Seeking Alpha

Theodore Cohen

 
View as an RSS Feed
View Theodore Cohen's Comments BY TICKER:
Latest  |  Highest rated
  • Dendreon's Provenge: Some On The Street Doth Protest Too Much [View article]
    Thanks for the information. I wasn't aware of that, bdm3. This is good to know.

    Ted
    Oct 14 12:19 PM | Likes Like |Link to Comment
  • Dendreon's Provenge: Some On The Street Doth Protest Too Much [View article]
    Hi, gilad28,

    Yes, there are times when Mr. Market puts things on sale. I hope someday people will say to you: "Well bought!"

    Good luck.

    Ted
    Oct 14 11:19 AM | Likes Like |Link to Comment
  • Dendreon's Provenge: Some On The Street Doth Protest Too Much [View article]
    There are many considerations to be addressed, not the least of which is the patient's condition (which should, of course, be the major driver). But once through the 'donut hole', it would make good sense.

    Ted
    Oct 14 11:18 AM | Likes Like |Link to Comment
  • Dendreon's Provenge: Some On The Street Doth Protest Too Much [View article]
    Yes...absolutely. Many, no doubt, will run one patient through, submit the paperwork, and wait to see how long it takes for the money to show up. Once they feel comfortable, they will begin in earnest. Even serving one patient a month can provide significant revenue to a provider.

    Ted
    Oct 13 03:05 PM | Likes Like |Link to Comment
  • Dendreon's Provenge: Some On The Street Doth Protest Too Much [View article]
    The subject of reimbursement has repeatedly come up in this venue and other fora. Here is the latest information found on Dendreon's Provenge site regarding the guidance provided and the assistance available.

    Reimbursement Resources

    Reimbursement Resources
    Other Resources

    Understanding your insurance options

    You have unique circumstances that can affect your insurance coverage. Be sure to speak with your doctor's office and/or your insurance company to find out more information about your coverage, as well as whether you are eligible for additional financial support during PROVENGE treatment.

    Patient Assistance Programs

    The makers of PROVENGE provide a patient assistance program that may help you cover the cost of treatment with PROVENGE.

    A dedicated case manager will:
    •Help with co-pays, co-insurance, and deductible costs by referring patients to independent foundations*
    •Assist uninsured patients and those who are uninsured due to payer claim denials†
    •Support patients with treatment-related travel costs by referring patients to independent foundations*

    * Co-pay and travel assistance foundations provide assistance regardless of the choice of medicine, and decisions are based on financial need and according to criteria established by individual foundations. Dendreon can assist patients by referring them to these independent organizations. Dendreon cannot guarantee that patients will be eligible for or receive assistance after referral.Dendreon does not have controlling or managerial influence on these independent organizations.

    † Uninsured patient assistance program eligibility criteria can be changed or program can be discontinued at any time at the sole discretion of Dendreon.

    Please call PROVENGE support services, known as Dendreon On Call, at 1-877-336-3736, to learn more about PROVENGE patient assistance programs.

    Next: Other Resources

    http://bit.ly/n4ERCG
    Oct 13 10:51 AM | Likes Like |Link to Comment
  • Dendreon's Provenge: Some On The Street Doth Protest Too Much [View article]
    Thanks, George.

    I try. Don't always succeed the first time, but do attempt to hunt down the facts in whatever issues seem to be bothering people at the time.

    Nice to hear from you.

    Ted
    Oct 13 10:42 AM | Likes Like |Link to Comment
  • Dendreon's Provenge: Some On The Street Doth Protest Too Much [View article]
    BTW, NF, I just received a note from an MD to whom I had sent a query regarding wash out times. His response: wash out time 28 days for steroids; chemo, 3 mos radiation: 28 days. I thought you might find this interesting.

    Take care.

    Ted
    Oct 12 04:08 PM | Likes Like |Link to Comment
  • Dendreon's Provenge: Some On The Street Doth Protest Too Much [View article]
    Hi, bdm3.

    Thanks for commenting.

    I'm on Medicare. I carry supplemental insurance...have for many years. Other than having to pay for having an annual refraction performed on my eyes (which Medicare will not pay for), I haven't paid a cent out of pocket of any service. True, I pay for my Medicare supplement plan, but there is no free lunch, if that's what you were expecting. I pay for Medicare A, B, and D, plus my supplemental plan. Anyone who thinks that people on Medicare are on the dole simply do NOT understand how the system works and how much health insurance costs retirees.

    Now, if drug companies want to assist retirees with the purchase of their drugs, that's another story. I get coupons all the time that offer discounts on many of the pharmaceuticals I use.

