Medicare contractors, because Dendreon has indicated off-label use is unlikely and the underlying product technology is new and Medicare contractors need flexibility to determine coverage (you can read the complete CMS memo here).
UPDATE: RW Baird analyst Chris Raymond writes this in an investor note: "No off-label endorsement, but no binding restriction either. Delving into the detail of the proposed National Coverage Determination, CMS leaves the door open for regional MACs to determine noncoverage. We view the lack of an outright off-label restriction as positive."
5 Comments
100k to survive for 4 additional months. No wonder medicare is broke.
There's a special place in hell
Eventually patients, theit family, and taxpayers are suffering from the "magic" treatment. IT was wrong from the beginning and it is wrong at the end. There was no convincing evidence showing an improvement in survival but rather a consistent difference in survival between the trial groups because of the consistent use of the NEGATIVE control in all the three trials. The overall internal consistency is not in line with sciences.
Patients who want to shorten their life are welcomed to use Provenge, an immature product but a mature diaster in modern medicine and a landmark scam that fleeces taxpayers. Heartfelt pain!
Dr. Scott Gottlieb, a former senior official at CMS and a fellow at the American Enterprise Insitute had revealed that Medicare has only 20 doctors and 40 total clinicians making coverage decisions, AND NOT A SINGLE ONCOLOGIST ON STAFF. Yet, since the year 2000, they've issued 165 restrictions and directives on the use of cancer drugs and diagnostic tools.
Private insurers, on the other hand, employ thousands of doctors and nurses to do this. Medicare put off-lable drug decision making (which some 60% of cancer drugs are used) in the hands of compendia writers in the private sector, many of whom are on the payrolls of the companies that make the drugs. The public knows nothing about the financial relationships between drug companies and the physicians, biostatisticians and other scientists who comprise the panels that write clinical practice guidelines and determine which drugs, indications and weight of evidence that are included in its compendium.
The evidence for including many of the off-label uses in these compendia is thin. Many, at best, add just a few months of life, just like Provenge. Yet they must be taken throughout the final months or even years of the diseases' progress.
I am just wondering if this had anything to do with what CMS administrator for Medicare in Southern California, Palmetto GBA did after the previous CMS administrator, National Heritage Insurance Company (NHIC) spent almost the entire 2006 doing an extensive, transparent tech assessment of chemoresponse assays and made the decision that the assays were a perfectly appropriate medical service, worthy of coverage on a "non-investigational" basis for the whole FDA-approved kit.
It amazes me that they don’t emphatically mandate this testing as a requirement for obtaining chemotherapy reimbursement against "ill-directed" treatments. Evidence in support of these tests is more than sufficient to justify them, particularly in light of the Duke University impact study of chemoresponse assays on the treatment costs for recurrent ovarian cancer (PMID: 20417480).
For haiguibio... at least we now know that you place little value for your life... like ALL products, the initial cost is high, and then over time and use, these numbers always come down... extensive off label use will drive the cost down even faster...
not apple to apples, but a 42" plasma television in 2005 ran over $5,500... an improved version today is under $500...