Moataz Karmalawy, vice president and general manager of Varian Medical Systems’ Particle Therapy Business, remembers when people weren’t sure what to do with proton beams. Back in 2007, “We talked about whether or not proton therapy had a place in the future,” he recalls. “At this point, I think that has been resolved.”

Clinical data accrues, candidacy qualifications improve, technology evolves, costs and size go down — that is the story so far for proton therapy. The innovative cancer treatment’s real-world medical value is becoming increasingly clear, and its stratospheric costs are slowly coming down to Earth. The exact number of proton facilities depends on the source for your data, but it’s not unreasonable to estimate that there are roughly as many centers under construction worldwide as there are in operation today. In the U.S. alone, The National Association for Proton Therapy (NAPT) website says there are 13 active facilities and an additional 10 under construction.

This rapid growth underscores that proton therapy’s relevance in cancer treatment is no longer “if” but “how soon?” When is the cost justified to an insurance company? When are the benefits vastly superior to those of radiation therapy? When will patients who need the treatment have access to it?

HealthCare Business News spoke with the top executives from three of the biggest and most innovative proton beam manufacturers, to get their insight on proton therapy’s gradual transition from exotic to everyday. And also to find out what this growth means for them, and what makes them stand out from their competitors.

Proton therapy on Main Street
There are two industries that inevitably invite analogies to health care equipment conversations — automobiles and cellular phones. Where proton therapy is concerned, the latter is most applicable. In a few short years, proton systems have become smaller, more powerful, and — although still upwards of tens of millions of dollars — significantly less expensive.

Joe Jachinowski, CEO of Mevion Medical Systems, knows well the benefits of creating affordable single-room proton therapy systems. His company manufactures the MEVION S250, a system which has already been demonstrating its value at the S. Lee Kling Proton Center at Barnes-Jewish Hospital in St. Louis, Missouri, for over a year.

“It’s been the fastest ramp-up of any proton center in the world, measured on a per-room basis,” says Jachinowski, who does not take that early clinical workflow for granted, “New technology can have a bumpy road and struggle in the first year or two of deployment, but we did not have that issue.”
Varian has also entered the compact market with a single-room version of their ProBeam system; a business move that Karmalawy says was made carefully. “One critical decision we made was not to compromise clinical efficacy of the patient treatment or therapist usability of the system,” he says.

“If you have the patient volume to utilize the cyclotron and support more than one room, then multi-room is the way to go,” says Karmalawy. “However,” he adds, “in most cases, if you look worldwide, the patient volume is smaller than most people expect.”

Access to proton therapy for ideal candidates is far from satisfactory, but a regional patient population may not necessitate a traditional multi-room center. Where traditional systems are massive construction jobs that may cost hundreds of millions of dollars, compact systems bring smaller-footprint benefits to facilities with fewer treatment demands.

Compact proton therapy centers have been a part of the IBA install-base since their ProteusONE was installed at the Willis- Knighton Cancer Center in Shreveport, Louisiana, in 2013. Currently, they have sold seven of those systems. They have also sold 25 of the multi-room counterpart, the ProteusPLUS, which Olivier Legrain, CEO of IBA, says makes them the industry leader in terms of sheer sales volume.

The multi-room industry is growing, but Legrain says that growth is modest in comparison to what they’re seeing with the single room systems. “From a tech standpoint, the beauty of the compact system is that you provide the same quality of treatment for smaller volume of patients; it’s just for serving a clinical workflow instead of academic,” says Legrain.

The smaller size also means faster construction. Which, coupled with a high degree of up-time for the system, can yield significant — although less visible — cost benefits.

Pencil beam
Having a cell phone implies certain uniquely modern capabilities; you can text-message on them, you can access email; but from a technical capability standpoint, there is a big difference between a budget cell phone and a premium smart phone. Similarly, according to Karmalawy, “Not all proton systems are created equally,” and he points to the breakthroughs in pencil-beam technology as evidence of this.

“We have had pencil-beam scanning, which is now the industry standard, since 2007,” he says. “Everybody else used scattering technology and many are now retrofitting their systems with pencil beam.”

Pencil-beam therapy, a way of delivering intensity modulated proton therapy (IMPT), has emerged as a faster alternative to scattering, but the benefits extend well beyond throughput. “If you think about beam-on time as 20 or 40 seconds with our system and compare it to several minutes per field with another, the patient would move and things would change even within a minute,” says Karmalawy. That movement can compromise the treatment’s dosimetry.

