A study finding that proton-beam therapy is no more effective than standard radiotherapy in treating patients with prostate cancer has again raised questions about the validity of the expensive and emerging treatment in a cost-conscious healthcare environment.
The study, published Friday in the Journal for the National Cancer Institute, found no differences in gastrointestinal and genitourinary toxicity, both of which are common side effects of radiation therapy. About 25,000 Medicare beneficiaries who received proton radiotherapy or intensity-modulated radiotherapy in 2008 or 2009 were involved in the study.
The median Medicare reimbursement for proton-beam therapy is nearly $14,000 higher than reimbursement for standard radiotherapy.
“It's commonly accepted wisdom that we're spending too much on healthcare as it is,” said Dr. James Yu, assistant professor of therapeutic radiology at Yale and the study's lead author. “It was of interest that here's this even more expensive treatment, with limited comparative effectiveness, that's now being rapidly adopted.”
Proton radiotherapy is a relatively new cancer treatment that is growing in use in the U.S. There are 10 proton-beam therapy centers in the U.S., seven of which are owned by hospitals.
Proponents of proton radiotherapy, who say the treatment decreases side effects that include gastrointestinal and genitourinary toxicity, had their own questions about the study, including the fact that researchers relied on billing data rather than patient-reported data.
“Any of these large databases that rely on billing codes are coarse measures of patient experience,” said Dr. Jason Efstathiou, associate professor of radiation oncology at Massachusetts General Hospital and Harvard Medical Center, both in Boston.
Mass General has operated a proton-beam therapy facility since 2002. According to Efstathiou, researchers at the 907-bed hospital and the University of Pennsylvania recently launched a trial that aims to gather patient-reported outcomes.
“The debate that is ongoing is: Is it worth the additional cost?” said Efstathiou. “Our randomized trial will hopefully answer that. The truth also is that pricing considerations can range all over the board, it's very hard to know what the exact cost of one thing. The other important point is that with any advanced technology, with time, they improve.”
Leonard Arzt, executive director of the National Association for Proton Therapy, said in an e-mail that proton therapy will “cost less with reduced recurrence, reduced toxicity, [and] reduced side effects” for patients over longer periods of time than the two-year period that the study looked at.
“If all hospitals could afford to have proton therapy, they would all have it,” Arzt said.
Dr. E. David Crawford, professor of surgery, urology and radiation oncology, and head of the urologic oncology section at the University of Colorado Medical Campus in Aurora, Colo., said proton-beam therapy can be effective for conditions such as pediatric brain tumors. However, facilities would have to to expand the use of proton-beam treatment to other areas in order to recoup costs.
Crawford said one could find fault with the Medicare data-based study in that it didn't include younger patients, but that doesn't counter the findings that show little benefit for prostate cancer patients for the expensive treatment.
The 437-bed hospital had explored building a facility but chose not to.
“We looked at the need. It's nice to have something everybody doesn't have,” he said, adding that ultimately it wasn't worth the expense.
The high costs associated with proton-beam therapy have caught the attention of payers.
The CMS has no national policy on proton-beam therapy, which leaves coverage to the discretion of private insurers under contract with Medicare to process and pay claims, according to CMS spokesman Donald McLeod, in an e-mail.
The agency has not yet decided whether to draft a national policy for proton radiotherapy for prostate cancer, which could mandate Medicare coverage or exclude the treatment from benefits. The treatment was added to a list of candidates for review of Medicare coverage in November.
Geisinger Health Plan does not cover proton-beam therapy for prostate cancer for its 290,000 members, excluding those covered on its Medicare Advantage plan.
Dr. Bret Yarczower, the plan's medical director, said the committee lacked evidence that would show proton beam therapy was superior, inferior or equal to existing treatments such as external beam therapy, radiotherapy or brachytherapy.