As if Dendreon doesn't have enough problems. A new survey shows that 68 percent of payers believe utilization for its controversial Provenge prostate cancer vaccine will remain flat over the next to six to nine months. And 69 percent say the true cost is anywhere from $101,000 to $120,000, when factoring in lab tests, administrative costs and lost productivity, as opposed to the $93,000 price tag.
Meanwhile, 79 percent of payers report low uptake among physicians. Of that group, 60 percent also believe that many physicians are not yet prescribing Provenge. Why? They listed limited clinical value; high cost; a lack of physician confidence in the vaccine; a lack of qualifying patients and an insufficient number of cancer centers willing to administer Provenge.
What's more, the insurers believe docs face substantial barriers before using Provenge - 31 percent cite strict policies toward utilization, 27 percent point to high patient cost sharing and 14 percent note a complex treatment regimen, according to the survey of 20 medical and pharmacy directors from health plans and pharmacy benefit managers who are responsible for formulary or coverage decisions.
"Physician demand just isn't there right now and, in the payers' opinion, they don't see it changing for a few months," says Rhonda Greenapple, who heads Reimbursement Intelligence, the market research firm that earlier this month conducted the survey. "What payers are telling me, in their view, is that physicians are reluctant to use Provenge because of the utilization policies, high cost share and complicated regimen. I don't think the problem is the payer, but physician reluctance."
The findings underscore the difficulties confronting Dendreon, which earlier this month shocked investors by lowering its sales forecast for the year. The vaccine maker, which is also laying off workers, blamed skittishness among physicians who are concerned about reimbursement (read here). However, some doctors say the concerns are mostly with Medicaid (see this).
The episode subsequently renewed debate about the extent to which Dendreon execs and its board are capable of managing the fast-growth scenario they are trying to navigate. Several shareholders with varying holdings privately wrote the vaccine maker to do a better job of communicating to investors, including one who renewed his public calls for the board to diversify (look here).
Nonetheless, most third-party payers are giving a green light to Provenge - 84 percent of those surveyed say they cover the vaccine, albeit with varying restrictions to ensure on-label use. And 91 to 100 percent of physician requests are approved by 26 percent of the plans surveyed. Another view - 58 percent of payers are approving 80 percent of physician requests to administer Provenge.
Meanwhile, one biotech watcher says the survey suggests payers are demanding criteria that goes beyond what Medicare requires for coverage, which he claims is problematic. "The NCD (National Coverage Determination) doesn't have some of the requirements" noted in the survey, says David Miller of Biotech Stock Research, who holds an option position in Dendreon stock. He also expressed surprised that payers reported they are reimbursed separately for apheresis when the process is covered by Dendreon. "These people are supposed to be experts on reimbursement," he says.
In response, Greenapple notes that NCD coverage requirements may not be as specific as what payers require. For instance, she says that plans can add criteria for coverage in Medicare Advantage, which means commercial plans with Medicare Advantage can restrict beyond the NCD criteria. As for apheresis, she notes the wording and timing of the question may have been confusing, since the Medicare coding that mentions apheresis was issued just before the survey was conducted.
angry face two from istolethetv on flickr
23 Comments
FYI - Medicare advantage plans CAN NOT be more restrictive than NCD guidelines. Anything and everything that is covered in an NCD MUST be covered by Medicare advantage plans. Discression for Medicare advantage plans comes in their ability to manage coverage in areas without an NCD, or to expand serivecs beyond an NCD, but NEVER to be more restrictive than an NCD!
It seems like the survey talked to the wrong types of payers. This is a drug for Medicare-eligible people overwhelmingly. NCDs are binding. I think either Rhonda talked to Commercial payers who are about 5% of the market for Provenge, or are just conjecturing about what MDs are thinking.
Unfortunatley it seems like both. Asking commercial payers about a medicare-dominated market isn't particularly helpful for a part-b drug. Asking them about drivers of physician behavior (aside from payer restrictions) is just conjecture - there is a reason hearsay is inadmissable in court...
There is a misperception of the survey. The purpose of the survey is to get payer perspectives of why there is slow uptake of Provenge. First, the majority of payers had both Medicare Advantage and commercial lives.
Reimbursement Intelligence only used people who are on the pharmacy and therapeutics committee and coverage committee that decided to cover both Medicare and commercial plans in their company. For example if Aetna has both a Medicare advantage and commercial productand. Our plans almost always follow the same policy for both medicare and commercial lives. The total Medicare lives represented by our survey respondents was 8MM covered lives.
The idea they are the wrong audience is not appropriate is sour grapes.. Also, there is a misunderstanding that we are saying plans do not follow the NCD. All Medicare patients have access to Provenge based on indication. That said there can be other requirements for use such as life expectancy.
My company does oncology research with top plans and this survey included Aetna, Humana, Express Scripts, United Health Care, Coventry, Healthnet including the Directors of Medicare Medical Directors.
Actually it is sour grapes that they do not like the results which were objective. They are entitled to their opinions either way.
Ed, I'm not sure over what period survey cited above was performed (it wasn't not shown in the article above), but CMS provided clarity on reimbursement on August 8, 2011, when it published the National Coverage Determination (NCD) for all Medicare Administrative Contractors.
