Scripps Health and Scripps Clinic Medical Group are allowing their name and their doctors to help build a $185 million proton beam center for cancer therapy, a for-profit venture in San Diego that could be the ninth accelerator in the nation when it opens in 2013, and the second in the Western United States.
The Scripps Proton Therapy Center will be financed and owned by Advanced Particle Therapy (APT) LLC of Minden, NV, but will be managed by Scripps Clinic physicians. The 102,000-square-foot center will be built starting next month about 5 miles east of the Scripps campus. When complete, it will have the capacity to treat 2,400 patients a year for cancers of the prostate, pancreas, lung, head and neck, breast, colon, eye, and digestive system. The only other such center in the West, at Loma Linda University, was the first in the U.S. in 1990.
The proton beam approach delivers radiation more directly to the tumor site and avoids collateral damage to surrounding cells and tissue, says Prabhakar Tripuraneni, MD, head of radiation oncology at Scripps Green Hospital in La Jolla.
That collateral damage is believed responsible for secondary tumors that often occur after more generalized doses of radiation treatments. He said proton beam is increasingly used for deep-seated but localized tumors—those that have not spread—that are difficult to remove surgically, including ocular and lung cancers.
Proton beam radiation treatment is perhaps the least well known of radiation cancer strategies, because there are only seven such installations centers in the country. Also, at about $45,000 for a course of treatments, it is perhaps the most expensive radiation therapy offered today.
The center will be equipped by Varian Medical Systems of Palo Alto, Varian's first proton beam installation in the U.S.
While the center plans to accept patients from all health systems in the region, clearly attaching the name Scripps to the center will bring the five-hospital healthcare system prestige and stature, several proton beam experts note.
Besides Loma Linda, proton beam accelerators operate at the following locations:
- Francis H. Burr Proton Center at Massachusetts General Hospital in Boston
- Roberts Proton Therapy Center at the University of Pennsylvania in Philadelphia
- ProCure Proton Therapy Center at the INTEGRIS Cancer Center in Oklahoma City
- Proton Center at M.D. Anderson Cancer Center in Houston
- Proton Therapy Institute at the University of Florida in Jacksonville
- Midwest Proton Radiotherapy Institute at Indiana University
Four other centers are trying to launch proton beam centers, but some have been delayed, in part because of difficulty raising money during the recession, says Leonard Arzt, executive director of the National Association for Proton Therapy. An eighth center in Hampton, VA, is scheduled to open this August.
However, proton beam treatment is controversial. Some policymakers and researchers worry that there has not been the kind of clinical trial validation to assure that proton beam approaches are really better than standard radiation, brachytherapy, CyberKnife, or Image Guided Radiation Therapy (IMRT).
Last September, the National Cancer Institute said in a bulletin that of the estimated 1.47 million Americans who will be diagnosed with cancer in 2009, 60% to 75% will undergo radiation therapy for their disease.
"In select cities around the country, some of these patients who are hoping to improve their odds for a cure and minimize the long-term adverse effects of radiation therapy will be treated with a relatively new form of it called proton therapy.
"Public interest in proton therapy has grown substantially since the FDA approved it in 2001. However, there is concern among members of the medical and research communities that enthusiasm for this promising therapy may be getting ahead of the research.
The NCI paper continued, quoting Kevin Camphausen, MD, chief of NCI's Radiation Oncology Branch, who has referred patients to be evaluated for the treatment when he felt it might work well for their tumor type. "Proton therapy has wonderful potential as a treatment for some cancers. But I don't think its use should become widespread until we can validate where it's needed, and where it has the greatest potential benefit for patients."
Added Norman Coleman, MD, associate director of the Radiation Research Program (RRP) at NCI, "Theoretically, proton beams are much more exact than x-rays. On the computer screen, the calculations look great, and the enthusiasm is understandable. But is that what's really happening in the patient?"
"There is no published evidence to indicate that proton therapy is detrimental to patients," Coleman said, but "when you have something that is so precise with such sharp edges, you need to make sure that it's also accurate. This requires being certain that the target is hit as planned on the computer, including accounting for the uncertainties in diagnostic imaging, reproducibility in patient setup, and internal organ motion."
Another uncertainty is whether the Centers for Medicare and Medicaid Services will change the way it reimburses for proton beam and other radiation therapies for certain cancers. CMS allows this determination by regional contractors at a local level, and policies vary across the U.S. depending on the contractor.
In April, CMS convened a meeting to determine if radiation therapy reimbursement decisions for prostate cancer—a mainstay for most of the existing proton beam installations—should be made on a national basis. And if it is made on a uniformly national basis, whether more controlled clinical trials and comparative effectiveness should first prove that proton beam therapies are better than other radiation treatments for cancer.
No decision has yet been made.
But there's a lot of money is at stake, because, so far, proton beam treatments remain among the most expensive, with 30-session sets estimated to cost about $45,000.
By comparison, conventional x-ray treatments cost $36,024; intensity modulated radiation therapy or IMRT costs $12,141; and brachytherapy or the implantation of radiation seeds implanted in or near the tumor, costs $5,484, says Jeffrey Bordok, president and CEO of APC.
According to a 2010 comparison chart by the Advisory Board Company, Medicare reimbursement alone for major radiation therapy options varies widely, from $8,917 for HDR brachytherapy, $10,667 for 3-D Conformal Radiotherapy, $11,090 for stereotactic body radiotherapy (CyberKnife), $11,321 for LDR brachytherapy, $19,299 for image guided radiotherapy or IMRT, and $28,894 for proton beam.
Bordok, however, says he is not worried that Medicare will stymie proton beam revenue streams. He notes that during the presidential campaign, Barack Obama touted the procedure and praised efforts to build a proton beam center at the University of Illinois.
And at the first of this year, he says, Medicare increased reimbursement rates across the board for most proton beam treatments by 40%. "They did it for both simple and complex treatments. They felt that for certain indications, it is effective treatment, with fewer side-effects and fewer secondary cancers."
He estimates that with Medicare, Medicaid, and private insurance reimbursement and ancillary fees, he estimates gross revenues of $150 million a year.
And it's a big plus for Scripps as well, Bordok says. "At M.D. Anderson's proton beam center, I'm told they have an 80% self-referral. They learn about proton beam treatments and just show up. Maybe they get proton treatment, or maybe surgery or chemotherapy or some other treatment. But the entire patient base grows.
"And they're also able to recruit leading-edge thinking doctors who want to take advantage of these research opportunities."
Scripps CEO Chris Van Gorder agrees. "Scripps is excited to help provide access to one of science's most sophisticated weapons against cancer," he said in a statement. "This will be an immensely valuable resource for all of San Diego County and beyond ... a major step forward, allowing us to provide the most comprehensive range of radiation therapy options available today."