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Post by Allen on Jul 8, 2014 21:14:53 GMT -8
ASTRO, in their recently published model policy, wrote: Lancet followed with an editorial in which they wrote: Pretty strong language!
I think randomized clinical trials (RCTs) and registries are great. We should have more of them for every treatment. I also agree with Lancet that proton therapy benefits, if any, may not be worth the cost. My concern, as a patient advocate, is the dampening effect such statements may have on innovation. I also wonder if proton therapy is being held to a higher standard than other therapies.
Robotic surgery never had to beat open surgery in a randomized clinical trial. In fact, a recent analysis showed that it probably would have failed in a RCT in its early days while most surgeons were on their learning curve. Even now, robotic surgery, while prevalent, has not been found to have any cost/benefit advantage over open prostatectomy (see this link)Yet more costly robotic surgery has largely supplanted open surgery.
While IMRT has recently shown a small toxicity advantage over 3DCRT in primary PC therapy, in salvage RT it seems to confer no significant efficacy or toxicity advantage, yet it costs more. This has been demonstrated repeatedly (here and here). Yet IMRT has largely supplanted 3DCRT with the tacit approval of ASTRO and without benefit of RCTs or registries.
The use of SBRT as primary treatment for favorable risk PC began in 2003. While it began with a non-randomized clinical trial, CyberKnife treatment centers soon sprang up all over the US in spite of the fact that it never went head-to-head against IMRT in an RCT. (There are RCTs in process now that will do that.) An SBRT registry was established just a couple of years ago. The results so far, both oncological and toxicity, have looked excellent in monadic testing, and it has a cost advantage over IMRT. It recently received ASTROs imprimatur. Here’s what they say in their model policy on SBRT: As an aside, I would quibble with ASTROs call for 10-year results for SBRT, since there is only one series of dose-escalated IMRT results that has run that long. Why are they asking for more proof from SBRT than they ask from IMRT? And why isn’t proton treated the same way as SBRT?
LDR brachy, the least expensive and one of the most effective radical therapies, would never be used if it had had to prove itself in RCTs in its early years. Here are the rather dismal early results at UW Seattle, arguably the best seed center in the world.
And what is the gold standard that proton therapy ought to be measured against? Active Surveillance for low risk? LDR brachy monotherapy, because it’s the least costly? HDR brachy monotherapy because it has the lowest level of sexual, urinary and rectal side effects with some of the best oncological outcomes? SBRT because it’s the external beam version of HDR brachy or because its cost is the lowest of external beam therapies? High dose IMRT just because it’s been around for 10+ years?
Recent reports of proton therapy at centers that have used the newer pencil-beam proton devices are impressive in oncological control and toxicity. They have the potential to far exceed their older conventional proton brothers, which don’t seem to be any better than IMRT.
While cost is indubitably higher for proton vs IMRT, we don’t seem to question the very high costs of such treatments as Provenge, Yervoy or Xtandi that only add a few months to life expectancy. Rightly so, in my opinion. Perhaps trials of proton hypofractionation will reduce its costs. Perhaps it will find new uses in be-bulking or met treatment. Shouldn’t proton therapy be encouraged to mature and perhaps reduce its costs?
I am suggesting that there may be an advantage in letting new therapies go through a gestation period.
Perhaps some of the doctors involved in research on innovative technologies would care to offer their perspectives.
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Post by John thompson on Jul 17, 2014 17:01:10 GMT -8
Comments from Dr Brian Lewanda:
My thoughts about protons are unchanged from my blog article on it. There are no data showing superiority of protons for prostate cancer over IMRT. Until we have that we can’t really justify a treatment that costs $50-250K compared with $15-35 (IMRT.) Studies need to be done and they should enroll patients prospectively whenever possible.
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Post by Tony Crispino on Jul 17, 2014 19:04:50 GMT -8
In further dialog, Dr. Lawenda also pointed out that what is needed is a strong RCT to prove it effectiveness. It's important to point out that as the Chief Resident at the Harvard Radiation Center, he is quite experienced with PBT. I pointed out that Harvard and MD Andersaon are currently enrolling patients into a clinical trial comparing IMRT and PBT: PARTIQoL Trial
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Post by CedarChopper on Jul 21, 2014 8:31:21 GMT -8
Not specific to the prostrate nor the specific talking points of this discussion - but proton therapy technology is still advancing and the cost will come down - much like it did for DaVinci Robotic equipment. Studies not influenced by interested parties is the goal. Today from FermiLab: www.fnal.gov/pub/today/archive/archive_2014/today14-07-21.html
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Post by Allen on Jul 22, 2014 8:21:17 GMT -8
Thanks for supplying that link, CedarChopper. I agree with you that costs will come down with volume, time and competition.