    But the bottom line is this: the portion of the bill not covered by Medicare will be taken care of my a patient's supplemental insurance policy, if he has such a policy.

    if you'd like to see how it works, here's an interview I conducted with Dr. Leonard Liang, a California urologist, in which he showed me his billings on two patients. You'll see that the 20% was covered by the patient's supplemental plan in the first case, and almost completely covered by MediCal in the second:

    http://bit.ly/r1J4PZ

    By the way, Dr. Liang just posted a new video on Provenge to the Web; I think you will find it very instructive.

    http://bit.ly/ru6SEk

    As for doctors and the money they make, those administering Provenge receive, I believe, $5600 for the full three-course treatment. (Doctors prescribing Zytiga, of course, receive nothing for writing a prescription, though obviously, there are responsible for following the patient's progress, ensuring that the proper tests are performed to monitor liver functions, and so forth.)

    I hope I have addressed your concerns.

    Ted
    Oct 12 04:00 PM | Likes Like |Link to Comment
  • Dendreon's Provenge: Some On The Street Doth Protest Too Much [View article]
    Thanks for the considered comments and responses, NF. I appreciate them, and certainly, what you've stated above is useful both to the patient and practioner alike. I was not familiar, for example, with researchtopractice.com.

    I did not mean to imply that the blood was processed where it was withdrawn. You were correct to clarify this. The blood, of course, can only be withdrawn by the provider or some other ageng (e.g., the Red Cross, under agreements with Dendreon, if I understand correctly), and then shipped to one of three processing Dendreon facilities. These are strategically located in CA, GA, and NJ. There, the blood is infused with a protein, whereupon it is shipped back to the provider for reinfusion. The process is well documented on such sites as:

    http://www.provenge.com/

    And yes, in the one example I provided, where only Zytiga and Provenge were considered, the Journal of Clinical Oncology the sequencing of these two drugs recommended that Provenge be administered first. In any specific case, what treatment(s) is/are given and in what order depend on a number of factors specific to the individual. And that's something only the patient's doctor, as you indicate, can determine in consultation with the patient.

    Finally, it is unfortunate the Dendrawn has unfortunately been cast in the poster boy role you described. There are treatments on the market today that not only are far more expensive, but that never went through a CMS review. Which raises serious questions regarding the motives behind the CMS review conducted last November.

    Have a great evening.

    Ted
    Oct 12 03:38 PM | Likes Like |Link to Comment
  • Dendreon's Provenge: Some On The Street Doth Protest Too Much [View article]
    Thanks. Here's my take:

    #1. Provenge does not replace chemo, but it does offer a better option in AS/MS patients. And because Provenge doesn't affect tumor progression or PSA, patients may elect to go on to other treatments (as you indicated above). The FDA statistical review document confirmed that Provenge's survival benefit was independent of Taxotere use and the timing of use.

    Also, most patients that are candidates for Provenge are asymptomatic. That point is often missed. Even though these patients have HRPC, they are diagnosed with it before they have pain or symptoms in the vast majority of cases. It makes more sense to give Provenge early. Even in the Provenge trials, a minority were asymptomatic. So, there may be a reason to irradiate or give Aytiga first if the patients have significant symptoms.

    #2. No disagreement.

    #3. I'm not sure where you got the 3 months washout period (clinical trial protocol). In the real world, I don't know what an appropriate wash out period is but it could be as little as 30-60 days. Zytiga would also require a washout period for reasons related to the the concurrent prednisone. But if Taxotere or Zytiga can reduce pain in symptomatic patients, then they could become Provenge-eligible. This also shows why sequencing studies should be initiated.

    By the way, the recommendation is to use Provenge first, then Zytiga.

    "The practical dilemma of the appropriate sequence of use of the two new noncytotoxic agents (sipuleucel-T and abiraterone) is being addressed by trials that are under development. For now, given the broader window of applicability of abiraterone and the longer time required to develop an immune response with sipuleucel-T, if both agents are to be used, it seems reasonable to administer sipuleucel-T first with Abiraterone after additional disease progression. Biomarkers to help define the optimal use of immunotherapy are needed."

    http://bit.ly/oWIylJ

    #4. If I recall, Provenge was initially issued a temporary, miscellaneous J code that required the filing of manual claims, which extended reimbursement times. My understanding, though, is that CMS bundled the treatment in the Q-code issued last July, so now, separate codes are not required for each step in the process. That some providers are reporting reimbursement in under two weeks would seem to attest to this.

    Finally, the drawing of blood (pheresis) and subsequent refusion is a routine procedure in community and academic medical settings these days. Certainly, it's not unique to Provenge. Have you ever given blood in a firehouse or gym? As for being 'frequent' in the case of Provenge, a patient has blood withdrawn three times, and reinfused three times. given the benefits, I don't think patients are complaining.

