Clearing Hurdles

It would be both a terrible pun and a tremendous understatement to say that proton therapy is one of the hottest trends in the field of radiotherapy. It’s precise, adaptable and because it creates
minimal damage to the surrounding, healthy tissue, proton therapy is becoming a popular choice for dealing with everything from pediatric cancer to benign growths.

But, here’s the catch: You can’t just go down to the local hospital and get proton therapy treatments if you need them.

Only a handful of facilities in the United States are (or will soon be) equipped to offer proton therapy. To be exact, there are five facilities that are currently operational, and they appear as pinpoints on a map: Boston; Jacksonville, Fla.; Loma Linda, Calif.; Houston; and Bloomington, Ind.

Projects in the works could bring protons to a handful of other sites in the next decade or so, but the vast fields of asphalt in between means most families who are depending on this new treatment need a plane ticket and a place in line.

Even in this uncertain interim, Hadley Ford is decidedly optimistic about the future of proton therapy in the United States. By Ford’s calculations, the market for proton therapy could include as many as 250,000 Americans – and that’s his conservative estimate. As the CEO of the Bloomington, Ind.-based ProCure Treatment Centers Inc., he’s staking quite a bit on his hunch.

“There are three basic ways to treat cancer: cut it out, poison it out or use radiation to disrupt its DNA,” says Ford. “We’ve sort of narrowed it down over the last hundred years to get more and more radiation into the tumor and less into the healthy tissue. If you believe in radiation therapy, you almost have to be a proponent of proton therapy. It’s just radiation that accomplishes more of what you want to do.”

Overcoming Obstacles

ProCure’s senior management team has been involved in the development of five of the seven proton therapy centers completed or underway in the United States. If the treatment modality is to become ubiquitous, Ford says, “we are the ubiquitizers.”

By his reckoning, there are only five obstacles keeping proton therapy from becoming more widespread: technology, efficacy, insurance recognition, cost and project planning.

According to Ford, the first three hurdles have almost all but been cleared in the past decade. As scanning technology advances, proton therapy becomes more precise – or able to maneuver around healthy areas in the body while focusing accurately on disease sites.

Improved dose plans have improved the efficacy and feasibility of the treatment, meaning that patient slates can be more accurately calculated, and proton accelerators, which require tremendous amounts of energy to operate, are less frequently inactive, providing greater return on investment.

Widespread insurance recognition, mainly driven by government authorization of proton therapy as a viable medical treatment, has inspired confidence in capital investors, healthcare institutions and private insurers that the modality will be around for some time to come.

Addressing the remaining two obstacles – cost and project planning – has given ProCure its niche in the emerging market of “ubiquitizing” proton therapy, like the captains of industry at the turn of the 20th century who integrated the U.S. steel, coal and railroad industries, ProCure discovered that the best way to bypass these hurdles was via a business model that aligns the company with providers and communities as an interested party to the process.

“We’re good at protons,” says Ford. “Our doctor partners are good at radiation. The hospitals we partner with are leaders in patient care. I like to work with people who are good with what they do and partner with them.”

If You Build It…

Proton therapy treatment centers are tremendously expensive to construct, operate and maintain. To gain some leverage, ProCure standardized its facility model on a building with a smaller footprint, and devised an innovative robotic couch that revolves the patient around an inclined stationary beam, thus, cutting back on the need for multiple gantries in a given facility.

With these cost-cutting measures alone, the ProCure model scales down the traditional capital investment required to construct a proton therapy center by as much as 30 percent or 40 percent, Ford says.

“These projects are complex. The levels of detail and planning are endless,” he says. “If you have to write an RFP [request for proposal] to do a technical selection, that can take you a year or more. Then, you have to evaluate it. It’s not something everyone has the time, manpower or expertise to undertake. If you’re a community hospital, you don’t have the people on staff to put this thing together.”

By Ford’s reckoning, the proton therapy center in development at the Philadelphia-based University of Pennsylvania has been a 10-year project. The Jacksonville-based University of Florida Proton Therapy Institute took seven years. When six doctors from Oklahoma City contacted ProCure about building a private proton therapy center, however, Ford says, “it took 18 months before we were putting a shovel in the ground.”

So how does ProCure put shovels to ground so quickly? The answer: by assuming an equal share of the risk.

“We put our own equity into the project,” says Ford. “We become the majority owner of the center, and we only get paid if the center makes money.”

“We have all the technical innovations done and all the specifications done,” he continues. “We’ve got a team that understands all the issues around installation and commissioning. We know where all the games get played. We have close working relationships with suppliers and banks that we have taken the time and energy to educate on proton therapy, and we have a proven financial structure that allows us to get financing.”

Moving Toward the Mainstream

Niek Schreuder is ProCure’s senior vice president of medical physics and technology. Originally from South Africa, he hails from a medical culture where innovation was often stymied by a lack of government funding and an absence of private investment.

“In Cape Town, we thought, this is just such an expensive modality; it will remain in the hands of the elite,” Schreuder says. “Jean-Pierre Blaser, director of the Paul Scherrer Institute (PSI) in Switzerland, challenged us. He believed it could be mainstream. A year or two later, I came to the United States, where proton therapy could be financially viable without government aid. Now, we are at the brink of achieving that.”

Schreuder describes ProCure as “a combination of excellent technology and the people who know how to get this thing working financially.” When there was no money to build the gantry center in Cape Town, he was forced to investigate cheaper alternatives.

In concert with Ford’s financial models, some of his ideas – such as the inclined beam with the robotic couch that rotates the patient around the beam instead of the gantry around the patient – provided the seed of what ProCure hopes will become a nationwide network of proton therapy treatment centers.