A proton CT scanner, if built into the proton beam therapy, would be similar to the way Tomotherapy operates with X-rays. I can see a big advantage in that it could account for intra-fractional prostate motion, thus reducing toxicity.
I've also had my eye on carbon ion beam therapy that has been used for several years now in Japan and Germany. It seems to get around some of the problems (e.g., secondary neutrons) inherent in proton therapy. I haven't seen one proposed for the US yet.
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Post by KC on Jul 22, 2014 13:24:43 GMT -8
I’d like to follow-up with a commentary about treatment costs, and in particular to the comment, “but proton therapy technology is still advancing and the cost will come down - much like it did for DaVinci Robotic equipment.”
My comments here are all directly related to cost, not necessarily related to outcomes with the different technologies.
First a few comments about costs related to the Intuitive Surgical Inc. da Vinci robot, which is the only FDA approved surgical robot currently on the market. Robotic technology has penetrated the deepest in the field of urology, and the radical prostatectomy (RP) is the most common application. The market ramp-up has been dramatic—in 2001 only 1% of all RPs were robotically assisted, but by 2009 more than 50% were robotic.
The costly outlay for a hospital to acquire a da Vinci robot is significant, on the order of $1-2 million (newer versions are more expensive, and without competition this cost has remain relatively constant across the nearly 2,000 (by January 2013) units sold. Furthermore, the ongoing annual maintenance/service cost is reportedly $340,000, and robotic surgery requires disposable or limited use instruments (versus the mostly reusable instruments in open surgery).
The primary potential for overall cost savings (to the patient) is a decreased hospital stay, and indeed there is a cost benefit for the shorter average length of hospital stay (one day) for robotically assisted RP versus the average two day stay for open RP, however, that savings does not make up for the higher operating costs of robotic RP, even before considering the additional cost for the purchase and maintenance of the robot.
A second (interesting) perspective is the potential cost benefit to the hospital, rather than to the patient. When a hospital is deciding whether the purchase of a robot is appropriate for their institution, it is looking at a large upfront investment and yearly maintenance costs which are not directly passed on to the patients. The financial decision is based on the number of nights in the hospital (previously mentioned) that is saved. From the perspective of the hospital which is constrained in the number of in-patient procedures they can perform due to a shortage of beds, the investment in a robot could generate significant financial returns by conducting more procedures.
For instance, if we assume a hospital can use the robot on 280 cases annually and that these procedures reduce patient hospital stay time by one day relative to open procedures, the hospital would gain 280 bed days of capacity. The hospital could fill those beds by conducting more procedures. If the average in-patient procedure requires one day of hospital stay, the hospital could perform 280 additional procedures in a year. Finally, if each of these procedures generates $4,000 of contribution margin to the hospital, total value created for the hospital would exceed $1.1 million dollars annually.
Interesting perspective into the business of medicine for us laypersons! A long winded commentary, but bottom line is that robot RP costs have not dramatically gone down, nor will they until there is increased competition in the market place.
While the start-up costs of robotic surgery are “significant,” the costs related to starting a proton beam therapy (PBT) facility are “colossal,” in the range of $100-300 million. The high cost is driven by the need for a dedicated particle accelerator and beam transport system, housed in a concrete vault to shield radiation, and there is little indication that these high construction cost would actually decrease. There are currently 14 proton centers in operation in the U.S., and 12 more are in development.
Much of the current PBT cost controversy is because the PBT centers can cost 10-times as much to build compared to the similarly sized conventional facility (without demonstrating improved outcomes), and also have higher operating costs for treatment planning, quality assurance, machine operation and maintenance.
One troubling aspect of PBT is the notion that it is a “solution looking for a problem, and it has found prostate cancer.” Financial pressures have driven PBT centers to seek an expanded market share of PC cases. The only business model that makes any sense is treating a lot of PC cases, and PC now makes up nearly 50% of the caseload of most PBT centers. At the cost of each PBT centers, how many more PC cases must be diagnosed to pay for the number of centers in existance or in develpment? The societial costs seem very large.
The best opportunity for some limited cost reduction is with the future advent of compact PBT centers, but those (not yet FDA approved) will (at least initially) be focused on treating cancers of the breast, chest, central nervous system, head, neck and eyes.
