When Harold Kobliner was diagnosed with aggressive prostate cancer in 1996, he was determined to do whatever it took to beat the disease. The Long Island resident received radiation treatment at Memorial Sloan-Kettering Cancer Center in Manhattan and went into remission. But a year later, the cancer spread to his bones -- typically a death sentence. The medication that saved his life, according to Kobliner and his oncologist, Dr. Howard I. Scher, was Taxol, a chemotherapy approved for use against ovarian and breast cancer. "When your life is at stake, you want to have the most cutting-edge treatment," says Kobliner, now 74 and still cancer-free.
In the cancer world, cutting edge commonly means unapproved. Most cancer drugs win marketing approval for only one type or stage of the disease, but they are often effective against other tumors. Consequently, oncologists frequently experiment with so-called off-label treatments -- using drugs that were approved for another type of cancer. Such prescriptions are legal and so common that a 1997 survey of oncologists by the American Cancer Society found that 60% prescribed drugs off-label.
In an ill-conceived cost-containment maneuver, U.S. health authorities are considering slapping constraints on this treatment strategy, which has not only saved patients but also greatly expanded doctors' understanding of how cancer drugs work. The Centers for Medicare & Medicaid Services (CMMS) is mulling a policy change that would allow it to end automatic reimbursements for off-label uses of four expensive cancer drugs. If the change goes through, it will set a precedent that could be applied to a broad range of cancer drugs. "Many, many patients would be seriously harmed," warns Sloan-Kettering's Scher.
To be fair, Medicare is struggling with the need to ration its dollars in an era of runaway health-care inflation, and some novel cancer drugs carry sky-high price tags. Two of the drugs under review, Zevalin from Biogen Idec (BIIB ) and Bexxar from Corixa (CRXA ) and GlaxoSmithKline (GSK ), are radically new treatments for advanced non-Hodgkin's lymphoma, a disease that strikes about 53,000 Americans each year. Each costs more than $22,000 for a one-time dose. The other two, Pfizer Inc.'s (PFE ) Camptosar and Eloxatin from Sanofi-Synthélabo (SNY ), are both for advanced colon cancer -- of which there are 106,000 new cases every year. Each of these drugs costs about $3,000 for a course of treatment.
Historically, Medicare allowed reimbursement for most off-label uses of all drugs under its purview, says Dr. Sean R. Tunis, chief medical officer at CMMS. "That practice wasn't a problem when drugs cost $100 to $150 per patient, but it's another thing when they are $3,000 to $4,000 per patient," he says.
Yet oncologists argue that their ability to practice good medicine would be severely hampered if they were restricted to approved uses. There are a number of studies, for example, showing that both Camptosar and Eloxatin can be effective against some of the deadliest forms of lung cancer. If the proposed Medicare changes went through, doctors could still appeal to Medicare for reimbursement, but that process could take months -- time that few lung cancer patients can spare.
Right now, the CMMS says it's willing to consider alternatives. To continue its review, the agency delayed a decision on reimbursement changes that was due at the end of January. Oncologists argue that Medicare should change the framework for the debate. "A disease that happens to be expensive should not be singled out for cost-containment measures for that reason only," says Deborah Y. Kamin, senior director for cancer policy at the American Society of Clinical Oncology.
Cancer is not the reason health-care spending is out of control. Broader use of generic drugs, an emphasis on disease prevention, reducing obesity and smoking, and coverage of the uninsured would all result in greater savings than a decree that cancer victims can't have life-saving medicines only because they cost a lot.
By Catherine Arnst