February 2015
Proton Therapy and Cost
By Beth W. Orenstein
Radiology Today
Vol. 16 No. 2 P. 22
In an era of increasing cost scrutiny, investigators are studying the cost of proton treatments. What they're finding may not match many people's perceptions.
Most agree that proton therapy can be more effective than conventional radiation for treating certain cancers, such as pediatric, spine, and head and neck tumors.
Because the charged particles found in the nucleus of an atom can be delivered more precisely to the tumor than the photons used in traditional radiation, proton therapy is more likely to cause less damage to surrounding healthy tissue and organs. Its precise delivery can mean fewer complications for patients, especially in the long term. That precision also means protons potentially can be delivered in higher doses requiring fewer treatments than conventional radiation therapy.
There is much to debate, however, largely because building and operating a proton therapy center is an expensive proposition. According to a 2012 Journal of the National Cancer Institute study, median Medicare reimbursement for proton beam therapy (PBT) for prostate cancer is $32,428, compared with $18,575 for intensity-modulated radiation therapy (IMRT). According to Loma Linda University Medical Center in California, which opened the nation's first hospital-based proton therapy center in 1990, the cost of building a multiroom proton center can be as much as 40 times that of a center that delivers conventional radiation therapy or IMRT.
Some radiation oncologists believe the cost-to-build comparisons are unfair. Vinai Gondi, MD, codirector of the Cadence Brain Tumor Center and associate research director at the CDH Proton Center (now a part of Northwestern Medicine), both in Warrenville, Illinois, says it depends on who is doing the math and what goes into the calculation. "When you divide the cost of the equipment among five rooms and consider that the lifespan of a proton therapy center is in the range of 30 years, you get cost figures that are comparable to the cost of linear accelerators," he says.
Jason Efstathiou, MD, DPhil, is cochair for comparative effectiveness at NRG Oncology as well as an associate professor at Harvard Medical School and radiation oncologist at Massachusetts General Hospital in Boston, which has treated patients with protons since the 1960s, in collaboration with the Harvard Cyclotron, and opened the nation's second hospital-based proton center in 2002. Efstathiou says it's difficult to state exactly how much more expensive a course of proton therapy is than other forms of radiation therapy. "It depends on the payers and the market you're in. Pricing is fluid and rapidly evolving, and cost ultimately needs to take into account comparative value based on outcomes as well as future health care utilization related to treatment and its side effects," he says.
Cost and Outcomes Research
Some believe because the cost of a proton therapy center is so high the treatment can't be discussed or studied without the issue coming into play. Others say including a cost analysis in randomized prospective clinical trials is no different for those that involve proton therapy than it would be for any other new drug or technology for treating cancer or any other disease. In today's health care landscape, the cost of any care is a large and growing focus for physicians, hospitals, patients, insurers, and the government, Efstathiou says. "I don't think the cost concerns are unique to proton therapy," he says.
Steven J. Frank, MD, medical director of the MD Anderson Proton Therapy Center, believes because of the "health care environment we are in, the bar is set higher. It requires us to be more cost conscious." However, he says, when comparing PBT to conventional radiation therapy, cost has to include the entire cost of treatment. "If a patient is suffering more side effects and you have to pay more for managing them," Frank adds, "that may override the cost on a day-to-day basis."
Efstathiou is a leader of a multicenter randomized trial sponsored by the National Cancer Institute to help determine whether PBT is more effective than IMRT for localized prostate cancer. Some men may prefer PBT to IMRT because they assume it reduces side effects. However, Efstathiou says, reluctance on the part of some third-party payers to cover PBT for prostate cancer is making it harder for researchers to enroll some patients in the trial and find out. "Some payers pay for proton therapy for prostate cancer if the patient's doctor says it's medically necessary. Some pay if the patient is treated in a prospective study, and some don't pay regardless," he says. "What we need is the first two and not the last to successfully complete this study. Patients whose insurance won't cover it can't be expected to pay for their treatment out of pocket and the trial isn't funded sufficiently to pay for treatment for all who are eligible."
While Medicare routinely covers PBT, the reluctance on the part of some third-party payers could slow the timely completion of the trial, which opened in 2012 and is fully activated at three sites (Massachusetts General Hospital, University of Pennsylvania, and MD Anderson), and will open at a number of other sites this year, Efstathiou says. The hope is to complete enrollment of 400 patients over the next three to four years. It's a catch-22 of sorts, Efstathiou says. The research is needed to determine whether proton therapy is the better treatment for prostate cancer and, if so, in which patients. If PBT were to prove that it is not only the better treatment, but also cost effective, more insurance companies clearly would support it. But some won't support it without first having that evidence. Efstathiou is hoping the trial will serve as a model for evaluating PBT's effectiveness and comparative value.
Challenging Preconceptions
Eric Strom, MD, FACR, is the principal investigator of a clinical trial sponsored by the National Cancer Institute at the University of Texas MD Anderson Proton Therapy Center to determine whether patients with early-stage breast cancer could benefit from accelerated partial breast irradiation (APBI) with proton therapy vs whole breast irradiation (WBI). Strom had people say to him, "You're wasting time doing this clinical evaluation of proton therapy for breast cancer because it would be too expensive for patients even if it did prove to be better." Believing that statement to be wrong, Strom and his colleagues did a separate cost analysis based on typical patient characteristics. They used Medicare reimbursement codes to analyze allowable charges for eight different types of partial breast irradiation and WBI therapies and treatment schedules available to early-stage breast cancer patients.