I don’t see a lot of cost reduction likely going on for either robotic RP or PBT...not in the near future.
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Post by Tony Crispino on Jul 22, 2014 14:09:17 GMT -8
Robotic RP costs are expected to continue to decline. With more and more devices out there, and that Version 6 is said to be the least expensive when it gets released later this year, you will see a natural drop. The one thing that can slow any drop is less use. If there are going to be less procedures then the maintenance costs will hold the pricing where it is.
Same is somewhat true with PBT. There are concept drawings for community base PBT already in testing but it will be years before we see them coming to a clinic near you. The costs of deployment are still high. The cost of maintenance of a single proton treatment position roughly 5 times that of an IMRT device. PBT will never be comparable in cost to IMRT. And using IGRT technology has shown to be just as effective in claims and little evidence to the contrary.
Personally, I do not think the Lancet went too far. I think the PBT clinicians and providers went way too far in not posting efficacy studies to date. Loma Linda went online in the early 1990's. The best opportunity to prove anything has left us all glowing in the dark.
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Post by Tony Crispino on Jul 22, 2014 17:31:09 GMT -8
Just some graphics in the files attached: Davinci1: Set up for surgery. Davinci2: The robot Davinci3: A typical surgery with doc at the console.
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Post by CedarChopper on Jul 22, 2014 20:31:25 GMT -8
Hello KC! Nice discussion of some of the money pressures on treatment choices and - therefore - pressures for skewed research. Like the "solution in search of a problem" (device in search of a procedure), too often research is a policy in search of unethical and/or skewed and/or sloppy research.
KC, when the "GENERIC" version for robotic surgery and ("Tomotheraphy X-Ray" technique for- Thanks Allen) PBT enter the healthcare market, advances in technology will bring the costs down. Until then, so many interests will try to recoup their costs. (cf., My type-2 anti-tensor receptor blocker blood pressure med went from $120 a month to $5 the day it went generic.)
As Tony noted, the fly in the ointment is the new pressure from the ruling bodies to stop testing and discourage treatment (e.g., prostrate and breast). Their data seems self-serving, too. Their policies will be reflected in each of these decision trees.
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Post by Allen on Jul 22, 2014 21:30:14 GMT -8
There actually are other uses for PBT other than prostate. Michael Steinberg, head of radiation oncology at UCLA, said UCLA will be building one, principally to treat pediatric tumors. We'll have to see if they stick to his policy, especially with Scripps and Loma Linda so nearby.
I agree with Tony that there has been a dearth of basic efficacy data, and perhaps they are getting their just deserts for that unprofessionalism, if not deceptive practice.
I also agree with KC that it's hard to see how these investments can pay out without PC patients. But as a former marketing guy, I see another perspective. Some institutions want to be known as the ones who have all the latest sexiest equipment. That image attracts patients, and the prestige is attractive to donors (who contribute a surprisingly large share of capital costs.) The other perspective, which I personally very much lack, is that of the 1%. To those for whom money is no object and who have elite insurance policies, protons will be a badge of distinction. Since many of these rich folks are older, this may be a big market for them. The proton folks have the sales end down pat, and follow up with a great communal spa-like experience (at least at Loma Linda). These people will not be troubled by the lack of randomized clinical trials.
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Post by KC on Jul 23, 2014 13:45:09 GMT -8
I’d like to add an update on da Vinci robot costs to my earlier posting…
• I under-reported the numbers of da Vinci units which had been sold. The installed base as of end of 1Q 2014 was 3,039 globally, 2,116 in the US alone. Since 2011, greater than 25% of their new robot sales has been from “trade-ins,” which has generally meant a greater number of features and higher price per unit.
• The newest model robot—the da Vinci Xi—was just released in the US in 2Q 2014. Pricing of the new model, as expected, did NOT decline from the previous model (the older model is shown in Tony’s posting, above). The new Xi model price ranges between $1.85 million to $2.3 million, depending on options purchased.
• Intuitive Surgical will also release another new model—the da Vinci Sp—in 2015 (under development now) which will cost less than the Xi, but it will have a more limited capability (not intended for RP). The Sp is for single-incision procedures only (cholecystectomy and benign hysterectomy/oophorectomy).
• Interestingly, BTW, Intuitive makes MORE REVENUE from the ongoing sales of instruments & accessories ($1.0B in 2013) than in sales of robots ($0.8B in 2013). Annual services agreements added $0.4B revenue in 2013.
