Dr.Carl Rossi in a treatment
room in San Diego's Scripps
Proton Therapy Center
Proton therapy goes mainstream
October 07, 2015
by Gus Iversen
, Editor in Chief
If you live in the UK, the name Ashya King probably rings a bell. Last September, the 5-year-old boy was taken to Prague against the wishes of the UK’s National Health Services (NHS) for proton therapy treatment on a brain tumor. When the child disappeared from the Southampton General Hospital where he was under care, his parents were suspected of negligence and an international manhunt ensued.
After turning up in Madrid, Ashya’s parents were briefly imprisoned. As for their child, he completed his renegade tumor treatment in Prague and is reportedly cancer free.
That highly publicized bit of drama brought proton therapy to the front page and perhaps underscored the absence of a vital treatment option to pediatric patients in the UK — a demand currently being addressed on multiple fronts.
In July, Varian Medical Systems announced contracts with the NHS to bring their multi-room ProBeam proton therapy system to two locations. One at UCLH (University College London Hospitals NHS Foundation Trust) in London, and the other at the Christie NHS Foundation Trust in Manchester.
Ion Beam Applications (IBA) has also signed three binding term sheets with Proton Partners International (PPI) to install its ProteusONE compact solution in Newport, Newcastle, and a third location that has not been announced. Those single-room systems will meet the lower volume needs of private physicians hoping to provide their patients with state-of-the-art cancer care.
Ashya King’s story is one of a kind, but the rapid investment in proton therapy is hardly unique to the UK.
A booming install base
Proton centers are popping up around the world — particularly in the U.S. where the treatment is more accessible than anywhere else on the planet. Despite that, there is still a “severe shortage of facilities,” according to Dr. Carl Rossi, medical director of the Scripps Proton Therapy Center in San Diego.
Rossi’s proton therapy career goes back to 1990, when he was performing treatment at Loma Linda University Medical Center — the first hospital-based proton facility in the country. Needless to say, a lot has changed since then.
In those days, Rossi says the systems were not advanced enough to treat common cancers. Instead, X-ray therapy represented the best clinical option for most patients.
Today, improved delivery techniques like pencil beam scanning have replaced the old methods, and what were once uniformly behemoth systems with costs exceeding a hundred million dollars, are now a more versatile range of systems, with price tags that are — in some cases — only tens of millions.
Companies like IBA and Mevion Medical Systems have designed smaller footprint, single room, proton solutions (ProteusONE and MevionS250, respectively) that can treat a lower volume of patients at a fraction of the price. Single room systems are the biggest growth market in the U.S. and industry insiders credit that to the country’s relatively mature proton therapy install base.
With so many facilities already operating, emerging U.S. proton centers do not anticipate the clinical demand to necessitate multiple rooms. This is not the case in most countries, however, where a multi-room facility — and its superior capacity — is still the more logical investment.
In late April, the Ackerman Cancer Center in Jacksonville, Florida, became the first privately owned proton therapy center in the world. The center’s MevionS250 was only the second to become operational. Since then two more units have been installed in the U.S. and another three are in the pipeline.
“After only three months of operation, we are now running at a rate of 350 patients per year in Jacksonville,” says Joe Jachinowski, CEO of Mevion, “That exceeds the treatment rate, to the best of our knowledge, on a per room basis, of any place in the world today.”
IBA installed its first ProteusPLUS in 2001, at Massachusetts General Hospital, and since built up the largest install base in the industry. The ProteusPLUS is in use at 19 locations throughout the world. IBA’s single-room solution, ProteusONE, features integrated cone beam CT and is treating patients in Shreveport, Louisiana, at the Willis-Knighton Health System.
“Over 12 months we put almost 20 rooms into clinical use,” says Olivier Legrain, CEO of IBA, adding that the company has sold 36 systems in total. His company reported an increase of order-intake of 86 percent from the first half of 2014 in comparison to the first half of 2015.
Hitachi is also heavily engaged in the proton therapy market, with the majority of its systems installed in Japan. The MD Anderson Proton Therapy Center in Texas uses a Hitachi system and the company will also soon have two systems operating for the Mayo Clinic, and another at St. Jude Children’s Research Hospital in Memphis.
