Off-Label Drug Use, Advanced Technologies Driving Up Medicare Cost of Cancer Care

Neil Canavan

August 2011, Vol 2, No 5 - ASCO Annual Meeting

Neil Canavan

Chicago, IL—A series of studies presented at this year’s ASCO annual meeting suggest that the use of unwarranted high-cost imaging procedures, a surge in the use of innovative treatment technologies, and off-label use of supportive cancer agents are helping to escalate Medicare costs, leading researchers to suggest that further regulation may be needed to rein in unnecessary expenses.

The first study examined trends in the use of advanced imaging techniques in elderly patients with metastatic cancer. “Like all interventions in patients with metastatic solid tumors, imaging may contribute to palliation but is unlikely to lead to long-term survival,” said investigator Yue-Yung Hu, MD, a surgical research fellow at Brigham and Women’s Hospital, Boston, MA. “We wanted to determine pattern use, because costs have been rising so rapidly.”

Dr Hu and colleagues compared 2 retrospective data sets from Sur veil – lance, Epidemiology and End Results (SEER)-Medicare claims dating from 1999 to 2005. The first set accounted for the use of high-cost imaging procedures— such as computed tomography, magnetic resonance imaging, positron-emission tomography, and nuclear medicine—in elderly patients with metastatic disease (stage IV; N = 64,267); the second data set consisted of orders for imaging studies in patients with early-stage disease (N = 127,827).

Excess High-Cost Imaging in Late-Stage Disease

The results were striking: stage IV patients underwent a mean of 2.4 high-cost imaging procedures during their first 60-day diagnostic period compared with 0.8 procedures in patients with early-stage disease.

In addition, after the initial diagnosis, elderly patients were imaged on average once every 43 days, and 41% of the terminally ill patients underwent an imaging procedure in the last month of life (regardless of tumor type).

“We thought that the longer you’re expected to live, the more imaging would be done, but that was not the case,” said Dr Hu. “It’s hard to say exactly what all these scans were for. One of the things we’ll be looking at in the future is if there was some change in management that happens around the time of these scans that could justify the procedure—but really, in the last 30 days of life, what useful information could be new?”

Trends in Prostate Cancer Treatment

A second study looked at the escalating use of intensity-modulated radiation therapy (IMRT) for the treatment of prostate cancer compared with other, less costly standards of care. “In the last decade, a number of novel treatment options have been developed, including minimally invasive radical prostatectomy and IMRT,” said coinvestigator Michaela Dinan, Duke Clinical Research Institute, Durham, NC. Ms Dinan and colleagues were interested in the financial implications of the availability of these new technologies.

Based on Medicare records for patients with prostate cancer from 1999 to 2007 (N = 20,399), IMRT has replaced standard 3-dimensional conformal radiation therapy (3D-CRT) as the most common method of prostate radiotherapy, which was used in 66% of all Medicare patients with prostate cancer who were receiving radiotherapy.

“With Medicare reimbursement for IMRT averaging $48,000 per beneficiary versus $22,000 for 3D-CRT, this trend has significant budgetary implications,” stated Ms Dinan, especially given the aging of the US population and the inevitable increase in future prostate cancers.

Prescribers of Off-Label Use

A third study examined prescribing trends for the already well-known offlabel use of erythropoiesis-stimulating agents (ESAs), which are approved to treat debilitating anemia in chemotherapy patients. “These are drugs that are associated with significant costs to the overall healthcare system,” said Jason D. Wright, MD, Columbia University, New York. “And we already know that these are drugs that are often utilized in a way that’s different from what they were approved for by the FDA.”

Dr Wright and colleagues wondered if it was possible to identify the physician characteristics responsible for the varied patterns of ESA misuse.

In a retrospective analysis of prescribing patterns using a SEERMedicare data set dating back over the past 10 years, records of 21,091 patients with cancer were reviewed. Of these patients:

  • 5099 (24.2%) received ESAs for <1 week (misuse)
  • 1601 (7.6%) received ESAs for >14 weeks (prolonged use is often misuse)
  • 2876 (13.6%) patients received ESAs while not actively receiving chemo – therapy (off-label).

In a multivariable analysis, ESA misuse was associated with physicians with an MD degree and greater number of years since medical school graduation. Treatment by high-volume oncologists, private-practice physicians, and oncologists who graduated from US medical schools predicted prolonged duration of ESA use. ESA use should be limited to times of chemotherapy administration. Female oncologists were less likely to prescribe prolonged ESA use.

“This study further bolsters the argument that a lot of noncancer-related factors are driving how we prescribe ESAs,” said Dr Wright, although he is quick to point out that off-label use is not by definition irresponsible.

“Each patient is a unique individual. There are circumstances where use beyond the label is reasonable,” he said. The problem is not so much unreasonable use as it is increasingly untenable expense.