• Speaking of marketing, Allen, Intuitive’s strategy of simultaneously marketing to hospitals AND directly to consumers was brilliant…
Re-emphasizing, the PBT cost driver is construction. Anyone seen construction costs go down…ever?
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Post by Tony Crispino on Jul 23, 2014 15:23:58 GMT -8
There are cheaper options available right now: "The Mevion system's smaller cyclotron costs around $30 million, compared to $150 million to $250 million for a traditional cyclotron. It also takes up significantly less space. However, the Mevion system treats only one patient at a time, compared with the $220 million Scripps center, which has the capacity to treat five patients at a time." This is from this interesting article on PBT centersSo yes it is getting cheaper ~ depending. A 30m unit, a 150m unit, and a 250m unit all described here. I do not have a features and specs but I have heard that the lesser expensive units are coming out and this article agrees. But a lot of Q's need to be settled. Is the Mevion S250 as efficient as the other larger units. Heck we don't even know how effective the larger units are compared to IMRT. So PBT get's the big Q of the day. Why have these centers been slow to providing peer reviewed data? Very suspicious.
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Post by Tony Crispino on Jul 23, 2014 16:24:11 GMT -8
And BTW, IGRT Truebeam linear accelerators cost about $2m each and can also serve 20 patients per day by treating one at a time like the S250 "mini-cyclotron". Not sure of the cost of a Cyberknife? But that's one at a time as well. I understand from a few "brothers of the balloon" that they were on the table longer than I was. I was only on the table about 10-15 minutes for 39 fractions. My longest time on a table involved casting, mapping, tattoos, and yuckie tasting drinks. And I'm not a fan of noisy MRI machines.
But those are things you have to do in all cases. PBT equipment is expensive and the costs are passed down the line. Now it only makes sense to prove its efficacy.
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Post by Tony Crispino on Jul 23, 2014 16:56:10 GMT -8
Kurt in the link below the cost of the newest Davinci system is as you stated. However, the next line points out that older versions will remain available. These systems will have to be marked down significantly and typically are. The Davinci prior to last months release was about the same price as the new product but simple consumer rules apply. They'll continue to sell the older products with new rebates or discounts and there is a market for them. Davinci XiIn addition, one of the reasons that Intuitive Surgical (IS) posted slow numbers last quarter was do to a lack of trade in value for existing installations. Something they were addressing. I can also see a market for "Re-Furbished" units increasing with time as they take them back in. But the comment I made before was that the cost of the latest Davinci surgical systems was going to come down with a newer product release ~ is correct in that there are older models brand new available from IS with lower price tags. Used Davinci market -----So your center has a "new" Davinci? You might ask what model? Or... What do you mean by "new?". I'm sure there are plenty of used linear accelerators out there. Probably not too many used cyclotrons... But I could be wrong.
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Post by KC on Jul 24, 2014 6:04:29 GMT -8
Hahaha…now there’s a marketing slogan opportunity for the “used” robot market:
“Come have your prostatectomy at Converse County Memorial Hospital (Wyoming)…our new, ‘road tested’ robot has lots of experience, even if our surgeons don’t.”
No, the “used” robot market is mostly overseas, in Intuitive Surgical’s largest growth markets: Europe, Japan, Australia, South Korea and Canada...in markets where their healthcare expendatures are not so insatiable and limitless. Their long-term growth plans are targeting a 50%/50% split of robot sales between US and international markets (today, sales in the US makes up 70% of sales).
Converse County Memorial, in fact, just bought a new $2M da Vinci robot (interesting article on the business side in the periodical “Modern Healthcare”). Their return-on-investment won’t be as fast the big city hospitals, but they were losing patients (procedures, ie, revenue) to another hospital many hours-drive away because they didn’t have the flashy new robot. They couldn’t afford NOT to buy the robot. In fact, they were also losing out on surgeon recruiting opportunities—which in small communities is a very big problem—without the robot. Doctors coming through the major medical education centers have all been trained on the robot and want to go work in a community that has that asset.
BTW, regarding the economics of the smaller PBT centers (which cost only about 20% as much as the larger centers), treating one patient at a time versus five at a time only has 1/5th the revenue opportunity...the cost-per-unit is not very different.
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Post by Tony Crispino on Jul 24, 2014 11:14:25 GMT -8
One other cost factor is real estate. If the smaller units don't have a "campus" requirement that makes it much cheaper. In fact in the attached press release the system was delivered in one day in New Jersey. This may revolutionize PBT construction and implementation. Press Release from MevionClearly much smaller than full scale PBT systems.