    I enjoy a good debate, but let's not stretch crudility.

    Ted
    Oct 12 12:09 PM | Likes Like |Link to Comment
  • Dendreon's Provenge: Some On The Street Doth Protest Too Much [View article]
    Fsoler,

    I don't disagree. It all starts at the top.

    Thanks for stopping by.

    Ted
    Oct 12 09:14 AM | Likes Like |Link to Comment
  • Dendreon's Provenge: Some On The Street Doth Protest Too Much [View article]
    Thanks.

    Yes, we all would want the company to be more aggressive, but frankly, there are limits to what any company can do, imposed both by the SEC and in the case of drug companies, by the FDA.

    The best disinfectant for the lies, rumors, and misinformation found in the 'press' today is, as always, validated data. For an operational company, however, the stock price, however, will be driven by sales.

    Ted
    Oct 12 09:13 AM | Likes Like |Link to Comment
  • Dendreon's Provenge: Some On The Street Doth Protest Too Much [View article]
    Gedeon,

    I think it's been clear since 2007 that segments of the so-called 'press' have been captured by elements of Wall Street when it comes to Dendreon. Some of it is subtle, some, blatant. A few of the attacks are byproducts of journalists (or those who fancy themselves as journalists) 'reaching' for stories--that is, grabbing for the 'snit de jour'--simply to garner readership. After a while, you see through the games being played and learn to recognize them and the publishers involved for who and what they are.

    I'm saddened, frankly, that Reuters would stoop to publish such a biased piece as the one I cited at the beginning of my article.

    It was almost amusing, if it wasn't so serious, to see Dr. Slovin of MSK being quoted: "Dr. Susan Slovin, an oncologist with Memorial Sloan-Kettering Cancer Center, said many patients and doctors are gravitating instead toward J&J's Zytiga -- a pill approved in recent months for advanced prostate cancer patients that have failed to benefit from chemotherapy.

    ...

    "The patient says, 'Look, I really don't see the need to sit here and send my (blood) to wherever. I really don't want to wait. I want to take a pill and go to Florida.' "

    If you look carefully at what a patient on Zytiga really must endure, it's not quite so simple. The data are easily available--I dropped them in an earlier reply--but just to save you time, consider this:

    The recommended dose of ZYTIGA TM is 1,000 mg [4 x 250 mg] administered orally once daily in combination with prednisone 5 mg administered orally twice daily. ZYTIGA TM must be taken on an empty stomach. No food should be consumed for at least two hours before the dose of ZYTIGA TM is taken and for at least one hour after the dose of ZYTIGA TM is taken (see Clinical Pharmacology). The tablets should be swallowed whole with water.

    There are significant concerns regarding hepatic impairment. For example, in patients with moderate hepatic impairment monitor ALT, AST and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter.

    Hepatotoxicity presents similar issues.

    I will say it again: there is a place for both treatments: Zytiga and Provenge. And in the case of these two treatments, they are not mutually exclusive, but can be used consecutively.

    Thanks for your comments.

    Ted
    Oct 12 08:45 AM | Likes Like |Link to Comment
  • Dendreon's Provenge: Some On The Street Doth Protest Too Much [View article]
    slowtime, we are legends in our own minds!

    But yes, it will be nice to see Rajaratman put away! It's long overdue. Then the court will be free to focus on others who were working with him.

    As well, I'm waiting for the Hon. Preet Brahaha, US Attorney for the Southern District of New York to take on the expert networks serving hedge funds that invest in medical and pharmaceutical companies. Now, that will give us both plenty about which to write.

    Ted
    Oct 11 03:32 PM | Likes Like |Link to Comment
  • Dendreon's Provenge: Some On The Street Doth Protest Too Much [View article]
    I believe Moon Kil Woong is referring to Dupuy

    http://on.wsj.com/oi4WCB/

    "Pulling Implants: If you’re keeping tabs on Johnson & Johnson’s string of recalls, here’s another: the company’s DePuy Orthopaedics unit is pulling two hip implants because of unusually high replacement rates, the WSJ reports. J&J had already phased out the implants and this recall affects “the very few” remaining on the market, the paper says. Combined with earlier recalls of over-the-counter medicines and this week’s recall of contact lenses in Asia and Europe, the latest news “deepens concerns about quality controls at the company,” the WSJ says."

    Correct me if I'm wrong, Moon.

    Ted
    Oct 11 07:12 AM | 1 Like Like |Link to Comment
COMMENTS STATS
1,898 Comments
1,411 Likes