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=344&ncdver=1&bc=AAAAgAAAAAAA&
The Q-code says that: "Q2043 Sipuleucel-T...including leukapheresis and all other preparatory procedures."
The final J-code for reimbursement will be published January 1, 2012.
An interview recently published on Seeking Alpha with Dr. Leonard Liang, a California urologist and transplant surgeon with a solo practice, suggests that the reimbursement problem is well on the way to being resolved.
http://seekingalpha.com/instablog/160858-theodore-cohen/203920-provenge-reimbursement-already-on-the-way-to-a-solution
What's clear, above all, is that the reimbursement and physician landscape is changing rapidly. For example, the last time I checked, there were over 600 providers authorized to administer Provenge. That hardly squares with the statement above, to the effect that there is "...an insufficient number of cancer centers willing to administer Provenge."
Reimbursement Intelligence needs to revisit this survey as it contains many inaccuracies. It's a shame! You call this a research company???
It's been a while since I looked into the Provenge issue so can anybody tell me off-hand how much the alternative treatments for these prostrate cancer patients cost, including all testing, administrative costs and lost productivity?
I've noticed that whenever there's a story about Provenge it always seems to focus on the high price, but the articles I've run across never include the cost of the other available treatments so readers can make a comparison.
It's about the same as chemo, as David Miller showed some time ago, Evelyn.
http://www.minyanville.com/businessmarkets/articles/dendreon-provenge-cost-taxotere-sanofi-aventis/7/29/2010/id/29371
Ed, I have a question for Ms. Greenapple. But first, a statement:
Ms. Greenapple's article appears to have been picked up/copied by a number of other venues around the Internet. One comment I found on the FiercePharma site (see below*) quotes that old canard regarding Provenge recipients enjoying 'only four more months of life.' The fact is, the MEDIAN survival advantage is 4.1 months, with some end stage PCa survivors who received Dendreon's immunotherapy surviving up to 7 years. A more understandable way of describing the benefits patients receiving Provenge enjoy is as follows: The pivotal IMPACT trial of Sipuleucel-T showed an extension of 4.1 months median survival time in the treatment arm beyond the control arm. Further, the odds of a patient treated with Sipuleucel-T surviving at 3 years was about one in three comparing to the odds of about one in five for an untreated patient. This level of efficacy coupling with a mild side effect profile [mile flu-like symptoms] was remarkable when compared to the current standard of care, the chemotherapy Taxotere, which showed only a 2.5 months median improvement with possibly delibitating side effects.
Now, have conducted surveys myself (though in another field), I know that what questions are asked and how they are asked can have a significant impact on the types and number of responses received. So, here is my question to Ms. Greenapple:
To what extent did the subject of "four more months of life" play in the questions asked of survey participants?
Thank you.
*"Reimbursement Intelligence's Rhonda Greenapple said doctors are likely to go through their own cost-benefit analyses when deciding whether to use Provenge. 'You're sitting in front of a patient with an 80/20 plan, and you know that this drug gives them only an extra four months to live," Greenapple said. "That's the issue. These patients have to pay 20%. It's one thing to say patients have access to the product, but that doesn't account for what patients have to go through in real life.'
Read more: Payers expect Provenge sales to stay flat - FiercePharma http://www.fiercepharma.com/node/60974/www.reimbursementintelligence.com#ixzz1W5mCApja Subscribe: http://www.fiercepharma.com/signup?sourceform=Viral-Tynt-FiercePharma-FiercePharma
In other words, there is no black and white comparison out there with dollar figures that the average reader who knows nothing about prostrate cancer, or it's treatment, could readily understand.
For instance, I think it would be highly relevant to show how many patients receive and pay for radiation before chemo and how many patients receiving chemo end up in the hospital, which certainly would add to the cost of that kind of treatment. And I would assume those hospitalized patients wouldn't be too productive.
That's why I find it amazing that everybody reporting on the matter keeps giving specific dollar figures for Provenge, which just happen to sound outrageous to the average reader, especially when they know nothing about the cost of the alternatives.
I don't mean to single you out Ed. I know you're just reporting on a survey that was done. But I can't help but wonder how many more ways the radiation-chemo cartel can come up to pound away on the same drum, without having to reveal the full, comparative costs of the alternative treatments.
Amen! And on another tack, there somehow always seems to be a mob out there with torches and pitchforks that is bound and determined to run Dendreon into the ground without stopping to look at the facts in any given issue. Yet, I have never seen one word in the press questioning the price tag, for example, of Bristol-Myers Squibb's Yervoy, which costs $30,000 per dose, or $120,000 for a four-dose course of treatment. I guess it's easier to get 'hits' on one's articles/Web site by kicking DNDN than going after a BMS, a Pfizer, of other member of Big Pharma.
Hi MyPharmalotID and Evelyn,
Thanks for the comments and the interesting discussion. I went back to the survey and I do not see questions that refer to the median of four months of additional life, one way or the other. And as the research firm noted, the responses reflect the opinions or outlooks of the payers. And yes, they are going to be interested in saving money. For the record, though, I have noted in past items on this site that the cost of chemotherapy may run about the same as the vaccine.
