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Prescribing Off-Label:
Cutting-Edge Awareness

The use of off-label anti-cancer therapies has increased since 2000.

The oncologists interviewed confirm that while they do look to drug summaries for reimbursement guidance, they rely heavily on peer-reviewed literature and other broader reference sources for clinical decision making.

The Covance study emphasizes that cancer treatment is in an exciting era, one in which rapidly-advancing technology can often improve the length and quality of life for patients. Sometimes the results come much too quickly for the drug summaries and other approved communication vehicles on which the insurance industry has based its coverage decisions. And while most oncologists are aware of cutting edge treatments almost immediately, some are hesitant to offer them because of the uncertainty of reimbursement. Says Dr. John Feldman of the Regional Cancer Center in Greensboro, North Carolina, “The question is not evidence-based medicine but what is acceptable evidence and who should be the judge of that information.” Feldman continues, “Reimbursement rules are unclear at best, and there are extremely long delays in payment even when claims are successful. Unfortunately, many oncologists, in the end, feel it is easier and less risky to avoid offering these new therapies than to jump through the many hoops required to recover money already spent on the drug in question.” Indeed, cites the study, there is a profound effect of the red tape hassle on the practice of oncology and on the newest treatments available to patients. 

One of the goals of the study was to determine if Medicare or private insurers were creating barriers to the use of off-label anti-cancer therapies. Forty-three percent of oncologists interviewed said their use of off-label anti-cancer therapies is increasing for reasons like more aggressive cancer treatment and narrower FDA labeling on approved drugs. However, 30 percent said their off-label use is decreasing. Of that audience, 33 percent cited reimbursement as an issue. Fifty-four percent of the oncologists interviewed said that Medicare coverage issues frequently or very frequently cause them to alter treatment decisions. Twenty-nine percent indicated that private policies have had this effect on them. Since 1991, a law has been in place requiring Medicare to cover off-label use of anti-cancer therapies if it is supported by drug compendia or peer-reviewed literature. So while the law is in place to help doctors and patients alike, more progress needs to be made on what is considered proper support documentation..

But wow. In a world of hurt, the last thing a cancer patient wants to know is that a decision about whether or not a treatment will be covered by insurance might take precedence over its efficacy. The Declaration of Geneva, which has for some medical schools replaced the Hippocratic Oath, states, “The health of my patient will be my first consideration.” First. Not last. Not sometimes. Patients invest a great deal of faith and trust in their oncologists and depend on them to make healing decisions that should have nothing to do with money. That oncologists are people too with businesses to run is a fact of life. That we patients humbly ask them to be more is part and parcel of their having chosen to be a healer. 

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