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Post by KC on Jul 25, 2014 10:50:51 GMT -8
Tony, again, the size of the facility (the real estate) will indeed be proportionally smaller, and if your perspective is that of the business entity (or the investors), that can be a big plus (especially in the smaller communities that are installing the Mevion systems). Smaller machine, less real estate, etc. all translate to a lower barrier to market entry. In other words, less capital $$ they need to raise to break ground. But the revenues, as I pointed out, are similarly proportional to the costs. (The costs for the large systems are about 5X or more, but the large "campus" facilities have capacity to serve 5X as many revenue-generating patients...and, in fact, the large facilities would have some economies of scale that the smaller units wouldn't have, but these are "small potatos" compared to the astronomical PBT facility costs large or small.) If, on the other hand, your perspective is that of the payer (or responsible citizen) instead of the profit-oriented business entity, the size of where you were treated is going to mean next to nothing. The cost of providing service per patient (and therefore the price charged per patient) will be about the same in both the large and smaller institutions…and this will be the lingering issue for insurance companies, Medicare and our society which to deal, someday, with runaway healthcare costs…clearly. As Amitabh Chandra, director of health policy research at the Harvard Kennedy School of Government said in a ModernHealthcare article, “It's very hard to spot waste in healthcare. Proton therapy is an example of waste you can spot right away.”
There are good uses for PBT, to be sure. But here’s a discussion in this article ModernHealthcare which highlight what I will phrase as the “ moral” issues with prostate cancer treatment: Proton-beam centers sprout despite evidence drought. Please do read the article for yourself, but you will find that Mayo Clinic took a stand to NOT treat low-risk prostate cancer patients with PBT, despite the rush of other PBT centers to fill greater than 50% of their appointment bookings with PC cases. Dr. Robert Fotte, chairman of radiation oncology for Mayo said, “We had never planned on treating early stage prostate-cancer patients. A lot of those men [low-risk] don't need any treatment at all.” Mayo will, by the way, treat intermediate- or high-risk patients, but through institutional donation funding for their PBT they did not have to depend on the abundance of low-risk PC patients to fund their system. Nice moral position.
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Post by lupronjim on Aug 1, 2014 11:20:08 GMT -8
Tall Allen already made the point that proton goes way beyond PCa. I am a member of Univ of Florida & Shands Metastatic Disease Program who built the second PBT Facility in Jacksonville FL with first being MD Anderson. I actually go to Gainesville facility that is a couple hours closer to where I live. When I met the director of admissions who himself is a radiation oncologist I commented on how impressive the You Tubes on the VERO technology were, and his reply was hopefully that's the closest I ever get to it, not pejoratively, just that there are other options My medical oncologist at Shands advised that PBT is more for very precise treatments like a child's brain cancer. The one thing I have continually observed is that those who have had the PBT are all zealots about their choice, I have yet to hear any one speak adversely about it other than the costs and insurance issues. protonbob.com/proton-treatment-homepage.aspLupronJim
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Post by Allen on Aug 1, 2014 12:23:13 GMT -8
I just came across another example of how technological innovation improves outcomes over time. It comes as no surprise that the FDA turned down approval of whole-gland HIFU therapy for PC. In Japan, where it is approved, they looked at the 5-year biochemical disease-free survival (bDFS) for men treated by newer models of the Sonablate HIFU device. To summarize:
oldest model |
SB200/500 |
48% | | SB500 v.4 | 62% | newest model | SB500 TCM | 82% |
source: Improved Outcomes Owing to High-intensity Focused Ultrasound Devices Version-up for the Treatment of Patients with Localized Prostate Cancer.While even 82% is unacceptably high compared to other therapies for low risk PC, and the toxicity is also high (20% urethral stricture!), there may be subgroups for whom radiation or surgery may be precluded. Perhaps, with continued development, HIFU may someday become an acceptable alternative.
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Post by John thompson on Aug 6, 2014 11:59:46 GMT -8
Brian refers to the impact of PBT on healthcare. Referring to it as a financial crisis. In another reply I asked him about Loma Linda not participating in current trials to test efficacy. He answered as I expected, no surprise. Which is a direct hit on LLMC. Brian and I have spoken about that in the past that LLMC is indeed trying to prolong their “PBT dynasty” I think it is significant that a Harvard trained guy, an institution that has PBT, is not so up on it for PCa. www.integrativeoncology-essentials.com/2013/03/proton-beam-therapy-the-rolls-royce-of-radiation-oncology/
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