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As early as the 1950s, physicians in nuclear research facilities had been using particle accelerators to explore the practical application of protons against disease, but over the last decade the treatment has become a central — and sometimes polarizing— topic in the conversation about curing cancer. Using protons (instead of photons, such as X-rays) to eliminate tumors that have solid borders has proven to be a superior method for treating certain cancers. Proton therapy is preferable to standard radiation because it conforms to the shape and depth of a tumor to achieve optimal dose distribution and effectively spares nearby tissue and organs of residual toxicity, which may reduce susceptibility to side effects and post-treatment complications.
Although the price of proton beam technology has gone done in recent years, the cost continues to dwarf traditional radiation. Since the true value of proton therapy is still being defined, some experts fear the health industry is running headlong into a costly treatment option with too little clinical data to responsibly recommend it. Work is currently being done to assess benefits as they pertain to specific cancer sites and how those benefits compare with traditional radiation, but with so few proton therapy centers in existence that work takes time.
Currently, there are 14 proton therapy centers operating in the U.S. and 12 more in development. They are also emerging on a worldwide scale, with centers popping up in China, Europe, Japan, Russia, and Korea. With more facilities being built, more patients receiving the treatment, more companies investing in the technology, and more studies being published, proton therapy appears to be at a major tipping point. For insurance providers, this influx of interest paired with relatively few completed studies, presents a costly paradox.
Leonard Arzt, the executive director of the National Association for Proton Therapy, spoke to DOTmed HealthCare Business News about a few insurance providers, such as Aetna and Blue Shield of California, who have stopped covering the treatment. “It’s an evolving situation that is rapidly changing while ongoing clinical trials are being conducted providing more evidence of the value of proton therapy,” says Arzt. Patients should be fully informed of all treatment options and should have access to the mbest choice when it comes to their quality of life.”
Success with head and neck
At the MD Anderson Proton Therapy Center in Houston, Texas, patients have been receiving proton therapy since 2006. DOTmed spoke with their medical director, Dr. Steven J. Frank. “We’re seeing, before our eyes, a rapid evolution of the most advanced form of radiation therapy delivery,” says Frank. “It’s a very exciting time because we’re able to treat cancer with high curative intent and minimize patient side effects.” Frank was referring specifically to the latest advancement in proton therapy, a new form called Intensity Modulated Proton Therapy (IMPT) which has been used to successfully treat complicated head and neck tumors, and is believed to cause fewer side effects than cases where the alternative — Intensity Modulated Radiation Therapy (IMRT) — is used.
The American Cancer Society estimates that 36,000 people in the U.S. were diagnosed with cancer of the oral cavity and oropharynx last year, (representing a 20 percent increase since 2010). Those cancers primarily affected men in their 40s and 50s and were typically triggered by an infection with human papilloma virus or HPV. “The thing about HPV cancer in the head and neck, specifically the throat, is that it’s highly curable,” says Frank, who described the number of diagnoses as a national epidemic. “Being highly curable means that not only will they survive, but they will have to live with the side effects of the treatment for potentially 40 or 50 years.” With IMPT, Frank says the frequency of those side effects (such as loss of taste and inability to swallow) are being cut in half.
“IMPT uses small spots of radiation that are deposited in a pencil beam fashion. They are stacked in layers on top of the tumor where you can intensify the radiation and the treatment where the tumors are and minimize it where it’s not,” says Frank. With the alternative IMRT treatment, there is the problem of surplus radiation, like the exit dose that continues beyond the tumor and through healthy organs and tissue. Frank described his first IMPT patient as a 33-year-old woman who had a tumor growing around her brain stem. Traditional IMRT physicians refused to treat the tumor for fear the procedure would be fatal. With IMPT however, the cancer was completely eradicated and the patient experienced a full recovery.
Meeting consumer demands
Just as a cell phone once cost thousands of dollars, advocates for PBT anticipate costs will go down as the technology is implemented on a larger scale. Meanwhile, new modalities are expected to become more compact. DOTmed spoke to Joseph K. Jachinowski, chief executive officer of Mevion Medical Systems, about their smaller-scale, single gantry proton therapy system, the MEVION S250. “Mevion is the only manufacturer of single room proton therapy solutions,” says Jachinowski. “All the other single gantry solutions actually require a multi-room installation, and that leads to facilities that range from twice, to four times, as large as a Mevion facility.” Jachinowski believes the reduction in square footage alone translates to millions of dollars in construction cost savings in comparison to traditional centers.
