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US system to rate health therapies (MS)

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By Lisa Wangsness
Globe Staff / March 2, 2009

WASHINGTON – "Harder on Cancer, easier on you," proclaims the banner on the University of Florida Proton Therapy Institute website, a pitch to men scouring the Internet for advice on prostate cancer. This type of radiation treatment targets tumors more precisely than X-rays, the site claims, reducing side effects.

But a study found that though proton beam therapy is at least five times as expensive as other forms of radiation, only a few small, brief studies have examined its effectiveness. There was no evidence that it was better at curing prostate cancer, and insufficient evidence that it was superior at preventing side effects.

With US healthcare spending on track to nearly double in the next 10 years to $4.4 trillion, the federal government is building a system to study the relative benefits of different treatments for diseases.

The economic stimulus package contains $1.1 billion for "comparative effectiveness research," a down payment on a project that could ultimately cost hundreds of billions of dollars. The legislation also creates a council in the Department of Health and Human Services to coordinate the work.

But how this research will be used is politically contentious – and is likely to grow more so as new studies are conducted, and policy makers and insurers decide whether care that is not deemed most effective should be covered by Medicare or private insurance. The program has become a talking point for Republican critics of the stimulus plan, who argue that it is a step toward rationing healthcare.

Cutting costs will probably be one of the major topics at a White House summit on healthcare that President Obama plans on Thursday.

Drug and medical device manufacturers, as well as some patient advocacy groups, say they support such research so doctors and patients can make better decisions about treatment. But they say the research should not determine whether procedures or drugs will be paid for by Medicare or private insurers. They lobbied vigorously – and successfully – to keep out language suggesting that it could be used to cut the cost of healthcare.

"Medicare denials of coverage could have a devastating effect in terms of one-size-fits-all determinations that could make it very, very difficult for patients to find alternatives," said Rick Smith, vice president of policy for the Pharmaceutical Research and Manufacturers of America.

Dennis Smith, a senior research fellow in health economics for the conservative Heritage Foundation, said restricting treatment options based on a government-run board’s interpretations of research could result in a kind of "cookbook medicine" that ignores individual differences that make medicine "an art as well as a science."

"Healthcare is full of stories of doctors trying to do something better for their patients because what they had wasn’t working," he said. "My concern is that comparative effectiveness, in the hands of government, starts stifling that kind of innovation."

But unless there are financial incentives to channel patients toward the most effective treatments, it is unlikely that the research alone will cut health costs significantly, Douglas W. Elmendorf, director of the Congressional Budget Office, testified last week before the Senate Finance Committee.

And proponents of comparative cost effectiveness, including health insurance companies and large businesses, say the United States cannot afford to ignore the potential for savings.

The nation already spends more on healthcare than every other industrialized country, and health expenses will account for one-fifth of the economy a decade from now, more than twice the proportion in 1980, according to government estimates.

Rising health costs make it harder for US businesses to compete globally, crowd out other government priorities, and consume workers’ wages. A number of other Western countries, including the United Kingdom, Germany, and Australia, have created comparative effectiveness panels.

Massachusetts General Hospital has developed a rating system for the clinical and cost effectiveness of various medical treatments.

Dr. Steven Pearson, president of the Institute for Clinical and Economic Review at the hospital, said the question "is whether we as a society are going to get serious about judging whether something that is a teeny bit better but vastly more expensive is a wise way to go."

The institute, which conducted the review of the scientific literature on proton beam therapy for prostate cancer, found little evidence favoring proton beam over other kinds of radiation, even though payers typically paid $50,000 to $80,000 for proton beam therapy, compared with $10,000 for the implantation of radioactive seeds, or $20,000 for radiation therapy using an X-ray technology.

"Our system is not set up to look at whether the evidence suggests that paying so much more for proton beam therapy makes sense for anybody," Pearson said. Instead, hospitals and clinics have the reverse incentive – to channel patients to the most expensive treatments, he said.

Karen Ignagni, president of America’s Health Insurance Plans, an association of health insurers, said one way insurers could take the results of the research into account may be to offer a tiered system that requires patients to pay more for treatments that are seen as less cost-effective.

The most cost-effective drugs may not work for everyone, though, said Joff Masukawa, senior director of government relations and public policy for Shire Ltd., which makes specialty biopharmaceuticals. Assigning a cost-effectiveness grade to a drug or therapy could eventually discourage drug companies from pursuing innovative drugs that treat rare diseases or help relatively few patients, he said.

Proponents of comparative effectiveness research acknowledge that studying the relative value of different therapies does not always yield straightforward answers.

Thomas Lee, network president of Partners Community HealthCare Inc. and an associate editor of the New England Journal of Medicine, points to a study in the journal’s current issue that compared the effectiveness of bypass surgery and angioplasty for patients with advanced coronary disease.

The researchers found that the rate of complications was lower for bypass surgery, but that was not the end of the story. Most of the complications with angioplasties were experienced by patients who had returned for repeat procedures; meanwhile, the rate of stroke for bypass patients is much higher.

"They answers you get may or may not be clean and simple," Lee said, "but at least you will get reliable answers to important questions – as good as we can get – and patients and insurance companies will be able to make better decisions."

The money included in the stimulus package for comparative effectiveness research may be just the beginning. Max Baucus, chairman of the Senate Finance Committee, filed legislation last year that would create a nonprofit corporation to oversee a vast research operation, underwritten by a small surcharge on private health insurance.

Baucus, who will play a leading role in the healthcare debate in the coming months, argued forcefully for robust research in a policy paper he issued late last year that was intended to lay the groundwork for a sweeping overhaul of the healthcare system this year.

Researchers are already preparing to apply for research grants funded by the stimulus money. Anthony Zietman, a radiation oncologist at Massachusetts General Hospital, is part of a team that wants to compare two or three different kinds of radiation therapies for prostate cancer, including proton beam. Such work, he said, is urgently needed.

"We’ve got to help patients sort their way through this morass of options," he said. "If these new technologies are better – prove it. If it’s worth the cost, we should pay the cost. If it’s not worth it, we should dispense with them or not cover them."

Lisa Wangsness can be reached at