For Cancer Centers, Proton Therapy’s Promise Is Undercut by Lagging Demand


Many have. There are 27 proton therapy centers now operating in the United States. Nearly as many are being built or planned. Georgetown’s, which vies for patients with a struggling unit in Baltimore, will soon compete with another in Washington and one in Northern Virginia.

But about 30 years after the Food and Drug Administration first approved proton therapy for limited uses, doctors often hesitate to prescribe it and insurers often will not cover it.

That means there simply may not be enough business to go around.

“The biggest problem these guys have is extra capacity,” said Dr. Peter Johnstone, the chief executive at Indiana University’s proton center before it closed in 2014, in need of an upgrade but lacking the potential patients to pay for it. “They don’t have enough patients to fill the rooms.”

At Indiana, he added, “we began to see that simply having a proton center didn’t mean people would come.”

Proton therapy was initially used to treat tumors in delicate areas where surgery was not an option — near the eye, for example — and in children, and it remains the best choice in such cases.

But its pinpoint precision has not been shown to be more effective against breast, prostate and other common cancers. One recent study of lung-cancer patients found no significant difference in outcomes between people receiving proton therapy and those getting a focused kind of traditional radiation, which is much less expensive. Other studies are still underway.

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Jason Pappas, left, the Maryland Proton Treatment Center’s acting chief executive, and Dr. William Regine, the executive director. The center has not attracted the number of patients it expected, prompting a financial restructuring.

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Chiaki Kawajiri for Kaiser Health News

“Commercial insurers are just not reimbursing” for proton therapy except for pediatric cancers or tumors near sensitive organs, substantially limiting the potential treatment pool, said Brandon Henry, a medical device analyst for RBC Capital Markets.

Medicare covers proton therapy more readily than private insurers, but relying solely on Medicare patients does not allow backers of some treatment centers to recoup their investments, much less turn a profit, analysts said.

For a glimpse of what can go wrong, consider the Maryland Proton Treatment Center in Baltimore, which is affiliated with the University of Maryland Medical Center.

Opened two years ago with a “Survivor”-themed party and lofty financial goals, the unit is already undergoing a restructuring that is inflicting large losses on its outside investors, including wealthy families from Texas.

Before the Baltimore center opened, those behind it saw their market stretching from Philadelphia to Northern Virginia and encompassing 20,000 potential patients a year. Officials predicted the unit would treat “north” of its current rate of about 85 patients a day, said Jason Pappas, the acting chief executive.

How far north?

“Upper Canada,” said Mr. Pappas, declining to provide hard numbers. He said the center would break even by the end of the year.

The patient shortage might not be a good sign for projects in the pipeline, but it is encouraging for those who take a dim view of proton therapy’s rise.

“Something that gets you the same clinical outcomes at a higher price is called inefficient,” said Dr. Ezekiel Emanuel, a health policy professor at the University of Pennsylvania, which operates one proton center and is developing another. “If investors have tried to make money off the inefficiency, I don’t think we should be upset that they’re losing money on it.”

The proton therapy boom effectively began in 2001, when Massachusetts General Hospital in Boston opened a proton unit, raising the profile of what was a little-used technology. By 2009, developers were flocking to the field, lured by the belief that insurers would cover treatment bills that run to $48,000 and more.

The treatment held particular promise for prostate cancer patients, given the potential side effects, including incontinence and impotence, associated with traditional radiation.

But a 2013 Yale study found little difference in those conditions among patients getting proton therapy versus those getting traditional radiation. Within a year, several insurers stopped covering the therapy for prostate cancer or were reconsidering it.

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The New York Proton Center, which is being built in Manhattan by Memorial Sloan Kettering, Mount Sinai Health System and Montefiore Health System, is among the projects where hospitals are teaming up to make the finances work.

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Joshua Bright for The New York Times

Indiana University’s center was the first to close. Before long, others were in dire financial straits.

California Protons in San Diego, which was once associated with the Scripps Health hospital network, filed for bankruptcy protection last year. An abandoned proton project in Dallas is in bankruptcy as well.

In Virginia, the Hampton University Proton Therapy Institute has lost money for at least five straight years, financial statements show. In Knoxville, Tenn., the Provision CARES Proton Therapy Center lost $1.7 million last year on revenue of $23 million, $5 million short its target.

Centers in Somerset, N.J., and Oklahoma City run by privately held ProCure have defaulted on their debts, according to the investment firm Loop Capital. A center associated with Seattle Cancer Care Alliance, a hospital consortium, in Washington State lost $19 million in the 2015 fiscal year before restructuring its debt, documents show. A center near Chicago lost tens of millions of dollars before its own restructuring as part of a 2013 sale to hospitals now affiliated with Northwestern Medicine, according to regulatory documents.

Scott Warwick, executive director of the National Association for Proton Therapy, a trade group, blames “over-exuberant expectations” for the problems.

“I think maybe that’s what went on with some of the centers,” he said. “They thought the technology would grow faster than it has.”

The industry is using advertising and marketing to urge patients and lawmakers to press insurers to pay for proton therapy. Oklahoma recently passed a law requiring that insurers evaluate the treatment on an equal basis with other therapies. Virginia has considered similar legislation. At the National Proton Conference in Orlando last year, a full day was devoted to winning over insurers. The Alliance for Proton Therapy Access, another industry group, has software for generating letters to the editor demanding coverage.

Until the insurance outlook changes, those developing new proton centers have scaled back their ambitions. Georgetown’s unit, for example, cost $40 million and has a single treatment room. The one in Baltimore cost $200 million and has five.

Following the Georgetown model, with one or two treatment rooms, should allow centers in major metropolitan areas to make money, said Prakash Ramani, a senior vice president at Loop Capital, which is involved with projects in Alabama, Florida and elsewhere.