Jachinowski also emphasized how easy the MEVION S250 is to operate, saying it is the only proton therapy system on the market today that does not require a dedicated team of engineers or physicists to operate it. “The therapist sets the patient up directly using built-in CT quality image guidance, they walk out of the room, and they press the ‘beam on’ button just like they would with a linear accelerator.” Jachinowski says the value of a single-room modality lies partially in the limited consequences of technical problems. “With conventional proton systems the accelerator, or parts of the complex beam transport system, will fail. When that happens you lose the entire facility at one time. Just as X-ray therapy machines don’t share an accelerator, we think proton therapy will inevitably go that way because of inherent benefits.
Another new proton therapy system from Ion Beam Applications (IBA) called ProteusONE is also being marketed as a small scale alternative in proton therapy. With a price tag of around $25 million, the ProteusONE costs roughly the same as the MEVION S250. In July, IBA announced it had received Marketing Authorization from the U.S. Food and Drug Administration for its Compact Gantry Beam Line, a regulatory green-light they believe will bolster international interest in the ProteusONE.
Today, small-scale systems like the MEVION S250 and IBAs ProteusONE make up only about 7 percent of proton therapy rooms. In the future, Chris Pericak, a consultant for Research and Insights at the Advisory Board Company, predicts that figure will grow to 30 percent. Pericak says, “We’ve seen that the cost of investing in protons is actually decreasing in some respects. Historically, you’d have to [spend] $200 million for a four-room center that takes up the size of a football field. Now, hospitals can buy a single-room system for about $30 million in their current space.”
“Compact proton machines have many cost saving advantages for medical centers seeking the latest radiation oncology tool and the capability to provide a mix of treatment options,” says Arzt, “but the larger multi-room centers, although more costly, provide substantially more access and treatment opportunities for cancer patients. There’s room for both in the proton therapy landscape.”
Jachinowski sees a future when proton therapy becomes implemented on a larger scale. “Maybe in 20 years protons will become a majority treatment, but I think within the next 10 years we will get to a point where, say, 15 percent of treatments are done with protons.” He also says that the MEVION S250 is the first and only proton therapy system to have been purchased by a private physician, a facility called First Coast Oncology in Jacksonville, Florida.
Market activity seems to indicate the health care industry is optimistic about the potential for proton therapy. Varian has been a leader in the industry with its ProBeam modality, which was recently installed at the Scripps Proton Center near San Diego as well as the King Fahad Medical Center in Saudi Arabia. Varian has also been selected to provide equipment for new proton therapy centers at the University of Maryland and in Mestre, Italy. Besides IBA, Mevion, and Varian, companies like Sumitomo, Mitsubishi, Hitachi, P-Cure, ProTom International, and Panacea, have all committed themselves to manufacturing their own modalities.
This September, at the 56th annual meeting of The American Society for Radiation Oncology (ASTRO), at least a dozen companies intend to showcase products and services they’re offering in relation to proton therapy. Among them are Logos Systems International, which has introduced a proton beam inspection system called XRV- 100, Architection; the oncology design and construction company responsible for building the proton beam at MedStar Georgetown University Hospital in Washington D.C., the imaging specialists at Anatom-e XRT Information Systems, an outsource manufacturer of proton beam equipment called .decimal, and others.
Waiting on results
At the 2014 NAPT annual conference, Dr. Bhadrasain Vikram, chief of the clinical radiation oncology branch at the National Cancer Institute, said eight randomized trials will soon be getting off the ground comparing the results of proton treatment versus photon treatment. The outcome of those trials, and others like them, will be vital in gauging the significance of proton therapy’s advantages as they pertain to various cancer sites.
The Affordable Care Act has played a role in shifting health care cost emphasis away from services rendered and towards patient outcomes. “[At MD Anderson] we just treated our 5,000th patient. We have generated 100 publications in our first eight years. More than any publications of any other center treating with proton therapy ever,” says Frank. “Our aim is to put out another 100 publications in the next four years.” As more studies are performed, more literature may define the value of proton therapy as it applies to different treatments and success ratios.
ASTRO recently issued a Policy Model for proton therapy which details the cancer diagnoses they believe should be covered by private insurers and Medicare. They emphasize cases where proton therapy has shown proven benefits, like pediatric cancers, as well as certain adult cancers such as ocular melanoma. In the interest of medical research they also encourage coverage for cancer sites where ongoing trials are being performed and benefits are suspected, such as the breast, prostate, and lung.
Reducing fatalities, improving patient post-treatment quality of life, and diminishing the frequency of side effects, are all breakthroughs that would justify the expense of proton therapy, and the continued advancements promoting affordability and accessibility. Defining those benefits is an intrinsic part of the scientific process, and an essential step in the responsible adoption of the treatment. With every completed study and every randomized trial, physicians and patients alike become better equipped to weigh the benefits of proton therapy against the cost.
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