Full article reprinted from "The Gray Sheet" - October 6, 2008
Find out why a private insurer is calling for CMS to issue a national non-coverage decision for proton therapy in treating prostate cancer.
Full article reprinted from "The Gray Sheet" - October 6, 2008
A private insurer is calling for CMS to issue a national non-coverage decision for proton therapy in treating prostate cancer, claiming Medicare payments will encourage rapid spread of the costly technology before there is enough clinical evidence to deem the treatment reasonable and necessary.
"A formal NCD of 'no coverage' for prostate cancer will help stop the unwarranted proliferation of this technology in Michigan and across the nation," writes Thomas Simmer, senior vice president and chief medical officer for Blue Cross Blue Shield of Michigan, in response to the Medicare agency's list of potential national coverage decision (NCD) topics issued this summer (1"The Gray Sheet" Aug. 4, 2008, p. 10).
Supporters of proton therapy prefer to leave Medicare coverage decision-making where it is, at the local level, arguing that a premature national coverage decision could hurt attempts to gather more evidence through clinical trials or patient registries.
Cost Issue Called Into Question
The fact that CMS even made mention of the "high upfront costs" for proton therapy centers in its NCD topics list raised red flags for some proponents of the technology, who rallied against the idea that cost should play into a CMS coverage decision.
"Simply put, cost effectiveness is not considered in CMS's evaluation regarding whether to open an NCD," writes Ruthita J. Fike, CEO of California-based Loma Linda University Medical Center, which runs the longest operating proton therapy treatment center in the U.S. She cites a 2006 CMS 2guidance stating, "The cost of a particular technology is not relevant in the determination of whether the technology improves health outcomes."
Still, the $150 million-$250 million price tag for building a proton therapy treatment center is significant. The technology uses enormous cyclotrons to accelerate sub-atomic protons as a central component of the particle beam that delivers a targeted dose of radiation to kill cancer.
Only five centers currently operate across the U.S., but that number could increase tenfold within a decade 3("The Gray Sheet" Sept. 15, 2008, p. 15).
In Michigan, several health care groups are lobbying for the right to build proton therapy centers, with one already approved.
The move to build new proton therapy centers "seems to be driven, in large part, by the fact that Medicare will reimburse them for treatment and that they can become huge profit centers," BCBS of Michigan writes.
The insurance company agrees that proton therapy may be indicated to treat "a very small subset of cancers," but argues that prostate cancer is "not one of these indications."
Some opponents even suggest proton therapy centers deliberately market to prostate cancer patients as a way to justify the expense of their facilities when they cannot fill them to capacity with patients suffering from other cancers, such as eye tumors and pediatric brain malignancies.
According to Brian Moran, medical director for the Chicago Prostate Cancer Center, "There is no doubt that a rapid increase in development of new proton centers will far exceed the need for appropriately selected patients. My concern is that there will soon be abuse of proton technology with very common cancers such as lung cancer and prostate cancer."
But scores of patient advocates who submitted comments defending coverage of proton therapy say such comments are merely an attempt to stave off competitors of more conventional forms of prostate cancer radiation treatment. They profess that proton therapy offers greater protection from side effects, such as rectal complications and impotence.
Robert Wood, chairman of the Prostate Cancer Support Association of New Mexico, comments that he frequently hears regret from patients who did not choose proton therapy to treat their prostate cancer, citing the minimal quality-of-life impact the treatment is supposed to have compared with other forms of radiation or surgery because it more accurately targets the tumor and avoids non-cancerous tissue.
Quality Of Life Outcomes Need Study - ASTRO
The American Society for Therapeutic Radiology and Oncology (ASTRO) is working to develop a study to assess patient-reported quality of life outcomes at three years, ASTRO says in comments.
The medical society favors a "coverage-with-study-participation" national Medicare policy for proton therapy, in which coverage would be limited to circumstances in which the technology is used in the context of controlled data collection.
ASTRO proposes its study, in development with the 4Center for Medical Technology Policy, as an effort that would qualify for such conditioned coverage.
The "registry trial," as ASTRO CEO Laura I. Thevenot refers to it in comments to CMS, would enroll about 1,600 low-to-intermediate-risk prostate cancer patients and compare outcomes from proton and intensity modulated radiation therapy. It would not principally be a randomized trial, but may have a parallel randomized arm, Thevenot says.
The study "is likely to provide meaningful answers on the safety and effectiveness of proton beam radiation therapy in the treatment of prostate cancer in the context of current clinical practice," she writes.
The American College of Radiology/Radiation Therapy Oncology Group backs such an effort, and says it would "welcome further discussion with CMS regarding study indications and parameters, if such study is implemented and funded."
Infrastructure Is Limited For Randomized Trials
Some radiation oncologists, however, suggest proton therapy should not be covered for prostate cancer until there are randomized clinical trials showing a benefit over more standard radiation therapies.
But ASTRO and some proton treatment facilities question the feasibility of this approach. "The cost and complexity of developing proton facilities has imposed significant limitations on its availability and the ability to conduct randomized clinical trials to compare the efficacy of this important new technology," Thevenot writes.
Stuart Klein, executive director of the University of Florida Proton Therapy Institute, goes further, calling comparative studies of proton therapy and conventional radiation therapies "unnecessary" and likely to lead to "the suboptimal use of very limited resources."
In the time it takes to place 800 patients in a randomized comparative trial of proton therapy versus IMRT in treating the disease, Klein writes, "one could perform eight progressive pilot studies to define an optimal algorithm for proton therapy for prostate cancer."
Because there are so few proton therapy centers in operation, he continues, "800 proton slots for such a trial would represent approximately 1/3 of the annual proton slots available in the U.S."
Further, Loma Linda University's Fike asserts that randomized phase III clinical trials for proton therapy might be "unethical," because any study comparing proton to photon radiation would require researchers to expose patients' "normal tissue" to radiation in the photon therapy group.
"Since there is overwhelming evidence that all radiation is harmful, how could one ethically design a study wherein half of the participants would be receiving two to three times more radiation to normal tissue with no expected clinical benefit?" she asks.
Others working in proton therapy do support randomized clinical trials comparing proton therapy and IMRT, but do not want CMS to cut off funds before the evidence is in. A prominent group of physicians is collaborating to develop a randomized clinical trial for proton therapy and IMRT, but it will take years of follow-up before they are able to give CMS the evidence it needs, according to John Lewis, executive director of the Northern Illinois Proton Treatment and Research Center, which is slated to open in 2010 at Northern Illinois University.
While the higher cost of proton therapy treatment is not disputed, proponents predict treatment costs could decline as technology advances.
For example, studies have begun at some of the proton therapy centers to evaluate whether hypofractionation for prostate cancer therapy can decrease the number of daily treatments patients require without reducing the overall dosage.
"An overall decrease in treatment time leads to a decrease in the total cost of treatment," Loma Linda's Fike says.
- Monica Hogan
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