Will Proton Beam Therapy Overcome the Cost Conundrum?

Data on proton beam therapy shows increasing promise, but high equipment costs mean that provider adoption and payer coverage remain iffy.

The pace is closer to baby steps than the speed of light, but proton beam therapy (PBT) appears to be gaining ground as an alternative to more conventional photon-based radiation oncology treatments.

PBT facility operators are well aware, however, that adoption of the technology will continue to lag as long as equipment costs remain prohibitively high. The American Society for Radiation Oncology (ASTRO) has embraced PBT, but costs have placed a limit on the warmth of that clinch. Meanwhile, insurers such as Aetna say there are financial bounds for medical technology that should not be exceeded lightly.

Carl Rossi, MD, medical director of the Scripps Proton Therapy Center in San Diego, is confident that proton beam devices will eventually gain a significant share of the radiation oncology market.

Rossi says PBT has a fundamental physical edge over comparable photon-based radiation treatment with X-rays and gamma rays. "We have a beam that stops, and they don't," he told me last week after presenting data from the new pencil-beam PBT devices that Scripps fired up early last year. "We will always have a better beam."

Despite having physics on their side, he says PBT advocates have faced two daunting obstacles in their quest to match photon-based technology: astronomical equipment costs and the paucity of clinical studies on PBT in the United States. But the results achieved in the first 15 months of operating pencil-beam PBT devices at Scripps indicate those obstacles are eroding.

The facility that houses the pencil-beam PBT devices at Scripps is owned by San Diego, CA-based Advanced Particle Therapy, which spent about $220 million to develop the site. Even with that jaw-dropping price tag, Scripps has managed to achieve cost-competitiveness with photon-based treatments for some tumors, including early-stage breast cancer, Rossi told me.

"We can treat patients in two weeks compared to as many as seven weeks with other forms of radiation therapy. … We're able to treat them in a faster manner, with the same toxicology and the same side effects. It also cuts the costs of treatment dramatically."

Although Rossi declined to name names, he says two commercial payers have concluded that pencil-beam PBT at Scripps is delivering more cost-effective treatment for early-stage breast cancer than comparable photon-based radiation treatment. "Insurers have looked at this and said we are cheaper and contracted on that basis."

The cost of producing PBT equipment also is falling, he says, noting that several companies have entered the proton cyclotron construction market over the past decade.

"There has been an increase in proton beam therapy center construction world-wide," says Rossi, who worked earlier in his career at the country's first PBT facility, which the federal government built at Loma Linda (CA) University Medical Center. "Part of that construction boom is you can go out and get these things. You no longer have to go to a national lab to build a cyclotron."

Scripps has joined several other PBT facilities across the country to gather clinical data that will help determine the efficacy of treating tumors with proton radiation.

In conjunction with researchers at Oakland-based UC Health, Scripps is set to start a clinical trial for lung cancer treatment that will compare patients who receive proton-based radiation against patients who receive photon-based radiation. "It will answer these questions about how much better proton beam therapy is for patients," Rossi says.

In addition to participating in other clinical trials for specific types of tumors, Scripps has enrolled 150 of its pencil-beam PBT patients into a clinical data registry with other PBT facilities across the country. "We are doing this deliberately to see how much of a gain is realized from not treating normal tissue with radiation. In the long run, we know we need to get the data," Rossi says.

Cost remains a crucial challenge

As noted in last week's column, cost is king in the health plan world. "If the cost to the insurers of delivering proton beam therapy was the same as [photon-based therapy], these viability discussions would stop," Rossi says.

Sameer Keole, MD, the medical director of Mayo Clinic's PBT facility in Arizona, also serves as a board member of the society of radiation oncologists, ASTRO. He says ASTRO is aware of both the costs and benefits of PBT.

"The issue is the cost differential," Keole told me yesterday. "At ASTRO, we acknowledge this has higher costs, but it has tremendous potential for some classes of patients. In pediatrics, proton beam therapy is already emerging as the superior treatment. In adults, because there is a high cost and the benefits are not as clear, we have to prove the efficacy. But we are talking about an FDA-approved technology. ASTRO does not feel it is investigational or experimental. We do acknowledge, at this time, that it is more expensive."

With cost reigning supreme among payers, a chicken-and-egg conundrum is constraining PBT: Clinical trials are required to convince commercial payers to cover PBT treatment for a wide swath of tumors, but it is difficult to generate the patient volumes necessary to conduct clinical trials without PBT treatment coverage from payers.

"ASTRO doesn't take sides with vendors or different technologies. The only side we're on is the patient's. There is going to be a certain number of patients that are going to benefit. We want to see proton therapy get a fair shake," Keole says. "We can't get the data we need until we can conduct clinical trials, and to do that we need the help of everybody; from radiation oncologists, who actually do the work, to payers, who are needed to fund the work."

The PBT coverage policy at Aetna illustrates the challenge.

The Hartford, CT-based commercial payer offers coverage for PBT treatment of tumors that have been proven effective in clinical trials conducted in the United States. Aetna's list of tumors eligible for PBT coverage is limited to pediatric malignancies, chordomas or chondrosarcomas at the base of the skull or cervical spine, and uveal melanomas confined to the globe of the eye.

Particularly with the recent introduction of pencil-beam technology, PBT facilities are treating a far wider variety of tumors. At the Scripps pencil-beam PBT facility, Rossi told me, doctors have treated a dozen types of tumors such as cancer in breast, lung, and digestive system tissue.

Despite the potential of PBT, Andrew Baskin, MD,vice president and national medical director for quality performance at Aetna, says cost and effectiveness must be balanced.

"We want the right treatments to be available to members who need them," Baskin told me yesterday. "At the same time, we, like many others, are concerned about the nation's ability to sustain continued escalating costs of new therapies. Several studies have attempted to analyze the simple cost and cost-effectiveness of proton beam therapy, as noted in Aetna's clinical policy bulletin, but more studies are needed. The U.S. must address how the healthcare system can reward clinical innovation while also ensuring access to affordable treatments and services."