"Taken together, these represent roughly 98% of the treatment options available to these patients," Strom says. Their analysis was as they expected: The total allowable charges for proton APBI, completed in 10 treatments over one week, were estimated at $13,833. Comparatively, WBI for six weeks using IMRT resulted in the highest Medicare charges at $19,599. Multicatheter brachytherapy approaches to APBI also had higher total charges than proton APBI. The average charges across the eight treatment regimens were $12,784. Thus, proton beam APBI costs were similar to that of other types of radiation, Strom says.
Like Efstathiou, Strom says he had some trouble enrolling patients in the ongoing clinical trial because insurers are reluctant to cover PBT for breast cancer. "Right now, it is carrier by carrier and even state by state," he says. "I have trouble getting BlueCross/Blue Shield of Texas to allow its patients to participate in our clinical trial, but BCBS of Louisiana pays for PBT if the patient is in a clinical trial." Strom did the cost analysis, he says, because he feels as researchers "it is our job to show if we want people to pay more for something new, it has to earn that reimbursement or, alternatively, we have to figure out approaches that are less expensive." He's hoping his cost analysis, which he plans to publish, will make more insurers open to enrolling patients at least for partial breast radiation. "When people say proton therapy is too expensive to consider for breast, we can point to our data and say, 'It's not as expensive as you think.'" Meanwhile, the clinical trial is ongoing to determine what, if any, the benefits of APBI with protons for breast cancer are and if it has fewer side effects.
Gondi, of the CDH Proton Center, and Minesh P. Mehta, MBChB, chair of the NRG Oncology Brain Tumor Committee and a professor of radiation oncology at the University of Maryland and medical director of the Maryland Proton Treatment Center, both in Baltimore, are conducting a clinical trial to evaluate photon IMRT and PBT for newly diagnosed glioblastoma brain tumors, the most common primary malignant brain tumor. The median survival time for patients with glioblastoma who undergo the standard treatment of surgery followed by chemoradiotherapy is 15 to 16 months, with the vast majority of patients experiencing recurrence in the region of the treated tumor. Mehta says when evaluating the cost of proton therapy, the consideration has to include not only the cost of delivering whatever number of treatments is deemed optimal, but also the potential benefit of reducing long-term effects, especially with brain tumors. "If, with proton therapy, we are able to eliminate a number of those late tissue effects, it may turn out to be the more cost-effective therapy in the long run," he says. Mehta says one patient, a young child with a medulloblastoma, was successfully treated with conventional radiation therapy only to have a soft tissue sarcoma develop three years later at the site where the radiation exited his body. "Had the patient been treated with PBT, there would have been no exit radiation and the family would not be battling a second life-threatening cancer," he says. "In cases like that, I don't think you can measure the cost of PBT in dollars and cents."
Evolving Technology
Sameer R. Keole, MD, is director of the PBT program at the Mayo Clinic in Arizona, which, when it opens in 2016, will feature pencil beam scanning, an advance over current radiation and proton therapy methods because its beam conforms more closely to the tumor, better sparing surrounding healthy tissue from harm. The Mayo Clinic will have eight proton beam treatment rooms open in 2017 at its sites in Arizona and Minnesota. Keole says many disease sites (prostate, breast, lung, etc) have excellent clinical prospective trials suggesting proton therapy is at least equivalent to IMRT. "There are some retrospective studies that may suggest protons have a questionable role at best, but prospective clinical trial data always trumps retrospective data," he says.
PBT is not experimental "and should be moving forward," Keole says. He agrees that there is a need for prospective studies. However, he says, "We're not going to be able to conduct these studies if we don't have buy-in from payers. We can't execute clinical trials in this country for radiation therapy without the cooperation of the insurance carriers." Mayo Clinic, Keole says, is trying to take cost out of the equation by telling insurance carriers it will charge the same regardless of whether patients receive IMRT or PBT. "We're going to make it price-neutral to payers." Mayo can make the offer thanks to funding for its PBT from the Mayo Clinic Foundation and its benefactors. No venture capital or taxpayer dollars have gone into building its centers. Keole doesn't know whether that offer will convince more insurance carriers to allow their patients to enroll in the clinical trials, but he is hoping the answer is yes. "It's a tremendous technology that can really help a lot of patients, but we need the trials to figure out where it's better and if so, by how much, and at what cost." So far, he says, the insurance carriers he's had discussions with are making no guarantees.
The researchers expect that the cost of proton therapy will come down over time. Like any new technology, it will take time to be adopted and become more mainstream. But it will, the researchers are convinced, as more centers are built and more evidence is gathered proving PBT is not only a better treatment in some cancers but more cost effective in the long run for patients and their families.
"Ultimately proton therapy centers will be able to take advantage of operational efficiencies and technological advances, which will reduce costs," Efstathiou says.
"The cost for your institution is going to be less and less as time goes by," Strom agrees. "You've seen that model in a variety of places in medicine. If you made the first CT scanner in the world, you paid a great deal. By the time they've made thousands, they're pretty good at doing it and so the cost of building the facility to house it and maintain it is less. Same with PBT."
The American Society for Radiation Oncology has developed a proton model policy that creates a framework researchers can use to communicate with third-party payers which patients need to be covered, says Frank. "Third-party payers are struggling with advanced technologies like proton therapy because they are trying to control health care costs." But, he says, researchers have a unique opportunity and responsibility to run clinical trials in order to answer important questions about the comparative effectiveness and value of PBT. The results of these clinical trials will help educate payers when it is medically necessary to treat cancer patients with proton therapy, he says.
— Beth W. Orenstein is a freelance medical writer based in Northampton, Pennsylvania. She is a frequent contributor to Radiology Today.