As to the other point concerning cost and whether it has been raised in connection with other drugs, earlier this week, I noted that Seattle Genetics is charging the equivalent of about $108,000 for its newly approved med for treating Hodgkin's Lymphoma and whether this might cause a ruckus. I ran a reader's poll, in fact, in which a slight majority voted this med is reasonably priced.
http://www.pharmalot.com/2011/08/hodgins-lymphoma-and-a-high-priced-drug/
The short answer is, yes, I do run pieces about drug prices on a regular basis, including those for biologics. Pricing also comes up in the context of importation, although that is obviously in a different context referring to other forms of medication. Nonetheless, medication pricing is a recurring theme. Read the site regularly and you'll see.
Cheers ed
It's a bit late to join this debate but working from memory, I was originally struck by the fact that Provenge was priced to exactly match the cost of the current therapy "all in" - which I decided was "it's what the market will bear."
The arguments seemed to be that the better quality of life and lower impact on the patient and family made it an added value, in addition to the median survival rate. That's a good argument - it was the setting of the Provendge price point that got the attention. At least that's what I remember thinking.
Thanks, Ed.
By the way, to the point of four months, please review this video.
http://www.youtube.com/watch?v=1MfVMVQO0Pk
Yea thanks Ed.
Again I didn't mean to single you out. Your site is my favorite on the internet and the one I read the most, so it's probably just that I end up seeing the news about Provenge here. I'll try to make a mental note that if another story pops up with the price, but no comparison, to go to the original site and bitch to make sure you don't feel picked on - cause I really don't mean to make you feel that way.
I think I did see the blog where you talked about the price of the lymphoma drug and didn't comment cause I know nothing about it.
While I've got your ear, I want to thank you for changing the verification methods to post a comment. I can do simple math but trying to read those letters was killing me. LOL.
Perhaps those in the media who read this Blog might find the following discussion useful when it comes to describing the benefits of Provenge:
Instead of talking about a 4.1-month MEDIAN survival advantage (which some people can’t understand because of the statitics involved), perhaps it would be better to talk about a 38% improvement in 3-year survival and/or a 22.5% improvement in risk of dying.
Or put another way, the pivotal IMPACT trial of Sipuleucel-T showed an extension of 4.1 months MEDIAN survival time in the treatment arm beyond the control arm. Further, the odds of a patient treated with Sipuleucel-T surviving at 3 years was about one in three comparing to the odds of about one in five for an untreated patient.
This level of efficacy coupling with a mild side effect profile [mile flu-like symptoms] was remarkable when compared to the current standard of care, the chemotherapy Taxotere, which showed only a 2.5 months median improvement with possibly debilitating side effects.
These data are substantiated by material submitted to the FDA by Dendreon, and are available in the archival literature.
I recognize that the 'easy way out' is simply to talk (erroneously) about a four-month life extension. But it is incorrect to do so and only shows ignorance of the subject...perhaps to the detriment of patients who could benefit from Provenge. Importantly, think about this: spreading false information about any treatment, even unknowingly, can kill if even one patient makes a life-determining decision based on something you wrote.
I have a couple of questions, Rhonda:
1. How do you explain the fact 95% of your respondents say they pay for the apheresis separately when this is impossible? Dendreon picks up 100% of this cost and even the newly issued Q-code indicates the apheresis is included.
2. At least one respondent mentioned weight-based dosing and a dose of 1,000mcg. Provenge is not dosed by weight and is a cellular product not measured in mcg. Wouldn't an "expert" in Provenge reimbursement know this?
3. If these "experts" can't get these most basic item of Provenge reimbursement correct, why should we believe what they have to say on anything else?
Am I correct in understanding there is no other FDA approved treatment for this cancer or any cancer that has efficacy equal to the extended median survival of 4.1 months... if there is what is it?
Yes...we are talking end stage prostate cancer only, here.
Prior to Provenge, the standard of care for this group of patients was Taxotere (docetaxal). Docetaxal showed a 2.1 month survival advantage over the then standard of care. This was a survival rate of approximately18 months versus 16 months, but with more debilitating side effects (http://nyp.org/news/hospital/209.html). On the other hand, Provenge showed almost double (4.1 months) the survival advantage of Taxotere and with relatively very mild side effects. This was based on a survival rate of approximately 24 months versus 20 months. However, Provenge was compared to a less effective version of itself in the clinical trial which itself conferred a survival advantage. The true benefit of Provenge is greater than 4.1 months median. The costs of Provenge have been shown to be similar to other treatments. A doctor who would not prescribe Provenge for a patient in this category is really doing their patient a great disservice.
Actually, I think the 4 month median survival benefit explains the situation pretty well. If you look at the survival curves in the prescribing information, the percentage of Provenge treated patients still alive at 3 years and 4 months is about the same as the number of placebo patients still alive at 3 years.
The oft-quoted increase in three year survival is often presented in a way that implies a huge increase in long term survivors. The survival curves do not support that conclusion.
Do most insurance providers cover the cost of the provenge vacine, or part of it? Just curious to know what to expect