What Insurers Say About The Provenge Vaccine
23 CommentsBy Ed Silverman // July 8th, 2010 // 7:21 am
The Centers for Medicare & Medicaid Services is unexpectedly conducting a national coverage analysis of the Provenge prostate cancer vaccine (back story), but what do private insurers think? A new survey of medical and pharmacy directors from 50 national and regional insurers finds two-thirds do not have concerns the vaccine is available, but 65 percent may restrict patient access in some form.
At the time the survey was conducted last month by Reimbursement Intelligence, 80 percent of the respondents hadn’t yet reviewed the Dendreon vaccine, but 74 percent expected to require some form of prior authorization - such as documented use of two courses of hormonal therapy - with only 19 percent indicating no restrictions. And 46 percent would not reimburse without prior chemotherapy treatment, while 56 percent will require documented metastatic disease for reimbursement. Since then Aetna and Humana offered coverage, albeit with some restrictions.
One participant, who was not identified, commented that Provenge “is an extremely expensive treatment and will probably be limited to as small a niche as possible. The price is not justified by the incremental survival.” The price, by the way, is $93,000 per patient, and led another respondent to say the best case scenario would be $300,000 per QALY, or quality of life year, which asseses the value of medical intervention.
“Payers are going to be much more skeptical of high-cost therpaies, especially Provenge,” says Rhonda Greenapple, who heads the consulting firm. “It’s very expensive and has a minimal survival rate - people are already refractory and get four months for $93,000. There are many states where you must put oncology drugs on formularies, but insurers will try to limit this and put as many hooops as they can for doctors. The number of requirements and restrictions will be the issue.”
For instance, Provenge clinical trials demonstrated a four-month survival benefit, while the survey revealed most payers believe a six-month survival benefit for a new drug would demonstrate a clinical benefit over standard care. And 50 percent foresee vaccine usage based strictly on the label.
Another interesting finding - 46 percent believe oncologists will be hit harderst by Provenge as urologists and aphresis centers are given the opportunity to administer the vaccine.
myPharmalotID
Scheeeeesch…where do you dig up these people up, Ed. May I respectfully suggest you first issue a test to the people you interview, making sure they understand what they are talking about. Once again, you quote someone who apparently hasn’t CLUE ONE regarding the advantages to using Provenge. I quote:
“Payers are going to be much more skeptical of high-cost therpaies, especially Provenge,” says Rhonda Greenapple, who heads the consulting firm. “It’s very expensive and has a minimal survival rate - people are already refractory and get four months for $93,000.”
Who does she work for? The chemo cartel? Please send her the following, if you would be so kind:
Three Phase 3 studies involving 737 patients were submitted to FDA to support licensure. The pivotal study was the Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial (D9902B), a 512-patient, multi-center, randomized, double blind, placebo-controlled study that evaluated men with asymptomatic or minimally symptomatic, metastatic CRPC. Provenge extended median survival beyond two-years, demonstrating a median improvement of 4.1 months compared to the control group (25.8 months versus 21.7 months). Overall, Provenge reduced the risk of death by 22.5 percent compared to the control group (HR=0.775). Results from the similarly designed Study D9901 in asymptomatic metastatic CRPC also demonstrated a survival advantage of similar clinical magnitude as the IMPACT study.
As noted by David Penson, M.D., Professor of Urologic Surgery at Vanderbilt University Medical Center, “The approval of Provenge represents a significant advancement in the care of men with advanced prostate cancer. Provenge offers a new choice in the front line treatment for these men who – until today – had few appealing treatment options.” [Emphasis added.]
http://www.psa-rising.com/blog/2010/04/fda-approves-provenger-for-the-treatment-of-men-with-advanced-prostate-cancer/
Maybe the first question on your test should be: Can you tell the difference between average and median?
My G_d…how many times do we have to go through this?
rhonda
in fact all the payers saw the Phase III data but in their mind of many whether median or mean it is not enough.
Payers are not oncologists and look at all the treatment comparators and their costs. As comparative effectiveness research grows in the US, your comment is irrelevant since the impact of 4.1 or 5.1 months on survival based on cost per QALY it will still be a high cost for incremental survival.
Kerry Donahue
Rhonda
The study (IMPACT trial) of Provenge compared itself in some instances to patients that were on the control arm (placebo) of the trial, but were allowed to cross over and use a weaker (frozen) form of Provenge. So, Provenge, at times, competed against a lesser version of itself. Dendreon cannot tout that which it cannot prove but the expectation is that Provenge will increase life much more than 4 months. For many men that have taken Provenge they have lived quality lives for many years. Many of the men from the trial are still alive so if the trial was still tracking these men, in an official way, then the median would still be increasing. We don’t know exactly how well it will work but there are signs that when men are treated earlier, Provenge is more effective. Many of the trial participants were the sickest of the sick. Immunotherapy is a new paradigm and at this point the absolute best way to use it is not even known. It will become known over the years and looking back ten years from now this debate will seem silly. Many men will be speaking!
