Whenever a new medical technology comes out in the U.S., a few things happen. Doctors, hospitals, the media, and, of course, the drug and device makers cheer. Newer technology must always be better, right? Never mind if it costs a little extra. We’re talking about a patient’s life and well-being, after all.
But when we ignore the higher cost of the new technology, or don’t consider cost in a broad contextual view of the standard of care, we allow perverse market incentives to take root. We end up as a society directing people to the new and expensive treatment option, regardless of the evidence.
This kind of attitude has helped create a dysfunctional market with runaway health spending, as Time magazine recently described in a devastating cover story. The piece resonated for me, because as a journalist, I see plenty of new medical technologies come along that don’t have solid evidence that they provide benefits that outweigh their added cost.
The latest advance I’ve seen follow this familiar pattern is happening in my community of Seattle. I toured the region’s new proton therapy center run by a private company called ProCure and the Seattle Cancer Care Alliance—a collaboration of three renowned institutions—the University of Washington, Fred Hutchinson Cancer Research Center, and Seattle Children’s Hospital.
This facility, the 11th of its kind in the U.S., is a scientific marvel. Instead of using standard radiation beams to zap tumors, the $152 million facility covers two-thirds of a football field, and houses a 220-ton cyclotron that forms proton beams to precisely whack tumors. Although standard radiation beams can be shaped and conformed to tumors with pinpoint precision to minimize damage to healthy surrounding tissues on the way in and out of the body, proton therapy is thought to be even a more precise way to hit the tumor and reduce side effects, says George Laramore, the chair of the Department of Radiation Oncology at the University of Washington, and the medical director of the new Procure/Seattle Cancer Care Alliance facility.
Cutting-edge as it sounds, proton therapy isn’t new. It’s been around since the 1950s, but because of the size and cost of the capital equipment required, it’s been limited mostly over the years to patients willing to travel to just a few sites in the U.S., including ones in Southern California and Boston. About 84,000 patients have been treated worldwide with proton therapy, and many have lived long and healthy lives afterward, Laramore says.
Even after all those years and that many patients, the medical evidence to support use of proton therapy has its limits. It does appear to have value for medulloblastoma, a dangerous type of brain tumor more common in children than adults. Laramore says data shows that kids with medulloblastoma who were followed for 20 years after they got standard chemo and radiation often suffer long-term side effects. Almost half (47 percent) of the children suffer from a loss of IQ points, heart toxicity, hearing loss, and the appearance of secondary malignant tumors. In contrast, a longstanding proton therapy site in Switzerland has reported only 7 percent of its patients suffered such long-term side effects from treatment, Laramore says.
That might sound like an intriguing benefit, but it could be misleading for any number of reasons. The gold standard of medical evidence comes from studies in which patients of similar prognosis are randomly assigned to one treatment vs. another and followed over time at multiple clinical sites. The reduced complication rate from Switzerland is the kind of finding that just might persuade a researcher to start such a well-controlled study to ask whether protons are a superior form of treatment for medulloblastoma.
Picking apart one study or another isn’t the real story here. The real problem comes back to the business model, and the financial math required to make this facility pencil out. The Northwest’s new proton center, like many others around the U.S., cost $152 million to build and to operate for its first year, says Annika Andrews, the president of the new center. It has 43 employees, and expects to ramp up to more than 80 at full capacity, Andrews says. When maxed out, the Seattle proton facility should be able to serve 1,400 patients per year, from a five-state regional area, running daily from 7:30 am to 10 pm.
Whenever a private, venture-backed company like ProCure and its lenders pump $152 million into a new facility, you know they have run the numbers on what it will take for this facility to make money. The basic math says it needs a lot of patients, and they each need to pay a lot. While treatment courses vary from tumor type to tumor type, and insurance reimbursement varies by region, proton therapy is typically about 40 percent more expensive than standard treatment, Andrews says. Median Medicare reimbursement for prostate cancer patients on proton therapy is about $32,428, compared with $18,575 per patient for standard radiation, a 75 percent pricing premium, according to a recent article in the Journal of the National Cancer Institute.
Those numbers say a lot about why proton centers are popping up all over the country.
“High reimbursement per case X High throughput X High volume = High profit,” wrote Theodore Lawrence and Mary Feng, a pair of radiation oncologists at the University of Michigan, in the Journal of the National Cancer Institute.
Studies that compare proton therapy and standard radiation for prostate cancer are limited, as it’s historically been difficult to run randomized head-to-head studies with only a few active proton therapy facilities. But one study published last April in the Journal of the American Medical Association said that patients on the standard IMRT (intensity-modulated radiation therapy) had fewer gastrointestinal side effects than patients on proton therapy. Lawrence and Feng note that another study said that 6 percent of prostate cancer patients suffered genitourinary side effects six months after getting proton treatment, compared with 10 percent on standard IMRT. But that apparent advantage disappeared after 12 months.
“Proponents of proton therapy may argue that any reduction in toxicity is worthwhile. However, is this small transient difference enough to justify a 70 percent higher cost per patient?” Lawrence and Feng wrote.
OK, so the evidence on prostate cancer at this point—albeit from a limited data set—says you’ll pay more for proton therapy and not necessarily get more. In fact, you might pay more and get less.
Now, let’s come back to the finances. In Seattle, ProCure has been blanketing local media outlets with ads, encouraging cancer patients to consider proton therapy, to build up the necessary patient volume. Andrews and Laramore wouldn’t say how many patients they need to treat to reach the break-even point, but Laramore did note that the facility is built for a 30-year lifespan, and “we don’t need to pay it off in the first year.”