Varian, perhaps the major manufacturer with the fewest facilities in operation, has what Mitch Latinkic, the company’s vice president of marketing, calls “the most advanced install base anywhere in the proton therapy field.” Its ProBeam is new enough that it was designed specifically for pencil beam scanning. Like IBA, Varian also offers cone beam CT for treatment imaging, something the company initially offered on its linear accelerator, TruBeam.
The multi-room ProBeam is treating patients at Scripps Proton Therapy Center in San Diego with Rossi’s team and also at the Rinecker Proton Therapy Center in Munich, Germany. According to Latinkic, Varian currently has 13 other confirmed contracts in some stage of development.
Those include a facility in Maryland that is expected to start treating patients by the end of the year, another at the Emory Proton Therapy Center in Georgia is currently under construction, and the recently announced New York Proton Center which has just broken ground in upper Manhattan.
The U.S. will be home to 29 proton therapy centers by 2020, according to a report by RNCOS, a business consulting service firm, entitled “U.S. Proton Therapy Market Outlook 2020.” It projects the market will attain revenue of around $1.22 billion by 2020, growing at a compound annual growth rate (CAGR) of 11.4 percent between 2014 and 2020.
As U.S. market saturation increases the viability of single room proton solutions, larger capital investments are being seen in countries with less access to treatment. The precise numbers are hard to find, but China is home to approximately 22 percent of the new cancer cases in the world, and 27 percent of the world’s cancer deaths, according to the World Health Organization.
“There is big momentum in China to move toward protons, they plan everything centrally and it looks like they are on the move, so we see a lot of potential there,” says Legrain. IBA is contracting to build a three-room facility in Guangzhou and another in Hebei which, with five treatment rooms, will likely be one of the largest facilities on the planet when it opens next year.
Mevion recently announced the formation of a joint venture with Chinese investors to set up marketing, sales, service, and manufacturing operations in China. It also received an equity investment worth up to $200 million to help it create greater access to the treatment.
Jachinowski says there are currently two proton therapy centers in China. “One is treating in Shanghai, but only a low number of patients.” That facility was built by Siemens before it stopped building proton centers, the other is a two-room ProteusPLUS facility located in Zibo.
“You have the Chinese market and government involvement and participation, then you start to look at a large population base — their small cities are what we in the U.S. consider our largest cities,” says Latinkic, who describes the Chinese market as “erupting” and says Varian is mindful of China’s demand for greater access to treatment.
Proton for prostate: gold standard or cash cow?
Researchers have been experimenting with protons as a form of radiation therapy since the 1950s, so it’s nothing new. The rapid growth of proton therapy may be credited to the accumulation of evidence and the maturing of the technology.
“Radiation is a very effective tool to cure cancer, but we also know radiation has significant side effects to normal tissue – the elimination of unnecessary radiation is critical to patient care,” says Dr. Steven Frank, medical director at the MD Anderson Proton Therapy Center. He and his colleagues in Texas have been treating patients with proton therapy for nearly a decade.
But not everyone is convinced that the benefits justify the cost. Amitabh Chandra, a professor at Harvard University’s Kennedy School of Government and Harvard Business School, says the increasing investment in proton therapy is financially irresponsible and an indication that real health reform is a long way off.
Chandra readily acknowledges the importance of proton therapy for head and neck tumors (and pediatric patients like Ashya King), but points to the frequent use of proton to treat prostate cancer as an example of reckless spending where the evidence has yet to illustrate the benefits.
“We are covering a technology that’s extraordinarily expensive in an immensely lucrative manner without any evidence that it works,” says Chandra. He says case studies have not been conducted to illustrate the benefits of treating prostate cancer because, “it would basically turn off the lights” — meaning the business model would collapse.
A 20-year study from Johns Hopkins recently concluded that for very unaggressive prostate cancers, the best treatment is to simply monitor the disease. The findings, published in the Journal of Clinical Oncology, revealed that only two out of 1,298 study participants actually died of the cancer. Even with the reduction of side effects, treating very unaggressive prostate cancer with proton therapy may do more damage than not treating it at all — it would also create unnecessary spending.
Prostate cancer is extremely common, with over 3 million cases diagnosed in the U.S. every year, according to the Mayo Clinic. For the cases that do require radiation therapy, protons are either a new gold standard in care or a cash cow — or perhaps both.