Also, Ed, I see where you said a significant amount of the insurers will require chemotherapy first. That is a mistake because many men will refuse chemotherapy due to the severe side effects. In addition it has been demonstrated that if chemotherapy is to be used that it should be used after Provenge not before.
Thanks.
kyoto27
Rhonda, Provenge showed a 14.2 month survival benefit over the 25% of men who were “pure placebo” and elected not to cross over. This would be the largest survival benefit EVER in any late stage cancer trial. And all the results of the IMPACT trial will be published soon in a major medical journal. In short, Provenge is the real thing with real survival benefits and a quality of life that are unmatched.
David Miller
If you had done much work on this drug, the outcome of your research would have been different and, I dare say, more accurate.
The last line in your quote is most telling:
“Another interesting finding - 46 percent believe oncologists will be hit harderst by Provenge as urologists and aphresis centers are given the opportunity to administer the vaccine.”
Talking to oncologists about Provenge is always going to give you a skewed result. Most don’t understand the drug and those who do are scared to death of it because they know it will delay the time to when they can get their hands on PCa patients from the urologist.
I note the oncology community tried (and failed) to launch over three dozen trials trying to bring Taxotere to early-stage PCa patients based on a median OS that Provenge exceeds by 177%. There was no reimbursement brouhaha even though recent research shows the average cost for chemotherapy at over $100,000 per patient.
In this day and age where anyone can have an opinion and the fact it shows up as words on a page on the web lends credence, those of us who are quoted as experts have a responsibility to be careful to ensure the conclusions we draw are supported by facts.
Ms. Greenapple fails her responsibility here by not digging a little further to place Provenge in context and by failing to understand possible motivations behind those who are giving her information.
Our firm has covered Dendreon from the financial side for almost 10 years. We were the only firm to consistently state Provenge was a safe and efficacious drug during this period. It’s likely we’ve talked to more docs and KoLs about Provenge than any other firm.
Ellen M Martin
Lots of shooting at the messenger here. You may be passionately convinced of the “obvious” survival benefit and the superiority of a Provenge-before-chemotherapy regimen. And the evidence cited may well even support those positions. But a reasonable sample of payers don’t see it that way right now, and in a health care system where patients mostly don’t pay for their own treatment, the PAYERS are the people you will have to convince, not the folks doing the market research.
rhonda
I do not understand why the commenters can not understand this is PAYERS response to the data. It is not meant to change the trials. Whether the drug works or is the best treatment ever Payers do not match the perspectives of patients and providers.
The sad thing is those who are so focused on selling the drug and only their perspective the lose the point of the survey.
If manufacturers used this information effectively than there products would have more commercial success.
Again, mr Miller did not read the article because he thinks I spoke to oncologist.
Perhaps he should reach the article.
mitch
“Provenge showed a 14.2 month survival benefit over the 25% of men who were “pure placebo” and elected not to cross over. This would be the largest survival benefit EVER in any late stage cancer trial.” — The above statement is misleading: the 25% fraction of “pure placebo” patients had worse clinical prognosis based on their baseline characteristics. So, in reality, those pure placebo patients died faster, rather than the rest of the placebo and provenge patients living longer. You can compare their baseline prognostic factors and median survival to placebo groups from other prostate cancer trials, or to the Provenge patients from the same trial: they are distinctly worse off.
myPharmalotID
By the way, just to clarify the current situation, here is an except from an e-mail one investor received this afternoon from Dendreon IR:
“Last week, the Centers for Medicare and Medicaid Services (CMS) initiated a National Coverage Analysis (NCA). A NCA is generally a review of evidence to determine if the use of a product is reasonable and necessary. In CMS’ announcement of the NCA, CMS stated it is requesting public comments on the effects of PROVENGE on health outcomes in patients with prostate cancer. It is not a change in Medicare coverage policy.
“What that means for physicians is that NCAs do not impact existing coverage decisions, nor do they restrict local Medicare contractors from covering PROVENGE. Therefore, Medicare beneficiaries are still able to access PROVENGE and private payers can also still cover PROVENGE.
From: Rightmire, Judy (jrightmire@Dendreon.com)
Sent: Thu 7/08/10 3:22 PM
Source:
http://www.investorvillage.com/smbd.asp?mb=971&mn=361096&pt=msg&mid=9242826
William Sheakspeare had it correct:
“The first thing we do, let’s kill all the lawyers”. - (King Henry VI, Act IV, Scene II).
