You are right Provenge is a good and important product. All facts about
Provenge can be read on Provenge threat here on Healing Well.
last "Seeking Alpha" article on Dendreon that you posted: everybody can right down his opinion on "Seeking Alpha" and some articles that posted there very informative that base on Facts, some articles is very objective like this that don't use facts and just wright down trash. I don't think that it is good to post such disinformation on this board because it is only scared P.C. patients from this treatment and don't serve main purpose: educate and support. So for fear balance I will post some response for this article
" Theodore Cohen Comments (1801)
Interesting article, but you need to check your facts. Let's begin by correcting several misstatements/errors regarding treatment regimens, costs, and pre-chemo vs. post-chemo approvals (among other things).
First, Dendreon costs $94,000 for three treatments given over a month's time (weeks 0, 2 and 4). That's it...done! There are no 'annual' treatment costs. Provenge is given as a one-time, three-infusion, 'treatment.' It provides, on-label, a median (NOT average) overall survival (mOS) benefit of 4.1 months. Post hoc analyses of the three Phase 3 studies performed for FDA approval showed that for patients with a PSA less than 22.1, the mOS was 13 months.
In the pre-chemo Phase 3 trial that led to Zytiga's approval late last year in Provenge's space, the treatment period was 14 months. The cost of Zytiga used to be around $5,700 per month, but was raised earlier this year. A full 14-month treatment, plus co-administered prednisone, now costs around $84,000 (and this does NOT include the required monthly blood tests to monitor patient liver functions). Note that Zytiga does NOT provide any median survival benefit. It was approved mainly on the basis of having achieved a statistically significant progression free survival endpoint in its Phase 3 trial.
Xtandi is NOT approved for pre-chemo use. It currently is being tested in a Phase 3 trial for such use, but any pre-chemo applications would be off-label at this time. The cost of Xtandi is around $7,500. So, a year on the drug would cost almost as much as Provenge. Importantly, Xtandi does not require co-administration with prednisone. (BTW, urologists normally do not prescribe off label, and so, I would not expect many are prescribing Xtandi for their pre-chemo patients' clinical pathways at this point. Thus, Provenge's main competition is Zytiga.)
In sum, Provenge is the ONLY pre-chemo treatment for asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer that provides a median overall survival benefit to patients.
Regarding reimbursement, doctors are reimbursed directly by Medicare for Provenge, with more than 70% of patients having no or little co-payment charges (source: Dendreon IR). In the case of Zytiga and Xtandi, these are pills, and so, they are covered under Part D...which means, patients usually end up in the 'donut hole' at some point during their treatment. More often than not, users of Zytiga and Xtandi have to shell out more than do patients receiving Provenge...
But frankly, I do wish that if you want to present data on a company--any company--you would invest a little more time in checking your facts and present the correct information on matters of importance...;
Theodore Cohen Comments (1801)
I wouldn't use the term 'comical.' Actually, it's tragic, especially for patients.
Let's cut to the chase. The problem, unfortunately, is with the label, which goes back to the protocols established years earlier for the three Phase 3 trials. Now, doctors must certify (and CMS/Medicare is very insistent that certification be provided and verified) that patients present with mets. This is highly restrictive and, unfortunately, requires a patient's disease load to progress to a point where such mets can be detected. True, there are techniques to push detection to earlier stages. I discussed this matter with Dr. Kapoor on several occasions. And while he and others are pushing detection to the earliest possible times, that does come with a cost.
Zytiga (and Xtandi, if and when it is approved for pre-chemo applications) has no such label restriction. So, it's far easier for a doctor simply to write a prescript
ion and send the patient off into the sunset...except for the fact that in the case of Zytiga (the jury is still out on Xtandi), pre-chemo, Zytiga provides no survival benefit. Zero. Zip. Nada!...
portosanta95 Comments (216)
Right Ted, it is really sad that someone writes an article and does not even know the facts - really sad...
Bill Maurer Comments (2380)
It's tragic for shareholders, not patients. Provenge will be fine in the end, whether in Dendreon's hands or someone else...
Theodore Cohen Comments (1801)
Yes, I agree...there certainly were times where they could have raised money in the past. No question. It will be interesting to see how they address the near-term debt...Schiffman indicated this was one of his priorities. (At the same time, he suggested a path towards to addressing the larger debt problem.)
A tragedy all the way around...beginning with the travesty of a corrupted advisory committee meeting (and the events that followed) in 2007. That cost the lives of tens of thousands of men with PCa who would otherwise have been candidates for Provenge to die early, painful deaths. Recall...even Dr. Howard I. Scher of Memorial Sloan Kettering--who, at the time, was working with Cougar Biotech on Zytiga and Medivation on Xtandi--stated he was frustrated by the fact he had no other options to offer these men (pp. 322, 323 of the advisory committee transcript
)...yet he did everything within his power to ensure the treatment was not approved.
Theodore Cohen Comments (1801)
It was Huber's quack science and the articles planted in Reuters on her and her specious 'immunodepletion theory (sic)' that Kaiser attempted to use to block a man from receiving Provenge early in 2012. The got whacked by the State of Washington for that.
erniewerner Comments (21)
The FDA approved Zytiga label does claim a pre-chemo survival benefit. It does note that the p value does not reach the preset level of significance, but the medians, upper and lower limits, HR's and attained p value are listed. I understand why DNDN investors would find this particularly galling, but let's take off the blindfolds and quit pretending..." seekingalpha.com/article/1682432-dendreon-crushed-by-jnj-medivation-or-by-own-management?v=1378764471&source=tracking_notify#comment_update_link