DNDN era scesa anche a $5 nel novembre 2007 e a $2,61 il 6 marzo 2009 , ma all' inizio di maggio 2010 aveva persino superato i $55 ; oggi è a circa $36
Nov. 10 2010 - 5:32 pm
By M. Herper.
Shares of Dendreon surged in after-hours trading following the publication of a government report on the Seattle biotechnology company’s only product, Provenge, that will be used in discussions at a meeting being held by the Centers for Medicare and Medicaid Services on November 17.
But
the document, assembled by the Agency for Healthcare Research & Quality, is far from kind to Provenge, a prostate cancer treatment designed to teach immune cells to attack tumors. AHRQ says it has only “moderate” confidence that the data clearly represent the treatment effect of Provenge, pointing to three factors that have dogged interpretations of Dendreon’s main clinical trials.
Patients who did not get Provenge did not receive a true placebo, but instead a sham version of Provenge followed by a frozen Provenge they could receive the treatment later on. (Provenge involves removing, altering, and replacing immune cells.) Patients who did get Provenge may have gotten placebo faster. And the Provenge studies were originally designed to measure whether Provenge affects tumor growth (it doesn’t) and only later used to try and see if it extends survival (it appears to).
One of the trials, IMPACT, was formally re-engineered, showed a four-month median survival benefit for Provenge, and was published in the New England Journal of Medicine. But AHRQ rated all three of the main Provenge trials as being only “FAIR” in quality. See the executive summary and pages 19 and A-3 of
the report for these key passages.
Here’s AHRQ in its own words:
The body of evidence was graded as moderate. Although the findings of the studies are mostly consistent in showing a similar magnitude hazard ratio, estimates of the effectiveness of sipuleucel-T are imprecise due to the relatively small total sample size of the clinical trials, and unmeasurable biases due to potential confounding effects of frozen salvage product and post-progression treatments. The magnitude and direction of these potential biases cannot be determined.
So why is the stock rallying? There is a fear that by taking the unusual step of making a National Coverage Assessment (NCA) of Provenge, Medicare is looking to avoid paying for Provenge at all. Given the number of prostate cancer patients who are covered by Medicare, this could be disastrous for Dendreon.
But the AHRQ report is basically consistent with the idea that Medicare will try to restrict payment for Provenge, which costs an expensive $93,000 per three-course treatment, to patients who are within the drug’s indication as described in the labeling approved by the Food and Drug Administration. Often, Medicare does pay for so-called off-label uses, but as cancer drugs get more expensive it may want to find ways to tighten what gets reimbursed. This would still be big enough to generate Provenge sales of more than $1 billion, so investors may be breathing a sigh of relief. For Dendreon, “good enough” will be enough to make sales much better than good.
Dendreon Data Are Merely Moderate, But Stock Surges Anyway - Matthew Herper - The Medicine Show - Forbes
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