“We can do two things to make sure we survive,” says Schreuder. “We can drive the initial costs down or we can increase efficiency to meet with lower reimbursement rates. The bottom line for us is that we are trying to bring new stimulus to the industry and bring proton therapy to the mainstream.”

One way to help accelerate that process, Schreuder says, is by standardizing the ProCure technology model. Two proton therapy equipment manufacturing companies – IBA and Accel Instruments – agreed to work with ProCure centers to integrate their approach to standardized delivery.

The parts they deliver will be identical in every proton therapy center ProCure builds, which is a significant benchmark for the industry. To date, Schreuder says, no two of the five existing proton therapy centers in the United States are identical. 

The second way to encourage more widespread adoption of proton therapy, according to Schreuder, is to synchronize proton research with that done in parallel sciences, like X-rays and particle physics.

“We want to incorporate the existing approaches into our mindset to make what we do less expensive,” Schreuder says. “We want to make sure that when someone has solved image-guidance modalities in the X-ray field, we can incorporate the therapies into our processes. We want the proton therapy to work with the same techniques that are used in the X-ray field. If 90 percent of the process is exactly the same, then we ought to be able to use 90 percent of the technology for the proton therapy.”

Schreuder continues, “The proton community should be based on widespread adoption and implementation, rather than on competition. What we now need to solve is to do it right and to show that it works, because a lot of people still don’t believe that proton therapy is ready for mainstream adoption. If we keep on inventing the wheel, then we will remain experimental. The clinical results are well-established, and now we need to start treating more people.”

If Schreuder and Ford get their wish, ProCure will be well-established when the market is ready to embrace proton therapy more fully. While staking its claim to the equity needed to build the centers, ProCure is also working to protect its investment by training the workers who will staff them. Its virtual laboratory in Bloomington, Ind., which also doubles as a 24/7 technical support call center, provides another logistical component to the integrated business model.

“Because we’re building a network of centers, that means we made the investment to do before-the-job training,” says Ford. “We can simulate any kind of issue or concern so that when you open up your center, you don’t have to spend a year getting up to speed.”

The Missing Pieces

Even for all this forethought, Ford admits there are some components to his business model that have not yet been realized, and other obstructions that keep proton therapy from becoming more widespread.

One such challenge is the question of housing and transportation. Until a proton therapy network can be rolled out nationwide, many of the quarter-million patients Ford hopes to reach will still need to be flown into areas where they can receive weeks – or sometimes months – of treatment. It’s a situation with which he is personally familiar.

“My stepfather died of cancer a few years ago,” says Ford. “He and my mother traveled to M. D. Anderson, [the proton therapy center in Houston], and stayed in a Marriot Suites for six months. That’s a big [inconvenience]. Ideally, you’d like to have a residence closeby to the treatment center and you’d like to have some kind of 24/7 medical care. Part two is, ‘who’s going to pay for that?’ A lot of insurance companies don’t.”

Ford says that some hoteliers have approached ProCure to help develop an independent greenspace facility alongside the Oklahoma project. It’s something he’s considering, along with other links in care like nursing and shuttle services.

A future model might absorb some of these costs, he posits, by establishing a philanthropic arm, á la Ronald McDonald House, that would help families manage and meet travel and lodging bills during the time of treatment.

Another significant concern for Ford and ProCure is a question any innovative medical company faces these days: how to stay afloat in the explosively costly American private insurance system.

“Stability encourages innovation,” Ford says. “If the playing field’s always changing, you don’t know where to plant your feet. You’ve got to be ready to respond every year, and that involves huge unknown costs. Bigger margins are built into things to absorb price shock better, and then everything’s inflated.”

“We should be able to sit down with the government, or Medicare, or a private insurer, and deliver better long-term costs,” he says. “I can even guarantee you better short-term costs if you can give me visibility as to what my revenues will be. Then, you can manage your own costs much more effectively.”

To Schreuder, the larger question is how to assure that the treatment does not come to be so dominant that it cannibalizes existing modalities.

“We need to make sure that we’re not being seen as a replacement therapy,” says Schreuder. “We want to be seen as a supplement to the existing treatments. We don’t want to tell people to shut down their X-ray machines; we want to give people a tool to treat the
percentage of their patients that will better benefit from proton therapy.”

One of the emerging applications in which Schreuder sees proton therapy expanding is the field of re-treatment. Cancer patients who have received volume doses of radiation from previous X-ray treatments are better candidates for proton therapy than for traditional X-ray chemotherapy because the treatment is less damaging to the surrounding organs.

“We have a great opportunity to give those patients a second chance,” says Schreuder. “There are certainly tumors that radiotherapy just can’t cure be-cause it can’t treat the patient to a clinical dose. You might cure the cancer, but you get a lot of side effects. With protons, we can treat beyond that threshold.”

The other area in which proton therapy could prove viable, says Schreuder, is in treating non-malignant growths and target areas that, were they to be bombarded with X-rays, could create a future malignancy. As opposed to that from X-ray therapy, the comparatively low integral dose distributed by proton therapy would make it a principal treatment modality in these kinds of situations. It’s a question that may only be addressed with broader adoption of proton therapy at a greater number of treatment centers, he says.

“People are saying that proton therapy is such a scarce resource that shouldn’t be used for this limited benefit; but, it could be if the centers were more widely available,” says Schreuder.


— Matthew N. Skoufalos is a freelance writer based in N.J. Questions and comments can be directed to editorial@rt-image.com.