Paladin
Reply to Rhonda’s Payer comments, since the other issues were covered so well by others:
You brandish the word “payers” about as friends soon to part. Possibly, this is your driving force. A fight to the bitter end of ones cash cow.
Listen,you say this is about the payers perspective and others don’t understand when you have shown, either complete ignorance of the data, or a clear understanding of the data. The latter being far worse since knowingly misinforming payers and whoever else may be reading your words to save your clients skin or their money pit, is truly a terrible thing. In other words you wouldn’t be caring about the payers perspective other than controling it to suit your own agenda. Giving you the benefit of the doubt I’ll assume your simply ignorant of the data. Therefore, I’ll give you some advice: subscribe to Miller’s research, check out Frog’s research on Investor village, and by all means quit speaking on this topic until you become better informed. Oh I had an after thought, how about reading Provenge’s trial data.
-Paladin
grr
Why would payers object to paying $93,000 for a life extending treatment that has few side effects, is more effective, and less expensive than chemo which they currently cover?
Chemo costs even more than Provenge when you add in all the additional treatments for the horrendous side effects (which includes death).
If the payers want to balk at paying for a treatment, they should balk at paying for chemo, now that Provenge is available.
Ed Silverman
Hi Folks,
I appreciate the comments here, but would like to remind everyone to please engage in civil discourse.
I liken this site to a large lawn party in which one can wander among groups, stopping to listen or participate when the mood strikes. But the verbal equivalent of throwing wine glasses makes the atmosphere uninviting.
For those who may be unclear, the survey canvassed private health insurers and does not represent the opinion of Rhonda Greenapple or Reimbursement Intelligence.
Feel free to debate, but please confine your remarks to the issues at hand.
Thanks,
Ed
OncologyWonk
“And 46 percent would not reimburse without prior chemotherapy treatment”
This frightens me as the Provenge label is for mildly syptomatic or asymptomatic mCRPC. The data does not support having the patient fail chemo first. The respondents to this survey would be wasting the $93k giving it to post-docetaxel patients where there is no proven benefit. So my takeaway is that these respondents don’t yet understand Provenge/IMPACT trial or were given inadequate product profiles as part of the research. I appreciate insurers wanting to control use of the drug, but I hope they will at least make the effort to understand where it works before making decisions.
old prof
Cost per QALY is not an appropriate measure for assessing the comparative value of therapies used for end-of-life care. (Frankly, it’s not much use in other types of coverage decisions due to 1) the lack of a universally-accepted measurement and 2) its failure to consider budget constraints.
What payers dislike are pricing surprises and the uncertainties associated with predicting utilization.
Rick
Ed Silverman,
Throwing wine glasses at each other is nothing compared to the disservice you are doing to cancer patients with shoddy/biased/incomplete research and leading patients to chemo rather than to a proven life savings drug. When are you going to say that chemo and related costs are higher than what it costs provenge?
Ed Silverman
Hi Rick,
Thanks for your note. but I’m afraid you seem to have misinterpreted the post, which was a survey of what insurers told a consulting firm.
I applaud the debate surrounding the vaccine, which I have covered since 2007, particularly the concerns about charges of undisclosed conflicts of interest that were leveled at FDA advisory committee members.
However, it seems there remains some confusion about the fact that the survey captures what insurers were thinking last month. It does not represent my view of the vaccine or any issues concerning the product.
Those who are upset with the results may want to consider contacting their insurers.
I hope this helps,
ed
Bill
I am somewhat curious as to how Mitch came to his findings that the 25% arm that did not cross over to Provenge/Frovenge had a “worse clinical prognosis based on their baseline characteristics”. Can you share the source of your knowledge with us Mitch?
yobo
Hey, the bottom line is it extends life 4 months for a lot of money (read very, very carefully the studies). And it may not be “good” life… no ballroom dancing. Currently, here in the US we leave it to the evil insurance companies to make these judgements and then we get upset with them. Also, Medicare - the government - is the largest insurer in the US and they are by far the biggest denier of care, including cancer treatments, than any other insurer, but for some reason we don’t get mad at them. Could it be that it’s because the media doesn’t repot it? Anyway. Plus things will probably get worse rather than better with Obamacare. Example: look at the Untied Kigdom’s agency, it’s called NICE, that approves medicines and what they’ve done with Avastin from Genentech/Roche. Avastin is a fairly well proven therapy for cancer yet NICE will not approve it for certain cancers that we here in the US routinely use it for. Prediction: no way will NICE approve Provenge either! And we will see these types of decision from our bureaucrats going forward too.