Still, there’s no denying you need a lot of patients to pay off such an expensive facility. It creates an incentive for doctors within a network to steer their patients to proton therapy. And there definitely aren’t enough kids in the Northwest with medulloblastoma to keep the place running day and night. All kinds of other cancer patients are being encouraged to consider proton therapy. I have to wonder how many might benefit just as much from an existing, lower-cost alternative.
Protons aren’t for everyone, Laramore acknowledges. People with diffuse tumors, or tumors that are hard to precisely locate, aren’t good candidates. Even so, he says there are plenty of patients who are appropriate candidates. Here in the Northwest, there are about 40,000 cancer patients who get treated in the five-state Washington, Wyoming, Alaska, Montana and Idaho (WWAMI) territory that UW Medicine serves, Laramore says. About 60 percent (27,000 patients) get some form of radiation each year, he says. Even if only 10 percent of those radiation patients get referred to proton therapy, that means the region could support two proton therapy centers, he says. There should be plenty of demand from patients for the new treatment option, and plenty of appropriate patients to refer, Laramore says.
“We feel there is a surplus of demand for the capacity of this particular center, but it’s going to take time,” Andrews says. “It’s a very specialized service. Patient selection is very important.”
Patient selection, I’d agree, is very important. But if you’re going to get 1,400 patients a year, and run them through as many as 40 or so visits for proton therapy, you’re going to have to start referring patients with the really common malignancies—things like prostate cancer and breast cancer. And that is where the medical evidence supporting proton therapy isn’t as compelling. He agrees there isn’t good data from randomized, head-to-head studies that say proton therapy is superior for prostate cancer. When pressed on the data, Laramore kept coming back to the value of protons, as demonstrated in pediatric cancer patients.
Laramore, like I’m sure many physicians would, bristled when I suggested that physicians in the network might be influenced to refer patients to proton therapy for business reasons. He insisted that expert medical judgment, and ultimately the patients themselves, will determine who ends up getting proton therapy.
“Every patient is not a hammer that we’re going to hit with a proton,” Laramore says. (I think he meant to say ‘nail,’ instead of hammer, but you get the idea.)
Still, I have a hard time accepting answers like that, especially when I see such an aggressive media campaign going on to market proton therapy to the masses.
The massive business interest, and the proton marketing campaigns, have invited critics from within the medical community.
Todd Barnett, a radiation oncologist at Swedish Medical Center in Seattle, says he’s personally interested in the potential of proton therapy, and even had a series of business meetings with the ProCure folks when they were considering their Northwest expansion plans five years ago. He says he believes protons offers a proven benefit in certain pediatric cancers. But Swedish backed away from a business deal with ProCure because it believed there weren’t nearly enough pediatric patients to pay for a $150 million facility, and that the high price tag created a perverse economic incentive to direct prostate cancer, and breast cancer patients, to a treatment that may not offer them an advantage.
I spent an hour at Dr. Barnett’s office recently learning about radiation diffusion patterns for standard intensity-modulated radiation therapy, which show great improvement in the ability to precisely target tumors. Laramore agrees that conventional radiation has come a long way, and is much more targeted than it once was. This new kind of standard radiation equipment, made by companies like Elekta and Varian Medical Systems, tends to cost less than $3 million. And unlike proton therapy, these systems have real-time imaging capability that can tell when the tumor has shifted outside the radiation beam, potentially causing harm to healthy tissues.
“There’s no problem that needs a solution here,” Barnett says. “If you have a toaster at home and you want to make toast, you can already do that just fine. If somebody came out with a $9,000 toaster, you’d say, ‘Why would I do that, my toast is fine?’”
I asked another oncologist at Swedish Medical Center, Jack West, what he’d recommend to his dad if he had prostate cancer. Standard IMRT, he says, no doubt.
Both West and Barnett say they are interested in protons, but more curious about the next generation of proton therapy, which may come with real-time imaging capabilities and at a far lower investment in the $25 million to $30 million range. The new technology is in the works at Littleton, MA-based Mevion Medical Systems.
I understand there are people out there who swear by proton therapy, and who say they owe their lives to it. That’s a wonderful thing. Anecdotes make for great stories, and if it’s your life that’s been affected, a pile of medical studies mean nothing but a hill of beans. But that doesn’t mean we can go around buying up every new technology offering that lacks medical evidence.
Andrews, the president of the new ProCure center, acknowledges that medical science can’t yet tell us with a high degree of confidence that protons are superior to standard radiation. If I’m being asked to pay more, I told her, I’d like to know if I’m going to get a documented advantage in survival time, fewer side effects, and an improvement in quality of life.
“These are all good questions,” Andrews says. “Whenever you introduce any new medical technology, there’s a period in which you think about whether this makes sense. Then you come up with new research questions, gather further evidence, and publish it in the literature. That’s the process and the journey we’re undertaking.”
So after thinking about this for a couple weeks, here’s what I think is being proposed. A few businesspeople in our healthcare system have decided to spend massive amounts of money on equipment and marketing, to advance a new treatment paradigm with a mixed bag of medical evidence behind it.
If we really want to know the answer to these research questions, scientists could run a few well-controlled trials at existing proton centers. To my mind, these are the kinds of questions people should know the answers to before investments are made in a dozen proton centers around the country, at $150 million to $200 million a pop. We can’t afford to go on like this forever, blindly worshiping the shiny and new.
By posting a comment, you agree to our terms and conditions.