Radiation for prostate cancer lacks data -U.S. panel

Wed Apr 21, 2010 4:01pm EDT

* Medicare advisers say more trials, data needed

* Panel seeks patient registries, centralized trials

* CMS will weigh recommendation, payment not on table

By Susan Heavey

WASHINGTON, April 21 (Reuters) - There is not enough evidence to sort out the effect of various radiation treatments for prostate cancer patients, especially newer, so-called focused radiation, an advisory panel told the U.S. Medicare agency on Wednesday.

The Center for Medicare and Medicaid Services (CMS) panel of outside experts said large gaps in available data make it hard to weigh the impact particular radiation options may have on patients, including possible death or side effects. But it was divided over just how to collect much-needed information.

There is "insufficient evidence across the board," said panel chairman Clifford Goodman, a senior vice president at the Lewin Group.

CMS, which oversees the Medicare insurance program for 45 million elderly and disabled Americas, is taking a closer look at such treatments at a time of great debate over how to treat the cancer that affects roughly more than 2 million men in the United States. About 40 percent of Medicare patients are men.

While the agency has no immediate plans to change its reimbursement rates for such radiation, it will weigh the advice and could use it to later revisit its payment policies. Any changes could impact devicemakers such as Accuray Inc (ARAY.O), Siemens AG (SIEGn.DE), TomoTherapy TOMO.O, and Varian Medical Systems (VAR.N).

Surgery, radiation and simply "watchful waiting" are all possible courses of action. But researchers are increasingly concerned that excessive screening may be leading to overagressive treatment when studies show many prostate cancers grow so slowly that most men will die from other causes first.

CMS said reviewing all of the possible therapies would be too big a task for its advisers at one meeting.

In looking just at radiation therapy, the advisers lamented the fact that just a handful of studies have been done and that most don't follow patients long-term for at least five years. Radiologists that use the treatments told the panel more data is being done.

Panelists were split over whether strict, randomized controlled trials, patient registries and other types of informational gathering were most needed.

Many urged various medical groups to band together to compare all types of treatments, not just radiation, to each other -- also known as comparative effectiveness research.

"Given the paucity of evidence ... any evidence that can be gathered will be useful," said panel member Jeffrey Jarvik, a radiologist at the University of Washington.

How that evidence impacts the potential for future payments is a particular concern for newer radiation therapies, such as Accuray's CyberKnife, that are not paid for by Medicare in some U.S. states.

Several prostate cancer patients from Oklahoma and Texas, two states that don't cover it, called on the panel to back such treatments.

Marcel Salive, head of the CMS's division that oversees prostate cancer coverage, said the agency would weigh the panel's advice as it decides whether further action is needed.

But he added that the overall lack of data on radiation would likely cause "a real difficulty in drawing conclusions" and make it tough to make any nation-wide coverage decisions.

Accuray officials did not speak at the meeting but have said they are concerned CMS could later reject payment for use of its device in prostate cancer patients. (Reporting by Susan Heavey; editing by Carol Bishopric)

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