MikeK
How about we listen to a family member who’s grandfather got to enjoy 8 more years of life as a result of Provenge. This man’s doctor told him it didn’t look good for him and then he went into a Provenge trial. Also remember, the treatment was tested in the worst case scenarios. I say start rebuilding the immune system ASAP. Here is that story:
About six years our grandfather was diagnosed with prostate cancer. It was a difficult time for me and my family because he was the patriarch of our family. We had always known him to be very energetic and fun. In fact, at 60 he started his own business. He enjoyed taking us camping and to the movies, and for his age he was extremely active. Shortly after the cancer spread to his bones, however, he became listless. He no longer had the energy or the will to do things he regularly did. He was often tired and wasn’t able to play with his dogs or take his regular walks. His illness was keeping him from doing the things he loved.
Doctors offered him few treatment options, including radiation and chemo. They warned him about the side effect profile and the little benefit they may - he may receive from treatment for his advanced diseases. My grandfather refused because, as he put it, he preferred to die with dignity. Then his doctor mentioned a study that was being done for an experimental treatment. We urged him to try it and he figured he had nothing to lose. Just a few months after beginning the clinical study for Provenge, his bone scans showed that the cancer had stopped growing. After a while, he started to get some of his energy back. Even his mood improved. He was able to play with his dogs again, which you have to understand is a very important part of his life. He was able to travel and see his friends. He was back to doing the things that he loved to do regularly before the cancer. As you can imagine, it was a relief for all of us.
Before my grandfather took part in Dendreon’s study, we had been preparing ourselves for the end. This new drug offered us some hope. We’re grateful for it because Provenge extended his life. Since taking Provenge he’s had the opportunity to see two grandchildren get married and the birth of his first great-grandchild. He’s taken multiple trips to Mexico and toured around Europe. He’s even making plans to open another business. As far as his family is concerned, we’re extremely grateful for Provenge because it’s given us more time with him.
David Miller
Rhonda, if you think these insurers are not getting their opinions on this from oncologists, you have a great deal to learn.
A few points:
1. If you think Dendreon did not do exactly this analysis long before your firm, you are mistaken.
2. With 80% of respondents saying they haven’t done a review, I submit the data are not particularly instructive. “I don’t know what I’m talking about but here’s my opinion” sounds like what this survey does.
3. 65% of the respondents said they’d do a restriction. 50 percentage points of that 65 is restricting it to the label. No surprise there. The remaining 15 percentage points are likely to be pre-authorization (Dendreon is geared up for this already with their call center), proof of hormone-refractory disease (ditto), and statements like “require metastatic disease” which are already in the label.
P888
Very sorry for patients. HOwever, big big issues coming up in trial design. Placebo patients lost a lot of tcells that Provenge patients did not — expect FDA might re-examine this one. It looks like placebo arm could have been harmful.
Full analysis here if interested:
http://mfi.re/?zdiewnyttqg4vnz
Provenge Analysis
Kim
I’ve also done several qualitative studies with MCOs (who by the way are not payers but rather financial intermediaries for the real payers–employers and government agencies) on various specialty drugs over the past couple of years. The results of this study are pretty consistent with what I’ve seen in my own work.
There’s a bigger question not addressed here which is “what’s the patient’s cost sharing obligation for this product?” We’ve seen a relatively significant move to impose ingredient-specific cost sharing burdens on patients for products administered under a medical benefit (as Provenge certainly will be). The EMD Serono Digest says that over a third of commercial plans and over half of MA-PD plans already do so. Co-insurance is far more common than co-payment, and the most common requirement is 20%. All things being equal, that would be about $18,000 a year for Provenge. While most plans currently have caps on patient out-of-pocket costs (often in the $3,000-$5,000 range per specialty Rx), I’m hearing from MCO medical and pharmacy directors that in the future those caps will be going up dramatically and possibly disappearing altogether. Therefore, a better question than the one on coverage is “how many potential advanced prostate CA patients are willing and able to come up with the money to cover their escalating cost sharing requirement?” I’ll bet that given the relatively low net worth of average Americans, that number is a lot lower than many people would expect.
DC
Wow P888 that’s actually interesting data you’ve posted there.
People who have an emotional or financial interest in the success of this experimental treatment should probably stfu for a minute.
The same shrill “debate” over payment for bone marrow transplants in late stage breast cancer didn’t help the thousands of women who needlessly suffered gruesome graft versus host exits.
If you’re unable to even consider the possibility that Provenge is more hype and hope than benefit, then sit back and be quiet as the adults review the risks and benefits. We’ll let you know whether to move your venture capital elsewhere.