Not all the new units are small. In some cases, hospitals are joining forces to make the finances work. In New York, Memorial Sloan Kettering, Mount Sinai Health System and Montefiore Health System have teamed up on a $300 million unit with an 80-ton particle accelerator and four treatment rooms that is set to open in East Harlem next year.

Officials, counting on the New York area’s vast population and referrals from three major health systems, expect the center to treat 1,400 people a year. They will soon learn whether their project fares better than the Indiana proton center did.

“What places need now are patients,” Dr. Johnstone, that center’s former chief, said, “a huge supply of patients.”

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A Lifesaving Pump for Cancer Patients Is Being Phased Out


“They’ve increased survival more than anything else in this disease,” Dr. Kemeny said.

At least 10 operations to implant the pump at Sloan Kettering have been postponed, according to Dr. Michael D’Angelica, a liver surgeon at the hospital. Other medical centers have also advised patients with advanced cancer that the pump may no longer be an option.

At Northwestern University, Dr. Ryan P. Merkow said he had only one pump but many patients who needed it. “Now I have to decide who gets this potentially lifesaving therapy,” he said. One patient is about to become a father, and Dr. Merkow said, “I desperately want to help him.”

The devices, called Codman pumps, are made by Cerenovus, a subsidiary of Johnson & Johnson, which told doctors in a letter dated April 4 that it had decided to stop production effective April 1 “because of significant and multiple raw material supply constraints within the manufacturing process.”

Dr. Kemeny said she and other physicians had appealed to the company to keep making the device, but it had declined.

“It has likely saved many lives and prolonged the lives of many more,” Dr. D’Angelica wrote to the company. “I would implore you to reconsider this decision, if not just for economic or logistic reasons, for ethical reasons.”

Mindy Tinsley, a spokeswoman for Cerenovus, said demand was “very low,” with sales of about 300 pumps a year in the United States.

“Unfortunately, some of the suppliers that provide the materials, such as titanium rods required for production of these pumps, have elected to exit the business or have found that the required materials are no longer available,” she said. The company was still pursuing alternatives, she added, but declined to explain what they were.

Angela Stark, a spokeswoman for the Food and Drug Administration, said the agency could try to help, but did not have the authority to compel manufacturers to sell a specific product.

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Dr. Nancy E. Kemeny, in her office at Memorial Sloan Kettering in Manhattan. The hospital has been a leader in the pump’s use, and Dr. Kemeny has been recommending it since the 1980s.

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Jackie Molloy for The New York Times

Another company, Medtronic, makes a similar pump, but it is approved for use in the spine, not the liver. Dr. Kemeny said she hoped it could be used for her patients.

Medtronic issued a statement saying, “We acknowledge there is an important medical need for these patients, and physicians should use their best clinical judgment when evaluating the use of any commercially available pump outside of its labeling.”

One obstacle is that the Codman pump requires a catheter that the Medtronic pump lacks. It’s not clear whether replacement catheters could be obtained, or whether the Food and Drug Administration would allow the adaptation.

Patients at Memorial Sloan Kettering who received the Codman pump lived about two years longer than those who did not, Dr. Kemeny and her colleagues reported last year, in the Journal of Clinical Oncology. They looked at 2,368 consecutive patients with colorectal cancer who had surgery to remove tumors that had spread to the liver. They were treated from 1992 to 2012.

Those who received pumps (785) survived a median of 67 months, compared with 44 months for patients who did not get them (1,583). The result was especially striking, Dr. D’Angelica said, because patients who got pumps were sicker to begin with.

The report was not based on the strongest type of evidence, which would come from a controlled study with patients picked at random to receive one treatment or another. But the researchers said the evidence was the strongest that could be obtained without a randomized study.

Dr. Kemeny began recommending the pump in the 1980s, and Memorial Sloan Kettering has been a leader in its use. Other centers also used it, but many stopped in the mid-to-late 1990s, thinking that improved chemotherapy would make it unnecessary. But there were still patients who needed the pump. Now, just as the device is being phased out, medical interest in it has started to rebound.

Dr. Kemeny never gave it up. She said patients came to Sloan Kettering from all over the United States and from overseas for the treatment, referred by doctors or based on their own online searches for help.

Peter Beckerman, 69, a carpenter from Holbrook, N.Y., said that after surgery for colon cancer, his doctor told him his liver was covered with tumors and he had about 20 months to live. But the surgeon also urged him to consult Dr. Kemeny.

That was 10 years ago. Mr. Beckerman received the pump as part of a clinical trial. Gradually, over about a year, his tumors disappeared, and for the last eight years he has had no sign of cancer.

“The pump saved my life,” he said.

“There’s a whole lot of people out there in the same boat, doing good because of that pump,” he said. “I’m really disheartened that they would stop making it, if it saves one life.”

Another patient was 32 and learned just a few weeks after giving birth that she had colon cancer, and it had spread to her liver. She asked that her name be withheld because her child does not yet know she had cancer. Treatment with the pump shrank the liver tumors enough so that they could be surgically removed. Now, 10 years after the diagnosis, she has no evidence of cancer. She said she felt “extremely upset” to hear that the device that saved her life would no longer be manufactured.

“I want other people to have the same opportunity I had,” she said.

Recently, doctors from a dozen other hospitals in the United States and Europe, and the National Cancer Institute, have visited Memorial Sloan Kettering to learn how to use the pump, Dr. Kemeny said. But now, no one will be able to obtain it.

Dr. Myron E. Schwartz, a liver surgeon at Mount Sinai in New York, said: “There’s a group of patients where we can’t figure out what to do. This thing really does work.”

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