Not long after receiving FDA approval, ProBeam, Varian’s pencil-beam system, started treating patients at the new Scripps Proton Therapy Center in San Diego, California. The system is also being used at the Rinecker Proton Therapy Center in Munich, and at the Paul Scherrer Institute in Switzerland. Varian currently has contracts for system installations at seven other sites around the world.

IBA is also providing pencil-beam scanning, and Legrain says, “The benefits have unleashed the full power of proton therapy.” The ProteusONE systems they’ve sold in the last year all have pencil-beam capabilities.

For Mevion, a new beam delivery technology called HYPERSCAN was introduced at ASTRO in 2014, and is allowing pencil beam scanning delivery of IMPT treatments at a higher speed than was previously possible. The company credits the technique to the single-room construction of the system, which simplifies proton delivery by eliminating the need for a beam transport system.

Mevion is optimistic that studies will reveal HYPERSCAN as a desirable alternative to other forms of IMPT, particularly when treating tumors in areas where movement happens, like the chest or abdomen.

Pediatric patients to the front of the line
In recent years, certain centers have come under fire for treating indications that may not be of the highest priority. Prostate treatment, in particular, has been the source of some controversy and over-utilization may be driven by the revenue generating needs of the facility.

As long as proton centers are scarce and the cost of treatment is high, Karmalawy says it’s essential to focus on caring for the patients who can benefit the most from it. “From an ethical standpoint, you must not hesitate to treat pediatric patients,” says Legrain. “You should give it to them because of the reduction in side effects and the impact it has on the growing child and also the brain.”

As the clinical data accumulated, the last twelve months have seen a great step forward in terms of studies outlining and defining the top-priority indications for proton therapy. Over the summer, ASTRO released its Proton Beam Therapy Model Policy, which outlines appropriate use coverage guidelines.

Establishing protocols to define which cancers highly benefit from proton treatment, need more clinical evidence to recommend them, or yield little or no benefit over radiation alternatives, has been as much a part of the progress in the industry as the technology itself.

Jachinowski says that the advent of compact systems will allow facilities to treat a better distribution of indications as the need does not exist to fill multiple treatment rooms. The MEVION S250 at S. Lee Kling, for example, only treated 11 percent of its first-year patients for prostate cancer.

“Proton reimbursement is based on the aggregate of hospita-based costs, so proton reimbursement over time will gradually come down as more single room proton systems are deployed,” says Jachinowski.

Getting clinical
In September of 2014, the MD Anderson Cancer Center in Texas reported that treating advanced stage head and neck cancer with pencil-beam proton therapy can actually be less expensive overall than treating with intensity modulated radiation therapy (IMRT). The findings state that although proton treatment itself costs significantly more than conventional radiation therapy, the side-effects of radiation required extra spending, which ultimately made IMPT 20 percent less expensive.

For Legrain, 20 percent is the magic number, but for an entirely different reason; it’s the amount of cancer patients who should be receiving proton therapy instead of conventional radiation therapy. As it stands, only about 1 percent of those patients are getting access to the superior treatment, and improving those figures is a crucial element of IBA’s core objectives. “More and more, proton therapy is clinical. More publications are available and the quality is improving,” says Legrain, “This will only continue exponentially with more people making the decision to move toward proton.”

Varian manufactures linear accelerators for IMRT as well as proton beams, and recognizes the importance of both modalities. “We want to do the right things for our patients and for health care,” says Karmalawy, “We benefit from the right outcomes.”

Mevion is currently installing one of their systems at the Ackerman Cancer Center in Jacksonville, Florida. “It will be the first private physician-owned proton therapy center in the world,” says Jachinowski, “Which we think highlights how we’ve made protons more accessible from an economic, technical, and clinical deployment perspective than anyone else has done to date.”

“At the end of the day, we use protons not because they’re cheaper, but because it’s a better way to treat patients,” says Karmalawy. “Over the past 15 years there has been a lot of confusion in the industry, and we need equipment providers — all of us, Varian and our competitors — to make sure we target lower costs that retain clinical value.”

“In the future,” he says, “anything we see benefits in — whether it’s electronics or anything else — it always gets smaller and cheaper.”