More health systems are investing in proton therapy as the cost drops despite mixed evidence about its efficacy.
Proton therapy, which uses targeted forms of radiation to fight cancer while limiting exposure, is becoming less expensive, which is expected to fuel investment in the coming years. But many proton therapy centers are still struggling to attract enough patients or high enough reimbursement to justify the investment as science hasn't given protons a definitive edge over photons.
"As we get more facile with protons finding head and neck cancers, there's a lot of potential," said Dr. Peter Johnston, interim chair and clinical director of the radiation oncology department at the Moffitt Cancer Center, noting that more hospitals and cancer centers—including Moffitt—are exploring adding proton therapy centers as the equipment gets smaller and less expensive. "But there are always going to be marketing stunts, no matter what you do—every time you turn around there's new technology."
Proton therapy's ability to lessen the collateral damage of cancer treatment outweighs the significant capital expenses, proponents claim, citing fewer side effects and the significant benefit for pediatric patients compared to traditional radiation. Others point to the limited evidence proving proton therapy is more effective than traditional radiation, claiming that proton therapy is mainly a marketing ploy that will drive up healthcare costs.
Several proton therapy centers have filed for Chapter 11 bankruptcy protection as they've struggled to get enough patients. The latest was Provision CARES Proton Therapy Knoxville, which plans to sell nearly all of its assets for about $87 million, according to November bankruptcy filings in a Tennessee district court.
Covenant Health will pay more than $45 million for Provision's Knoxville-based proton therapy center. Provision Trust, a Tennessee-based not-for-profit foundation, will pay $26.5 million for a proton therapy center in Franklin, Tenn. and $15.5 million for a nearly completed center in Hamlin, Florida, which cost about $95 million to build.
Before the COVID-19 pandemic, the Knoxville center treated an average of 66 people per day and the other Tennessee facility treated about 43. Their max capacity is about 90 people a day.
Those volumes, coupled with lower-than-expected reimbursement rates, were not enough to sustain the centers, which defaulted on its bond issues and had been relying on credit, according to court filings.
"If you don't have the patient flow, one of the most difficult things is to live with the cost of a proton center," Johnson said, who works for Tampa, Florida-based Moffitt. "You will always have people who have more money than sense, that's why there's a cyclotron sitting 60 miles from here without patients."
Provision's centers use the most precise form of proton therapy called "pencil beam scanning," which uses a millimeters-wide beam to spare organs and tissue from radiation. Low doses of radiation enter the body via protons, match the tumor's shape and depth and deposit most of their energy into the mass.
Proton therapy, in general, costs an estimated $32 million per treatment room, according to court filings. There are around three dozen proton centers throughout the country.
"It's a marketing play more than an outcomes play, and it can be expensive," said Dr. Harry Greenspun, chief medical officer for the consultancy Navigant. "There is often a lot of hype and marketing appeal to these kinds of centers—people want the cutting-edge stuff. But some of these treatments got out ahead of their true capabilities."
Memorial Sloan Kettering Cancer Center, Mount Sinai Health System and Montefiore Health System launched New York Proton Center about two years ago. The $300 million facility in East Harlem has treated about 1,500 patients' cancers, including brain, head and neck, breast, lung, gastrointestinal, prostate and pediatric cancers.
It has reduced side effects and improved patients' quality of life, NYPC executives said.
"Most of the country doesn't know how incredible this technology can be," said Jonathan Weinbach, CEO of the New York Proton Center, adding that the coverage indications are expanding. "Some recently published article shows that almost every disease site has clear survival and side effect benefits."
Still, commercial insurers deny about 70% of the claims, he said.
"The long-term benefits of proton therapy will reduce costs," Weinbach said. "But insurance companies don't think about long-term costs. It's a shame—there's a missed opportunity."
Proton therapy was associated with a nearly two-thirds reduction in unplanned hospitalizations 90 days after treatment compared to traditional photon radiation treatment, according to a 2019 analysis of nearly 1,500 patients published in the Journal of the American Medical Association.
But survival rates were similar across both cohorts. While there were promising results regarding proton therapy reducing toxicity, the theory remains unproven, researchers said.
Given some of the study's limitations, "the evidence needed to truly justify the expenses of proton therapy … will need to come from phase 3 randomized clinical trials," wrote Dr. Henry Park and Dr. James Yu, radiation oncologists at the Yale School of Medicine, wrote in an accompanying editorial.
There are a small number of patients where proton therapy can have a greater benefit than radiation, said Dr. Jeffrey Balser, president and CEO of Vanderbilt University Medical Center.
"I'm still not bullish yet," he said, adding that more fail than succeed. "The number of clear indications for proton therapy is limited. That will change, though."
The University of Kansas Health System plans to open a proton therapy center early next year. It will be first in the state, as well as its surrounding states, including Iowa, Nebraska, Colorado and Arkansas. Mayo Clinic is planning a 110,000-square-foot, $200 million expansion to its proton therapy center in Rochester. McLaren Health Care is moving forward with a $46 million expansion of its proton therapy center in Flint, Michigan.
"There are things you can do with protons that you can't do with a linear accelerator," said Johnstone, noting skull base tumors and other targeted therapies, particularly for children. "Health systems will be interested because the technology is smaller and cheaper."
The number of projected cancer cases that will require radiation is, unfortunately, rising, said said Brant Phillips, a lawyer at Bass, Berry & Sims who has worked on a certificate of need for a proton therapy center.
"The million-dollar question is when commercial payers will be more flexible about when and how they reimburse this care and at what rate," he said. "As the number of centers continue to proliferate, particularly as the technology continues to allow for proton mini-beam therapy that requires far less capital expenditure, we'll see more evidence-based information that commercial insurers say they want to see to justify a wider range of coverage for proton therapy."
The next logical location for another facility in Tennessee if Memphis, Phillips said.
"Given the centrality of Memphis in the mid-South, that is the next obvious location for another facility," he said, noting that the St. Jude Children's Research Hospital proton center in Memphis is exclusively for the hospital and limited to pediatric cases. "I would expect regulators to be incredibly supportive of that type of resource in the Memphis area, especially if there was collaboration between providers."