For Frank, it’s a complex problem with converging interests. “The emotions run high from patients that are diagnosed with prostate cancer who want access to proton therapy and the physicians that are trying to provide it for them, health care policy makers that are trying to control and reduce costs, insurance companies that are trying to increase profitability, and hospitals, urologists and radiation oncologists that lack access to proton therapy and may ‘lose’ their patients financially,” he says.
Rossi, at the Scripps Proton Therapy Center, estimates there are approximately 3,000 intensity modulated radiation therapy (IMRT) facilities in the U.S. versus 18 proton facilities. “If we get to the point where the cost is similar, there will be a severe lack of resources,” he says. “We already know that protons are better,” adds Rossi. “That’s been proven six ways to Sunday.” For him, the only mystery remaining is how much better.
Chandra characterizes prostate cancer as the main reason proton therapy is a big business, and while physicians using the technology may not entirely disagree with him (Scripps treats more prostate cancer than any other indication, at MD Anderson it's the leading indication alongside lung cancer at about 25 percent), their goal of radiating as little healthy tissue as possible includes all tumor sites.
“With prostate cancer, protons allow me to treat less of the bladder, less of the rectum, and a lot less of the small intestine,” says Rossi, adding that with an aging population, physicians must be more cognizant than ever about the risk of delayed injury or side effects, which can be very costly in their own right.
“Proof-of-concept studies are showing that toxicity’s dose effects have a cost that is not always measured in the amount of reimbursement that comes from delivery. We need to look at the episodic cost of care through time-driven activity-based costing methods (TDABC) instead of just the reimbursement of treatment,” says Frank.
If advocates of proton therapy for prostate cancer are correct, the benefits simply need time to illustrate themselves. In the meanwhile, research from the University of Florida Proton Therapy Institute, published in the International Journal of Radiation Oncology Biology Physics, found that 99 percent of patients treated for prostate cancer were experiencing “excellent” quality of life five years after treatment.
“These proton therapy results compare very favorably with IMRT results, particularly for intermediate risk-disease, where disease control rates of 70 percent to 85 percent are typical,” said Dr. Nancy P. Mendenhall, lead author and medical director of the UF Proton Therapy Institute, in a statement accompanying the study’s publication.
Demonstrating value to payors
As with computers and cell phones, the proliferation of proton therapy is expected to continue reducing its costs. If prostate treatment is still a point of some controversy, cost benefits for other tumor locations are coming increasingly into focus.
For treating head and neck cancer, new research out of MD Anderson outlines the economic value of reducing side effects. It found that when treating with proton therapy only 20 percent of patients required a feeding tube, versus 65 percent with IMRT. The direct cost of using a feeding tube for over a year was estimated to be $31,000 per patient, in 2001. Assuming the cost of those tubes has not changed since then, almost $1.4 million could be saved for every 100 head and neck cancer patients, from feeding tube expenses avoided with proton therapy.
For Frank, those kinds of statistics are essential to helping people realize the full potential of superior care. “As the novel approaches and technologies are proven to be safe and effective, competition in advanced technology such as proton therapy will generate a smaller footprint, become less expensive to manufacture and provide greater access to benefit the larger population,” he says.
Last year the American Society of Radiation Oncology (ASTRO) issued a model insurance policy to help insurance companies figure out which cancer diagnoses meet evidence-based standards for proton treatment and warrant coverage. For prostate, ASTRO supports insuring patients treated in clinical trials or within prospective registries, so their outcomes can help establish the body of evidence.
While Medicare covers proton therapy for most indications, it has sometimes been a battle with private insurers. “Over the last two years, several of the large commercial insurers have stopped covering prostate cancer because they feel they can get the same outcome in terms of ‘cure’ without having to pay as much,” says Rossi.
One example of this was when a patient in Texas with aggressive prostate cancer, complicated by insulin-dependent Type 2 diabetes, was refused coverage from Aetna despite doctor’s recommendations. The ordeal went to court and the insurance company was recently made to cover the treatment.
The patient’s lawyer, Robert C. Hilliard, issued a statement after the ruling. “This is not some unknown experimental treatment. It works. And my client should be given the opportunity to have the treatment to save his life.” That sentiment, echoed by the parents of Ashya King, perhaps best explains the rapid growth of proton therapy.